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CSPC’s Antibody-Drug Conjugate SYS6002 Gains CDE Approval for Clinical Study
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China-based CSPC Pharmaceutical Group Co., Ltd (HKG: 1093) announced that it has received approval from the Center for Drug Evaluation (CDE) to conduct a clinical study for SYS6002, an antibody-drug conjugate (ADC) developed in-house by its subsidiary CSPC Jushi Biopharmaceutical Co., Ltd. The intended indication for SYS6002 is advanced solid…
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Luye Pharma’s Long-Acting IL-4Rα Antibody BA2101 Gains CDE Approval
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China-based Luye Pharma Group (HKG: 2186) announced that its controlling subsidiary Shandong Boan Biotechnology Co., Ltd has received clinical trial approval from the Center for Drug Evaluation (CDE) for its in-house developed long-acting monoclonal antibody (mAb) BA2101. BA2101: Drug Profile and MechanismBA2101 is an innovative long-acting human monoclonal IgG4 antibody…
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Ausper Biopharma’s COVID-19 Nasal Spray Antibody Gets NMPA Approval
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Ausper Biopharma Inc., a Hangzhou-based developer of hepatitis B virus (HBV) drugs, announced that its joint venture Chongqing Mingdao Haoyue Biotechnology Co., Ltd has obtained clinical trial approval from the National Medical Products Administration (NMPA) for its nasal spray COVID-19 neutralizing antibody MY-586. Drug Mechanism and AdvantagesMY-586 is described as…
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Merck’s Q3 Sales Rise on Key Drug Performances, China Growth
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US-based Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) reported its Q3 2022 financial results, with sales reaching USD 45.45 billion over the first nine months, marking a 32% year-on-year (YOY) growth excluding exchange rate impact. For the three months of Q3, the company generated USD 14.96 billion in sales,…
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Salubris Partners with Anlong Bio for Small Nucleic Acid Drugs in Hypertension
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China’s Shenzhen Salubris Pharmaceuticals Co., Ltd (SHE: 002294) has entered into a partnership with Beijing Anlong Biopharmaceutical Co., Ltd to jointly research and develop small nucleic acid drugs for the treatment of hypertension. The collaboration aims to leverage the combined expertise of both companies in the field of nucleic acid…
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Ocumension Initiates Second Phase III Denali Study for OT-301 in US
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China-based Ocumension Therapeutics (HKG: 1477) announced the initiation of a second Phase III Denali study for its OT-301 (NCX 470) in the US, with the first patient enrolled on November 9. This marks a significant milestone in the clinical development of the drug, which is designed to lower intraocular pressure…
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Nankai University Establishes Postgraduate Practice Base with China Resources Biopharma
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The College of Pharmacy at Nankai University has established a postgraduate practice base at the research and development (R&D) center of China Resources Biopharmaceutical Co., Ltd. This collaboration includes the appointment of multiple senior R&D and technical staff from China Resources Biopharmaceutical as new professional tutors for master’s degree programs…
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Yiming and WZ Biosciences Collaborate on mRNA Process Platform
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China-based Yiming (Beijing) Cell Biotechnology Co., Ltd, also known as Ubrigene, and compatriot firm WZ Biosciences Inc., announced the establishment of a refined mRNA process platform. The collaboration offers comprehensive services ranging from gene synthesis, efficient in vitro transcription template preparation, plasmid linearization, IVT mRNA synthesis, purification, and quality inspection,…
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BeiGene’s Brukinsa Receives Multiple Marketing Approvals in Latin America
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China-based biotech BeiGene Inc. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) announced receiving multiple marketing approvals in Latin America for its Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib). The in-house developed drug is now approved for various indications across several Latin American countries. Approvals and IndicationsBrukinsa has received approval to treat…
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Zhaoke Ophthalmology Completes Enrollment for Intrarosa Phase III Trial
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China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622) has completed patient enrollment in a Phase III clinical study for Intrarosa (prasterone). The drug is a vaginal non-estrogen treatment for moderate to severe painful sex due to menopause. Phase III Trial DesignThe multi-center, randomized Phase III…
