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China-based dermatology specialist Cutia Therapeutic (HKG: 2487) has revealed a positive readout from its Phase II study for the potential Category 1 drug CU-20401, a recombinant mutant collagenase, in the treatment of subcutaneous fat accumulation, meeting its primary endpoint. Efficacy and Safety Profiles of CU-20401The treatment efficacy rates of both…
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China-based gene therapy Contract Research Organization (CRO) OBiO Technology (Shanghai) Co., Ltd (SHA: 688238) has announced a partnership with compatriot firm Hanxin Biotechnology (Suzhou) Co., Ltd. The collaboration is focused on the lipid nanoparticle (LNP) delivery system field, aiming to enhance the clinical application of mRNA and other nucleic acid…
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The National Medical Products Administration (NMPA) has granted approval to Shenzhen Mindray Bio-Medical Electronics Co., Ltd (SHE: 300760) for its innovative ultrasound diagnostic system, as announced on the bureau’s website. Introducing the First Dual-Mode Imaging Product in ChinaThe approved product is hailed as China’s first dual-mode imaging product, integrating both…
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China’s National Medical Products Administration (NMPA) has granted approval to Hangzhou Ruidi Biotechnology Co., Ltd for its steep pulse therapy equipment and disposable steep pulse ablation needle, as reported on the bureau’s website. This marks a significant advancement in the field of minimally invasive interventional treatments for tumors in China.…
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In a swift succession of actions, China’s Center for Drug Evaluation (CDE) has added two more rare disease drugs to its patient-centered rare disease drug development pilot program, known as the Care Plan. This follows three other approvals within a 10-day period. The latest inclusions are Ractigen Therapeutics’ RAG-17 and…
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The National Medical Products Administration (NMPA) has released the “Medical Representative Management Measures (draft proposal)”, which has been developed in consultation with the Ministry of Public Security, National Healthcare Commission, State Administration for Market Regulation, National Healthcare Security Administration, National Administration of Traditional Chinese Medicine, and National Bureau of Disease…
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Japanese pharmaceutical company Daiichi Sankyo (TYO: 4568) is significantly increasing its investment in China with a RMB 1.1 billion outlay to establish a new antibody drug conjugate (ADC) manufacturing plant in Zhangjiang, located in Shanghai’s Pudong New Area. This strategic move by the firm is aimed at addressing the escalating…
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Jiangsu Kanion Pharmaceutical Co., Ltd (SHA: 600557) has announced that it has received clinical clearance from the National Medical Products Administration (NMPA) for its investigational product, KYS202003A. The Chinese company is set to initiate a clinical study assessing this Category 1 biologic product for the treatment of advanced solid tumors.…
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China-based gene therapy specialist Lingyi Biotechnology Co., Ltd has entered into a comprehensive collaboration agreement with Zhejiang Jolly Pharmaceutical Co., Ltd. The partnership aims to leverage the respective strengths of both companies in equity, research and development (R&D), and sales. Enhancing Drug Development and CommercializationUnder the terms of the agreement,…
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a China-based pharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) for its antibody drug conjugate (ADC), BL-M08D1, to enter clinical trials. The drug is intended for the treatment of recurrent or refractory hematological malignancies and…
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received clearance from the US Food and Drug Administration (FDA) to initiate a clinical study assessing its HDM1005 in patients with obstructive sleep apnea (OSA) who are overweight or obese. HDM1005: A Dual GLP-1 and GIP Receptor AgonistHDM1005…
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Sino-US biotech company Laekna, Inc. (HKG: 2105) has announced the initiation of an Investigational New Drug (IND)-enabling study for its monoclonal antibody (mAb), LAE123, which has successfully met the preclinical candidate compound (PCC) requirements. This development marks a significant step forward in the drug’s journey towards clinical trials for severe…
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China-based contract development and manufacturing organization (CDMO) Apeloa Pharmaceutical Co., Ltd (SHE: 000739) has announced a strategic partnership with CORXEL, formerly known as Ji Xing Pharmaceuticals. The financial details of the agreement have not been disclosed, but it is confirmed that Apeloa will provide professional CDMO services to CORXEL on…
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, also recognized as Wuhan Union Hospital of China, has announced plans to transfer its invention patent, titled “A Primer Probe Combination and Kit for Detecting Common Mutation Sites in Hereditary Thrombophilia Based on ARMS-PCR Method,” to Kingmed Diagnostics (SHA:…
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Partners Eisai Co., Ltd (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) have jointly announced the commercial launch of their co-developed amyloid-beta (Aβ) monoclonal antibody, Leqembi (lecanemab), in South Korea. The Ministry of Food and Drug Safety (MFDS) had previously approved the drug in May 2024 for the treatment of adult…
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Germany-based Bayer AG (ETR: BAYN) has announced the opening of its new life science incubator, Bayer Co.Lab Berlin, which will initially house MyoPax GmbH, a local startup specializing in muscle regeneration therapies through stem cell and gene editing technologies. Expanding Bayer’s Global Incubator NetworkBayer Co.Lab Berlin joins Bayer’s global network…
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On December 27, the 12th Conference of the Chinese Pharmacopoeia Commission (ChPC) Executive Committee concluded with the approval of the draft for the 2025 edition of the Chinese Pharmacopoeia (ChP 2025 Edition). The approval paves the way for the imminent implementation of the new edition. Enhancements in Scientificity and StandardizationThe…
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its drug Arcalyst (rilonacept), indicated for the treatment of cryo-pyrin-associated periodic syndromes (CAPSs), including familial cold autoimmune syndrome (FCAS) and muckle-well syndrome (MWS). Understanding CAPS and Its SubtypesCAPS is a…
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for Elahere (mirvetuximab soravtansine), an antibody drug conjugate (ADC) targeting folate receptor α (FRα), for the treatment of FRα positive platinum-resistant ovarian cancer (PROC) in patients who have…