Board Change • Jul 01
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Non-Executive Director Xue Lei was the last director to join the board, commencing their role in 2026. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. New Risk • Jun 11
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Hong Kong stocks, typically moving 12% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (12% average weekly change). Shareholders have been diluted in the past year (15% increase in shares outstanding). Significant insider selling over the past 3 months (HK$440k sold). New Risk • Mar 24
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Hong Kong stocks, typically moving 10% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m. Minor Risks Share price has been volatile over the past 3 months (10% average weekly change). Shareholders have been diluted in the past year (27% increase in shares outstanding). Ankündigung • Mar 24
SinoMab BioScience Limited, Annual General Meeting, Jun 12, 2026 SinoMab BioScience Limited, Annual General Meeting, Jun 12, 2026. Ankündigung • Mar 10
SinoMab BioScience Limited to Report Fiscal Year 2025 Results on Mar 23, 2026 SinoMab BioScience Limited announced that they will report fiscal year 2025 results on Mar 23, 2026 Ankündigung • Aug 18
SinoMab BioScience Limited to Report First Half, 2025 Results on Aug 29, 2025 SinoMab BioScience Limited announced that they will report first half, 2025 results on Aug 29, 2025 New Risk • Aug 16
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 25% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (23% average weekly change). Revenue is less than US$1m (CN¥2.0m revenue, or US$282k). Minor Risk Shareholders have been diluted in the past year (25% increase in shares outstanding). Ankündigung • Jul 23
SinoMab BioScience Limited has filed a Follow-on Equity Offering in the amount of HKD 369.606972 million. SinoMab BioScience Limited has filed a Follow-on Equity Offering in the amount of HKD 369.606972 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 182,072,400
Price\Range: HKD 2.03
Transaction Features: Subsequent Direct Listing Ankündigung • Jun 30
SinoMab BioScience Limited Announces Board and Committee Appointments, with Effect from 30 June 2025 SinoMab BioScience Limited announced that Ms. Chi Sau Giselle LEE and Mr. Nan SHEN have been appointed as independent non-executive Directors and members of each of the audit committee and nomination committee of the Company with effect from 30 June 2025. Ms. Chi Sau Giselle LEE, aged 54, has over 25 years of experience in asset management and financial services, with a distinguished career spanning roles in global financial institutions and advisory capacities. Ms. Lee currently serves as an independent director and advisor in several institutions, including PeRK Advisory as an associate advisor, Asia Frontier Capital as an independent director and Habitat for Humanity as a fundraising committee member, offering guidance and strategic oversight on financial services, business development and governance. Ms. Lee is also the founder of GLOHS, an organic skincare and health brand in Hong Kong. Before founding her own brand, she held senior positions at top-tier investment firms, including Barings Asset Management as a managing director and head of Asia from 2013 to 2016, Man Group as an executive director and head of sales, North Asia, from 2004 to 2012, and Deutsche Asset Management as a director and the head of office from 1998 to 2003. Ms. Lee obtained a Master of Science degree in Industrial Relations and Personnel Management from the London School of Economics and an Honours Bachelor of Arts degree in Economics from the University of Manchester. Mr. Nan SHEN, aged 44, has over 20 years of experience in corporate finance, and venture investment. Mr. Shen has served as a managing director at Sedgwick Yard, a venture capital firm specializing in early-stage investments in novel biotechnologies stemming from prestigious academic institutions globally, since September 2018. Based in Beijing and London, he oversees the firm's strategic direction and investment activities. Prior to joining Sedgwick Yard, Mr. Shen worked in the investment banking divisions of several leading financial institutions, including Goldman Sachs and UBS, and primarily focused on financing and M&A transactions across the Greater China region and Asia- Pacific. Mr. Shen holds a Bachelor of Arts (Honours) degree and a Master of Arts (Honours) degree in Economics from University of Cambridge, and a Master of Sciences (Honours) degree in Experimental & Translational Therapeutics from University of Oxford. Mr. Shen is licensed by the U.S. SEC (Series 7) and the Hong Kong Securities and Futures Commission (SFC). Upon the appointments of Ms. Lee and Mr. Shen as members of the Nomination Committee, the Company has re-complied with Rule 3.27A of the Listing Rules in respect of the requirement regarding establishing a nomination committee comprising a majority of independent non-executive directors. Ankündigung • Jun 09
