Ankündigung • Mar 26
Simcere Pharmaceutical Group Limited, Annual General Meeting, Jun 12, 2026 Simcere Pharmaceutical Group Limited, Annual General Meeting, Jun 12, 2026. Ankündigung • Mar 13
Simcere Pharmaceutical Group Limited to Report Fiscal Year 2025 Results on Mar 25, 2026 Simcere Pharmaceutical Group Limited announced that they will report fiscal year 2025 results on Mar 25, 2026 Ankündigung • Feb 27
Simcere Pharmaceutical Group Limited Provides Consolidated Earnings Guidance for the Year Ended December 31, 2025 Simcere Pharmaceutical Group Limited provided consolidated earnings guidance for the year ended December 31, 2025. For the period, the Group will record a revenue of approximately RMB 7,700 million to RMB 7,800 million for full year 2025, representing an increase of approximately 16.0% to 17.6% as compared to the revenue of approximately RMB 6,635 million for the year ended December 31, 2024 (Full Year 2024). The Group will record a profit attributable to equity shareholders of the Company of approximately RMB 1,300 million to RMB 1,400 million for Full Year 2025, representing an increase of approximately 80.1% to 93.9% as compared to the subtracted profit attributable to equity shareholders of the Company of approximately RMB 722 million for Full Year 2024. The growth in the aforementioned items is primarily attributable to increases in revenue from innovative pharmaceutical business, income from out-licensing, and net gains in the fair value of the Group's investment portfolio. Ankündigung • Jan 13
Simcere Pharmaceutical Group Limited (SEHK:2096) commences an Equity Buyback for 247,469,761 shares, representing 10% of its issued share capital, under the authorization approved on June 13, 2025. Simcere Pharmaceutical Group Limited (SEHK:2096) commences share repurchases on January 12, 2026 under, the program mandated by the shareholders in the Annual General Meeting held on June 13, 2025. As per the mandate, the company is authorized to repurchase up to 247,469,761 shares, representing 10% of its issued share capital. The purpose of repurchase program is to enhance the net assets and/or its earnings per share. The repurchases will be made out of the funds legally available for such purpose in accordance with the Articles, the Listing Rules and the applicable laws of Hong Kong. The authority shall expire at the earliest of the next Annual General Meeting, the date on which the next Annual General Meeting is required to be held or the date on which the authority is carried out to the full extent, unless varied or revoked in a General Meeting. As of June 13 2025, the company has 2,474,697,618 hares in issue.
On August 21, 2025, the company announces a share repurchase program. Under the program, the company will repurchase up to CNY 500 million worth of its shares. The program will be funded from the company’s internal resources. The repurchases will commence from August 22 2025 and run until the date of the next annual general meeting, Ankündigung • Nov 10
Simcere's IL-2 Mutant Fusion Protein Sim0278 Enters Phase II Clinical Trial Stage Simcere Pharmaceutical Group Limited announced that its regulatory T cells (Treg) -preferential IL-2 mutant Fc fusion protein (IL-2 mu-Fc), SIM0278, has officially entered a Phase II clinical study in China for the treatment of moderate-to-severe atopic dermatitis (AD). The first dose was achieved in Hangzhou First People's Hospital. This randomized, double-blind, placebo-controlled, multi-center Phase II study is aiming to evaluate the efficacy, safety, and pharmacokinetics of continuous subcutaneous administration of SIM0278 in participants with moderate-to-severe AD. Atopic dermatitis is a chronic, recurrent, inflammatory skin disease characterized by symptoms such as dry skin, intense itching, and erythema, which significantly impact patients' quality of life. As a high medical need for the treatment of moderate to severe AD remains, there are opportunities to further optimise treatment options and technologies. The critical role of Treg cells in peripheral immune tolerance is a major focus in current immunology research and was recently awarded the 2025 Nobel Prize. SIM0278 was developed on Simcere's proprietary protein engineering platform. Its mechanism of action involves introducing mutations that reduce its affinity for effector T cells while maintaining high affinity for Tregs. This selectivity allows SIM0278 to activate Tregs specifically, helping to restore immune balance without affecting effector T cells or natural killer cells and shows potential for treating a variety of immune disorders. SIM0278 has demonstrated good tolerability, appropriate pharmacokinetic properties, and preliminary efficacy in the completed Phase I clinical study in China. It is expected to achieve sustained efficacy and become a best-in-class (BIC) product. In September 2022, Simcere signed an exclusive license agreement with Almirall, S.A., granting Almirall rights to develop and commercialize SIM0278 for all indications outside Greater China. The Phase I clinical study conducted by Almirall in the United States has been completed and a Phase II study on another skin condition will start in the coming months. Ankündigung • Sep 11
Simcere Pharmaceutical Group Limited has completed a Follow-on Equity Offering in the amount of HKD 1.56695 billion. Simcere Pharmaceutical Group Limited has completed a Follow-on Equity Offering in the amount of HKD 1.56695 billion.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 121,000,000
Price\Range: HKD 12.95
Transaction Features: Subsequent Direct Listing Ankündigung • Sep 02
