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Johnson & Johnson Secures Licensing Deal with Kaken Pharmaceutical for STAT6 Program
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US giant Johnson & Johnson (J&J, NYSE: JNJ) has announced an exclusive licensing agreement with Japan-based Kaken Pharmaceutical Co., Ltd. This agreement grants Johnson & Johnson global development, manufacturing, and commercialization rights for a STAT6 program aimed at treating autoimmune and allergic diseases, including atopic dermatitis (AD). Under the terms…
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Ascentage Pharma Announces Secondary Offering on Nasdaq, Expanding Global Reach
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China-based Ascentage Pharma (HKG: 6855) has unveiled plans for a secondary offering of up to 33,739,347 shares on the Nasdaq, as reported by the China Securities Regulatory Commission. This strategic move is aimed at bolstering the company’s financial capacity to further its research and development efforts in innovative oncology treatments.…
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Auzone Submits NDA for Oral Edaravone TTYP01 to Treat ALS
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Auzone Biological Technology has announced the submission of a New Drug Application (NDA) for its product candidate TTYP01 (edaravone) (Product Name: AUKONTALS）to the US Food and Drug Administration (FDA). The Chinese company is seeking approval for the drug to treat amyotrophic lateral sclerosis (ALS). Notably, the FDA previously awarded an…
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Pediatrix Therapeutics’ Neffy NDA Accepted by NMPA for Allergy Treatment
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China-based Pediatrix Therapeutics has announced that the New Drug Application (NDA) for its neffy (epinephrine nasal spray) has been accepted for review by the National Medical Products Administration (NMPA). The intended indication for neffy is the emergency treatment of type I allergic reactions, including severe allergic reactions, in adults and…
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Immunochina Pharmaceuticals and Cell Store Partner to Advance Cell Therapy Commercialization in China
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Beijing-based firms Immunochina Pharmaceuticals and Cell Store have announced a strategic partnership aimed at bolstering the industrialization and commercialization of cell therapies in China. The financial details of the collaboration have not been disclosed. Innovative Cryopreservation Technology from Cell StoreCell Store is an innovative biotech company that specializes in “controlled…
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Hinova Pharmaceuticals Enrolls First Patient in Phase II Study for HP518 in mCRPC
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China-based biopharma Hinova Pharmaceuticals has announced the enrollment of the first patient in an open, multi-center Phase II study assessing the safety, pharmacokinetics, and anti-tumor activity of its Category 1 chemical drug, HP518, in patients with metastatic castration resistant prostate cancer (mCRPC). Innovative Mechanism of Action for HP518HP518 is an…
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Xbiome Partners with ZoHealth to Advance Microbiome Drug Development and Precision Nutrition
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China-based Xbiome, an AI-driven microbiome drug development company, has announced a strategic alliance with Australia-headquartered ZoHealth. This collaboration focuses on the development of human gut microbiota, precision nutrition, and health product innovation. Core Program Focused on Probiotic ProductsThe core program of the partnership will center around Xbiome’s proprietary bacterial strains,…
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Astellas Pharma Partners with Axcelead DDP for Targeted Protein Degraders Discovery
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Japan-based Astellas Pharma Inc. (TYO: 4503) has struck an accord with compatriot firm Axcelead Drug Discovery Partners, Inc. (Axcelead DDP) to collaborate on the discovery of new candidate compounds for targeted protein degraders (TPD). Axcelead DDP’s DegLead Platform to Support Astellas’ TPD DiscoveryAxcelead DDP, a company focused on targeted protein…
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AusperBio Secures $73 Million in Series B Financing to Advance Hepatitis B Therapy
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Sino-US liver therapy developer AusperBio has announced the completion of a USD 73 million Series B financing round, following a USD 37 million Series A funding in July this year. This latest round was led by HanKang Capital, with participation from Sherpa Capital, CDH Investments, and a strategic investor, along…
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Advaccine Biotechnology’s MICROEPAD Receives FDA Registration Approval
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China-based vaccine developer Advaccine Biotechnology has announced receiving registration approval from the US Food and Drug Administration (FDA) for its soluble microneedle drug, MICROEPAD. MICROEPAD: A Revolutionary Approach to Skin TreatmentsMICROEPAD, or Dissolvable Microneedle Blemish Patches, is an over-the-counter (OTC) medication designed to treat acne, acne scars, and blackheads, promoting…
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Shandong Buchang Pharmaceuticals Terminates Agreement with NOVAST Laboratories