Sinomab Bioscience Limited Announces Passing Away of Dylan Carlo Tinker an Independent Non-Executive Director SinoMab BioScience Limited regrets to announce that Mr. Dylan Carlo TINKER (``Mr. Tinker''), an independent non-executive director (``INED''), a member of the audit committee, and a member of the nomination committee (the ``Nomination Committee'') of the Company, passed away on 29 May 2025. The Board expresses its grave sorrow on the passing away of Mr. Tinker and extends its deepest condolences to his family. The Board also expresses its sincere gratitude to Mr. Tinker for all his invaluable contributions to the Company in the past. Following the passing away of Mr. Tinker, the Nomination Committee comprises two members, one of which is an executive director. The Company does not meet the requirement under Rule 3.27A of the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited (the ``Listing Rules'') that the Nomination Committee must comprise a majority of independent non-executive directors. To comply with the requirements of the Listing Rules, the Company will identify a suitable candidate to fill the position of a member of the Nomination Committee following the passing away of Mr. Tinker as soon as practicable and in any event within three months from 29 May 2025, and will make further announcement(s) as and when appropriate. notice of annual general meeting (the ``AGM Notice'') of the Company, both dated 25 April 2025 and the related form of proxy (the ``Proxy Form'') in relation to the annual general meeting of the Company to be held on Friday, 13 June 2025 (the ``AGM''). Due to the passing away of Mr. Tinker, the ordinary resolution numbered 2(d) in respect of the re-election of Mr. Tinker as an INED of the Company as set out in the AGM Notice and the Proxy Form, respectively, is no longer applicable and will not be put forward for consideration and approval by the shareholders of the Company (the ``Shareholders'') at the AGM. New Risk • May 30
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Hong Kong stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risk Revenue is less than US$1m (CN¥2.0m revenue, or US$282k). Minor Risk Share price has been volatile over the past 3 months (11% average weekly change). Ankündigung • May 14
SinoMab BioScience Limited has filed a Follow-on Equity Offering in the amount of HKD 124.091899 million. SinoMab BioScience Limited has filed a Follow-on Equity Offering in the amount of HKD 124.091899 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 112,810,817
Price\Range: HKD 1.1
Transaction Features: Subsequent Direct Listing Ankündigung • Apr 08
SinoMab BioScience Limited Announces Positive Topline Results of Its Phase 1B Clinical Trial of SM17 in China for the Treatment of Moderate-To-Severe Atopic Dermatitis The board of directors of SinoMab BioScience Limited announced the positive topline results of its Phase 1b clinical trial of SM17 in China for the treatment of moderate-to-severe Atopic Dermatitis (''AD') with differentiating efficacies, especially on antipruritus effect. The Phase 1b trial is a multi-centered, randomized, double-blinded, placebo-controlled study, aiming to study safety, tolerability and pharmacokinetics (PK) profiles of SM17, as well as to explore the preliminary efficacy of SM17 in moderate-to-severe AD patients. A total of 32 moderate-to- severe AD patients were enrolled in this Phase 1b study, and randomized as 3:3:2 to receive doses of either high dose of SM17 (600mg), low dose of SM17 (200mg) or placebo in a 12-week treatment period followed by a 4-week maintenance/follow-up period. Pruritus: PP-NRS (peak pruritus numeric rating scale, PP-NRS). Skin healing: EASI (eczema area and severity index), BSA (body surface area), SCORAD (SCORing Atopic Dermatitis), vIGA-AD (validated Investigator's Global Assessment for Atopic Dermatitis). AD patients' quality of life: DLQI (Dermatology Life Quality Index), POEM (Patient Oriented Eczema Measure) Immunogenicity, pharmacokinetics (PK) and pharmacodynamics (PD) profiles of SM17 in AD patients were also evaluated in this study. Study Results. Phase 1b POC data for SM17 treating patients with moderate-to-severe AD, achieving: However, there is still an unmet medical need for patients showing irresponsiveness to those approved therapies. The Company performed a first-in-human Phase 1 clinical trial (NCT05332834) in the US to evaluate the safety and tolerability of SM17 in healthy subjects. Clinical report obtained in the first quarter of 2024 revealed a good safety profile of SM17 with no drug-related serious adverse event reported. In May 2024, a Phase 1a bridging study was also completed in China and demonstrated that SM17 to have good tolerability and safety profile and comparable PK profile as in Caucasian population. Study results of SM17 were published in various leading international journals. Preclinical work of SM17, demonstrating the therapeutic efficacy of SM17 is comparable to, and in some parameters even outperform than, that of JAK1 inhibitor in treating animals with AD, were published in Allergy, an official journal of the European Academy of Allergy and Clinical Immunology (EAACI), on 9 April 2024. Pre-clinical models and Phase 1 clinical study of SM17 on healthy participants, showing SM17's outstanding profile in terms of safety, tolerability, and pharmacokinetic in healthy participants, were also published in Frontiers in Immunology, on 9 December 2024. The Company believes that therapies targeting upstream of the Company is targeting upstream of the Company's JAK1 inhibitor in treating animal with AD, and in some parameters, and in some parameters even performform than, that of Jak1 inhibitor in treating animals withAD, were published in Allergy. Reported Earnings • Apr 02
Full year 2024 earnings released: CN¥0.17 loss per share (vs CN¥0.24 loss in FY 2023) Full year 2024 results: CN¥0.17 loss per share (improved from CN¥0.24 loss in FY 2023). Net loss: CN¥185.1m (loss narrowed 24% from FY 2023). Over the last 3 years on average, earnings per share has increased by 19% per year but the company’s share price has fallen by 18% per year, which means it is significantly lagging earnings. Ankündigung • Mar 31