Simcere Pharmaceutical Group Limited has filed a Follow-on Equity Offering in the amount of HKD 1.56695 billion. Simcere Pharmaceutical Group Limited has filed a Follow-on Equity Offering in the amount of HKD 1.56695 billion.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 121,000,000
Price\Range: HKD 12.95
Transaction Features: Subsequent Direct Listing Ankündigung • Aug 12
Simcere Pharmaceutical Group Limited to Report First Half, 2025 Results on Aug 21, 2025 Simcere Pharmaceutical Group Limited announced that they will report first half, 2025 results on Aug 21, 2025 Ankündigung • Jul 10
Connect Biopharma Holdings Limited Announces Submission of Its New Drug Application for Rademikibart for the Treatment of Atopic Dermatitis in China Connect Biopharma Holdings Limited announced that the Company's collaborator and exclusive license in China, Simcere Pharmaceutical Co. Ltd. ("Simcere"), has submitted its New Drug Application for rademikibart to the National Medical Products Administration of China ("NMPA") for the treatment of atopic dermatitis ("AD") in adults and adolescents. In 2023, Connect and Simcere entered into an exclusive license and collaboration agreement for rademikibart in China. Under the agreement, Simcere was granted exclusive rights to develop, manufacture, and commercialize rademikibart for all indications in Greater China, including mainland China, Hong Kong, Macau, and Taiwan, while Connect retains rights in all other markets. As part of the agreement, Connect is eligible to receive milestone payments up to an aggregate remaining amount of approximately $110 million upon the achievement of certain development, regulatory and commercial milestones. Connect is also eligible to receive royalties at tiered percentage rates up to low double-digit percentages on net sales in Greater China. The AD market in China represents considerable opportunity, with an estimated 70 million patients with AD. Rademikibart is a fully human monoclonal antibody targeting interleukin-4 receptor alpha (IL-4Ra), a common subunit of interleukin-4 receptors (IL-4) and interleukin-13 receptor (IL-13). By binding with IL-4Ra, rademikibart can block the functions of IL-4 and IL-13 effectively, thereby blocking the T helper 2 (Th2) inflammatory pathway, thus achieving the goal of treating Th2 related inflammatory diseases such as atopic dermatitis and asthma. Ankündigung • Jul 08
Simcere Pharmaceutical Group Limited and Connect Biopharma Hongkong Limited Accepts New Drug Application of Rademikibart Simcere Pharmaceutical Group Limited announced that, on July 8, 2025, the new drug application (NDA) of the innovative drug Rademikibart, jointly developed by the Group and Connect Biopharma HongKong Limited (Xiang Gang Nai De Sheng Wu Yi Yao You Xian Gong Si) ("Connect Biopharma"), was accepted by the National Medical Products Administration (Guo Jia Yao Pin Jian Du Guan Li Ju) of China (NMPA) for the treatment of atopic dermatitis in adults and adolescents. Ankündigung • Jul 03
Simcere Pharmaceutical Group Limited Announces Approval for Marketing of Enzeshu®? in China by the National Medical Products Administration The board of directors of Simcere Pharmaceutical Group Limited announced that, on July 3, 2025, ENZESHU®? (Suvemcitug for injection), a category 1 biological new drug, was approved for marketing in China by the National Medical Products Administration (NMPA) of China. ENZESHU®? is indicated for the treatment of recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer in combination with paclitaxel, liposomal doxorubicin, or topotecan in adults who have received no more than one systemic therapy after platinum resistance. There are no anti-angiogenic therapies approved in China for the treatment of platinum-resistant ovarian cancer (PROC), particularly for patients with prior exposure to anti-angiogenic treatment, representing a significant unmet clinical need. The approval of ENZESU®? is expected to provide a much-needed new therapeutic option for patients with platinum-resistant ovarian cancer in China. Ankündigung • Jun 20
Simcere Pharmaceutical Group Limited Announces Approval for Marketing of QUVIVIQ in China by the National Medical Products Administration Simcere Pharmaceutical Group Limited announced that, on June 20, 2025, the new drug application of QUVIVIQ (daridorexant hydrochloride tablets), an anti-hypnotic drug jointly developed by the Group and Idorsia Pharmaceuticals Ltd. ("Idorsia"), was approved for marketing in China by the National Medical Products Administration (" NMPA") of China. The indication of QUVIVIQ®? is for the treatment of adult patients with insomnia characterized by difficulties with sleep onset and/or sleep maintenance and QUVIVIQ®? has not been designated as a controlled substance. Ankündigung • Jun 13
Simcere Pharmaceutical Group Limited Approves Final Dividend for the Year Ended December 31, 2024, Payable on or Before July 14, 2025 Simcere Pharmaceutical Group Limited at its annual general meeting held on June 13, 2025, declare a final dividend of RMB 0.16 per ordinary share of the Company for the year ended December 31, 2024 (the ‘Final Dividend’). The Final Dividend will be paid on or before July 14, 2025 to the Shareholders whose names appear on the register of members of the Company on June 24, 2025. Ankündigung • Apr 10
Simcere Pharmaceutical Group Limited Obtains Clinical Trial Approval from National Medical Products Administration Simcere Pharmaceutical Group Limited announced that, on April 9, 2025, SIM0686, an FGFR2b Antibody-Drug Conjugate ("ADC") which is an anti-tumor drug candidate independently developed by the Group, has obtained the Clinical Trial Approval issued by the National Medical Products Administration (Guo Jia Yao Pin Jian Du Guan Li Ju) of China, which is intended for commencing the clinical trial for advanced solid tumors. SIM0686 is an ADC drug targeting FGFR2b. Fibroblast growth factor receptor (FGFR) is a transmembrane tyrosine kinase receptor of fibroblast growth factor (FGF). At present, there are four known subtypes, namely FGFR1, FGFR2, FGFR3 and FGFR4. Such ADC is intended to be developed for the treatment of advanced malignant tumors like gastric cancer and lung cancer. Ankündigung • Mar 17
