공시 • Mar 19
LianBio(OTCPK:LIAN.Y) dropped from NASDAQ Composite Index LianBio has been dropped from NASDAQ Composite Index (^COMP) . 공시 • Feb 14
LianBio Intends to File Form 25 with SEC On February 13, 2024, LianBio, pursuant to an authorization by the Board, provided notice to Nasdaq that it intends to file a Form 25 with the U.S. Securities and Exchange Commission (the “SEC”) on or about March 8, 2024 to effect the voluntary delisting of the Company’s ADSs from Nasdaq and to deregister the ADSs under Section 12(b) of the Exchange Act. As a result, the Company currently expects that the last day of trading on Nasdaq will be on or about March 18, 2024, when Form 25 takes effect. Ninety days thereafter, the deregistration of the Company’s ADSs under Section 12(b) of the Exchange Act is expected to become effective. Following the delisting of the Company’s ADSs from Nasdaq, the Company intends to file a Form 15 with the SEC certifying that it has fewer than 300 shareholders of record, upon which the Company’s filing obligations under the Exchange Act will immediately be suspended, including the obligations to file all periodic reports. Following the delisting, any trading in the Company’s ADSs would only occur in privately negotiated sales and potentially on an over-the-counter market. The Company expects that its ADSs will be quoted on a market operated by OTC Markets Group Inc. (the “OTC”) so that a trading market may continue to exist for its ADSs. There is no guarantee, however, that a broker will continue to make a market in the ADSs and that trading of the ADSs will continue on an OTC market or otherwise. The Board believes that the decision to delist the ADSs from the Nasdaq and deregister and suspend its reporting obligations under the Exchange Act is in the best interests of the Company and the holders of its ordinary shares and ADSs. As the Company undertakes steps to wind down operations and return value to the shareholders through its asset sales, out-licensing efforts and the payment of dividends, the Board has determined that the burdens associated with operating as a registered public company outweigh any advantages to the Company and its holders of ordinary shares and ADSs. The Board’s decision was based on careful review of numerous factors, including the potential for curbing the significant costs associated with preparing and filing periodic reports with the SEC and the legal, audit and other expenses associated with being a reporting company, as well as the substantial costs and demands on management’s time under the Sarbanes-Oxley Act of 2002, SEC rules and Nasdaq listing standards. 공시 • Dec 22
LianBio Announces Chief Financial Officer Changes LianBio announced that Yi Larson, Chief Financial Officer, has resigned from LianBio to pursue other opportunities, effective December 19, 2023. In connection with her departure, the LianBio Board of Directors has appointed Ehong (Maggie) Gu, current VP, Head of Global Finance, as Interim Chief Financial Officer. Ms. Gu (51) has served in roles of increasing responsibility at the Company. She has served as VP, Head of Global Finance since April 2023 and VP of Finance, China since August 2021. From 2019 to 2021, Ms. Gu was AVP, Finance at CStone Pharmaceuticals, where she led the finance operations and established the financial infrastructure for the listing company. She was Sr. Finance Director at BeiGene from 2017 to 2019 and served as a member of BeiGene China Leadership Team, supporting a fast-growing business across China and APAC territories. Ms. Gu was Finance Director and China CFO at Celgene Corporation from 2009 to 2017. She was a founding member of the Celgene China Leadership Team. Ms. Gu earned an MBA degree in Finance from the Rotman School of Management at the University of Toronto, and a bachelor’s degree in English from Shanghai University. 공시 • Dec 07
Concentra Biosciences, LLC cancelled the acquisition of LianBio (NasdaqGM:LIAN) from Tang Capital Partners, LP, managed by Tang Capital Management, LLC and others. Concentra Biosciences, LLC submit non-binding proposal to acquire LianBio (NasdaqGM:LIAN) from Tang Capital Partners, LP, managed by Tang Capital Management, LLC and others on November 30, 2023. Concentra Biosciences will acquire LianBio for $4.30 per share in cash, plus a contingent value right (“CVR”) representing the right to receive 80% of the net proceeds payable from any license or disposition of LianBio’s programs (the “CVR Products”). The proposal is subject to limited confirmatory due diligence and is based on the availability of at least $515 million of cash and cash equivalents at closing, net of any residual liabilities and closing costs. Concentra expect to complete due diligence and negotiate a definitive merger agreement by December 22, 2023 and would be able to close acquisition through a cash tender by February 22, 2024.
