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China-based CARsgen Therapeutics Holdings Ltd (HKG: 2171) has announced a collaboration agreement with US mRNA giant Moderna Inc. (NASDAQ: MRNA). The partnership aims to investigate the use of CARsgen’s investigational Claudin18.2 (CLDN18.2)-targeted chimeric antigen receptor (CAR) T-cell product candidate, CT041, in combination with Moderna’s investigational CLDN18.2 mRNA cancer vaccine. Combining…
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Simcere Pharmaceutical Group Ltd (HKG: 2096) has announced that its subsidiary, Jiangsu Simcere Zaiming Pharmaceutical Co., Ltd, has entered into a cooperation agreement with Taizhou Mabtech Pharmaceutical Ltd, a subsidiary of Mabpharm Ltd (HKG: 2181), focusing on the molecule CMAB009. Under the terms of the deal, Simcere Zaiming has obtained…
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Ezisurg Medical Co., Ltd has announced a strategic partnership with Hunan Vathin Medical Instrument Co., Ltd. The collaboration aims to establish a long-term strategic cooperation on the development, commercialization, and marketing of disposable endoscope products on a global scale. Ezisurg’s Commitment to Comprehensive SolutionsEzisurg is dedicated to offering comprehensive and…
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Fosun Pharma (SHA: 600196) has declared adjustments to the investment amounts for some of its non-public offering projects in 2022, including new sub-investment projects. The company plans to reallocate the uninvested funds originally intended for the “API and Preparation Intensive Comprehensive Base” project, amounting to RMB 193.14 million, to another…
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China-based biopharmaceutical company HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced that the pivotal Phase III trial ESLIM-01 evaluating the investigational use of sovleplenib has successfully met its primary endpoint of durable response rate and all secondary endpoints in adult patients with primary immune thrombocytopenia (ITP). The trial was…
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China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced the enrollment and dosing of the first subject in a Phase I study for APAD, a small-molecule compound targeting sepsis with a novel mechanism of action. The study is a randomized, double-blind, dosage escalation, placebo-controlled trial designed to assess the safety,…
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HutchMed (China) Ltd (NASDAQ: HCM; HKG: 0013) has announced that its MET inhibitor, Orpathys (savolitinib), co-developed with AstraZeneca (AZ, NASDAQ: AZN) and approved in China on July 12, is to be awarded breakthrough therapy designation (BTD) in China. The BTD status is specifically for savolitinib’s use as a third-line treatment…
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China-based Humanwell Healthcare (Group) Co., Ltd (SHA: 600079) has announced the commencement of a Phase IIa clinical study for its Category 1 chemical drug, HW021199, in the treatment of idiopathic pulmonary fibrosis (IPF). The drug’s target has not been disclosed, other than to note that there is no market-approved product…
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GlaxoSmithKline (GSK; NYSE: GSK), a UK-based pharmaceutical giant, has announced that its respiratory syncytial virus (RSV) vaccine, Arexvy, is now available at all major pharmacies in the US. The vaccine received approval in the country earlier this year and was subsequently recommended by the Advisory Committee on Immunization Practices (ACIP)…
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Eyebright Medical Technology Co., Ltd (SHA: 688050), a Beijing-based company specializing in ophthalmic medical devices, is poised to issue 8,420,079 Global Depository Receipts (GRDs) on the SIX Exchange, pending approval from the Swiss bourse and regulatory filing in China. The listing is anticipated to generate a take-home amount of RMB…
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South Korea’s GC Biopharma (KRX: 006280) has presented evidence suggesting that Roche’s (SWX: ROG) hemophilia therapy, Hemlibra (emicizumab), may display a higher proportion of thrombotic adverse events (AEs) compared to coagulation factor VIII replacements. This finding is based on an analysis of US data reported to the FDA Adverse Event…
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Moderna (NASDAQ: MRNA) has announced preliminary data indicating that an updated version of its SARS-CoV-2 vaccine is immunogenic against the EG.5 and FL.1.5.1 variants, recently renamed Eris and Fornax by the World Health Organization (WHO), with Eris being classified as a variant of interest (VOI). This development marks a significant…
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China-based Contract Research Organization (CRO) Tigermed (SHE: 300347, HKG: 3347) has announced the opening of its international headquarters in Hong Kong, signifying a significant milestone in the company’s efforts to globalize its operations and corporate development. The new international HQ is set to enhance Tigermed’s ability to coordinate and manage…
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The National Medical Products Administration (NMPA) has granted marketing approval to Rapid Medical Ltd for its intracranial thrombectomy stent. This medical device, which comprises a head end, wire mesh, push shaft, control wire, and handle, is equipped with controllable expansion technology that enhances its utility in surgical procedures. Enhanced Surgical…
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China-based Luye Pharma Group (HKG: 2186) has announced the official commercial operation of its Rykindo (risperidone) extended-release injectable suspension in the United States. Developed on Luye Pharma’s microsphere technology platform, Rykindo is administered via intramuscular injection once every two weeks, utilizing long-acting and extended-release microsphere technology to deliver the active…
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Singapore-based cell therapy developer CytoMed Therapeutics Ltd (NASDAQ: GDTC) has announced the signing of a memorandum of understanding (MoU) with China’s Hangzhou CNK Therapeutics Co., Ltd. The agreement grants CytoMed a license to utilize CNK’s PiggyBac technology, enabling the permanent grafting of the Chimeric Antigen Receptor (CAR) gene into its…
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received the green light from the US FDA to conduct a clinical study for its bispecific antibody (BsAb), NBL-028, which targets CLDN6 and CD137. The initial focus of the study will be on advanced tumors with CLDN6 expression,…
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China-based Aurisco Pharmaceutical (SHA: 605116) has announced the successful completion of a current Good Manufacturing Practice (cGMP) inspection by the US Food and Drug Administration (FDA) at its Active Pharmaceutical Ingredient (API) and finished dosage form (FDF) plant located in Yangzhou, Jiangsu province. The inspection confirmed that the site was…
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Taiwan’s Formosa Pharmaceuticals (TPE: 6838) and US-based Eyenovia Inc., (NASDAQ: EYEN) have signed their second licensing and partnership agreement. Under this deal, Eyenovia has acquired exclusive US rights to commercialize APP13007 (clobetasol propionate ophthalmic nanosuspension, 0.05%), a treatment for inflammation and pain following ocular surgery. The total value of the…
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China-based Biocytogen Pharmaceuticals (Beijing) Co., Ltd (HKG: 2315) has announced the official start of operations at its US subsidiary, Biocytogen Boston Corp., located in Waltham, Massachusetts. The new 3,400 sq.m. facility boasts advanced amenities and a convenient geographical location, marking a significant expansion as it is three times larger than…