SinoMab BioScience Limited, Annual General Meeting, Jun 13, 2025 SinoMab BioScience Limited, Annual General Meeting, Jun 13, 2025. Ankündigung • Mar 19
SinoMab BioScience Limited to Report Fiscal Year 2024 Results on Mar 31, 2025 SinoMab BioScience Limited announced that they will report fiscal year 2024 results on Mar 31, 2025 Reported Earnings • Oct 01
First half 2024 earnings released: CN¥0.085 loss per share (vs CN¥0.13 loss in 1H 2023) First half 2024 results: CN¥0.085 loss per share (improved from CN¥0.13 loss in 1H 2023). Net loss: CN¥90.6m (loss narrowed 32% from 1H 2023). Over the last 3 years on average, earnings per share has increased by 3% per year but the company’s share price has fallen by 22% per year, which means it is significantly lagging earnings. Ankündigung • Sep 27
Sinomab Bioscience Limited Announces Resignation of Dr. Wenyi LIU as Non-Executive Director SinoMab BioScience Limited announced that Dr. Wenyi LIU has tendered her resignation as a non-executive Director with effect from 26 September 2024 in order to devote more time to personal affairs. Dr. Liu confirmed that she has no disagreement with the Board and there is no matter relating to her resignation that needs to be bought to the attention of the shareholders of the Company and The Stock Exchange of Hong Kong Limited. Reported Earnings • Aug 24
First half 2024 earnings released: CN¥0.085 loss per share (vs CN¥0.13 loss in 1H 2023) First half 2024 results: CN¥0.085 loss per share (improved from CN¥0.13 loss in 1H 2023). Net loss: CN¥90.6m (loss narrowed 32% from 1H 2023). Over the last 3 years on average, earnings per share has increased by 3% per year but the company’s share price has fallen by 27% per year, which means it is significantly lagging earnings. Ankündigung • Aug 06
SinoMab BioScience Limited to Report First Half, 2024 Results on Aug 19, 2024 SinoMab BioScience Limited announced that they will report first half, 2024 results on Aug 19, 2024 Ankündigung • Jun 13
SinoMab BioScience Limited Announces First Patient Dosed in A Phase 1b Clinical Trial of SM17 in China SinoMab BioScience Limited announced that, on 5 June 2024, the first patient has been successfully dosed in a phase 1b clinical trial of SM17 for the treatment of Atopic Dermatitis (AD) in China. As of the date of this announcement, no adverse event was observed. The phase 1b trial aims to study safety, tolerability and pharmacokinetics (PK) profiles of SM17, as well as to explore the preliminary efficacy of SM17 in AD patients. SM17 is a novel, First-in-Class (FIC), humanized, IgG4-kmonoclonal antibody which is capable of modulating Type II allergic reaction by targeting the receptor of a critical 'alarmin' molecule interleukin 25 (IL-25). SM17 could suppress Type 2 helper T (Th2) immune responses by binding to IL-25 receptor (also known as IL-17RB) on Type 2 Innate Lymphoid cells (ILC2s) and Th2 cells, to block a cascade of responses induced by IL-25 and suppress the release of the downstream Th2 cytokines such as IL-4, IL-5 and IL-13. IL-25 is a critical cytokine classified as 'alarmin'', which has shown to be implicated in the pathogenesis of autoimmune and inflammatory skin diseases, such as AD. Patients with AD also have an increasing all-cause mortality rate and disease-specific mortality rate in the following diseases, which include infections, respiratory diseases, gastrointestinal diseases and oncologic diseases. Current approved therapies for AD, including biologics, can significantly improve eczema area and severity index and patient's quality of life. However, there is still an unmet medical need for patients showing irresponsiveness to those approved therapies. The Company performed a first-in-human Phase I clinical trial (NCT05332834) in the US to evaluate the safety and tolerability of SM17 in healthy subjects. Clinical report obtained in the first quarter of 2024 revealed a good safety profile of SM17 with no drug-related serious adverse event reported. To allow for clinical studies in China, a phase 1a bridging study was also initiated in China that demonstrated SM17 to exhibit similar and comparable safety profile in both the US and the Chinese population. To validate the results of preclinical studies published in an international scientific journal Allergy that demonstrated SM17 to be as effective as JAK1 inhibitor in treating AD in mice, it is therefore important that a phase 1b corroborative and proof-of-concept study is performed. The Company believes that therapies targeting upstream of the Th2 inflammatory cytokine pathway, such as IL-25 receptor, will have broad effects on skin inflammation, implicating a great potential for SM17 as a differentiating, safer and more effective products for the treatment of AD. Ankündigung • Mar 26
SinoMab BioScience Limited, Annual General Meeting, Jun 14, 2024 SinoMab BioScience Limited, Annual General Meeting, Jun 14, 2024. Agenda: To consider to approve the proposed amendment; to consider to approve the refreshment of the Scheme Mandate Limit and the Service Provider Sublimit; to consider the Stock Exchange grating the listing of, and permission to deal in, such number of Shares, representing 10% of the issued Shares; and to transact such other business related issues. Reported Earnings • Mar 26
Full year 2023 earnings released: CN¥0.24 loss per share (vs CN¥0.29 loss in FY 2022) Full year 2023 results: CN¥0.24 loss per share (improved from CN¥0.29 loss in FY 2022). Net loss: CN¥243.1m (loss narrowed 14% from FY 2022). Over the last 3 years on average, earnings per share has fallen by 17% per year but the company’s share price has fallen by 29% per year, which means it is performing significantly worse than earnings. Ankündigung • Mar 14
