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3D Medicines’ Envafolimab Earns NMPA Breakthrough Designation for TMB-H Solid Tumors
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3D Medicines (HKG: 1244), a biopharmaceutical company based in China, has announced that its envafolimab has been granted Breakthrough Therapy Designation (BTD) by China’s National Medical Products Administration (NMPA) for an additional indication. The PD-L1 monoclonal antibody (mAb) is now indicated for the treatment of unresectable or metastatic solid tumors…
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Jiangsu Simcere’s Edaravone, Borneol Sublingual Tablet Earns FDA Breakthrough Therapy Designation for Stroke Treatment
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HONG KONG—Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) has announced that it has received Breakthrough Therapy Designation (BTD) from the US Food and Drug Administration (FDA) for its edaravone, borneol sublingual tablet, intended for the treatment of acute ischemic stroke (AIS). The edaravone, borneol sublingual tablet is a solid oral…
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Jiangsu Simcere Acquires Exclusive Rights to TargetRx’s TGRX-326 in Licensing Deal
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SHENZHEN—Shenzhen TargetRx, Inc., a leading developer of small-molecule kinase inhibitors, has entered into a licensing agreement with Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096), a fellow Chinese pharmaceutical company. The deal concerns TargetRx’s TGRX-326, an ALK/ROS1 dual receptor tyrosine kinase inhibitor currently at the clinical stage. According to the agreement,…
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Jiangsu Simcere and AnDiConBio’s Anti-Influenza Drug ADC189 Doses First Patient in Phase III Study
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JIANGSU—In a significant development for the pharmaceutical industry, Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096), in collaboration with AnDiConBio, has initiated a Phase III clinical study for their anti-influenza drug, ADC189. This study marks a crucial step in the advancement of pediatric treatment options, with the first patient dosed in…
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Jiangsu Simcere Pharmaceutical Gets NMPA Green Light for SIM0508 Clinical Trial in Advanced Solid Tumors
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Jiangsu Simcere Pharmaceutical Co., Ltd, a Chinese pharmaceutical company listed in Hong Kong (HKG: 2096), has announced that it has obtained clinical trial approval from China’s National Medical Products Administration (NMPA) for its pipeline candidate SIM0508. This molecule is a DNA polymerase theta (Pol theta) small molecule inhibitor, which is…
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R&D Investments and Operating Cash Flows Highlight Resilience in Simcere Pharma’s H1 2024 Financial Report
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Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) has reported its financial results for the first half of 2024, with revenues amounting to RMB 3.114 billion, marking a 7.9% year-on-year (YOY) decline. The innovative drug business contributed RMB 2.203 billion, representing approximately 70.7% of total revenues and reflecting an 8.7% YOY…
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Jiangsu Simcere Pharmaceutical’s Quviviq Approval Application Accepted for Review by China’s NMPA
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Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096), in partnership with Swiss pharmaceutical firm Idorsia Pharmaceuticals Ltd, has achieved a significant milestone with the acceptance of their marketing approval filing for Quviviq (daridorexant) by China’s National Medical Products Administration (NMPA). Quviviq is an innovative anti-insomnia drug that has already gained commercial…
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Simcere Pharmaceutical’s COVID-19 Therapy Xiannuoxin Earns Full Approval in China
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Simcere Pharmaceutical Group (HKG: 2096), a biopharmaceutical company based in China, has announced that its small-molecule COVID-19 therapy, Xiannuoxin (simnotrelvir, ritonavir), has received regular approval from the Chinese regulatory authorities, converting from its previous conditional approval status. This makes Xiannuoxin the first COVID-19 therapy of its kind to achieve full…
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Jiangsu Simcere Pharmaceutical Wins NMPA Nod for Biosimilar Version of Erbitux
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Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096), a Chinese pharmaceutical company, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for CMAB009, a biosimilar of Merck KGaA/Bristol-Myers Squibb’s (BMS) cetuximab, which is marketed under the trade name Erbitux. The EGFR-targeted monoclonal antibody (mAb) was…
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AnDiConBio Secures Over RMB 200 Million in Series A Financing to Advance Respiratory and Pain Therapies
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AnDiConBio, a Zhejiang-based innovative pharmaceutical company specializing in respiratory infections and pain management, has reportedly secured over RMB 200 million in a Series A financing round. The round was led by Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096), Huajin Investment, and Huajin Dadao Investment, with participation from Cowin Capital, Wenzhou…
