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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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Frontier Biotech’s FB2001 Inhalant Accepted for NMPA Review
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China-based Frontier Biotechnologies Inc. (SHA: 688221) announced that a registrational clinical filing for its FB2001 atomized inhalant bofutrelvir has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step forward in the development of FB2001 as a potential treatment for COVID-19. Global Rights and…
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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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Biden’s Executive Order Boosts US Bio-Economy, Targets China’s Biotech Rise
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US President Joe Biden signed an executive order on Monday, outlining steps to bolster the country’s bio-economy across industries ranging from agriculture and biofuels to medical supplies and bio-pharma manufacturing. The order, titled “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy,” aims to reduce US…
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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…
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Jiangsu Healthcare to Cover All Psychological Treatments Under BMI
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The Jiangsu Provincial Healthcare Security Administration is reportedly considering adding all psychological diagnosis and treatment items to the basic medical insurance (BMI) payment scope. The move aims to standardize payment categories, ratios, and standards on a provincial scale, with implementation expected by the end of October this year. Background and…
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Leadinno Medical Valley Raises RMB 100M in Series A Financing for Neuromodulation Devices
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Beijing-based neuromodulation medical device maker Leadinno Medical Valley reportedly raised over RMB 100 million (USD 14.4 million) in a Series A financing round led by Proxima Ventures and Med-Fine Capital. Other investors included TigerYeah Capital, Maron Investment, and Cowin Capital. The proceeds will be used for research and development (R&D)…
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Transcenta’s TST001 Shows Promise in Gastric Cancer Trial with 73.3% Response Rate
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China-based biotech Transcenta Holdings Ltd (HKG: 6628) announced interim safety and efficacy data from a Phase I/II study of TST001 (osemitamab), a humanized ADCC-enhanced anti-Claudin18.2 monoclonal antibody (mAb), in combination with capecitabine and oxaliplatin (CAPOX) as a first-line treatment for locally advanced or metastatic gastric or gastroesophageal junction (GC/GEJ) cancer.…
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CSPC Pharmaceutical’s TG103 Gains NMPA Approval for NASH and Alzheimer’s Trials
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China-based CSPC Pharmaceutical Group Co., Ltd (HKG: 1093) announced that it has received approval from the National Medical Products Administration (NMPA) to conduct separate clinical trials for its Category 1 biologic product TG103 in non-alcoholic steatohepatitis (NASH) and Alzheimer’s disease (AD). This marks a significant step forward in the development…