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JW Therapeutics Partners with 2seventy bio to Develop Cell Therapy Platform
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China-based JW Therapeutics (HKG: 2126) has entered into a partnership with US firm 2seventy bio Inc. (NASDAQ: TSVT) to establish a cell therapy translational and clinical development platform. The collaboration aims to enhance the development of T-cell therapies in mainland China, Hong Kong, and Macau. Initial Focus on MAGE-A4 T-Cell…
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Ascletis Pharma Files IND for Monkeypox Antiviral ASC10 with FDA
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China-based Ascletis Pharma Inc. (HKG: 1672) announced the submission of an Investigational New Drug (IND) filing with the US FDA for its ASC10, an oral antiviral drug candidate targeting the viral polymerase of the monkeypox virus. This marks a significant step in the development of new treatments for monkeypox, a…
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Simcere Receives FDA Clearance for Clinical Study of SIM0237
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China-based Simcere Pharmaceutical Group (HKG: 2096) announced that it has received clearance from the US FDA to conduct a clinical study for its SIM0237, an in-house developed bispecific antibody (BsAb) targeting programmed-death ligand 1 (PD-L1) and interleukin-15 (IL-15). The molecule is intended for the treatment of locally advanced, unresectable metastatic…
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Ping An Life Insurance Reports Q3 Results, Advances Healthcare Strategy
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Ping An Life Insurance Company of China Ltd released its 2022 Q3 financial report, showing a 6.3% year-on-year (YOY) decrease in net profits to RMB 76.46 billion (USD 10.59 billion). The decline was attributed to the short-term impact of pandemic disruptions and a volatile capital market. However, the company’s operational…
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United Labs Gains NMPA Approval for Ozempic Biosimilar IND
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Hong Kong-based United Laboratories International Holdings Ltd (HKG: 3933) announced that the National Medical Products Administration (NMPA) has approved an Investigational New Drug (IND) application for its biosimilar version of Novo Nordisk’s Ozempic (semaglutide). Ozempic is a novel long-acting glucagon-like peptide-1 (GLP-1) analog with a seven-day half-life, used to treat…
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AccuMedical’s Blood Flow-Guided Stent Wins NMPA Approval for Brain Aneurysms
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AccuMedical Beijing Ltd has secured approval from China’s National Medical Products Administration (NMPA) for its blood flow-guided dense mesh stent, marking it as the 181st novel medical device approved in the country. The stent is indicated for the treatment of unruptured saccular or spindle wide-necked aneurysms in the internal carotid…
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InxMed and Huaota Bio Partner to Develop Novel Solid Tumor Combination Therapy
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China-based InxMed (Nanjing) Co., Ltd has entered into a strategic partnership with Shanghai Huaota Biopharmaceutical Co., Ltd to collaborate on pre-clinical and clinical studies for a combination therapy targeting various solid tumors. The partnership will focus on combining InxMed’s IN10018, a selective oral inhibitor of focal adhesion kinase (FAK), with…
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LEPU ScienTech Medical Technology Sets IPO Price Range Ahead of Hong Kong Listing
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China-based LEPU ScienTech Medical Technology (Shanghai) Co., Ltd is gearing up for an initial public offering (IPO) on the Hong Kong Stock Exchange. The company plans to issue 22.46 million shares at a price range of HKD 29.15 (USD 3.71) to HKD 31.45 (USD 4.01) per share, potentially raising up…
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WuXi AppTec Posts Stellar Q3 2022 Results with 209% Profit Surge
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China-based WuXi AppTec Co., Ltd (SHA: 603259, HKG: 2359) has released its Q3 2022 financial report, showcasing remarkable growth across key metrics. For the first nine months of 2022, the Contract Research Organization (CRO) reported revenues of RMB 28.395 billion (USD 3.9 billion), a 71.9% year-on-year (YOY) increase, and net…
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OriginCell’s CAR-T Therapy Receives FDA Orphan Drug Designation for Multiple Myeloma
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Shanghai-based tumor immunotherapy specialist OriginCell Therapeutics has announced that its investigational autologous chimeric antigen receptor (CAR)-T cell therapy, OriCAR-017, has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA). The therapy targets GPRC5D, a receptor highly expressed in multiple myeloma (MM) cells, and is being developed…