Simcere Pharmaceutical Group Limited Announces That New Drug Application of Deunoxavir Marboxil Tablets Was Accepted by the National Medical Products Administration of China The board of directors of Simcere Pharmaceutical Group Limited announced that, on March 15, 2025, the new drug application ("NDA") of Deunoxavir Marboxil Tablets, an anti-influenza drug, jointly developed by the Group and Jiaxing AnDiCon Biotech Co. Ltd. (Jia Xing An Di Kang Sheng Wu Ke Ji You Xian Gong Si) ("AnDiCon"), was accepted by the National Medical Products Administration ("Z Zhong Guo Guo Jia Yao Pin Jian Du Guan Li Ju") of China (NMPA), Deunoxavir Mar boxil Tablets are for treating uncomplicated influenza A and B in adults and adolescents. Deunoxavir MarBoxil is an endonuclease inhibitor for influenza polymerase acidic (PA) protein. As shown in the research, Deunoxavir Mar Boxil demonstrates several benefits, including the absence of central nervous system side effects, no effect of food intake on oral drug absorption and higher safety dose. The entire oral dose of DeunoxavirMarboxil Tablets is merely "one tablet" and is capable of stopping influenza (the "Infenza") virus replication in 24 hours, having a prospect of bringing great convenience to a large number of patients, including child patients. On October 10, 2023, the Group entered into a cooperation agreement (the " Agreement") with AnDiCon in relation to Deunoxavir Mar boxes (the "Product"). Pursuant to the Agreement, the Group obtained the exclusive commercialization rights of the Product in China for indications related to the Influenza. The results of phase II/III clinical study of Deunoxavir Marchboxil indicated that as compared with the placebo group, the median time of all the Influenza symptoms relief achieved 26.543% improvements and such difference was statistically meaningful (P<0.0001), while the safety level is line with the placebo group. On February 21, 2024, children's granules of Deunoxavir marboxil received the Clinical Approval and is currently initiating phase III clinical trials, aiming at evaluating the safety, pharmacokinetics and efficacy of children's granules of De unoxavir Marboxil among child patients of 2 to 11 years old with the Influenza. On January 12, 2025, the phase III clinical trial of children's granules of deunoxavir MarboxIL completed the Last-Patient-In (LPI). On February 27, 2025, children's granules of de unoxavir MarboxIL has obtained the Clinical Trial Approval issued by the NMPA, which is intended for commencing the clinical trial for post-exposure prevention of influenza type A and B among population aged 2 years old and above. Ankündigung • Mar 12
Simcere Pharmaceutical Group Limited to Report Fiscal Year 2024 Results on Mar 24, 2025 Simcere Pharmaceutical Group Limited announced that they will report fiscal year 2024 results on Mar 24, 2025 Ankündigung • Jan 06
Simcere Pharmaceutical Group Limited Announces the Clinical Trial Approval for Sim0505 (CDH6 Antibody-Drug Conjugate) Issued by the National Medical Products Administration Simcere Pharmaceutical Group Limited announced that, on January 2, 2025, SIM0505, a CDH6 Antibody-Drug Conjugate (ADC) which is an anti-tumor drug candidate independently developed by the Group, has obtained the Clinical Trial Approval issued by the National Medical Products Administration (Guo Jia Yao Pin Jian Du Guan Li Ju) of China, which is intended for commencing the clinical trial for advanced solid tumors. On December 28, 2024, the Investigational New Drug (IND) application of SIM0505 was approved by the U.S. Food and Drug Administration (FDA). CDH6, a type II classical cadherin, is highly expressed in a variety of tumors but with very limited expression in normal tissues. SIM0505 is a CDH6-targeting ADC molecule developed by the Group, which consists of CDH6 monoclonal antibody specifically binding to tumor cells and the Group's proprietary camptothecin derivative toxin, conjugated by a linker. By combining the tumor-specific targeting antibody with the high-efficiency killing effect of toxin molecules, SIM0505 can specifically target tumor cells and reduce the toxic side effects compared to traditional chemotherapies. Such ADC is intended for the treatment of malignant tumors such as ovarian and renal cancer. Ankündigung • Dec 02
Simcere Pharmaceutical Group Limited Announces Approval for Marketing of Sanbexin Sublingual Tablets in China by the National Medical Products Administration Simcere Pharmaceutical Group Limited announced that, on December 1, 2024, Sanbexin sublingual tablets (Edaravone and Dexborneol sublingual tablets) was approved for marketing in China by the National Medical Products Administration (NMPA) of China, the indication of which is to be used in the improvement of the neuro symptoms, the daily living abilities and dysfunction caused by Acute Ischemic Stroke ("AIS"). ABOUT SANBEXIN ® SUBLINGUAL TABLETS Sanbexin ® sublingual tablets is a brain cytoprotective agent composed of edaravone and dexborneol, two active ingredients with synergistic anti-oxidant and anti-inflammatory effects, which can significantly reduce brain cell injury or impairment caused by AIS. Such unique sublingual tablets formulation can quickly disintegrate once in contact with the saliva under the tongue and can be absorbed into the blood through the sublingual venous plexus, which is expected to increase the flexibility of stroke treatment. Sequential therapy consisting of the marketed Sanbexin ® Injection (Edaravone and Dexborneol Concentrated Solution for Injection) and Sanbexin ® sublingual tablets of the Company is expected to enable patients to receive a complete course of treatment in and outside of the hospital. Ankündigung • Nov 28