SinoMab BioScience Limited to Report Fiscal Year 2023 Results on Mar 25, 2024 SinoMab BioScience Limited announced that they will report fiscal year 2023 results on Mar 25, 2024 Ankündigung • Nov 29
SinoMab Bioscience Limited Announces First Cohort of the Health Subsidiaries Dosed in A Phase I Clinical Trial of SM17 in China The board of directors of SinoMab BioScience Limited announced that, on 25 November 2023, the first cohort of healthy subjects has been successfully dosed in a phase I clinical trial of SM17 in China. As of the date of this announcement, no adverse event was observed. The phase I trial aims to establish safety, pharmacokinetics (PK) and immunogenicity profiles of SM17 in Chinese population, as well as to test the preliminary safety, efficacy and pharmacodynamic characteristic of SM17 in Atopic Dermatitis (AD) patients. SM17 is a novel, First-in-Class (FIC), humanized, IgG4-k monoclonal antibody which is capable of modulating Type II allergic reaction by targeting the receptor of a critical ''alarmin'' molecule interleukin 25 (IL-25). SM17 could suppress Type 2 helper T (Th2) immune responses by binding to IL-25 receptor (also known as IL-17RB) on Type 2 Innate Lymphoid cells (ILC2s) and Th2 cells, to block a cascade of responses induced by IL-25 and suppress the release of the downstream Th2 cytokines such as IL-4, IL-5 and IL-13. IL-25 is a critical cytokine classified as 'alarmin'', which has shown to be implicated in the pathogenesis of autoimmune and inflammatory skin diseases, such as AD. Patients with AD also have an increasing all-cause mortality rate and disease-specific mortality rate in the following diseases, which include infections, respiratory diseases, gastrointestinal diseases and oncologic diseases. Current approved therapies for AD, including biologics, can significantly improve eczema area and severity index and patient's quality of life. However, there is still an unmet medical need for patients showing irresponsiveness to those approved therapies. A Phase I study for SM17 conducted in the US is near completion, with Last Subject Last Visit (LPLV) completed in September 2023, and the clinical study report is expected to be released by the first quarter of 2024. Ankündigung • Nov 17
Sinomab Bioscience Limited Announces IND Application for SM03 (Suciraslimab) for the Treatment of Alzheimer's Disease Accepted by NMPA CDE SinoMab BioScience Limited announced that on 14 November 2023, an Investigational New Drug application (IND), for Mild Cognitive Impairment (MCI) or Mild Dementia due to Alzheimer's Disease (AD) for Suciraslimab has been filed with and accepted by the Center for Drug Evaluation (theCDE) of the National Medical Products Administration of China (the 'NMPA'). The Company plans to initiate the Phase I clinical study in China upon approval of the present IND. The present IND submission, once granted, will enable the Company to conduct comprehensive clinical development program in China which leads to indication for treatment of early phase symptomatic AD, including MCI or Mild Dementia Due to AD. Suciraslimab is the Company's self-developed product and is a first-in-class anti-CD22 monoclonal antibody for the treatment of rheumatoid arthritis (RA''), and potentially other diseases such as systemic lupus erythematosus (SLE), non-Hodgkin's lymphoma (NHL), Sjogren's syndrome (SS) as well as Alzheimer's Disease (AD). It adopts a novel mechanism of action, which differentiates itself from the current treatments available in the market. Currently, there are relatively high worsening rates existing between mild cognitive impairment and mild dementia, as well as mild dementia and moderate to severe dementia due to Alzheimer's Disease, thus, the key therapeutic strategy for the disease is to delay the disease progression, and prevent the situation of mild dementia from turning into moderate to severe dementia. Suciraslimab are also developed in accordance with this strategy in Alzheimer's Disease. Suciraslimab, upon binding to CD22, promotes the clearance of b-amyloid and simultaneously suppresses neuroinflammation, offering a therapeutic advantage over other approved products which clear b-amyloid at the expense of neuroinflammation. With this unique mechanism of action, Suciraslimab could potentially reduce the risk of serious adverse reactions commonly associated with anti-b-amyloid treatments such as amyloid-related imaging abnormalities-Edema (ARIA-E) and Amyloid-related imaging anomalies-hemorrhage (ARIA-H). A biologics license application for Suciraslimab in the treatment of RA was accepted by the NMPA in September 2023 and is currently under technical review. A Phase III extension study on RA is also ongoing in China. Ankündigung • Sep 07
Sinomab Bioscience Limited announces Change of Non-Executive Directors The board of directors of SinoMab BioScience Limited announces that with effect from 6 September 2023: (1) Ms. Jie LIU (``Ms. Liu'') has resigned as a non-executive Director due to her other business commitments; and (2) Dr. Jianmin ZHANG (``Dr. Zhang'') has been appointed as a non-executive Director. Ms. Liu confirmed that she has no disagreement with the Board and there is no matter relating to her resignation that needs to be brought to the attention of the shareholders of the Company and The Stock Exchange of Hong Kong Limited (the ``Stock Exchange''). The Board would like to express its gratitude to Ms. Liu for her valuable contribution to the Group during her tenure of service. Jianmin ZHANG, aged 46, is currently the chief scientific officer and head of institute of innovative medicine of Hainan Haiyao Co. Ltd. (). From November 2019 to April 2023, Dr. Zhang