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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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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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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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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…
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I-Mab’s Lemzoparlimab Gains CDE Approval for HR-MDS Phase III Trial
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China-based I-Mab (NASDAQ: IMAB) announced that it has successfully completed an End-of-Phase 2 (EoP2) meeting with the Center for Drug Evaluation (CDE) in China and obtained approval to initiate a Phase III registrational trial assessing lemzoparlimab, a novel CD47 antibody, in combination with azacitidine (AZA) as a first-line treatment for…
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Takeda’s Modakafusp Alfa and TAK-981 Gain NMPA Clinical Trial Approvals
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The National Medical Products Administration (NMPA) website indicates that Japan-based Takeda Pharmaceutical Co., Ltd’s (TYO: 4502) modakafusp alfa and subasumstat (TAK-981) have obtained tacit clinical trial approvals. The targeted indications are multiple myeloma (MM) and CD20-positive relapsed/refractory non-Hodgkin’s lymphoma (NHL) combined with rituximab, respectively. TAK-573: A First-in-Class Drug for Relapsed/Refractory…
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Huahai Pharmaceutical Gains FDA Approval for Generic Fingolimod
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China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) announced that it has received Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (FDA) for its generic version of Swiss giant Novartis’ Gilenya (fingolimod). The application was filed by Huahai’s US unit, Prinston Pharmaceutical Inc. Drug Background…
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Vathin Medical Instrument Raises Pre-Series B Funding Led by IDG Capital
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China-based single-use bronchoscope specialist Hunan Vathin Medical Instrument Co., Ltd reportedly raised “hundreds of millions” of renminbi in a Pre-Series B financing round led by IDG Capital. Other investors included Founder Securities and Hunan Xiangtan Caixin Chanxing Equity Investment Partnership. The proceeds will be used to ramp up the company’s…
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NMPA Issues Guidelines on Medical Device Grading Administration
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The National Medical Products Administration (NMPA) has released a set of Guiding Opinions on “Medical Device Manufacturing and Operation Grading Administration,” aimed at strengthening supervision of medical device manufacturing and operation under the medical device marketing authorization holder (MAH) system. The guidelines will take effect on January 1, 2023. Regulatory…
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Luye Pharma’s LY03015 Receives FDA Approval for Phase I Clinical Study
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China-based Luye Pharma Group (HKG: 2186) announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase I clinical study of its LY03015. The study will assess the safety, tolerability, and pharmacokinetics of the next-generation vesicular monoamine transporter 2 (VMAT2) inhibitor. LY03015 is…
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Hengrui Medicine to Incentivize Employees with Share Distribution
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China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced plans to incentivize its employees through a share distribution program. The company will repurchase up to 12 million shares at an average price of RMB 29.37 (USD 4.22) per share, with the transfer price set at RMB 4.41 (USD 0.63).…
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QuantuMDx and Sansure Biotech Partner to Commercialize Q-POC in China
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UK-based QuantuMDx Group Ltd announced a global R&D, manufacturing, and commercial partnership with China’s Sansure Biotech Inc. The collaboration aims to accelerate the market penetration and commercialization of QuantuMDx’s Q-POC platform and related assays in China. Q-POC is a rapid, portable multiplex PCR device designed for real-world healthcare settings and…
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InnoCare Pharma’s BCL2 Inhibitor ICP-248 Gains NMPA Approval for Clinical Study
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China’s Beijing InnoCare Pharma (HKG: 9969) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its in-house developed BCL2 inhibitor, ICP-248. This Category 1 innovative drug becomes the company’s fifth drug to reach clinical trials in the blood cancer field…
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BeiGene’s Tislelizumab Meets Primary Endpoint in HCC Study at ESMO
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BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235) presented the latest results of the global Phase III RATIONALE 301 study evaluating tislelizumab in first-line unresectable hepatocellular carcinoma (HCC) at the 2022 European Society for Medical Oncology (ESMO) meeting. The study, which enrolled 674 patients in the US, Europe, and Asia, met…
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Luye Pharma’s BA-CovMab Receives NMPA Approval for COVID-19 Clinical Trials
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China-based Luye Pharma Group (HKG: 2186) announced that its subsidiary Shandong BoAn Biotechnology Co., Ltd’s BA-CovMab, a broad-spectrum neutralizing antibody against COVID-19, has obtained clinical trial approval from the National Medical Products Administration (NMPA). Mechanism of ActionBA-CovMab is a recombinant fully human monoclonal neutralizing antibody obtained through sequential immunization and…