Simcere Pharmaceutical Group Limited Announces Inclusion of Three Innovative Drugs, Cosela, Enlituo and Sanbexin, in the New National Reimbursement Drug List The board of directors Simcere Pharmaceutical Group Limited announced that, on November 28, 2024, the National Healthcare Security Administration and the Ministry of Human Resources and Social Security published the "Drugs Catalogue for the National Basic Medical Insurance, Work-related Injury Insurance and Maternity Insurance, pursuant to which three innovative drugs of the Group, including COSELA (Trilaciclib Hydrochloride for Injection), ENLITUO (Cetuximab Beta Injection) and Sanbexin (Edaravone and Dexborneol Concentrated Solution for Injection), were successfully included in the New NRDL. Except for Sanbexin, which is a renewed product under the national negotiation, COSELA and ENLITUO are new products under the current national medical insurance negotiation. Ankündigung • Oct 30
Simcere Pharmaceuticals Group Ltd. Announces That A New Clinical Study with Major Clinical Findings Regarding Sanbexin (Edaravone and Dexborneol Concentrated Solution for Injection) Has Been Published At the 16th World Stroke Conference Simcere Pharmaceuticals Group Ltd. announced that a new clinical study with major clinical findings regarding Sanbexin (edaravone and dexborneol concentrated solution for injection) has been published at the 16thWorld Stroke Conference (WSC). According to the latest data, the administration of edaravone dexborneol (Sanbexin®) in patients with acute ischemic stroke (AIS) before receiving endovascular thrombectomy significantly improved neuro-function recovery and reduced disability from stroke. Presented as a WCS late-breaking oral presentation by Professor Yongjun Wang from Beijing Tiantan Hospital, the study entitled "Treatment of Acute ischemic Stroke with Edaravone dexborneal 2" ("TASTE-2") has caught wide spread attention among neurology academic circle in the world. Stroke is the leading cause of death and disability in adults in China, while AIS accounts for about 70% of all strokes. About 40% of AIS patients fall into the category of large vessel occlusion (LVO), a subtype of AIS with higher disability and mortality. After stroke, reperfusion treatments (e.g., thrombolysis and thrombectomy) are used to restores blood supply to the brain as soon as possible. The endovascular thrombectomy (EVT), an important advance in reperfusion therapy in recent years, can achieve recanalization in about 70% to 90% of patients with the LVO stroke, but only half of these patients achieve favorable brain function recovery A significant proportion of the patients who received EVT remain disabled to varying degrees after 90 days of treatment. TASTE-2 study is a multicenter, double-blind, randomized, placebo-controlled clinical study. From March 2022 to May 2023, a total of 1362 AIS patients with a large-vessel occlusion (LVO) in the anterior circulation were enrolled. Patients were randomly allocated (1:1) to receive edaravone dexborneol (edaravone, 30 mg; (+) -dexborneol, 7.5 mg) or placebo prior to EVT and continued twice a day over a consecutive period of 10-14 days. As a primary efficacy outcome, 379 (55.0%) patients in the edaravone dexborneol group and 333 (49.6%) in the placebo group achieved a mRS 0-2 at day-90 (odds ratio [OR] 1.24, 95% CI 1.00-1.54; risk ratio [RR] 1.11, 95% CI 1.00-1.23). All safety outcomes were similar between both groups. This suggests that Edaravone dexborneol could improve the favorable functional outcome at 90 days in AIS patients within 24-hour of symptom onset who underwent EVT. Sanbexin® (Edaravone dexborneol Concentrated Solution for Injection) is a multi-targeted brain cell protection agent developed by Simcere Pharmaceutical Co., Ltd, and is the only approved innovative drug in the field of stroke treatment worldwide since 2015. Composed of edaravone and dexborneol, two active ingredients with synergistic anti-oxidant and anti-inflammatory effects, the drug can significantly reduce brain cell injury or impairment caused by AIS. According to the recommendations of the Stroke Academic Roundtable Meeting (STAIR), brain cytoprotectants can reduce ischemic brain injury, especially when combined with thrombectomy. The scientific community has also been working on brain cytoprotective agents for stroke treatment for decades. However, due to the complexity of stroke pathophysiology, single-target drugs have been found to have limited efficacy and difficult to be developed clinically. On the other hand, the clinical study of multi-target brain cytoprotectants continue to progress. Previously, the TASTE study led by Professor Yongjun Wang's team in Beijing Tiantan Hospital and the TASTE-SL study led by Professor Dongsheng Fan in Peking University Third Hospital confirmed the efficacy of edaravone dexborneol injection and sublingual tablets in AIS patients who do not receive reperfusion treatment. The latest results of the TASTE-2 study provide key clinical medical evidence for Sanbexn® as a multi-target brain cell protection strategy combined with reperfusion in the treatment of acute ischemic stroke. Sanbexin® is expected to be used as a concomitant drug for endovascular treatment such as thrombectomy, particularly before reperfusion, to further improve the effect of stroke treatment and reduce stroke disability. Ankündigung • Sep 05