served as a director of Medicinal Chemistry at Shanghai Jiyu Medical Technology Limited* (). Prior to that, he served as a leader of medical research and development of innovative drug division at ApoPharma Inc. from September 2012 to August 2019 and served as a medical research and development scientist at Tranzyme Pharma Inc. (now known as Ocera Therapeutics Inc.) from May 2011 to September 2012. Dr. Zhang obtained a master's degree in Polymer Chemistry and Physics from Wuhan University in 2002. In 2007, Dr. Zhang earned his Ph.D. in Chemistry from The University of Alberta and did his postdoctoral training in the University of British Columbia from November 2007 to March 2011. Save as disclosed above, as at the date of this announcement, Dr. Zhang (i) is not interested in any shares of the Company within the meaning of Part XV of the Securities and Futures Ordinance (Chapter 571 of the Laws of Hong Kong); (ii) is independent from and has no relationship with any Directors, senior management, substantial shareholders or controlling shareholders of the Company; (iii) has not held any other major appointments or qualifications or positions with the Company or other members of the Group; and (iv) has not held any directorship in any other listed public companies in the past three years. The Company will enter into a letter of appointment with Dr. Zhang. The initial length of services will commence from the date of appointment for a term of three years, subject tore-election and retirement as required by the articles of association of the Company. Dr. Zhang will not receive any remuneration from the Company for being a non-executive Director. New Risk • Aug 22
New minor risk - Financial position The company has less than a year of cash runway based on its current free cash flow. Free cash flow: -CN¥332m This is considered a minor risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 12% per year over the past 5 years. Revenue is less than US$1m (CN¥5.4m revenue, or US$741k). Minor Risks Less than 1 year of cash runway based on current free cash flow (-CN¥332m). Shareholders have been diluted in the past year (2.9% increase in shares outstanding). Ankündigung • Aug 09
SinoMab BioScience Limited to Report First Half, 2023 Results on Aug 21, 2023 SinoMab BioScience Limited announced that they will report first half, 2023 results on Aug 21, 2023 Ankündigung • Jun 13
Sinomab Bioscience Limited Announces IND Application for SM17 Accepted by NMPA CDE The board of directors of SinoMab BioScience Limited announce that on 9 June 2023, an Investigational New Drug application ("IND'', for atopic dermatitis ("AD'') for SM17 has been filed with and accepted by the Center for Drug Evaluation (the "CDE'') of the National Medical Products Administration of China (the "NMPA''). The Company plans to initiate a Phase I clinical study in China upon approval of the present IND. The presentIND submission, once granted, will enable the Company to conduct comprehensive clinical development program in China which leads to indication for treatment of AD. SM17 is a humanized, IgG4-k monoclonal antibody targeting IL-17RB. SM17 could suppress Th2 immune responses by binding to IL-17RB on Type 2 Innate Lymphoid cells (ILC2s) and Type 2 helper T (Th2) cells, blocking a cascade of responses induced by interleukin-25 (IL-25). IL-25 is a critical cytokine classified as "alarmin'', which has shown to be implicated in the pathogenesis of autoimmune and inflammatory skin diseases, such as AD. Patients with AD also have an increasing all-cause mortality rate and disease-specific mortality rate in the following diseases, which includes infections, respiratory diseases, gastrointestinal diseases and oncologic diseases. Current approved therapies for AD, including biologics, can significantly improve eczema area and severity index and patient's quality of life. However, there is still an unmet medical need for patients showing irresponsiveness to those approved therapies. Ankündigung • May 23
SinoMab BioScience Limited Announces Filing and Acceptance of Investigational New Drug Application for SM17 by the Center for Drug Evaluation of the National Medical Products Administration of China The board of directors of SinoMab BioScience Limited announced that on 19 May 2023, an Investigational New Drug application (IND'', for asthma) for SM17 has been filed with and accepted by the Center for Drug Evaluation (theCDE) of the National Medical Products Administration of China (the NMPA). Upon approval of the present IND, the Company plans to initiate a Phase I clinical study in China to bridge between Chinese (Asian) and American (CAsian/Black) populations, as well as to investigate the safety profile of SM17 in Chinese population. The present IND submission, once granted, will enable the Company to conduct comprehensive clinical development program in China which leads to indication for treatment of asthma. SM17 is a humanized, IgG4-k monoclonal antibody targeting IL-17RB. SM17 could suppress Th2 immune responses by binding to IL-17RB on Type 2 Innate Lymphoid cells (ILC2s), blocking a cascade of responses induced by interleukin-25 (IL-25). IL-25 is a critical cytokine classified as 'alarmin'', which has shown to be implicated in the pathogenesis of airway viral responses and allergic disease, such as asthma. Patients with severe, uncontrolled asthma are at a risk of recurrent asthma exacerbations and hospitalizations, and uncontrolled severe asthma is associated with increased mortality/morbidity, diminished quality of life and increased health expenditures. Current approved therapies for severe asthma, including biologics, can reduce asthma annual exacerbations to a certain extent. However, there is still an unmet medical need for additional effective therapies, particularly for patients who do not respond to current treatments. The company expects that targeting upstream mediators of the Th2 inflammatory cascade, such as IL-17RB, will have a broad effect on airway inflammation. Ankündigung • Nov 18
