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Sun-Novo’s STC007 Gains NMPA Approval for Postoperative Pain Study
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China-based Beijing Sun-Novo Pharmaceutical Research Co., Ltd has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study assessing its Category 1 drug candidate STC007 for postoperative pain. This marks a significant milestone in the development of this innovative therapy. Drug Mechanism…
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WuXi Biologics Partners with Elpiscience for Macromolecule Development
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China-based Contract Research, Development, and Manufacturing Organization (CRDMO) WuXi Biologics (HKG: 2269) has announced multiple partnerships with compatriot firm Elpiscience Biopharmaceuticals Inc. WuXi Bio will be involved in Elpiscience’s process development and pilot test facilities in Suzhou, facilitating their transformation into a top-tier macromolecule development and GMP compliant service base.…
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Tasly Pharmaceuticals Gains NMPA Approval for B1344 Diabetes Study
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China-based Tasly Pharmaceuticals (SHA: 600535) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its recombinant human fibroblast growth factor 21 injection B1344 in patients with type 2 diabetes. This marks a significant step in the development of this…
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Clover Biopharmaceuticals Reports Positive Phase III Data for COVID-19 Vaccine SCB-2019
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China-based Clover Biopharmaceuticals Ltd (HKG: 2197) has announced additional positive Phase III clinical trial data for its lead COVID-19 vaccine candidate, SCB-2019 (CpG 1018/Alum), as a universal booster shot. The data show that subjects who received SCB-2019 as the third booster, following two doses of inactivated vaccine, exhibited higher levels…
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RemeGen Announces Positive Phase III Results for Telitacicept in SLE
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China-based pharma firm RemeGen (HKG: 9995) has announced the conclusion of a Phase III confirmatory study for its fusion protein drug telitacicept in systemic lupus erythematosus (SLE) in China, releasing preliminary data. The study enrolled 335 patients, randomized to receive telitacicept (160mg) or placebo via subcutaneous injection once per week…
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BeiGene’s Brukinsa Receives New EU and UK Indications for BTK Inhibitor
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China-based biotech BeiGene Inc. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has received two new indication recommendations in the EU and the United Kingdom for its Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib). The approvals expand the therapeutic applications of this innovative treatment, further solidifying its position in the global oncology…
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Alphamab Oncology Doses First Patient in Phase I Study for JSKN003 in Australia
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Alphamab Oncology (HKG: 9966) has announced that the first patient has been dosed in a Phase I clinical study for its JSKN003-KN026 antibody drug conjugate (ADC) in Australia. The open, multi-center, dosage escalation Phase I study is designed to assess the safety, tolerability, and preliminary efficacy of JSKN003 in advanced…
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Beijing Launches HIV Precision Medicine Standardization Project
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On September 17, an HIV precision medicine standardization project was initiated in Beijing. The project, led by the National Center for Infectious Diseases (NCID) and the China National Health Association (CNHA) and sponsored by Gilead Sciences, aims to enhance the quality of HIV outpatient services in hospitals. The initiative seeks…
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Fosun Pharma Signs Exclusive Licensing Deal for H008 with Carephar
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China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has signed an exclusive licensing deal with compatriot firm Jiangsu Carephar Pharmaceutical Co., Ltd to develop H008 globally, including its oral preparation and injection forms, and covering all plausible indications. Agreement Details and Rights AllocationUnder the agreement, Carephar will…
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Suzhou Weiyou Gene Bio Raises Pre-Series A Funding for Gene Therapy Pipeline
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China-based Suzhou View Gene Biotechnology Co., Ltd has reportedly raised “tens of millions” of renminbi in a pre-Series A financing round. The round was led by Proxima Ventures, with proceeds directed towards clinical studies, new adeno-associated virus (AAV) carrier design, pilot-scale production line construction, and expansion of the gene therapy…