Simcere Pharmaceuticals Group Ltd. Announces Breakthrough Therapy Designation for Sanbexin Sublingual Tablets Granted by the United States Food and Drug Administration On September 2, 2024, Simcere Pharmaceuticals Group Ltd. announced that Sanbexin Sublingual Tablets (Edaravone and Dexborneol sublingual tablets), an innovative drug for stroke, has been granted the Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the treatment of Acute Ischemic Stroke (AIS). Sanbexin sublingual tablets is the first innovative drug in the world to be designated with the Breakthrough Therapy by the FDA for the treatment of stroke. The Breakthrough Therapy designation stems from the provisions of the "Food and Drug Administration Safety and Innovation Act". It is designed to expedite the development and regulatory review of drugs for treating serious diseases and addressing significant unmet medical needs. The designation will be beneficial for the drugs to obtain the FDA's guidance in the clinical development, accelerate the overseas clinical development process, and is also expected to significantly shorten the time for marketing review through the priority review designation. The Breakthrough Therapy designation is based on the significant improvement in efficacy metrics demonstrated by the sublingual tablets in a previous clinical study. The data from a multicenter, randomized, double-blind, parallel, placebo-controlled Phase III clinical study in China for the treatment of AIS demonstrated that Sanbexin subledual tablets significantly improved neurological recovery and independent living ability in patients with AIS compared to placebo, meeting the expected efficacy endpoints with a favorable safety profile. JAMA Neurology published the study's key findings online. The designation will be beneficial For Simcere to obtain the FDA's guidance In the clinical development of Sanbexin sublingal tablets, accelerate the overseas clinical development processes, and is also expected toificantly shorten the time for marketing review via the priority review designation. According to a recent article in The Lancet, stroke is the second leading cause of death and disability worldwide, with 12 million new cases and 6.6 million deaths each year. Among them, acute ischemic stroke is the most common type of stroke, accounting for about 70% of all strokes, and constituting a heavy disease burden for all countries around the world. The efficacy of acute ischemic stroke treatment is highly time-dependent. Receiving treatment as early as possible will help patients to improve their disease outcome and avoidability. Sanbexin subling manual tablets is a brain cytoprotective agent composed of edaravone and dexborneol, two active ingredients with synergistic anti-oxidant and anti-inflammatory effects, which can significantly reduce brain cell injury or impairment caused by AIS. Such unique sublingual formulation can quickly disintegrate once in contact with the saliva once place under the tongue and can be absorbed into the blood through the sublingual intravenous plexus, which is expected to increase the flexibility of stroke treatment. Sequential therapy consisting of the marketed Sanbexin concentrated solution for Injection. These two formulae enable patients to receive a complete course of treatment in and outside of the hospital. On June 28, 2023, the new drug application (NDA) for Sanbexin sublingually tablets in China is accepted by the National Medical Products Administration. The first indication is for the improvement of neurological symptoms, daily activities, and functional impairment due to AIS. Phase I clinical trials for Sanbexin subledal tablets on healthy volunteers have been completed in the United States. Ankündigung • Aug 22
Simcere Pharmaceutical Group Limited Obtains Clinical Trial Approval Issued by the National Medical Products Administration Simcere Pharmaceutical Group Limited announced that, on August 22, 2024, SIM0508, a small molecule inhibitor of DNA polymerase which is an anti-tumor drug candidate independently developed by the Group, has obtained the Clinical Trial Approval issued by the National Medical Products Administration (Guo Jia Yao Pin Jian Du Guan Li Ju) of China, which is intended for commencing the clinical trial for advanced solid tumors. Ankündigung • Aug 09
Simcere Pharmaceutical Group Limited to Report First Half, 2024 Results on Aug 21, 2024 Simcere Pharmaceutical Group Limited announced that they will report first half, 2024 results on Aug 21, 2024 Ankündigung • Jul 17
Simcere Pharmaceutical Group Limited Announces New Drug Application of Quviviq (Daridorexant Hydrochloride Tablets) Has Been Accepted by the National Medical Products Administration The board of directors of the Simcere Pharmaceutical Group Limited announced that, on July 16, 2024, the new drug application (“NDA”) of QUVIVIQ® (daridorexant hydrochloride tablets (“Daridorexant”)), a hypnotic jointly developed by the Group and Idorsia Pharmaceuticals Ltd. (“Idorsia”), has been accepted by the National Medical Products Administration (“NMPA”) of China. Daridorexant is a dual orexin receptor antagonist (“DORA”), which blocks the binding of the wake-promoting orexin neuropeptides (orexin A and orexin B) with its receptors. Rather than assisting sleep through sedation, Daridorexant only antagonizes the activation of orexin receptors by the orexin neuropeptides and consequently, Daridorexant decreases the wake drive, allowing sleep to occur without altering the sleep architecture. Phase III overseas data of Daridorexant has been reported in The Lancet Neurology: the pivotal studies