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China Medical System Licenses Botulinum Toxin from South Korea’s BMI Korea
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China Medical System Holdings (CMS; HKG: 0867) has announced the establishment of a licensing agreement with South Korea-based BMI Korea Co., Ltd. The agreement grants CMS exclusive development, regulatory filing, importing, and commercialization rights to BMI’s injectable botulinum toxin type A 100U freeze-dried powder in mainland China, Hong Kong, and…
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Junshi Biosciences Launches PD-1 Inhibitor Tuoyi for Advanced NSCLC in China
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Junshi Biosciences (HKG: 1877, SHA: 688180), a China-based biopharmaceutical company, has held a national market launch meeting for its programmed death-1 (PD-1) inhibitor, Tuoyi (toripalimab), as a first-line treatment for advanced non-squamous non-small cell lung cancer (NSCLC) in China. The drug received its sixth indication approval last month for treating…
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Betta Pharmaceuticals Raises $140.5M for Drug Industrialization Base in Zhejiang
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China’s Betta Pharmaceuticals Co., Ltd. (SHE: 300558) plans to raise RMB 1 billion ($140.5 million) through a private placement of 25,967,281 shares at RMB 38.51 ($5.41) per share. The shares will be issued to Ding Lieming, the company’s legal controller. The proceeds will be used to construct a novel drug…
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China’s Volume-Based Procurement Cuts High-Value Medical Consumables Costs by 84%
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The national high-value medical consumables alliance procurement office has released the results of the third round of volume-based procurement (VBP) for high-value medical consumables. A total of 152 manufacturers won the bids, with an average price cut of 84%. This will save approximately RMB 26 billion ($3.65 billion) in medical…
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Everest Medicines’ Xerava Approved in Hong Kong for Complicated Intra-Abdominal Infections
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Everest Medicines Limited (HKG: 1952), a China-based biopharmaceutical company, has announced that it has received market approval from the Department of Health of the Hong Kong Special Administrative Region for its antibiotic Xerava (eravacycline). The approval is for the treatment of complicated intra-abdominal infections (cIAI) in adult patients in the…
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Ascletis Pharma Doses First Patient in Phase II Study of ASC41 for NASH
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Ascletis Pharma Inc. (HKG: 1672), a China-based biopharmaceutical company, has announced that the first patient has been dosed in a 52-week Phase II clinical study of its thyroid hormone receptor β (THRβ) agonist, ASC41. The study is targeting patients with liver biopsy-proven non-alcoholic steatohepatitis (NASH). Phase II Clinical Trial DesignThe…
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Transcenta’s TST004 Receives FDA IND Clearance for IgAN Treatment
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China-based Transcenta Holding Ltd (HKG: 6628) has announced that it has received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) for TST004, a best-in-class, humanized monoclonal antibody targeting MASP2. The drug is set to be evaluated as a potential treatment for immunoglobulin A nephropathy (IgAN).…
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Connect Biopharma’s CBP-201 Shows Positive Results in Atopic Dermatitis Study
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China-based Connect Biopharmaceuticals Ltd has announced the topline results of a pivotal clinical study for its monoclonal antibody (mAb) candidate, CBP-201, targeting allergic inflammation in moderate-to-severe atopic dermatitis (AD). The study was conducted across multiple centers in China and evaluated the efficacy and safety of CBP-201, as well as the…
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Kira Pharmaceuticals Gets FDA Green Light for Phase II Study of KP104 in SLE-TMA
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Kira Pharmaceuticals, a Sino-US biotech company, has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase II clinical study of KP104. The study will assess the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of KP104 in participants with systemic lupus…
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BGI Genomics Added to US Defense Department’s Investment Ban List
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BGI Genomics Co., Ltd, a leading Chinese gene sequencing firm, has reportedly been added to the US Defense Department’s list of Chinese companies subject to an investment ban for Americans. The move follows the company’s collaboration with China’s military to develop prenatal tests, as noted by Reuters. Background and ImplicationsThe…
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Humanwell Healthcare’s Remimazolam Receives NMPA Approval for Bronchoscopy Use