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Lepu Medtech Receives Approval for Innovative Peripheral Cutting Balloon
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China-based cardiovascular disease solutions provider Lepu Medical Technology (Beijing) Co., Ltd (SHE: 300003) has announced that it has received Category III medical device approval from the National Medical Products Administration (NMPA) for its in-house developed peripheral cutting balloon. This approval marks a significant milestone for the company in expanding its…
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Lepu Medtech Prices GDR Offering for International Expansion
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China-based cardiovascular disease solutions provider Lepu Medical Technology (Beijing) Co., Ltd (SHE: 300003) has priced its offering of 11,910,286 global depository receipts (GDRs) to the SWX Swiss Exchange (SWX) at USD 12.31 to USD 12.68 per share. The proceeds from the offering are expected to range from USD 148.8 million…
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Zhong’ao Biopharmaceutical Secures Series A Funding for Cancer and HPV-Related Disease R&D
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China-based Zhong’ao Biopharmaceutical Technology (Guangdong) Co., Ltd. has reportedly raised an undisclosed amount of money in a Series A financing round. The investment was led by Huaying Capital from Zhongshan Torch Development Zone and Chengdu Shengrong Longke Technology Co., Ltd. The funding will support the company’s ongoing research and development…
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NHSA Launches Expert Review for 2025 NRDL Update in China
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The National Healthcare Security Administration (NHSA) announced on September 16 the commencement of the expert review process for this year’s National Reimbursement Drug List (NRDL) update. The three-day event, held in Beidaihe, Qinhuangdao, Hebei province, will conclude on September 22. This process is a crucial step in determining which drugs…
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Daehwa Pharmaceutical Files NDA for Liporaxel in China for Gastric Cancer Treatment
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South Korea’s Daehwa Pharmaceutical (KOSDAQ: 067080) has announced the filing of a New Drug Application (NDA) in China for Liporaxel/RMX3001, its innovative oral paclitaxel formulation. The application seeks approval for Liporaxel as a secondary treatment option for patients with advanced gastric cancer. Liporaxel: An Innovative Oral FormulationLiporaxel is an oral…
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Antengene’s ATG-101 Receives Orphan Drug Designation for Pancreatic Cancer
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China-based biotech Antengene Corp., Ltd (HKG: 6996) has announced that its pipeline candidate ATG-101, a PD-L1/4-1BB bispecific antibody (BsAb), has been awarded orphan drug designation (ODD) status from the US FDA for its use in treating pancreatic cancer. This designation is expected to facilitate greater communication with the FDA and…
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Ascletis Pharma and Roche Terminate Promotion Agreement for Pegasys
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China-based Ascletis Pharma Inc. (HKG: 1672) has announced a supplementary agreement with Swiss pharmaceutical giant Roche, terminating the promotion services previously provided by Ascletis for Roche’s Pegasys (peginterferon alfa-2a) as of December 31, 2022. The initial partnership, established in November 2018, granted Ascletis exclusive marketing and promotion rights to the…
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Apollomics Set to Merge with Maxpro Capital for Nasdaq Listing
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Sino-US biotech Apollomics Inc. has revealed plans to merge with the special purpose acquisition company (SPAC) Maxpro Capital Acquisition Corp., paving the way for a public listing on the Nasdaq stock exchange. The transaction values Apollomics at a pre-money equity of $899 million, with the company expecting to retain up…
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Everest Medicines Appoints Rogers Yongqing Luo as New CEO
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China-based biotech Everest Medicines (HKG: 1952) has announced the appointment of a new CEO, Rogers Yongqing Luo, effective immediately. Luo replaces Dr. Kerry Blanchard, who resigned in August this year. Luo’s Background and ExperienceLuo joins Everest Medicines from Brii Biosciences, where he served as president and General Manager (GM) for…
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Hainan’s Lecheng Zone Updates Special Drug Insurance List with Expanded Coverage
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Hainan Boao Lecheng International Medical Tourism Pilot Zone has released an updated special drug insurance list, allowing patients in the zone to access medicines not yet market-approved in China. The insurance scheme, first introduced in 2020, was the first government-guided provincial-level supplementary special drug insurance scheme in China. This year’s…