demonstrated that Daridorexant significantly improved sleep onset, sleep maintenance and self-reported total sleep time at the first and third month of treatment compared to placebo without altering the sleep architecture. In addition, the studies also showed that Daridorexant is safe and well-tolerated with no evidence of rebound insomnia, withdrawal symptoms or drug abuse, which is significantly different from those reported with benzodiazepine receptor agonists. Clinical data on Daridorexant are available for up to 12 months of continuous treatment, which can support the long-term medication of Daridorexant. In addition to improving nighttime sleep of adults with chronic insomnia disorder, Daridorexant also has a positive impact on the daytime functioning of the patients and is also the only DORA approved by the European Medicines Agency (EMA) that have an impact on daytime functioning. Previously, Daridorexant (Brand Name: QUVIVIQ) has been approved in the United States, United Kingdom, Italy, Germany, Switzerland and Canada. Ankündigung • Jul 11
Simcere Pharmaceutical Group Limited Announces Regular Approval of Xiannuoxin, an Anti-Sars-Cov-2 Innovative Drug The board of directors Simcere Pharmaceutical Group Limited announced that, on July 8, 2024, XIANNUOXIN ® (Simnotrelvir Tablets/Ritonavir Tablets (co-packaged)), an innovative drug of the Group, has been reviewed and approved by the National Medical Products Administration of China (the "NMPA") for conversions from conditional approval to regular approval. The indication is to treat adult patients infected with mild to moderate novel coronavirus (COVID-19). XIANNUOXIN became the first oral anti-SARS-CoV-2 drug which has obtained regular approval in China. XIANNUOXIN ® (Simnotrelvir Tablets/Ritonavir Tablets (co-packaged)) is an oral small molecule anti-SARS-CoV-2 innovative drug. Simnotrelvir targets 3CL protease which is essential for SARS-CoV-2 virus replication, and its combination with low-dose Ritonavir helps to slow down the metabolism and clearance of Simnotrelvir in body in order to improve the antiviral effect. On November 17, 2021, the Group entered into a technology transfer contract with Shanghai Institute of Materia Medica and Wuhan Institute of Virology, Chinese Academy of Sciences, pursuant to which, the Group obtained the development, production and commercialization rights on an exclusive basis of Simnotrelvir worldwide. The results of phase II/III clinical studies (NCT05506176) show that XIANNUOXIN can accelerate the recovery from symptoms, shorten the duration of the disease, reduce viral load of 96.9% rapidly and significantly, and demonstrate good safety. On January 28, 2023, XIANNUOXIN was conditionally approved for marketing by the NMPA and became the first domestic 3CL anti-SARS-CoV-2 innovative drug. On December 13, 2023, XIANNUOXIN was officially included in the 2023 New National Reimbursement Drug List. Ankündigung • Jun 25
Simcere Pharmaceutical Group Limited and Mabpharm Limited Announce Approval on the Marketing of ENLITUO in China by the National Medical Products Administration of China The board of directors of Simcere Pharmaceutical Group Limited announced that, ENLITUO (cetuximab beta injection), which is collaborated by theGroup and Mabpharm Limited ("Mabpharm"), has recently been approved for marketing in China by the National Medical Products Administration of China (the "NMPA"), the indication of which is to be used for the first-line therapy of RAS/BRAF wild-type metastatic colorectal cancer ("mCRC") in combination with FOLFIRI regimen. ENLITUO (product code: CMAB009) is a recombinant anti-EGFR chimeric monoclonal antibody and is a category 2.4 improved biologics. It is prepared using a specific expression process, effectively avoiding glycosylation modification that may lead to hypersensitivity. Its safety and efficacy has been confirmed from the results of various completed clinical trials. In March 2023, the drug marketing application of ENLITUO was accepted by the NMPA. On August 18, 2023, the Group entered into a cooperation agreement with Mabpharm, pursuant to which the Group obtained the exclusive commercial rights in respect of ENLITUO in Chinese mainland. ENLITUO is the first anti-epidermal growth factor receptor ("EGFR") monoclonal antibody innovative drug developed in China with independent intellectual property rights which has been approved by the NMPA for first-line therapy of mCRC. The successful launch of ENLITUO will provide high quality and affordable biological targeted remedy for Chinese patients with tumor. Ankündigung • Jun 20
Simcere Pharmaceutical Group Limited (SEHK:2096) commences an Equity Buyback for 260,976,161 shares, representing 10% of its issued share capital, under the authorization approved on June 14, 2024. Simcere Pharmaceutical Group Limited (SEHK:2096) commences share repurchases on June 18, 2024, under the program mandated by the shareholders in the Annual General Meeting held on June 14, 2024. As per the mandate, the company is authorized to repurchase up to 260,976,161 shares, representing 10% of its issued share capital. The purpose of repurchase program is to enhance the net assets and/or its earnings per share. The repurchases will be made out of the funds legally available for such purpose in accordance with the Articles, the Listing Rules and the applicable laws of Hong Kong. The authority shall expire at the earliest of the next Annual General Meeting, the date on which the next Annual General Meeting is required to be held or the date on which the authority is carried out to the full extent, unless varied or revoked in a General Meeting. As of June 14, 2024, the company has 2,609,761,618 shares in issue.
