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CDE Issues Guidelines for Anti-Tumor ADC Clinical Development
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The Center for Drug Evaluation (CDE) has released the “Technical Guidelines for Clinical Research and Development of Anti-Tumor Antibody Drug Conjugates” and is seeking public feedback for one month. The document aims to provide a framework for the rational design of clinical trials involving antibody drug conjugates (ADCs) for anti-tumor…
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Eli Lilly Announces Global C-Suite Changes, New Leadership in China
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US-based pharmaceutical giant Eli Lilly (NYSE: LLY) announced significant changes to its global C-suite. Julio Gay-Ger, the current president and general manager of Eli Lilly China, will transition to the role of chief marketing officer and vice president of global marketing for Eli Lilly’s diabetes business. In his new role,…
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China’s Policy Shifts Medical Device Procurement Toward Domestic Products
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Local government policies in China have begun to direct public hospitals to prioritize the procurement of certain medical devices and technologies from domestic producers, where available. According to Nikkei.com, notices to this effect were issued in April in Hubei, Anhui, Shanxi, and Ningxia. This move reportedly follows a national-level internal…
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Antengene Expands to Australia with New Melbourne Office
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China-based biotech firm Antengene (HKG: 6996) announced the opening of its new office in Melbourne, Australia. This strategic move is aimed at supporting the company’s expansion in the Asia Pacific region, with the office covering functions including commercial operations, finance, medical affairs, and clinical and business development. Clinical Trials and…
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Great Bay Bio Completes USD 15M Pre-Series B Financing to Advance AI Bioprocessing Platforms
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Great Bay Bio (GBB), a Hong Kong-based biotechnology firm, announced the completion of a USD 15 million pre-Series B financing round. The funding round was led by Tiger Med’s Tiger Jade Capital, with participation from an unnamed “top life science MNC,” AEF Greater Bay Area Fund (managed by Gobi Partners…
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Zhonghong Pulin Partners with Shanghai Pharma for Logistics and Distribution
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China-based Zhonghong Pulin Medical Product Co., Ltd (SHE: 300981) has entered into a partnership with compatriot firm Shanghai Pharmaceutical Co., Ltd (SHA: 601607). The five-year agreement is designed to leverage and integrate the respective advantageous resources of both companies to achieve mutually beneficial outcomes. Financial details of the partnership were…
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Suzhou Jade Biomedical Secures USD 10 Million Series B Financing
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China-based Suzhou Jade Biomedical Co., Ltd reportedly raised USD 10 million in a Series B financing round led by VMS Group, with participation from Panacea Venture. The proceeds will be used for the purchase of instruments, reagents, and consumables for the company’s biological GMP testing business. Additionally, the funds will…
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Worg Pharmaceuticals Raises RMB 400 Million in Series B Funding
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Worg Pharmaceuticals, a Hangzhou-based developer of novel allergic drugs, reportedly raised RMB 400 million (USD 57.3 million) in a Series B financing round. This follows an RMB 200 million (USD 28.65 million) Series A funding round in January last year. The latest round was backed by Junson Capital, Lapam Capital,…
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Luye Life Sciences Partners with Uzbekistan to Establish Vaccine Center
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China-based Luye Life Sciences Group has struck a partnership with the Ministry of Innovation and Development of the Republic of Uzbekistan. The collaboration, which leverages respective advantageous resources, will lead to the establishment of the Uzbekistan Innovative Vaccine Center in Tashkent, Uzbekistan. The partnership also marks a comprehensive collaboration on…
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Celregen Licenses Regenerative Therapy CLS001 from Japan’s Cellusion
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Hangzhou Celregen Therapeutics Ltd, a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd (HKG: 2196), has revealed a licensing deal agreement with Japan-based Cellusion Inc., a specialist in regenerative medicines. Under the deal, Celregen has secured development, manufacturing, and commercialization rights to Cellusion’s lead regenerative therapy candidate CLS001 – a…
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Transcenta’s First-in-Class Gremlin1 Antibody TST003 Receives FDA IND Clearance
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China-based Transcenta Holding Limited (HKG: 6628) announced that its TST003, a first-in-class, high affinity humanized monoclonal antibody (mAb) targeting Gremlin1, has received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA). This milestone allows Transcenta to proceed with clinical trials for this novel cancer treatment. Gremlin1…
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Bide Pharmatech Set for IPO on Shanghai’s STAR Market
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Shanghai-based Bide Pharmatech Co., Ltd, a specialist in drug building blocks, is set to make an initial public offering (IPO) of 16 million shares on the Shanghai Stock Exchange’s Sci-Tech Innovation Board (STAR), raising an estimated RMB 43.44 million (USD 6.2 million). The move marks a significant milestone for the…
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NMPA Releases 58th Batch of Reference Drugs for Generic Quality Consistency Evaluation
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The National Medical Products Administration (NMPA) has released the 58th batch of reference drugs for generic quality consistency evaluation (GQCE) work. This batch includes a total of 41 new specifications, among which 13 are injectables. The release aims to further standardize the quality of generic drugs in the Chinese market,…
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Alphamab/3DMed’s Envafolimab Gains FDA Fast-Track Status for Sarcoma Treatment
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Alphamab Oncology (HKG: 9966) and 3D Medicines’ envafolimab (KN035) has obtained fast-track status from the US Food and Drug Administration (FDA) for the treatment of locally advanced, unresectable, or metastatic undifferentiated pleomorphic sarcoma (UPS) and myxofibrosarcoma (MFS) that have progressed after chemotherapy. This designation is expected to accelerate the development…
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Guangdong Launches Free HPV Vaccination Program for School-aged Girls
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Guangdong province has rolled out a free HPV vaccination program this month, aimed at improving immunization rates among young girls. According to the “Work Plan for Free Human Papillomavirus (HPV) Vaccine Vaccination for School-aged Girls in Guangdong Province (2022-2024)” released in November last year, the program will provide free vaccines…
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Suzhou Zelgen Completes Phase II Study of Jakinib for Ankylosing Spondylitis
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) announced the successful completion of a multi-center, randomized double-blinded, placebo parallel controlled Phase II clinical study for its jakinib, a Janus kinase (JAK) inhibitor, in patients with active ankylosing spondylitis (AS). The study demonstrated robust results, meeting the pre-set statistical standards and showing…
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Hubei Province Proposes National TCM Patent Medicine Procurement Alliance
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The Healthcare Security Administration of Hubei Province has proposed the establishment of a national traditional Chinese medicine (TCM) patent medicines joint procurement office, alongside a national Chinese patent medicines alliance procurement system. This initiative aims to streamline the procurement process and reduce costs for TCM patent medicines across the country.…
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Buchang Pharmaceuticals Gains NMPA Approval for BC008-1A Clinical Study
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China-based Shandong Buchang Pharmaceuticals Co., Ltd (SHA: 603858) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its Category 1 biologic product BC008-1A in advanced solid tumors. This marks a significant step forward in the development of BC008-1A as a…
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CDE Prioritizes Review of Pearl Bio’s Breatinib for NSCLC Treatment
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The Center for Drug Evaluation (CDE) website indicates that Beijing Pearl Biotechnology Co., Ltd’s APL-101/PLB1001 (breatinib), a small molecule kinase inhibitor targeting c-MET, is set for priority review for its use in treating locally advanced or metastatic non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition factor (MET) exon 14 skipping.…
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Jiangsu Hengrui Medicine Gains NMPA Approval for HRS-6209 Clinical Study
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its investigational drug HRS-6209 in patients with advanced solid tumors. This marks a significant step forward in the development of HRS-6209 as a…