Concentra Biosciences, LLC cancelled the acquisition of LianBio (NasdaqGM:LIAN) from Tang Capital Partners, LP, managed by Tang Capital Management, LLC and others on December 6, 2023. After careful review and consideration, the LianBio Board unanimously concluded that the Proposal undervalues the Company and is not in the best interests of LianBio or its shareholders. 공시 • Oct 31
LianBio Announces Topline Results from Phase 3 LIBRA Trial of TP-03 in Chinese Patients with Demodex Blepharitis LianBio announced topline results from the Phase 3 LIBRA clinical trial evaluating TP-03 in Chinese patients with Demodex blepharitis. The co-primary endpoints of the LIBRA trial were mite eradication (mite density of 0 mites per lash) and complete collarette cure (collarette score of 0) at day 43. Results demonstrated statistically significant mite eradication in patients with Demodex blepharitis treated with TP-03 compared to vehicle (p<0.001). A positive, but not statistically significant trend (p=0.15) was also observed for complete collarette cure. TP-03 was well tolerated with a safety profile similar to that observed in other large-scale clinical trials, and there were no treatment-related discontinuations. LianBio plans to discuss these results with the China National Medical Products Administration (NMPA) and expects to use these data to support a New Drug Application filing in China. LIBRA is a Phase 3 multicenter, double-blind, randomized, vehicle-controlled registrational study that evaluated the efficacy and safety of TP-03 in Chinese adult patients with Demodex blepharitis, with an open-label pharmacokinetics sub-study. Blepharitis is a common ocular condition that is characterized by inflammation of the eyelid margin, redness and ocular irritation. Demodex blepharitis is caused by infestation of Demodex mites, the most common ectoparasite found on humans. Demodex mites cause approximately 69% of blepharitis. Currently, there are no treatments approved by the NMPA for Demodex blepharitis. TP-03 is a novel prescription eye drop for the treatment of Demodex blepharitis and is designed to target and eradicate the root cause of the disease – Demodex mite infestation. It is marketed in the U.S. under the brand name XDEMVY® (lotilaner ophthalmic solution) 0.25%. The active ingredient in TP-03 is lotilaner, a well-characterized agent that eradicates Demodex mites by selectively inhibiting the GABA-Cl channels. It is a highly lipophilic molecule, which may promote its uptake in the oily sebum of the eyelash follicles where the mites reside. TP-03 was evaluated in two pivotal trials in the United States collectively involving more than 800 patients. Both trials met the primary endpoint and all secondary endpoints, with statistical significance and no serious treatment-related adverse events. Most patients found TP-03 to be neutral to very comfortable. The most common ocular adverse reactions observed in the studies were site stinging and burning which was reported in 10% of patients. Other ocular adverse reactions reported by less than 2% of patients were chalazion/hordeolum (stye) and punctate keratitis. LianBio in-licensed rights from Tarsus Pharmaceuticals for the development and commercialization of TP-03 in Mainland China, Hong Kong, Macau and Taiwan. New Risk • Oct 29
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 0.1% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (34% average weekly change). Earnings are forecast to decline by an average of 0.1% per year for the foreseeable future. Revenue is less than US$1m. Minor Risk Currently unprofitable and not forecast to become profitable next year (US$98m net loss next year). 공시 • Oct 26
LianBio Announces Presentation of Data from Phase 2a Study of Infigratinib in Patients with Gastric Cancer at ESMO Congress 2023 LianBio announced the presentation of efficacy and safety data from a Phase 2a study evaluating infigratinib in Chinese patients with locally advanced or metastatic gastric cancer (GC) or gastroesophageal junction adenocarcinoma (GEJ) with fibroblast growth factor receptor-2 (FGFR2) gene amplification. The data were presented by Dr. Jiajia Yuan, Peking University Cancer Hospital and Institute, at the 2023 European Society for Medical Oncology (ESMO) Congress in a poster titled, “Efficacy and Safety of Infigratinib in Patients with Locally Advanced or Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma and FGFR2 Gene Amplification.” The study enrolled 21 GC and GEJ patients with FGFR2 gene amplification. 