On June 14, 2024, the company announces a share repurchase program. Under the program, the company will repurchase up to CNY 500 million worth of its shares. The program will be funded from the company’s internal resources. Ankündigung • Jun 01
Simcere Pharmaceutical Group Limited Announces Phase III Clinical Study of Daridorexant Hydrochloride Tablets in the Treatment of Insomia Patients in China The board of directors of Simcere Pharmaceutical Group Limited announced that the phase III clinical study of Daridorexant hydrochloride tablets in the treatment of insomnia patients in China (NCT06010693) has read out the topline results, and has met the primary endpoint. The analysis results demonstrated that, as compared to placebo, Daridorexant hydrochloride tablets can improve various sleep-related indicators significantly, such as night-time awakenings of insomnia patients, while demonstrating good safety and tolerability at the same time. The detailed results of the Study are expected to be published in academic journals or conferences in the near future. The Group plans to submit a New Drug Application (NDA) for Daridorexant hydrochloride tablets to the National Medical Products Administration (NMPA) of China. The Study is a multi-center, randomized, double-blind and placebo-controlled phase III clinical trial and is led by Xuanwu Hospital of the Capital Medical University, which has enrolled 206 patients at 33 research centers in China. The Study completed the first patient in (FPI) on December 17, 2023 and completed the enrollment of all patients on March 15, 2024. The success of the Study has verified the efficacy and safety of Daridorexant hydrochloride tablets in insomnia patients in China, which is expected to bring new treatment options for patients. Ankündigung • May 23
Simcere Pharmaceutical Group Limited and Idorsia Pharmaceuticals Ltd. Announces the Hypnotics Daridorexant Hydrochloride Tablets Obtains the Certificate of Drug/ Product Registration Issued by the Pharmacy and Poisons Board of Hong Kong The board of directors of Simcere Pharmaceutical Group Limited announced that, on May 20, 2024, daridorexant hydrochloride tablets, a hypnotic jointly developed by the Group and Idorsia Pharmaceuticals Ltd. ("Idorsia"), obtained the certificate of drug/product registration issued by the Pharmacy and Poisons Board of Hong Kong, which allowed "QUVIVIQ TABLETS 50MG" and "QUVIVIQ TABLETS 25MG" to be sold, offered for sale, distributed and possessed in Hong Kong. Daridorexant is a dual orexin receptor antagonist ("DORA"), which blocks the binding of the wake-promoting orexin neuropeptides (orexinA and orexin B) with its receptors. Rather than assisting sleep through sedation, Daridorexant only antagonizes the activation of orexin receptors by the orexin neuropeptides and consequently, Daridorexant decreases the wake drive, allowing sleep to occur without altering the sleep architecture. Phase 3 overseas data of Daridorexant has been reported in The Lancet Neurology: the pivotal studies demonstrated that, at the first and third month of treatment compared to placebo, Daridorexant significantly improved sleep onset and sleep maintenance, and extended the self-reported total sleep time without altering the sleep architecture. In addition, the studies also showed that Daridorexant is safe and well-tolerated with no evidence of rebound insomnia, withdrawal symptoms or drug abuse, which is different from those reported with benzodiazepine receptor agonists. Clinical data on Daridorexant are available for up to 12 months of continuous treatment, which can support the long-term medication of Daridorexant. In addition to improving nighttime sleep of adults with chronic insomnia disorder, Daridorexant also has a positive impact on the daytime functioning of the patients and is also the only DORA approved by the European Medicines Agency (EMA) that have an impact on daytime functioning. Previously, Daridorexant has been approved in the United States, Great Britain, Italy, Germany, Switzerland and Canada. Ankündigung • Mar 16
Simcere Pharmaceutical Group Limited Announces New Drug Application of Suvemcitug for Injection Accepted by the National Medical Products Administration of China The board of directors of Simcere Pharmaceutical Group Limited announced that, on March 15, 2024, the New Drug Application of Suvemcitug for injection has been accepted by the National Medical Products Administration of China ("NMPA"). The indication is Suvemcitug combined with chemotherapy for the treatment of recurrent platinum-resistant ovarian, fallopian tube or primary peritoneal cancer. Suvemcitug is a new-generation recombinant humanized anti-VEGF rabbit monoclonal antibody developed by the Group and Apexigen Inc. Pre-clinical studies have shown that Suvemcitug has higher affinity and anti-tumor efficacy than Bevacizumab at the same dose in multiple tumor models. The phase Ib clinical studies of Suvemcitug conducted in China for the treatment of ovarian cancer preliminary demonstrated its favorable safety profile and efficacy signals. On January 3, 2024, the phase III clinical trial of Suvemcitug for injection combined with chemotherapy versus placebo combined with chemotherapy in patients with recurrent, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer (the SCORES study) met the primary endpoint. On March 11, 2024, the Group submitted the New Drug Application of Suvemcitug for injection to the NMPA. Ankündigung • Mar 13
