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SSY Group’s Blonanserin and Paracetamol Approved by China’s NMPA
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China-based SSY Group Limited (HKG: 2005) has announced receiving market approvals from the National Medical Products Administration (NMPA) for its generic versions of blonanserin, paracetamol, mannitol, and levofloxacin. Notably, the generic versions of blonanserin and paracetamol are the first of their kind to be approved in China. Drug Details and…
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Innovent Biologics’ Tyvyt Approved for First-Line Esophageal Squamous Cell Carcinoma
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The National Medical Products Administration (NMPA) website indicates that China-based Innovent Biologics, Inc. (HKG: 1801) has received approval for a new indication of its PD-1 inhibitor Tyvyt (sintilimab) for the treatment of first-line esophageal squamous cell carcinoma (ESCC). This marks the fifth indication approval for the drug in China. Drug…
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InnoCare and Keymed Biosciences’ CCR8-Targeted mAb CM369 Accepted by NMPA
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China-based InnoCare (HKG: 9969) and Keymed Biosciences Inc. (HKG: 2162) announced that an Investigational New Drug (IND) filing for CM369, a monoclonal antibody targeting C-C chemokine receptor 8 (CCR8), has been accepted for review by the National Medical Products Administration (NMPA). This potential first-in-class drug is designed to enhance tumor-targeted…
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Henlius Biotech Begins Global Phase III Trial for Denosumab Biosimilar HLX14
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China-based Shanghai Henlius Biotech Inc. (HKG: 2696) has announced the first patient dosing in a global multi-center Phase III clinical study for its drug candidate HLX14, a biosimilar of Amgen’s Prolia/Xgeva (denosumab). The study targets the treatment of postmenopausal osteoporosis in women at high risk of fracture. Clinical Trial DesignThe…
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Cellular Biomedicine Group’s C-CAR039 Receives NMPA Approval for B-Cell NHL Study
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China-based Cellular Biomedicine Group Inc. (CBMG), a private company following a merger deal in February last year, has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase Ib clinical study of its chimeric antigen receptor (CAR)-T cell therapy C-CAR039 in patients with relapsed or refractory…
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Walvax’s mRNA Vaccine AWcorna Shows Superior Immune Response in Phase III Trial
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Walvax Biotechnology Co., Ltd’s (SHE: 300142) mRNA vaccine against SARS-CoV-2, named AWcorna, has reached the Phase III stage in multiple trial centers. The randomized trial (ChiCTR2100053701), led by the Academy of Military Medical Sciences and the Guangzhou Institute of Respiratory Health, enrolled 300 adults who had previously received two doses…
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Sichuan Meida’s Phentolamine Gains Priority Review for Pheochromocytoma Treatment
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The Center for Drug Evaluation (CDE) website indicates that Sichuan Meida Kangjiale Pharmaceutical Co., Ltd’s phentolamine has obtained priority review status as a “clinically urgent, in-shortage drug.” This non-selective alpha-adrenoceptor antagonist is used to control paroxysmal hypertension in patients with pheochromocytoma before and during surgery. Clinical Application and MechanismPhentolamine is…
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Mabwell’s 6MW3511 Accepted by NMPA for Advanced Solid Tumor Treatment
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China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) announced that a clinical trial filing for its 6MW3511 has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant milestone for the company’s innovative oncology pipeline. Drug Mechanism and Innovation6MW3511 is a bifunctional protein linking an…
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Takeda’s Obizur Accepted by China’s NMPA for Acquired Hemophilia A Treatment
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Takeda Pharmaceutical Co., Ltd’s (NYSE: TAK, TYO: 4502) China unit announced that a New Drug Application (NDA) filing for its Obizur (susoctocog alfa) has been accepted for review by the National Medical Products Administration (NMPA). The drug is intended for use as an on-demand treatment and prevention of bleeding in…
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Sirnaomics’ STP705 Shows Promising Results in Skin Cancer Trial