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China-based Humanwell Healthcare (Group) Co., Ltd (SHA: 600079) has announced that it has received another indication approval from the National Medical Products Administration (NMPA) for its remimazolam (benzenesulfonate), a Category 1 chemical injectable. The drug is now approved for use as a sedative in support of bronchoscopy procedures. Drug Overview…
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Biosyngen’s First-in-Class Drug Candidate BRG01 Accepted for IND Review
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Biosyngen has announced that its investigational new drug (IND) filing for the first-in-class (FIC) drug candidate BRG01 has been accepted for review by the Center for Drug Evaluation (CDE). This marks a significant milestone in the development of BRG01, an innovative therapy for the treatment of relapsed/metastatic nasopharyngeal cancer (NPC).…
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Zai Lab Reports Strong Revenue Growth in 2022 Interim Results
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Chinese biopharmaceutical firm Zai Lab Ltd (NASDAQ: ZLAB, HKG: 9688) has released its 2022 interim report, indicating significant year-on-year (YOY) revenue growth. The company reported revenues of $94.9 million, up 66.37% YOY, driven by strong product sales, which increased 64.22% YOY to $93.67 million. Product Sales PerformanceThe main drivers of…
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Alphamab Oncology’s KN019 Achieves Primary Endpoint in Phase II RA Study
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Suzhou-based biotech Alphamab Oncology (HKG: 9966) has announced that its China-based Phase II KN019-201 study, assessing the safety and efficacy of its cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) immunosuppressive fusion protein KN019 in active rheumatoid arthritis (RA) patients with inadequate response to methotrexate (MTX), has reached its primary endpoint. Study Design…
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WuXi Biologics Partners with neoX Biotech to Advance AI-Driven Drug Development
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China-based Contract Research, Development, and Manufacturing Organization (CRDMO) WuXi Biologics (HKG: 2269) has entered into a long-term partnership with compatriot firm neoX Biotech, an artificial intelligence (AI) empowered company. The collaboration will focus on the process development and large-scale manufacturing of neoX’s in-house developed macromolecule drugs. Financial details of the…
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Luye Pharma’s Shandong Boan Partners with Shanghai Pharmaceutical for Biologics Manufacturing
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China-based Luye Pharma Group (HKG: 2186) has announced that its controlling subsidiary, Shandong Boan Biotechnology Co., Ltd, has entered into a partnership with compatriot firm Shanghai Pharmaceutical Group (Benxi) North Pharmaceutical Co., Ltd. The collaboration will focus on the manufacturing of biologic drugs. Financial details of the partnership were not…
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Staidson’s STSP-0601 Receives Clinical Trial Approval for Hemophilia Treatment
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Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204), a China-based pharmaceutical company, has announced that it has received another clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 biologic, STSP-0601. The approval is for the on-demand treatment of bleeding in patients with hemophilia A or B…
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Henlius Biotech Gets FDA Nod for HLX07 Clinical Study in CSCC
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Shanghai Henlius Biotech (HKG: 2696) has announced that it has received approval from the US Food and Drug Administration (FDA) to initiate a clinical study for its epidermal growth factor receptor (EGFR)-targeted monoclonal antibody (mAb), HLX07, in patients with locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC). This marks…
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Suzhou Novoprotein Lists on Shanghai’s STAR Market for R&D Expansion
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Suzhou Novoprotein Scientific Co., Ltd, a China-based provider of protein technology and application solutions, has successfully completed its initial public offering (IPO) on the Shanghai Stock Exchange’s Sci-Tech Innovation Board (STAR). The net proceeds from the IPO will be used to advance the company’s capabilities in diagnostics raw materials and…
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Rainmed Medical’s caFFR System Receives TGA Approval for Coronary Disease Diagnosis
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China-based Rainmed Medical Limited has announced that it has received market approval from Australia’s Therapeutic Goods Administration (TGA) for its in-house developed coronary angiography-based fractional flow reserve system (caFFR System). The approval marks another significant milestone for the company in expanding its global footprint. Product Overview and BenefitsThe caFFR System…