20 patients (95.2%) who had >1 post-baseline tumor assessment per RECIST v1.1 were evaluable. Confirmed objective response rate (cORR) was 23.8% (95% CI: 8.2 – 47.2), disease control rate (DCR) was 76.2% (95% CI: 52.8 – 91.8) and median duration of response (DOR) was 3.8 months (95% CI: 3.6 – NE). Median progression-free survival (mPFS) was 3.3 months (95% CI: 2.3 – 4.5) and median overall survival (mOS) was 8.0 months (95% CI: 4.1 – NE). Among 20 evaluable patients who had post-baseline assessments, cORR was 25.0% (95% CI: 8.7–49.1) and DCR was 80.0% (95% CI: 56.3–94.3). Infigratinib was generally well tolerated with a manageable safety profile. There were no treatment-related adverse events (TRAEs) leading to dose discontinuation, death, or drug-induced liver injury. FGFR pathway aberrations are common in multiple cancer types, including gastric cancer. Infigratinib is an ATP-competitive, FGFR1-3 selective oral tyrosine kinase inhibitor. Infigratinib received Breakthrough Therapy Designation from the China National Medical Products Administration (NMPA) for the treatment of gastric cancer. The Phase 2 clinical trial is a multicenter, open-label, single-arm study in China designed to evaluate the safety and efficacy of infigratinib 125 mg QD in patients with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with FGFR2 gene amplification (Cohort 1) and other advanced solid tumors with FGFR alterations (Cohort 2) who have received at least two prior lines of systemic therapy. The primary endpoint is objective response rate (ORR). Secondary endpoints include duration of response, safety, disease control rate, progression-free survival, and overall survival (NCT05019794). Infigratinib is an orally administered, ATP-competitive, tyrosine kinase inhibitor of fibroblast growth factor receptor (FGFR) that targets the FGFR protein, blocking downstream activity. In clinical studies, infigratinib demonstrated a clinically meaningful rate of tumor shrinkage (overall response rate) and duration of response in cholangiocarcinoma. It is currently being evaluated in clinical studies for locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma, and other advanced solid tumors with FGFR genomic alterations. LianBio licensed rights from QED Therapeutics, a subsidiary of BridgeBio Pharma, for the development and commercialization of infigratinib for human prophylactic and therapeutic uses in all cancer indications in Mainland China, Hong Kong, and Macau. Infigratinib was granted Breakthrough Therapy Designation in China for the treatment of patients with gastric cancer in 2023. Price Target Changed • Oct 25
Price target decreased by 19% to US$6.24 Down from US$7.74, the current price target is an average from 4 analysts. New target price is 80% above last closing price of US$3.46. Stock is up 164% over the past year. The company is forecast to post earnings per share of US$0.13 next year compared to a net loss per share of US$1.02 last year. Breakeven Date Change • Oct 25
Forecast to breakeven in 2023 The 4 analysts covering LianBio expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$14.9m in 2023. Earnings growth of 20% is required to achieve expected profit on schedule. 공시 • Aug 04
LianBio Announces First Patient Treated in Phase 1 Trial of SHP2 Inhibitor BBP-398 in Combination with Osimertinib in Patients with Non-Small Cell Lung Cancer with EGFR Mutations LianBio announced the first patient has been dosed in its Phase 1 clinical trial of BBP-398, an investigational SHP2 inhibitor, in combination with AstraZeneca's osimertinib, an epidermal growth factor receptor (EGFR) inhibitor, for the treatment of patients with non-small cell lung cancer (NSCLC) with EGFR mutations. SHP2 is a protein-tyrosine phosphatase that links growth factor, cytokine and integrin signaling with the downstream RAS/MAPK pathway to regulate cellular proliferation and survival. Overactivity of SHP2 is a critical contributor to many forms of cancer, is a mechanism of resistance to several targeted therapies, and can suppress antitumor immunity. EGFR mutations occur in approximately 40-50% of NSCLC cases in Asia, more than twice the rate observed in the United States. By combining SHP2 inhibition and EGFR inhibition, there is potential to prevent oncogenesis and overactive cellular proliferation. The multi-center, open-label Phase 1 trial is designed to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of BBP-398 in combination with osimertinib in patients with locally advanced or metastatic NSCLC with EGFR mutations. The trial includes a dose escalation phase, followed by expansion cohorts. In July 2023, LianBio announced a clinical supply agreement with AstraZeneca in China to procure osimertinib for this trial. 공시 • Jun 27
