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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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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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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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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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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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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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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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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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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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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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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 (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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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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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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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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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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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…
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Jingxin Pharmaceutical Co., Ltd (SHE: 002020) announced that it has received clinical trial approvals from the National Medical Products Administration (NMPA) for its in-licensed products JBPOS0101 and JX7002. JBPOS0101 is being assessed for focal epilepsy in adults, while JX7002 is under development for hypercholesterolemia and mixed hyperlipidemia. JBPOS0101: A First-in-Class…
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According to the “China Retail Pharmacy O2O Development Report” released by Minenet, the “online drug purchase” model has gained significant traction due to the COVID-19 pandemic and online prescription drug sales policies, with O2O becoming a mainstream retail pharmacy online business approach. By the end of 2021, approximately 200,000 pharmacies…
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The national high-value medical consumables joint procurement office released a set of guiding opinions on the national high-value medical consumables volume-based procurement (VBP), publishing the filing invitation and procurement volume for orthopedic spine medical consumable products. The VBP round will include anterior cervical screw plates, posterior cervical screw rods, posterior…