SinoMab BioScience Limited Announces Executive Changes SinoMab BioScience Limited announces that Ms. WONG Pui Yin Peony has tendered her resignation as the company secretary of the Company with effect from 17 November 2022. The Board further announces that Ms. CHAN Sze Ting (``Ms. Chan'') has been appointed to replace Ms. Wong as the company secretary of the Company with effect from 17 November 2022. Ms. Chan is an associate director of the corporate services division of Tricor Services Limited, which is a global professional services supplier specializing in integrated business, corporate and investor services. Ms. Chan has over 16 years of experience in the corporate secretarial field and has been providing professional corporate services to Hong Kong listed companies as well as multinational, private and offshore companies. Ms. Chan is a Chartered Secretary (CS), a Chartered Governance Professional (CGP) and an Associate of both The Hong Kong Chartered Governance Institute (HKCGI) and The Chartered Governance Institute (CGI) in the United Kingdom. Ms. Chan holds a bachelor of arts from Hong Kong Polytechnic University and a bachelor's degree in law from the University of London, Britain. Board Change • Nov 16
Less than half of directors are independent There are 5 new directors who have joined the board in the last 3 years. Of these new board members, 2 were independent directors. The company's board is composed of: 4 independent directors. 6 non-independent directors. Independent Non-Executive Director Chi Ming Lee was the last independent director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of board continuity. Ankündigung • Sep 07
Sinomab Bioscience Limited Announces Enrollment in Phase I First-In-Human (FIH) Clinical Trial SinoMab BioScience Limited announced that, as of 31 August 2022, 22 subjects have been enrolled in the Phase I First-In-Human (FIH) clinical trial in the U.S. The subjects are currently in normal condition. The phase I study is a Single Ascending Dose (SAD) and Multiple Ascending Doses (MAD) to investigate the safety, tolerability, and pharmacokinetics of SM17 in healthy subjects. The Investigational New Drug (``IND'') application, for the treatment of patients with asthma, was approved by the U.S. Food and Drug Administration in March 2022. With respect to the clinical progress of other products of the Group, the Company has recently achieved considerable progress. The Board is confident in the future development of the Company and confirmed that the Group's business operation remains normal. For the Company's product SM03 (Suciraslimab), the preliminary result for primary endpoint of Phase III study at week 24 is expected in the third quarter of 2022 and the readout of the final study result for both safety and efficacy at week 52 is expected in the first quarter of 2023. The Company plans to submit the New Drug Application to the National Medical Products Administration (the ``NMPA'') of the People's Republic of China in the first half of 2023 and expects to commercialise Suciraslimab in the second half of 2023 at the earliest. Ankündigung • Aug 24
Sinomab Bioscience Limited Announces IND Approval for SN1011 by National Medical Products Administration of China The Board of directors of the SinoMab BioScience Limited announced that August 22, 2022, an Investigational New Drug application for SN1011 was approved by National Medical Products. Administration of China (the ``NMPA''). The IND approval would enable the Company to initiate the Phase II/III clinical study to evaluate the efficacy and safety of SN1011 in patients with NMOSD in China. The planned first patient enrollment is in the first quarter of2023. SN1011 is the Company's third generation, covalent reversible BTK inhibitor designed to exhibit high selectivity with prolonged but controlled drug exposure to achieve superior efficacy and good safety profile for the long-term treatment of systemic lupus erythematous, pemphigus, multiple sclerosis, and other rheumatology or neuro-immunological diseases. SN1011 differentiates from existing BTK inhibitors currently available in the market, such as Ibrutinib, in terms of mechanism of action, affinity, selectivity and safety. SN1011 had obtained four IND approvals (for systemic lupus erythematosus (SLE), pemphigus, multiple sclerosis (MS) and NMOSD) from the NMPA. Ankündigung • Jun 16
SinoMab BioScience Limited Announces First Healthy Subject Dosed in A Phase I Clinical Trial of SM17 in the U.S The board of directors of SinoMab BioScience Limited announced that the first healthy subject has been successfully dosed in a Phase I FIH (First-in-Human) clinical trial of SM17 in the U.S. on 14 June 2022. The phase I study is a Single Ascending Dose (SAD) and Multiple Ascending Doses (MAD) to investigate the safety, tolerability, and pharmacokinetics of SM17 in healthy subjects. SM17 is a humanized, IgG4-k monoclonal antibody targeting IL-17RB. SM17 could suppress Th2 immune responses by binding to IL-17RB on Type 2 Innate Lymphoid cells (ILC2s), blocking a cascade of responses induced by interleukin-25 (IL-25). IL-25 is a critical cytokine classified as "alarmin", which has shown to be implicated in the pathogenesis of airway viral responses and allergic disease, such as asthma. Patients with severe, uncontrolled asthma are at a risk of recurrent asthma exacerbations and hospitalizations, and uncontrolled severe asthma is associated with increased mortality/morbidity, diminished quality of life and increased health expenditures. Current approved therapies for severe asthma, including biologics, can reduce asthma annual exacerbations to a certain extent. However, there is still an unmet medical need for additional effective therapies, particularly for patients who do not respond to current treatments. Ankündigung • Jun 14