Lianbio Announces Marketing Approval of CAMZYOS®? (Mavacamten) in Singapore LianBio announced that CAMZYOS®? (mavacamten) has received marketing approval for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) from the Singapore Health Sciences Authority. Marketing approval in Singapore was based on data from the Phase 3 EXPLORER-HCM trial. Results from the Phase 3 EXPLorER-HCM trial, which evaluated CAMZYOS in patients with symptomatic obstructive HCM versus placebo, met all primary and secondary endpoints with statistical significance. In EXPLORER-HC Mavacamten, CAMZYOS demonstrated a clear treatment effect, with clinically meaningful improvements in exercise capacity and symptoms, and functional status, as well as clinically meaningful improvement in left ventricular outflow tract obstruction. CAMZYOS (mavacam ten) is the first and only cardiac myosin inhibitor approved by the U.S. FDA indicated for the treatment of adults withomatic New York Heart Association (NYHA) class II-III oHCM to improve functional capacity and symptoms. It has also received regulatory approvals in Australia, Canada, Brazil, Switzerland, Macau, South Korea and Singapore. CAMZYOS is an allosteric and reversible inhibitor selective for cardiac myosin. CAMZYOS modulates the number of myosin heads that can enter "on actin" (power generating) states, thus reducing the probability of force producing (systolic) and residual (diastolic) cross-bridge formation. 공시 • May 12
LianBio Announces Marketing Approval of CAMZYOS(R) (mavacamten) in the Macau Special Administrative Region (SAR) of China LianBio announced that CAMZYOS (mavacamten) has received marketing approval for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) from the Pharmaceutical Administration Bureau of the Macau SAR. In April 2023, the China National Medical Products Administration (NMPA) accepted with Priority Review the New Drug Application for mavacamten for the treatment of adults with symptomatic oHCM. In April 2023, LianBio announced positive topline results from the Phase 3 EXPLORER-CN trial investigating mavacamten for the treatment of Chinese patients with symptomatic oHCM. EXPLORER-CN met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in Valsalva left ventricular outflow tract (LVOT) gradient from baseline to week 30 compared to placebo (p<0.001). Additionally, mavacamten demonstrated clinically important improvements for all secondary endpoints, including change from baseline to week 30 in resting LVOT peak gradient, proportion of participants achieving a Valsalva LVOT peak gradient <30 mmHg at week 30, proportion of participants achieving a Valsalva LVOT peak gradient <50 mmHg at week 30, proportion of participants with at least one NYHA class improvement from baseline to week 30, change from baseline to week 30 in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS), and change from baseline to week 30 in left ventricular mass index evaluated by cardiac magnetic resonance imaging. Safety results in the trial were consistent with previous studies of mavacamten in symptomatic oHCM, and no new safety signals were reported. Price Target Changed • Dec 29
Price target decreased to US$8.23 Down from US$9.73, the current price target is an average from 4 analysts. New target price is 431% above last closing price of US$1.55. Stock is down 75% over the past year. The company is forecast to post a net loss per share of US$1.23 next year compared to a net loss per share of US$5.71 last year. 공시 • Dec 14
LianBio Announces the Resignation of Debra Yu, M.D. as President and Chief Strategy Officer, Effective January 1, 2023 LianBio announced that Debra Yu, M.D., LianBio's President and Chief Strategy Officer, has resigned from the Company, effective January 1, 2023, to pursue other business and professional interests and opportunities. To facilitate her transition, Dr. Yu entered into a consulting agreement with LianBio effective January 1, 2023, through June 30, 2023. Dr. Yu joined the Company when LianBio was first established in 2019. She has been a valued member of LianBio's executive team and an integral part of LianBio's transformation from an early-stage startup into a late clinical stage biotechnology company. Board Change • Nov 16
Less than half of directors are independent There are 6 new directors who have joined the board in the last 3 years. Of these new board members, 3 were independent directors. The company's board is composed of: 6 new directors. 4 experienced directors. No highly experienced directors. 3 independent directors (4 non-independent directors). Director Adam Stone is the most experienced director on the board, commencing their role in 2019. Independent Director Wei Chen was the last independent director to join the board, commencing their role in 2022. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of board continuity. Lack of experienced directors. Price Target Changed • Nov 12
Price target increased to US$12.00 Up from US$9.75, the current price target is an average from 3 analysts. New target price is 711% above last closing price of US$1.48. Stock is down 90% over the past year. The company is forecast to post a net loss per share of US$1.11 next year compared to a net loss per share of US$5.71 last year. 공시 • Nov 10