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Sino-US siRNA therapy developer Sirnaomics Ltd (HKG: 2257) announced the peer-reviewed publication of Phase IIa clinical study results of its lead therapeutic candidate, STP705, for the treatment of skin cancer, in the May 2022 issue of the Journal of Drugs in Dermatology (the “JDD”). Clinical Trial ResultsThe single-center, open-label, dose-escalation…
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Yabao Pharmaceutical’s YBSW015 Gets Australian Ethical Approval for COVID-19 Trial
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China-based Yabao Pharmaceutical Group Co., Ltd (SHA: 600351) has announced that it has received clinical trial ethical approval in Australia to conduct a Phase I clinical study for its YBSW015, a bispecific neutralizing antibody against SARS-CoV-2 developed to treat COVID-19 infection. Mechanism of ActionYBSW015 is a bispecific antibody (BsAb) targeting…
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Suzhou Zelgen’s JAK Inhibitor Jacktinib Gets NMPA Green Light for COVID-19 Trial
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China-based Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 Janus kinase (JAK) inhibitor, jacktinib, in patients with severe COVID-19. Mechanism of ActionJacktinib works by blocking the signal transducer…
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Sichuan Kelun’s KL340399 Wins NMPA Approval for Solid Tumor Trials
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China-based Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its next-generation small-molecule STING agonist, KL340399. The approval allows the company to proceed with trials for locally advanced, recurrent, or metastatic solid tumors suitable for intratumoral injection. Drug Mechanism…
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Jiangsu Hengrui Medicine’s SHR4640 Receives NMPA Approval for Gout Trial
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 innovative gout drug SHR4640. The study will evaluate the drug in combination with febuxostat for hyperuricemia in gout patients. Drug MechanismSHR4640 is…
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Beijing Aosaikang’s ASKG315 Receives NMPA Approval for Solid Tumor Trial
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Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) announced that its clinical trial application for ASKG315, an in-house developed recombinant human interleukin-15 prodrug Fc fusion protein, has been accepted by China’s National Medical Products Administration (NMPA). This marks a significant milestone for the company’s oncology pipeline. Drug Mechanism and InnovationASKG315 is…
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Hansoh Pharmaceutical’s Ameile Accepted for UK Regulatory Review
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) announced that a Marketing Authorization Application (MAA) for its epidermal growth factor receptor (EGFR) inhibitor Ameile (almonertinib) has been accepted for review by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). The application seeks approval for Ameile as a first-line treatment…
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Alphamab Oncology Doses First Patient in Phase I Trial for PD-L1/OX40 Bispecific Antibody KN052
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China-based Alphamab Oncology (HKG: 9966) has announced the dosing of the first patient in a Phase I clinical trial in China (KN052-CHN-001) for its pipeline candidate KN052. This bispecific antibody (BsAb) targets programmed-death ligand 1 (PD-L1) and OX40 and is being evaluated as a treatment for general advanced solid tumors.…
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Walvax Biotechnology Halts EV71 Vaccine Development Amid Changing Disease Trends
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China’s Walvax Biotechnology Co., Ltd (SHE: 300142) has announced the decision to terminate a clinical study and end development for its recombinant enterovirus 71 (EV71) virus vaccine (Pichia pastoris). The company’s press release states that the recombinant EV71 vaccine, which first entered clinical trials in China in June 2019, was…
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Jiangsu Hengrui Medicine’s Hetrombopag Olamine Receives FDA Orphan Drug Designation for ITP
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that it has received orphan drug designation (ODD) status from the US FDA for its hetrombopag olamine as a treatment for primary immune thrombocytopenia (ITP). The drug was approved in China in June 2021 for the treatment of ITP in…
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Zai Lab Ltd Makes FcRn Antagonist Efgartigimod Available for Myasthenia Gravis Treatment
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Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) has announced the availability of efgartigimod, the world’s first FcRn antagonist, via the Bo’Ao Lecheng Medical Tourism Pilot Zone for the treatment of myasthenia gravis (MG). Understanding Myasthenia GravisMyasthenia gravis is a rare and chronic autoimmune disease caused by the dysfunction of nerve…