SinoMab BioScience Limited Announces Retirement of Mr. Senlin LIU as Non-Executive Director The Board of SinoMab BioScience Limited announced that Mr. Senlin LIU, a non-executive Director, retired from office by rotation and did not offer himself for re-election at the 2022 AGM for the purpose of devoting more time to his personal business engagement. Mr. Liu retired as a non-executive Director of the Company with effect from the conclusion of the 2022 AGM. Board Change • Apr 27
Less than half of directors are independent There are 7 new directors who have joined the board in the last 3 years. Of these new board members, 4 were independent directors. The company's board is composed of: 4 independent directors. 7 non-independent directors. Independent Non-executive Director Chi Ming Lee was the last independent director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of board continuity. Ankündigung • Apr 21
Sinomab Bioscience Limited Announces an Investigational New Drug Application for SN1011 SinoMab BioScience Limited announced that on 19 April 2022, an Investigational New Drug application for SN1011 was approved by the National Medical Products Administration of China. The IND approval would enable the Company to initiate the Phase II clinical study to evaluate the efficacy and safety of SN1011 in patients with multiple sclerosis in China. The planned first patient enrollment is in the fourth quarter of 2022. SN1011 is the Company's third generation, covalent reversible BTK inhibitor designed for higher selectivity, superior efficacy and improved safety for the long-term treatment of systemic lupus erythematous, pemphigus vulgaris, multiple sclerosis, rheumatoid arthritis, and other immunological diseases. SN1011 differentiates from existing BTK inhibitors currently available in the market, such as Ibrutinib, in terms of mechanism of action, affinity, selectivity and safety. Ankündigung • Mar 23
SinoMab BioScience Limited, Annual General Meeting, Jun 13, 2022 SinoMab BioScience Limited, Annual General Meeting, Jun 13, 2022. Ankündigung • Feb 17
SinoMab BioScience Limited Provides an Update in Relation to Group's Key Products, SM17 SinoMab BioScience Limited announced that the Board announced that on 11 February 2022, an Investigational New Drug application, for patients with asthma for Company's First-in-Class therapeutic product SM17) has been submitted and accepted by the Division of Pulmonology, Allergy, and Critical Care, Office of Immunology and Inflammation, Center for Drug Evaluation and Research, U.S. Food and Drug Administration. The Company plans to initiate the First-In-Human study in the U.S. in first quarter of 2022, once IND is approved by FDA. SM17 is a humanized, IgG4-monoclonal antibody targeting IL-17RB, which is a type-I single transmembrane glycoprotein belonging to IL-17 receptor family. The binding of SM17 to IL-17RB could suppress Th2 immune responses induced by a category of cytokines called ``alarmin'', which has shown to be implicated in the pathogenesis of allergic disease and airway viral responses. Patients with severe, uncontrolled asthma are at a risk ofrecurrent asthma exacerbations and hospitalizations, and uncontrolled severe asthma is associated with increased mortality/morbidity, diminished quality of life and increased health expenditures. Current approved therapies for severe asthma, including biologics, can reduce asthma annual exacerbation rates to a certain extent. However, there is still an unmet medical need for additional effective therapies, particularly for patients who do not respond to current treatments. Alternative approach targeting upstream mediators of the Th2 inflammatory cascade, such as ``alarmins'', is expected to have a broader effect on airway inflammation and to provide more effective asthma control than currently available therapies, and products with similar mechanism of action as SM17 have been approved by FDA. Ankündigung • Feb 08
SinoMab BioScience Limited Files Investigational New Drug Application SN1011 The board of directors of SinoMab BioScience Limited announced that on 21 January 2022, an Investigational New Drug application (‘IND', for multiple sclerosis) for SN1011 has been filed with and accepted, on 28 January 2022, by the Center for Drug Evaluation (‘CDE’') of the National Medical Products Administration of China (the ‘NMPA'). The Company plans to initiate the Phase II clinical study in China upon approval of the present IND. The present IND submission, once granted, will enable the Company to conduct comprehensive clinical development program in China which leads to indication for treatment of multiple sclerosis. SN1011 is the Company's third generation, covalent reversible BTK inhibitor designed for higher selectivity, superior efficacy and improved safety for the long-term treatment of systemic lupus erythematous, pemphigus vulgaris, multiple sclerosis, rheumatoid arthritis, and other immunological diseases. SN1011 differentiates from existing BTK inhibitors currently available in the market, such as Ibrutinib, in terms of mechanism of action, affinity, selectivity and safety. Ankündigung • Dec 01