LianBio Doses First Patient in Phase 1 Trial of BBP-398 in Chinese Patients with Advanced Solid Tumors LianBio announced the first patient has been dosed in its Phase 1 clinical trial of BBP-398, a SHP2 inhibitor, in Chinese patients with advanced solid tumors. SHP2 is a protein-tyrosine phosphatase that links growth factor, cytokine and integrin signaling with the downstream RAS/MAPK pathway to regulate cellular proliferation and survival. Overactivity of SHP2 is a critical contributor to many forms of cancer, is a mechanism of resistance to several targeted therapies, and can suppress antitumor immunity. In this two-part, open label, dose escalation and dose expansion Phase 1 study, safety and preliminary anti-tumor activity will be examined. Part 1 is a dose escalation to establish the recommended Phase 2 dose (RP2D) of BBP-398 and assess the pharmacokinetic profile of BBP-398 in Chinese patients. Part 2 is a dose expansion to examine preliminary antitumor activity in patients with advanced or metastatic EGFR-mutant non-small cell lung cancer (NSCLC). LianBio has a strategic collaboration with BridgeBio Pharma Inc. for the development and commercialization of BBP-398 in Mainland China, Hong Kong, Macau, Taiwan, South Korea, Singapore and Thailand. LianBio plans to develop BBP-398 in combination with various oncology medications in solid tumors, including for the treatment of NSCLC. LianBio expects to initiate a Phase 1 clinical trial of BBP-398 in combination with an EGFR inhibitor in Chinese patients with EGFR-mutant NSCLC in the first half of 2023. 공시 • Nov 02
LianBio Doses First Patient in Registrational Phase 3 LIBRA Trial of TP-03 in Chinese Patients with Demodex Blepharitis LianBio announced the first patient has been dosed in the Phase 3 LIBRA clinical trial of TP-03 in Chinese patients with Demodex blepharitis. TP-03 is a novel investigational therapeutic designed to resolve the signs of Demodex blepharitis by targeting and eradicating the root cause of the disease – Demodex mite infestation. Lotilaner, the active ingredient in TP-03, is a well-characterized agent that eradicates Demodex mites by selectively inhibiting the GABA-Cl channels. In two pivotal Phase 3 studies of TP-03 conducted in the United States, TP-03 met all primary and secondary endpoints, effectively resolving Demodex blepharitis and was safe and well tolerated. LianBio in-licensed rights from Tarsus Pharmaceuticals Inc., for the development and commercialization of TP-03 in Mainland China, Hong Kong, Macau and Taiwan. LIBRA is a Phase 3 multicenter, double-blind, randomized, placebo-controlled registrational study designed to evaluate the safety and efficacy of TP-03 in Chinese patients with Demodex blepharitis. LIBRA is expected to enroll 162 patients. The co-primary endpoints are complete collarette cure (0-2 collarettes per eyelid) and mite eradication (mite density of 0 mites per lash) at day 43. Secondary endpoints include composite cure of collarette and erythema (0-2 collarettes per eyelid and grade 0 erythema) at day 43. LianBio expects to report topline results from the LIBRA trial in the fourth quarter of 2023. 공시 • Aug 11
Lianbio Completes Enrollment in Pivotal Phase 3 EXPLORER-CNTrial of Mavacamten in Chinese Obstructive Hypertrophic Cardiomyopathy Patients LianBio announced the completion of enrollment in the Phase 3 EXPLORER-CN clinical study of mavacamten in Chinesepatients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). EXPLORER-CN is a Phase 3 multicenter, double-blind, randomized, placebo-controlled registrational study designed to evaluate the safety and efficacy of mavacamten in Chinese patients with symptomatic oHCM. The primary endpoint is the change in Valsalva left ventricular outflow tract (LVOT) gradient from baseline to week 30. Eligible patients will continue in a long-term extension treatment period. 공시 • May 10
LianBio Completes Phase 1 Pharmacokinetic Study of Mavacamten in Healthy Chinese Volunteers LianBio announced the completion of a Phase 1 pharmacokinetic study of mavacamten in healthy Chinese volunteers. A single oral administration of mavacamten showed no new safety signals in Chinese healthy adult subjects. The data demonstrated a favorable pharmacokinetic and safety and tolerability profile comparable to that observed in the Phase 1 pharmacokinetic study of mavacamten conducted by our partner, MyoKardia, now a wholly owned subsidiary of Bristol Myers Squibb, in healthy volunteers in the United States. The pharmacokinetic study was an open-label, parallel-group, single-center Phase 1 clinical study evaluating a single oral administration of mavacamten in 44 healthy Chinese volunteers. The study was conducted in parallel to an ongoing Phase 3 clinical trial of mavacamten in Chinese patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). LianBio expects that the results of the pharmacokinetic trial, together with the results of its Phase 3 clinical trial, if positive, will enable it to submit a New Drug