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Sihuan Pharmaceutical’s Birociclib NDA Accepted for Review by China’s NMPA
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China’s Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) has announced that the National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for birociclib, a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, for review. The drug is intended for the treatment of HR+/HER2- advanced breast cancer in patients who have…
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Bloomage Biotech Terminates Joint Venture with Medytox Inc. for Botulinum Toxin Development
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China-based Bloomage Biotech (SHA: 688363) has revealed that a termination agreement has been signed with South Korea-headquartered Medytox Inc., and its subsidiary Bloomage Cayman, along with the joint venture (JV) Medybloom Ltd. This termination signifies the cancellation of two key agreements. Cancellation of Joint Venture and Sole Agency AgreementsThe first…
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Jointown Medical’s COVID-19 Drug Candidate SHEN211 Accepted for Review by NMPA
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China-based Jointown Medical Devices Group Co., Ltd (SHA: 600998) has announced that its clinical trial filing for the Category 1 COVID-19 drug candidate, SHEN211, has been accepted for review by China’s National Medical Products Administration (NMPA). SHEN211 is an oral broad-spectrum anti-novel coronavirus non-peptide 3CL protease inhibitor, co-developed by a…
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Hansoh Pharmaceutical Receives NMPA Approval for Generic Ofev (Nintedanib)
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of Boehringer-Ingelheim’s Ofev (nintedanib). This development marks a significant step for the company in expanding its portfolio of generic drugs. Nintedanib’s Approval History…
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Pilot Gene Technology Secures $13.8 Million in Series B Financing for Diagnostic Expansion
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China-based diagnostic reagents specialist, Pilot Gene Technology (Hangzhou) Co., Ltd, has reportedly raised RMB 100 million (USD 13.8 million) in a Series B financing round led by Simao Capital. The funds raised will be directed towards the research and development of fully automated instruments and equipment, including Point-of-Care Testing (POCT),…
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Chia Tai Tianqing’s Generic Entresto Approved by NMPA, Launch Expected in 2026
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The National Medical Products Administration (NMPA) website has indicated that Chia Tai Tianqing’s generic version of Swiss pharmaceutical giant Novartis’s heart failure therapy Entresto (sacubitril, valsartan) has been approved for marketing. However, the generic version will not be launched until 2026 when the originator’s patent expires. This follows the approval…
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Novo Nordisk’s Esperoct on Track for Priority Review in Hemophilia A Treatment
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The Center for Drug Evaluation (CDE) website has indicated that Denmark-based Novo Nordisk’s (NYSE: NVO) Esperoct (turoctocog alfa pegol) is on track for priority review for the treatment of hemophilia A in adults and children. The drug is indicated for on-demand treatment and control of bleeding events, perioperative management, and…
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Bayer Subsidiary’s Parkinson’s Treatment Bemdaneprocel Shows Promise in Phase I
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Germany-based Bayer (ETR: BAYN) has announced that its subsidiary BlueRock Therapeutics’ open-label Phase I study for cell therapy bemdaneprocel in Parkinson’s disease has successfully met the safety and tolerability primary endpoint. After one year, no bemdaneprocel-related serious adverse events (SAEs) were reported. Additionally, dose-dependent improvement in motor symptoms and evidence…