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Simcere Pharma’s Suvemcitug Shows Positive Results in Platinum-Resistant Ovarian Cancer Study
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Simcere Pharmaceutical Group (HKG: 2096), a biopharmaceutical company based in China, has presented updated data from the SCORES study for its drug candidate suvemcitug at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Suvemcitug, also known as sevacizumab; APX-003; BD-0801, is being studied in platinum-resistant ovarian cancer. The…
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Simcere Pharma’s Anti-Insomnia Drug Daridorexant Meets Primary Endpoint in Phase III Clinical Trial
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Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) has announced topline results from a Phase III clinical study for Quviviq (daridorexant), an anti-insomnia drug co-developed with Idorsia Pharmaceuticals Ltd, a Swiss pharmaceutical company. The study evaluated the efficacy and safety of daridorexant in Chinese patients with insomnia and successfully met its…
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Simcere Pharmaceutical’s Quviviq Secures Hong Kong Marketing Approval for Insomnia Treatment
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Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) has announced that it has received marketing approval from the Hong Kong health authorities for Quviviq (daridorexant), an anti-insomnia drug co-developed with Idorsia Pharmaceuticals Ltd. The dual orexin receptor antagonist (DORA) will now be available in 50mg and 20mg dosages in the region,…
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Simcere Pharmaceutical’s SIM0500 Earns FDA Fast-Track Designation for Multiple Myeloma
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Simcere Pharmaceutical Group (HKG: 2096), a leading China-based pharmaceutical company, has announced that its trispecific antibody SIM0500 has received fast-track designation from the US Food and Drug Administration (FDA) for the treatment of multiple myeloma (MM). The drug targets GPRC5D, BCMA, and CD3, and is intended for patients who have…
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Simcere Pharmaceutical Reports 4.5% Revenue Growth in 2023 Amid Shifts in Profitability
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Simcere Pharmaceutical Group (HKG: 2096), based in China, has released its 2023 financial performance report, revealing revenues of RMB 6.6 billion (USD 920 million) for the year, marking a 4.5% increase year-on-year (YOY). Within this total, drug sales and promotion services contributed RMB 6.567 billion, while out-licensing and research and…
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Simcere Pharmaceutical’s Suvemcitug Files for Approval in China for Recurrent Ovarian Cancer
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Simcere Pharmaceutical Group (HKG: 2096), a biopharmaceutical company based in China, has announced that an approval filing for its drug candidate suvemcitug (also known as sevacizumab; APX-003; BD-0801) has been submitted in China and accepted for review by the National Medical Products Administration (NMPA). The filing seeks the first indication…
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Simcere Pharmaceutical Gets NMPA Approval for Clinical Study of Trispecific Antibody SIM0500
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Simcere Pharmaceutical Group (HKG: 2096), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for SIM0500, a trispecific antibody targeting GPRC5D, BCMA, and CD3. This molecule is intended for the treatment of recurrent or…
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Simcere Secures FDA Approval for Clinical Study of Trispecific Antibody SIM0500 in Multiple Myeloma
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Simcere Pharmaceutical Group (HKG: 2096), based in China, has received approval from the U.S. Food and Drug Administration (FDA) to initiate a clinical study for its trispecific antibody, SIM0500, which targets GPRC5D, BCMA, and CD3. This innovative molecule is being evaluated as a treatment for recurrent or refractory multiple myeloma…
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Simcere Pharmaceutical’s Oncology Unit Raises RMB 970 Million to Advance Cancer Drug Development
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Simcere Pharmaceutical Group (HKG: 2096) has announced that its oncology subsidiary, Simcere Zaiming Pharmaceutical Co., Ltd., has secured RMB 970 million (USD 135 million) in financing, elevating the company’s market valuation to RMB 8.47 billion (USD 1.2 billion). The funding round was led by CS Capital, which contributed RMB 800…
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Alphamab and 3D Medicines License Envafolimab Rights to Glenmark for Multiple Regions
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Alphamab Oncology (HKG: 9966) and 3D Medicines (HKG: 1244), two Chinese pharmaceutical companies, have announced a licensing agreement with Glenmark Pharmaceuticals Ltd (NSE: GLENMARK). The agreement grants the Indian company exclusive development and commercialization rights to the co-developed drug envafolimab (KN035) in India, Asia Pacific (excluding Singapore, Thailand, Malaysia), Middle…
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Simcere Pharmaceutical Group Gets NMPA Green Light for USP1 Inhibitor SIM0501
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Simcere Pharmaceutical Group (HKG: 2096) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its cancer drug candidate SIM0501, intended for the treatment of advanced solid tumors. SIM0501 is a small-molecule inhibitor of ubiquitin specific peptidase 1 (USP1), a protein that is…
