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China-based Lee’s Pharmaceutical Holdings Ltd’s (HKG: 0950) former subsidiary, Zhaoke Ophthalmology Ltd (HKG: 6622), has announced that the National Medical Products Administration (NMPA) has accepted for review the Abbreviated New Drug Application (ANDA) for NVK002, an atropine external use eye solution aimed at pediatric myopia progression. NVK002: A Novel Ophthalmic…
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China-based Grand Pharmaceutical Group Co., Ltd. (HKG: 0512) has announced the first patient enrollment in a regulatory study designed to assess the safety and efficacy of GPN00289. This innovative temperature sensitive embolic product is intended for use in arterial chemoembolization of primary liver cancer. GPN00289: An Innovative Medical Device for…
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SCG Cell Therapy Pte. Ltd, a Singapore-based company with a presence in Shanghai, has received clinical trial approval from the National Medical Products Administration (NMPA) for its innovative therapy, SCG142. This human papillomavirus (HPV) specific T cell receptor (TCR) therapy is set to be tested in a range of HPV-related…
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Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its investigational drug HDM1005. This long-acting agonist targets both the GLP-1 receptor and GIP receptor and will be tested in metabolic associated fatty liver disease (MAFLD) and…
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Cygenta, a cell and gene therapy (CGT) focused Contract Development and Manufacturing Organization (CDMO) based in Beijing, has announced a strategic partnership with Russia-based IZVARINO Pharma Limited Liability Company. The collaboration aims to enhance the development and manufacturing capabilities for both companies, with a focus on advancing therapies in the…
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US pharmaceutical giant Pfizer (NYSE: PFE) has entered into a research collaboration with compatriot firm Atavistik Bio, with the aim of bolstering the discovery of novel precision allosteric therapeutics to address significant unmet medical needs. Leverage of Atavistik Bio’s AMPS PlatformUnder the agreement, Atavistik Bio will utilize its proprietary AMPS…
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The National Medical Products Administration (NMPA) in China has conditionally approved amimestrocel from Beijing-based Platinum Life with priority review status. This mesenchymal stem cells (MSCs) therapy marks the first of its kind in China, now available for treating patients aged 14 and above with acute graft-versus-host disease (aGVHD) that primarily…
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Singapore-based medical device company Genesis MedTech has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its groundbreaking device, the iReach Omnia. This marks a significant milestone as iReach Omnia is the world’s first powered stapler with 90° articulation capability. Enhancing Surgical Precision in…
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US pharmaceutical major Eli Lilly & Co. (NYSE: LLY) has announced the official market launch of its drug Mounjaro (tirzepatide) in China, expanding access to this treatment for patients in the region. Coverage of Two IndicationsThe launch of Mounjaro in China covers two specific indications. The first is for the…
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Beijing-based Prime Gene Therapeutics Co., Ltd (873969.NQ), a clinical-stage biotech company specializing in immune inflammatory diseases, has reportedly raised over RMB300 million (USD41 million) in a Series B financing round. The investment was led by a consortium of prominent financial backers, including Beijing Medical and Health Industry Investment Fund, E-town…
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China’s Shanghai Pharmaceuticals (SPH, HKG: 2607, SHA: 601607) has declared the termination of clinical trials and subsequent development of I001-B (US), I022 (US), and C012 (US). This decision comes after a comprehensive evaluation of the future market value, business collaboration, and development investment required for these projects. I001-B and I022…
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China’s National Medical Products Administration (NMPA) has indicated on its website that Japan-based Astellas Pharma Inc. (TYO: 4503) has received approval for its drug Vyloy (zolbetuximab-clzb). The drug is approved for use in combination with fluoropyrimidine- and platinum-containing chemotherapy for first-line locally advanced unresectable or metastatic claudin (CLDN) 18.2 positive,…
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China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its programmed death ligand 1 (PD-L1) monoclonal antibody (mAb), Ketailai (KL-A167). This treatment is now approved for use in recurrent or metastatic nasopharyngeal carcinoma (NPC) patients…
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China-based Sino Biopharmaceutical Ltd (HKG: 1177) has announced an exclusive market promotion agreement between its subsidiary Chia Tai Tianqing and Ping An-Shionogi Co., Ltd, a joint venture between China-based commercial insurance firm Ping An Insurance (Group) Ltd and Japanese pharmaceutical firm Shionogi & Co., Ltd. Under this initially 11-year accord,…
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HutchMed (China) Ltd (HKG: 0013, NASDAQ: HCM) has announced that the China National Medical Products Administration (NMPA) has accepted and granted priority review to the New Drug Application (NDA) for its Orpathys (savolitinib). The Chinese company is seeking approval for its MET tyrosine kinase inhibitor (TKI), when combined with Tagrisso…
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced a significant licensing agreement with Swiss pharmaceutical giant Roche (SWX: ROG). The agreement grants Roche global exclusive development, manufacturing, and commercialization rights to Innovent’s IBI3009, a DLL3-targeted antibody drug conjugate (ADC) that is anticipated to offer new treatment options for patients with…
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Immunotherapy biotech company Maxvax Biotechnology, based in Chengdu, has announced the successful closure of a convertible bonds financing round, raising RMB 200 million (USD 27.4 million). The financing was subscribed to by the Shenzhen Capital Group Manufacturing Industry Transformation and Upgrading New Materials Fund, highlighting the investor’s confidence in Maxvax’s…
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China-based Lee’s Pharmaceutical Holdings Ltd’s (HKG: 0950) former subsidiary, Zhaoke Ophthalmology Ltd (HKG: 6622), has announced positive topline results from the Phase III study for its core candidate drug TAB014 in the treatment of wet (neovascularization) age-related macular degeneration (wAMD). The study successfully met all primary and key secondary endpoints,…
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China-based HutchMed (China) Ltd (HKG: 0013, NASDAQ: HCM) has reached an agreement to divest its 45% equity interest in Shanghai Hutchison Pharmaceuticals Limited (SHPL) to GP Health Service Capital Co., Ltd and Shanghai Pharmaceuticals Holding Co., Ltd. (SPH, HKG: 2607, SHA: 601607) for a combined total of USD608 million. Background…