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Huadong Medicine Receives FDA Clearance for HDM1005 Clinical Study in Obstructive Sleep Apnea
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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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Laekna, Inc. Initiates IND-Enabling Study for Monoclonal Antibody LAE123 in Severe Diseases
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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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CORXEL Partners with Apeloa Pharmaceutical for CDMO Services Expansion
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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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Wuhan Union Hospital to Transfer Hereditary Thrombophilia Detection Patent to Kingmed Diagnostics
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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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Shanghai Yanyin Technology Partners with Castalysis Bioscience to Advance CRISPR Software Development
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Shanghai Yanyin Technology Co., Ltd has announced a strategic partnership with Castalysis Bioscience (Shanghai), a Shanghai-based gene editing technology developer, to strengthen the research and development and market expansion of CRISPR gene editing module software. The collaboration aims to leverage the technical advantages of both companies to jointly develop a…
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Eisai and Biogen Launch Alzheimer’s Treatment Leqembi in South Korea
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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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Bayer AG Launches Bayer Co.Lab Berlin, Focusing on Life Science Innovation
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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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Chinese Pharmacopoeia Commission Approves Draft for ChP 2025 Edition
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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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Huadong Medicine’s Arcalyst Receives NMPA Approval for Cryopyrin-Associated Periodic Syndromes
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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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Huadong Medicine’s Elahere (Mirvetuximab Soravtansine) Approved by NMPA for Ovarian Cancer Treatment
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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…
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MicuRx Pharmaceuticals’ MRX-4 Combo Shows Positive Results in Phase III Study
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Sino-US firm MicuRx Pharmaceuticals Inc. (SHA: 688373) has announced positive results from a Phase III study for its drug MRX-4 in combination with contezolid as sequential therapy for complex skin and soft tissue infections. The study successfully met its primary efficacy endpoint, demonstrating good clinical and microbiological efficacy. The regimen’s…
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National Reimbursement Drug List 2024 Expands Coverage with 91 New Drugs
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The National Medical Products Administration has released the finalized National Reimbursement Drug List (NRDL) for 2024, which includes 91 new drugs. Among these, 89 were added through negotiation/pricing bidding, and 2 were winning bids in the volume-based procurement (VBP). Concurrently, 43 drugs that had been supplanted in clinical use or…
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Allink Biotherapeutics Secures $42 Million in Series A Financing to Advance Bispecific Antibodies and ADCs
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Shanghai-based Allink Biotherapeutics, a clinical-stage biotech company specializing in the development of bispecific antibodies (BsAbs) and antibody drug conjugates (ADCs), has reportedly raised $42 million via a Series A financing round. The funding round was led by Lanchi Ventures, with additional contributions from YuanBio Venture Capital, Legend Capital, and Xiamen…
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China’s NHC Aims to Enhance Continuity of Medical Services with Referral System by 2030
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The National Health Commission (NHC) has released a notification aimed at enhancing the continuity of medical services through the establishment of a robust first visit and referral system. The plan outlines a timeline for the development of a smooth two-way referral system within compact medical consortia, including urban medical groups…
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Jiangsu Kanion Pharmaceutical Secures NMPA Approvals for KYHY2302 and KYHY2303
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China-based Jiangsu Kanion Pharmaceutical Co., Ltd (SHA: 600557) has announced receiving separate clinical trial approvals from the National Medical Products Administration (NMPA) for its two Category 1 products: KYHY2302 cream for mild to moderate plaque psoriasis and KYHY2303 tablets for recurrent or refractory malignant hematological tumors. KYHY2302 Cream for Plaque…
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NHSA Issues Guidelines to Suspend Direct Online Listing of In-Shortage Drugs
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The National Healthcare Security Administration (NHSA) has issued the “Guidelines for Risk Management of In-Shortage Drug Prices,” which call for all localities to temporarily suspend the acceptance of applications for direct online listing of in-shortage drugs before January 1, 2025. Suspension of Direct Online Listing and Price Increase RequestsThe guidelines…
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BeiGene’s Tevimbra Receives EC Approval for First-Line ESCC and G/GEJ Adenocarcinoma Treatments
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China-based biotech company BeiGene Ltd (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has received a marketing approval from the European Commission (EC) for its programmed death-1 (PD-1) inhibitor, Tevimbra (tislelizumab). The drug is now approved for use in combination with chemotherapy for the first-line treatment of esophageal squamous cell carcinoma (ESCC)…
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Fosun Pharmaceutical’s Daxxify Receives NMPA Approval for Cervical Muscle Tone Disorders
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196) has announced that the National Medical Products Administration (NMPA) has approved another indication for its product Daxxify (daxibotulinumtoxin, RT002). The type A botulinum toxin is now approved for the treatment of adult cervical muscle tone disorders in China. Background on…
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Phil Rivers Technology Secures IND Approval for PR00012 from NMPA’s CDE
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Beijing-based Phil Rivers Technology Co.,Ltd, a high-tech platform company incubated by the Institute of Computing Technology, Chinese Academy of Sciences, has announced receiving Investigational New Drug (IND) approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for its Category 1 drug, PR00012. Phase I…
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Hansoh Pharmaceutical’s Ameile Receives NMPA Review for Fifth Indication in NSCLC Treatment
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China-based Hansoh Pharmaceutical Group Co., Ltd (HKG: 3692) has announced that its fifth indication filing for Ameile (almonertinib) has been accepted for review by the National Medical Products Administration (NMPA). The epidermal growth factor receptor (EGFR) inhibitor is now under review for the first-line treatment of locally advanced or metastatic…