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Simcere Secures Approval for Local Manufacturing of Cosela, Boosting Patient Access
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China-based Simcere Pharmaceutical Group (HKG: 2096) has received supplementary filing approval for its drug Cosela (trilaciclib), enabling the transfer of its manufacturing technology from G1 Therapeutics to Simcere’s facility in Hainan. This transition paves the way for localized production of the CDK4/6 inhibitor, enhancing patient accessibility across the region. Trilaciclib,…
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Lynk Pharmaceuticals Initiates Phase III Clinical Trial for Rheumatoid Arthritis Drug in China
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China-based Lynk Pharmaceuticals Co., Ltd has announced that the first patient has been dosed in a Phase III clinical study for its drug candidate LNK01001, which is being developed to treat rheumatoid arthritis (RA). The trial is supported by Lynk’s commercialization partner, Simcere Pharmaceutical Group (HKG: 2096), and is being…
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Simcere Pharmaceutical’s SIM0501 Receives FDA Approval for Advanced Solid Tumor Clinical Trial
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Simcere Pharmaceutical Group (HKG: 2096) has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its cancer drug candidate SIM0501, which targets advanced solid tumors. The company’s clinical filing was previously accepted for review by China’s National Medical Products Administration (NMPA) in…
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Simcere Secures NMPA Approval for Edaravone Sublingual Tablets Targeting Post-Stroke Cognitive Impairment
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Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) has received clinical trial approval from the National Medical Products Administration (NMPA) for its edaravone, borneol sublingual tablets, targeting post-stroke cognitive impairment (PSCI) in patients suffering from acute ischemic stroke (AIS). The edaravone, borneol sublingual tablet is a solid oral formulation designed for…
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Simcere Pharmaceutical Secures Rights to Develop Rademikibart in China
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China’s Simcere Pharmaceutical Co., Ltd (HKG: 2096) has entered into an agreement to acquire the rights to develop the anti-inflammatory monoclonal antibody rademikibart from US-based Connect Biopharma Holdings Ltd (NASDAQ: CNTB). The deal, negotiated with Connect Bio’s China-based subsidiaries, Connect Biopharma Hong Kong Ltd and Suzhou Connect Biopharma Co., Ltd,…
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Simcere Pharmaceutical Group Secures Full Approval for Cosela in China
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Simcere Pharmaceutical Group (HKG: 2096), a leading pharmaceutical company based in China, has announced that the National Medical Products Administration (NMPA) has converted the first conditional approval in China for Cosela (trilaciclib) to full approval. Originally discovered by US biotech G1 Therapeutics Inc, trilaciclib was in-licensed by Simcere in August…
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Alphamab Oncology and 3D Medicines Gain FDA Approval for Envafolimab Phase III Trial
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Partners Alphamab Oncology (HKG: 9966) and 3D Medicines (HKG: 1244) have announced that they have received approval from the US Food and Drug Administration (FDA) to conduct a Phase III clinical study for envafolimab (KN035) in proficient mismatch repair (fMMR) advanced or recurrent endometrial cancer combined with lenvatinib. This approval…
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Simcere’s SIM0237 Receives NMPA Approval for Bladder Cancer Trial
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China-based pharmaceutical innovator Simcere Pharmaceutical Group (HKG: 2096) has announced the receipt of an additional clinical trial approval from the National Medical Products Administration (NMPA) for its investigational bispecific antibody (BsAb), SIM0237. This molecule, targeting both PD-L1 and IL-15, is set to be evaluated as a novel treatment for non-muscular…
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Simcere Pharmaceutical Secures Exclusive Rights to AnDiCon’s Anti-Influenza Candidate ADC189
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China-based Simcere Pharmaceutical Group (HKG: 2096) has announced a strategic collaboration agreement with domestic firm AnDiCon Bio. The collaboration centers on AnDiCon’s pipeline candidate, ADC189, with Simcere now holding exclusive commercialization rights for the drug in China. ADC189: A Novel Anti-Influenza TreatmentADC189 is an innovative anti-influenza polymerase acidic protein (PA)…
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Hong Kong Government Partners with AstraZeneca, Tigermed, and Simcere to Boost Innovation
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The government of the Hong Kong Special Administrative Region has entered into significant partnership agreements with AstraZeneca (AZ, NASDAQ: AZN), Tigermed (SHE: 300347), Simcere (HKG: 2096), and a total of 20 other companies. This initiative is set to generate cumulative investments of HKD 30 billion (approximately USD 3.83 billion) in…
