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Staidson Receives NMPA Approval for Clinical Trial of STSA-1301 in Primary Immune Thrombocytopenia
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Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204), a China-based pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its STSA-1301 subcutaneous injection. The drug is targeted for the treatment of primary immune thrombocytopenia (ITP), a condition characterized by a low…
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Allist Pharmaceuticals’ Furmonertinib Receives FDA Breakthrough Therapy Designation for NSCLC
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Shanghai-based biotech Allist Pharmaceuticals Co., Ltd (SHA: 688578) has announced that it has received breakthrough therapy designation (BTD) from the US FDA for its drug candidate furmonertinib. This designation underscores the drug’s potential as a treatment for previously untreated, locally advanced, or metastatic non-small cell lung cancer (NSCLC) with epidermal…
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Yirui Pharmaceutical’s YR001 Completes Successful Phase I Clinical Study in the US
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Hangzhou-based Yirui Pharmaceutical Technology Co., Ltd has announced the successful conclusion of a Phase I clinical study for its YR001 external preparation in the United States. The topical ointment, which is a small molecule Kv1.3 inhibitor, showed a good safety and tolerability profile in all subjects tested. YR001: Indications and…
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Danyang Huichuang Secures Over USD 13.7 Million in Series B Funding for fNIRS Development
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Danyang Huichuang Medical Equipment Co., Ltd, a China-based specialist in functional near-infrared spectroscopy (fNIRS), has reportedly secured over RMB 100 million (USD 13.7 million) in a Series B financing round. The funding round was led by Zhongke Haichuang, with additional contributions from Addor Capital, and existing investors Tsingyua Capital and…
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CDE Grants Priority Review to LaNova’s LM-302, Roche’s Alectinib, and Alphamab’s KN026
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China’s Center for Drug Evaluation (CDE) has indicated that LaNova Medicines’ LM-302, Roche’s (SWX: ROG) alectinib, and Alphamab Oncology’s HER2-targeted bispecific antibody (BsAb) KN026 (anbenitamab) are set for priority reviews. This designation is a significant step that could expedite the availability of these drugs to patients in need. LM-302: A…
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Boan Biotech Enrolls First Patient in Phase III Study for Opdivo Biosimilar BA1104 in China
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Boan Biotech (HKG: 6955), a biopharmaceutical company based in China, has announced the enrollment of the first patient in a Phase III clinical study for its drug candidate BA1104. This marks a significant milestone as BA1104 becomes the first biosimilar to Opdivo (nivolumab) to reach the Phase III stage in…
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China’s Health Authorities Release Third List of 41 Drugs for Recommended Generic Development
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The National Health Commission (NHC), National Healthcare Security Administration (NHSA), National Medical Products Administration (NMPA), and other bureaus have jointly released a third list of drugs recommended for generic development. This list comprises a total of 41 drugs, which are now open for public comment for a period of 5…
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CSPC Pharmaceutical Group Gains NMPA Approval for Bivalent COVID-19 mRNA Vaccine Study
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a prominent pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its bivalent COVID-19 mRNA vaccine SYS6006.32, targeting the XBB.1.5 and BQ.1 variants. Vaccine Development and ImmunogenicitySYS6006.32 is…
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