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China-based Shandong Buchang Pharmaceuticals Co., Ltd (SHA: 603858) has announced the termination of the development, supply, and marketing agreement with compatriot firm NOVAST Laboratories. The decision comes in response to changes in the market environment and the company’s operational status. Original Deal and Its TerminationThe original agreement, which was established…
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Chia Tai Tianqing’s Benmelstobart and Anlotinib Combo Meets Primary Endpoint in Phase III Study
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China-based Chia Tai Tianqing Pharmaceutical, a subsidiary of Sino Biopharmaceutical Ltd (HKG: 1177), has announced positive readouts from the Phase III TQB2450-Ⅲ-12 study for its anti-programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb) benmelstobart (TQB2450) combined with the multi-target kinase inhibitor anlotinib. Phase III Study Design and OutcomesThe multi-center, randomized, double-blinded,…
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![China Isotope & Radiation Corporation’s [18F] Piramide Receives NMPA Clinical Trial Approval](https://flcube.com/wp-content/uploads/2024/12/122701.png)
China Isotope & Radiation Corporation’s [18F] Piramide Receives NMPA Clinical Trial Approval
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On December 24, 2024, China Isotope & Radiation Corporation (HKG: 1763) announced that its subsidiary, HTA Co., Ltd., has received approval from the National Medical Products Administration (NMPA) to initiate clinical trials for their Class 1 innovative drug, [18F] Piramide Injection. [18F] Piramide: A PET Imaging Agent for Enhanced Melanoma…
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Hybio Pharmaceutical Receives US FDA Approval for Biosimilar Victoza (Liraglutide)
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China-based Hybio Pharmaceutical Co., Ltd (SHE: 300199) has announced receiving official approval from the US Food and Drug Administration (FDA) for the Abbreviated New Drug Application (ANDA) of its biosimilar version of Denmark firm Novo Nordisk’s (NYSE: NVO) Victoza (liraglutide). Liraglutide: A Crucial Treatment for DiabetesLiraglutide, an analog of human…
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Shanxi C&Y Pharmaceutical Initiates Clinical Study for Generic Ferric Maltol with NMPA Approval
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China’s Shanxi C&Y Pharmaceutical Group Co., Ltd (SHE: 300254) has announced the initiation of a clinical study for its generic version of UK firm Shield TX（UK）Limited’s iron supplement ferric maltol, following approval from the National Medical Products Administration (NMPA). The study aims to evaluate the drug’s efficacy in treating iron…
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Boji Medical Technology Receives NMPA Approval for TBA Clinical Study in Drug-Resistant Tuberculosis
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China-based Clinical Research Organization (CRO) Boji Medical Technology Co., Ltd. (SHE: 300404) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a clinical study for TBA, a novel treatment for drug-resistant pulmonary tuberculosis. TBA: A New Approach to Combating Drug-Resistant TuberculosisThe Category 1 chemical drug, co-developed…
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Jiangsu Hengrui Pharmaceuticals Secures NMPA Approvals for Prostate Cancer and Solid Tumor Clinical Trials
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced receiving separate clinical trial approvals from the National Medical Products Administration (NMPA). One trial will test the combination of HRS-4357 with ADT and a novel androgen receptor pathway inhibitor for prostate cancer. The other trial will assess SHR-4602 in combination with…
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Sichuan Biokin’s BL-M08D1 and CSPC’s SYS6010 Eye Breakthrough Therapy Designations in China
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The China’s Center for Drug Evaluation (CDE) website has indicated that China-based Sichuan Biokin Pharmaceutical Co., Ltd’s (SHA: 688506) BL-M08D1 and CSPC Pharmaceutical Group Ltd’s (HKG: 1093) SYS6010 are on track to obtain Breakthrough Therapy Designations (BTDs) from the agency. These designations are for the treatment of recurrent small cell…
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CDE Indicates Priority Review for Boehringer Ingelheim’s Zongertinib and Peers
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The China’s Center for Drug Evaluation (CDE) website has indicated that several drugs, including German giant Boehringer Ingelheim’s (BI) zongertinib, Visirna Therapeutics’ plozasiran, Chia Tai Tianqing’s anlotinib, and HutchMed (China) Ltd’s (HKG: 0013, NASDAQ: HCM) Orpathys (savolitinib), are on course to obtain priority review statuses. Boehringer Ingelheim’s Zongertinib for HER2-Mutated…
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Zelgen Biopharmaceuticals’ ZG005 Gets NMPA Green Light for Solid Tumor and Lymphoma Clinical Trial
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced receiving clinical approval from the National Medical Products Administration (NMPA) to test its Category 1 biologic product, ZG005, in combination with gecaicitinib for the treatment of advanced solid tumors and recurrent refractory lymphomas in China. ZG005: A Pioneering Bispecific Antibody for…