Application to the National Medical Products Administration to support regulatory approval in China. LianBio licensed rights from MyoKardia, now a wholly owned subsidiary of Bristol Myers Squibb, in August 2020 for the development and commercialization of mavacamten in Mainland China, Hong Kong, Macau, Taiwan, Thailand and Singapore. LianBio is currently conducting EXPLORER-CN, a Phase 3 multicenter, double-blind, randomized, placebo-controlled registrational study designed to evaluate the safety and efficacy of mavacamten in Chinese patients with symptomatic oHCM. Mavacamten was granted Breakthrough Therapy Designation in China for the treatment of patients with oHCM in February 2022. In April 2022, mavacamten was approved by the U.S. Food and Drug Administration under the brand name Camzyos for the treatment of symptomatic New York Heart Association (NYHA) class II-III oHCM to improve functional capacity and symptoms. 공시 • May 02
U.S. Food and Drug Administration Approves Camzyos (Mavacamten) for the Treatment of Adults with Symptomatic New York Heart Association Class II-III Obstructive Hypertrophic Cardiomyopathy to Improve Functional Capacity and Symptoms LianBio's announced that the U.S. Food and Drug Administration (FDA) approved Camzyos(TM) (mavacamten, 2.5 mg, 5 mg, 10 mg and 15 mg capsules) for the treatment of adults with symptomatic New York Heart Association (NYHA) class II- III obstructive hypertrophic cardiomyopathy (obstructive HCM) to improve functional capacity and symptoms. Camzyos is the first and only FDA-approved allosteric and reversible inhibitor selective for cardiac myosin that targets the underlying pathophysiology of obstructive HCM.LianBio licensed rights from MyoKardia, now a wholly owned subsidiary of Bristol Myers Squibb, in August 2020 for the development and commercialization of Camzyos in Mainland China, Hong Kong, Macau, Taiwan, Thailand and Singapore. LianBio is currently conducting EXPLORER-CN, a Phase 3 multicenter, double-blind, randomized, placebo-controlled registrational study designed to evaluate the safety and efficacy of mavacamten in Chinese patients with symptomatic obstructive HCM. Camzyos was granted Breakthrough Therapy Designation in China for the treatment of patients with obstructive HCM. Board Change • Apr 27
Less than half of directors are independent There are 9 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: 9 new directors. 1 experienced director. No highly experienced directors. 2 independent directors (5 non-independent directors). Director Adam Stone is the most experienced director on the board, commencing their role in 2019. Independent Director Susan Silbermann 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. Lack of experienced directors. 공시 • Apr 16
LianBio Announces Formation of Scientific Advisory Board LianBio announced the formation and members of its Scientific Advisory Board (SAB) comprised of industry leaders in global drug development. In addition to being named as founding members of the Scientific Advisory Board, these individuals also serve as Strategic Advisors to LianBio, assisting with program strategy, alliance matters and business development. The members of the Scientific Advisory Board are as follows: Mathias Hukkelhoven, Ph.D., is an experienced global regulatory leader, and has served as a Strategic Advisor to LianBio since September 2021. Dr. Hukkelhoven previously served as a Senior Vice President at Bristol Myers Squibb and was responsible for the company’s global Regulatory Sciences & Safety organization. Prior to this, Dr. Hukkelhoven held positions of increasing responsibility at Novartis, including as Head of US Regulatory Affairs and Head of Global Regulatory Affairs. He has also served as chairman of the Regulatory Affairs Coordinating Committee at Pharmaceutical Research and Manufacturers of America (PhRMA), which represents companies in the pharmaceutical industry in the US, and recently has worked as a PhRMA negotiator for the PDUFA VII negotiations with the Food & Drug Administration (FDA). Elliott Levy, M.D., is a highly experienced clinical development veteran and has served as a Strategic Advisor to LianBio since January 2022. Dr. Levy previously led the Clinical Development organization at Amgen Inc., where he was Senior Vice President, Global Development. In this role he oversaw over 70 programs, and his clinical development team gained approval for over two medicines per year on average, more than doubling the size of Amgen’s marketed product portfolio. Prior to joining Amgen in 2014, Dr. Levy served as Senior Vice President and head of Specialty Development at Bristol Myers Squibb. Over the course of Dr. Levy’s career, he has played a major role in the development of over 20 approved medicines across six therapeutic areas. Zhao Yan, M.D., is an industry expert in providing scientific and enterprise counsel for improving drug development in China. She has served as Strategic Advisor to LianBio since January of 2022. Dr. Yan has over 30 years of experience within the Chinese pharmaceutical industry, and most recently served in roles of increasing responsibility at Novartis International AG, including as Head of Oncology Development & Medical Affairs, Head of Global Drug Development, and Chief Innovation Officer. Throughout her career, Dr. Yan has also led multiple successful developments and investigational new drug/new drug application approvals in China across various therapeutic areas, including oncology, cardiovascular, hepatology, renal disease, ophthalmology, and neuroscience. 공시 • Apr 08
