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Coherus and Junshi Biosciences Await FDA Decision on Toripalimab After Inspection
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US-based Coherus Biosciences Inc., (NASDAQ: CHRS) has disclosed that the US FDA has recently completed the long-awaited pre-licensing inspection of its partner Junshi Biosciences Ltd’s (HKG: 1877, SHA: 688180) manufacturing site for toripalimab in China. The inspection resulted in “three observations” from the FDA, which Coherus described as “readily addressable.”…
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Betta Pharmaceuticals’ Befotertinib Approved by China’s NMPA for EGFR-Mutated NSCLC
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China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) has announced receiving market approval from the National Medical Products Administration (NMPA) for its third-generation epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI), befotertinib, for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with the EGFR T790M mutation that has…
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Antengene’s Xpovio Combination Therapy Approved for Reimbursement in Australia for R/R MM
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China-based biotech Antengene Corp., Ltd (HKG: 6996) has revealed that Australia’s Pharmaceutical Benefits Scheme (PBS) will reimburse the firm’s Xpovio (selinexor) plus bortezomib and dexamethasone combination therapy for the treatment of adult patients with relapsed/refractory multiple myeloma (R/R MM), specifically for those who have previously received one other therapy. This…
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Amoytop Biotech and Fosun Pharmaceutical Ink Licensing Deal for Pegfilgrastim in China
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Xiamen-based Amoytop Biotech Co. Ltd (SHA: 688278) has announced a licensing agreement with Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), granting Fosun exclusive promotion and marketing rights to Amoytop’s pegfilgrastim (Y shape) in mainland China. As part of the deal, Fosun is paying RMB 63 million (USD…
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HighField Biopharmaceuticals Presents Promising HF1K16 Data at ASCO Annual Meeting
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Hangzhou-based biotech HighField Biopharmaceuticals has revealed the publication of an abstract at this year’s American Society of Clinical Oncology (ASCO) annual meeting, showcasing preliminary data from a Phase Ia trial for its lead pipeline candidate, HF1K16. The trial, which focused on refractory metastatic cancer patients, indicated that HF1K16 was well…
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Luzhu Biotechnology’s Herpes Zoster Vaccine LZ901 Concludes Phase II Study
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Beijing Luzhu Biotechnology Co., Ltd (HKG: 2480), a leading maker of human vaccines and therapeutic biologics, has announced the successful conclusion of a Phase II clinical study for its herpes zoster vaccine, LZ901. The drug demonstrated statistically and clinically meaningful data, along with a good safety profile. The company is…
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CMS Receives NMPA Approval for Tildrakizumab for Plaque Psoriasis Treatment
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China Medical System Holdings (CMS; HKG: 0867) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its drug tildrakizumab, which will be used to treat adult patients with moderate to severe plaque psoriasis suitable for systemic therapy or phototherapy. Tildrakizumab: A Humanized Monoclonal Antibody for PsoriasisTildrakizumab…
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Cutia Therapeutics Lists on HKEX with HKD527 Million IPO for Dermatology Therapies
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Dermatology therapy developer Cutia Therapeutics (HKG: 2487) has successfully made its initial public offering (IPO), issuing 21.3 million shares at a price of HKD24.75 per share, raising a total of HKD527 million (USD 67.3 million). Company Background and Focus on Skin DiseasesFounded in 2019, Cutia is dedicated to the research…