SinoMab BioScience Limited Announces SM03 Completion of Enrollment in Phase III Clinical Trial in China The board of the SinoMab BioScience Limited announced that, on 30 November 2021, SM03 (Suciraslimab) Phase III clinical trial for rheumatoid arthritis (RA) has completed its targeted enrollment of 510 patients. The patients currently in screening will be randomized by end of December 2021, given eligibility criteria are met. The Phase III clinical trial is a multi-center, randomized, double-blind, placebo-controlled, parallel group study to confirm the clinical efficacy and long-term safety in active RA patients receiving methotrexate (MTX). The efficacy and safety of Suciraslimab was previously evaluated in a phase II clinical study in moderate-to-severely active RA patients. The study results were published recently and shown that Suciraslimab at a dose of 600 mg with 4 and 6 infusions respectively, were both efficacious and well-tolerated throughout the 24 weeks of treatment when compared with the placebo group. Suciraslimab was effective in suppressing disease activity and alleviates symptoms of moderate-to-severely active RA patients receiving stable doses of background MTX. The Company ' s flagship product, SM03 (Suciraslimab), a potential global first-in-target anti-CD22 monoclonal antibody for the treatment of RA and potentially for the treatment of other immunological diseases, is currently in Phase III clinical trials in China. Cautionary Statement required by Rule 18A.05 of the Rules of Governing the Listing of Securities on the Stock Exchange: The Company cannot guarantee that it will be able to ultimately develop and market SM03 (Suciraslimab) successfully. Shareholders of the company and potential investors are advised to exercise caution when dealing in the shares of the company. Ankündigung • Mar 11
SinoMab BioScience Limited to Report Fiscal Year 2020 Results on Mar 22, 2021 SinoMab BioScience Limited announced that they will report fiscal year 2020 results on Mar 22, 2021 Is New 90 Day High Low • Jan 21
New 90-day high: HK$4.70 The company is up 47% from its price of HK$3.19 on 23 October 2020. The Hong Kong market is up 20% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 36% over the same period. Ankündigung • Jan 16
Sinomab Bioscience Limited Announces First Healthy Subject Dosed in A Phase I Clinical Trial of SN1011 in China The board of directors of SinoMab BioScience Limited announced that the first healthy subject has been successfully dosed in a Phase I clinical trial of SN1011, an innovative third generation Bruton's tyrosine kinase ("BTK") inhibitor, in Shanghai, China. The Phase I clinical trial of SN1011 conducted in China is to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics and recommended Phase II dose of SN1011 in treatment for autoimmune diseases. SN1011 is the Company's third generation, covalent reversible BTK inhibitor designed for higher selectivity and superior efficacy for the long-term treatment of systemic lupus erythematosus, rheumatoid arthritis, pemphigus, multiple sclerosis and other immunological diseases. SN1011 differentiates from existing BTK inhibitors currently available in the market, such as Ibrutinib, in terms of mechanism of action, selectivity and affinity. Ankündigung • Dec 24
SinoMab BioScience Limited announced that it expects to receive HKD 100 million in funding from Haiyao International Group Limited SinoMab BioScience Limited (SEHK:3681) announced that it has entered into a subscription agreement with Haiyao International Group Limited for a private placement of convertible bonds due 2022 for gross proceeds of HKD 100,000,000 on December 22, 2020. The transaction is expected to close at a date three business days after the later of (i) the date on which the last condition precedent set out in above section is satisfied or waived; and (ii) the date on which a written notice from the company is given to the Investor notifying that all conditions precedent are satisfied with the company’s bank account for the payment. The convertible bonds are convertible into 20,000,000 shares at the initial conversion price of HKD 5 for each share. The bonds will carry an interest rate of 4.95% per annum. The bonds will mature at the first anniversary date from the date on which bonds are originally issued. The bonds are unsubordinated, unsecured and redeemable in nature. The transaction is subject to approval from the independent shareholders at the EGM, the board of directors of the investor. The company will incur HKD 1,100,900 as expenses. Is New 90 Day High Low • Dec 18
New 90-day high: HK$3.60 The company is up 3.0% from its price of HK$3.48 on 18 September 2020. The Hong Kong market is up 7.0% over the last 90 days, indicating the company underperformed over that time. However, it outperformed the Biotechs industry, which is down 3.0% over the same period. Ankündigung • Dec 01
SinoMab BioScience Limited Announces Executive Changes The board of directors of SinoMab BioScience Limited announced that due to work rearrangement, Mr. Jing QIANG has resigned as the president of the Company with effect from 30 November 2020 and has been re-designated from an executive Director to a non-executive Director with effect from the same date. Is New 90 Day High Low • Oct 27
New 90-day low: HK$3.15 The company is down 14% from its price of HK$3.66 on 29 July 2020. The Hong Kong market is up 2.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 2.0% over the same period. Ankündigung • Aug 31
SinoMab BioScience Limited to Report First Half, 2020 Results on Aug 24, 2020 SinoMab BioScience Limited announced that they will report first half, 2020 results on Aug 24, 2020