LianBio Appoints Wei Wei Chen to Board of Directors LianBio announced the appointment of Wei Wei Chen to the company’s Board of Directors. Ms. Chen brings over 17 years of experience serving as a Chief Financial Officer for a number of companies, including in the consumer retail and healthcare sectors. Most recently, she served as Vice President, Chief Financial Officer of Starbucks (China) Company Limited, where she drove significant business growth and played a key role in multiple business transformation initiatives. 공시 • Jan 12
Lianbio Announces First Patient Dosed in Registrational Phase 3 EXPLORER-CN Trial of Mavacamten in Chinese Patients with Obstructive Hypertrophic Cardiomyopathy LianBio announced the first patient has been dosed in the Phase 3 EXPLORER-CN clinical trial of mavacamten in Chinese patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Mavacamten is a potential first-in-class, oral, allosteric modulator of cardiac myosin in development for the treatment of conditions in which excessive cardiac contractility and impaired diastolic filling of the heart are the underlying cause of disease. In the global Phase 3 EXPLORER-HCM trial of mavacamten in oHCM patients with New York Heart Association (NYHA) class II–III symptoms, mavacamten met all primary and secondary endpoints with statistical significance and demonstrated clinically meaningful improvement in functional status, symptoms, and quality of life. LianBio in-licensed rights from MyoKardia, now a wholly owned subsidiary of Bristol-Myers Squibb, for the development and commercialization of mavacamten in Mainland China, Hong Kong, Macau, Taiwan, Thailand and Singapore. EXPLORER-CN is a Phase 3 multicenter, double-blind, randomized, placebo-controlled registrational study designed to evaluate the safety and efficacy of mavacamten in Chinese patients with symptomatic oHCM. EXPLORER-CN will enroll approximately 81 patients. The primary endpoint is the change in Valsalva left ventricular outflow tract (LVOT) gradient from baseline to week 30. Eligible patients will continue in a long-term extension treatment period. LianBio is also conducting a concurrent pharmacokinetic (PK) study of mavacamten in healthy Chinese volunteers. The PK study completed subject dosing in November 2021. 공시 • Dec 22
LianBio Announces Approval of Infigratinib Under Special Named Patient Program for the Treatment of Cholangiocarcinoma in the Pilot Zone of Hainan Province in China LianBio announced that infigratinib has been approved by the Health Commission and Medical Products Administration of Hainan Province, under the special Named Patient Program (NPP), for the treatment of patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or other rearrangement. The first cholangiocarcinoma patient in China was prescribed and treated with infigratinib at Bo’ao Super Hospital in Mainland China, marking the first prescription of infigratinib outside of North America. The special NPP was enacted by the State Council of PRC as a pilot program implemented in the Bo’ao Lecheng International Medical Tourism Pilot Zone to accelerate patient and physician access to urgently needed medicines that are approved in certain jurisdictions, but not yet approved in Mainland China. Infigratinib is an oral selective FGFR inhibitor being evaluated in global clinical trials based on demonstration of clinical activity in patients with advanced cholangiocarcinoma and urothelial carcinoma with FGFR genomic alterations. LianBio in-licensed rights from BridgeBio Pharma in 2020 for infigratinib for development and commercialization in Mainland China, Hong Kong and Macau. LianBio is currently conducting a Phase 2a clinical trial in China to evaluate the safety and efficacy of infigratinib in patients with locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with FGFR2 gene amplification and other advanced solid tumors with FGFR alterations. Board Change • Oct 30
No independent directors Following the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 7 non-independent directors. Director Jesse Wu was the last director to join the board, commencing their role in 2021. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model.