Simcere Pharmaceutical Group Limited Announces Clinical Trial Approval for Sim0500 for Injection (A Humanized Gprc5d-Bcma-Cd3 Trispecific Antibody) Issued by the National Medical Products Administration Simcere Pharmaceutical Group Limited announced that, on March 12, 2024, SIM0500 for injection, a humanized GPRC5D-BCMA-CD3 trispecific antibody, which is a new investigational anti-tumor drug independently developed by the Group, has obtained the Clinical Trial Approval issued by the National Medical Products Administration of China, which is intended to be investigated in a clinical trial for relapsed or refractory multiple myeloma. SIM0500 is a humanized GPRC5D-BCMA-CD3 trispecific antibody, which is a potential best-in-class (BIC) drug for the treatment of multiple myeloma based on the preclinical data. Through the research and development platform of multispecific antibody drugs with the Group's own T-cell engagers, SIM0500 is a tumor-targeted T-cell activating drug, composed with the Group's self-developed CD3 antibody with the feature activated by low affinity and high target activation and the antibody with anti-tumor associated antigen. It has the advantages of excellent tumor-killing effect and good tolerance. SIM0500 can potentially overcome the drug resistance caused by the existing treatments, and show excellent anti-tumor activity in various animal pharmacodynamic models with different expression levels and has multiple advantages such as low effective dose and no recurrence of tumors after drug withdrawal. On March 9, 2024, the Investigational New Drug (IND) application of SIM0500 has been approved by the U.S. Food and Drug Administration (FDA). Ankündigung • Mar 12
Simcere Pharmaceutical Group Limited Announces Approval of the Investigational New Drug for SIM0500 Simcere Pharmaceutical Group Limited announced that, on March 9, 2024, the Investigational New Drug application of SIM0500, a humanized GPRC5D-BCMA-CD3 trispecific antibody, which is a new investigational anti-tumor drug independently developed by the Group, has been approved by the U.S. Food and Drug Administration. SIM0500 is intended to be investigated in a clinical trial in patients with relapsed or refractory multiple myeloma. In addition, the IND application of SIM0500 in China was accepted by the National Medical Products Administration (Guo Jia Yao Pin Jian Du Guan Li Ju) of China on January 2, 2024. Ankündigung • Mar 09
Simcere Pharmaceutical Group Limited to Report Fiscal Year 2023 Results on Mar 20, 2024 Simcere Pharmaceutical Group Limited announced that they will report fiscal year 2023 results on Mar 20, 2024 Ankündigung • Feb 20
Simcere Pharmaceutical Group Limited Provides Consolidated Earnings Guidance for the Year Ended December 31, 2023 Simcere Pharmaceutical Group Limited provided consolidated earnings guidance for the year ended December 31, 2023. The group will record a revenue of approximately RMB 6,578 million to RMB 6,638 million for the year ended December 31, 2023, representing an increase of approximately 4.0% to 5.0% as compared to the restated revenue of approximately RMB 6,324 million for the year ended December 31, 2022. The Group will record a profit attributable to equity shareholders of the company of approximately RMB 685 million to RMB 745 million for fiscal year 2023, representing a decrease of approximately 20.0% to 26.4% as compared to the restated profit attributable to equity shareholders of the company of approximately RMB 931 million for fiscal year 2022. Ankündigung • Jul 01
Simcere Pharmaceutical Group Limited (SEHK:2096) commences an Equity Buyback Plan for 266,404,561 shares, representing 10% of its issued share capital, under the authorization approved on June 15, 2023. Simcere Pharmaceutical Group Limited (SEHK:2096) commences share repurchases on June 29, 2023, under the program mandated by the shareholders in the Annual General Meeting held on June 15, 2023. As per the mandate, the company is authorized to repurchase up to 266,404,561 shares, representing 10% of its issued share capital. The purpose of repurchase program is to enhance the net assets and/or its earnings per share. The repurchases will be made out of the funds legally available for such purpose in accordance with its company’s ordinance. The authority shall expire at the earliest of the next Annual General Meeting, the date on which the next Annual General Meeting is required to be held or the date on which the authority is carried out to the full extent, unless varied or revoked in a General Meeting. As of June 15, 2023, the company had 2,664,045,618 shares in issue.
On June 26, 2023, the company initiated a Market Repurchase. Under the program, the company will repurchase up to million CNY 500 worth of its shares.