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BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235), a China-based biopharmaceutical company, has announced that the global RATIONALE 305 trial has successfully met its primary endpoint of overall survival. The trial demonstrated that tislelizumab, in combination with chemotherapy, showed superior overall survival (OS) compared to chemotherapy alone in patients with advanced…
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China-based nerve and peripheral vascular interventional device developer Zylox-Tonbridge Medical Technology (HKG: 2190) has announced a strategic partnership with Guangdong Hicicare Science Co., Ltd. The collaboration aims to promote and sell Zylox-Tonbridge’s peripheral vascular intervention and neurovascular intervention guide wire products in China. Financial details of the agreement were not…
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Shanghai Ark Biopharmaceutical Co., Ltd’s Initial Public Offering (IPO) filing to the Shanghai Stock Exchange’s Sci-Tech Innovation Board (STAR) has been accepted for review by the exchange, with expectations to raise RMB 1.997 billion (USD 289.6 million). This move follows the company’s previous withdrawal of an IPO filing in Hong…
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Hunan Warrant Pharmaceutical Co., Ltd (SHA: 688799), a China-based pharmaceutical company, has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its generic version of Menarini’s brivudine. This approval signifies that Warrant Pharma’s version of the drug has successfully passed the generic quality consistency evaluation (GQCE) and…
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China-based Junshi Biosciences (HKG: 1877, SHA: 688180) has published the results of the Phase III Neotorch study for its programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab) combined with chemotherapy for the perioperative treatment of resectable non-small cell lung cancer (NSCLC) at the American Society of Clinical Oncology (ASCO) Plenary Series this…
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Jiangsu Aidea Pharmaceutical Co., Ltd (SHA: 688488), a China-based pharmaceutical company, has entered into a licensing agreement with South Korean firm Kainos Medicine Inc., concerning Kainos’ ainuovirine (ACC007) and its fixed dose preparation ainuovirine, lamivudine, tenofovir disoproxil (ACC008). The agreement grants Aidea commercial, development, and promotion rights for these drugs…
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China-based Acotec Scientific Holdings Ltd (HKG: 6669) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its Vericor-14 microcatheter. The product is now approved for use in percutaneous intervention surgery of coronary arteries and peripheral blood vessels, providing targeted access to the lesion site of narrow…
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Janssen’s Spravato (esketamine) has been granted approval by the National Medical Products Administration (NMPA) in China for the alleviation of depressive symptoms in adult patients with acute suicidal ideation or behavior when used in combination with an oral antidepressant. Spravato: A Novel Antidepressant with Rapid-Onset ActionSpravato marks a significant advancement…
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Jiangxi Jemincare Group, a China-based pharmaceutical company, has announced receiving clinical trial approvals for four category 1 innovative drugs. Three of these approvals were granted by the National Medical Products Administration (NMPA) in China, and one by the US FDA. The drugs are targeted towards treating kidney and cardiovascular diseases.…
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its antibody-drug conjugate (ADC), SYS6010, which is intended for the treatment of advanced solid tumors. Pre-Clinical Studies and Patent Protection for SYS6010Pre-clinical studies have demonstrated that…
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Shares of Legend Biotech (NASDAQ: LEGN) jumped an impressive 19.64% in a single day, attributed by industry media to the recent leak of positive data from the ongoing Phase III CARTITUDE-4 study. The study is assessing Legend’s BCMA-targeted chimeric antigen receptor (CAR) T cell therapy, Carvykti (ciltacabtagene autoleucel), as a…
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China-based Acotec Scientific Holdings Ltd (HKG: 6669) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its paclitaxel-coated arteriovenous fistula high-pressure balloon dilation catheter, ACOART AVENS. The product is intended for use in percutaneous transluminal angioplasty (PTA) for autologous arteriovenous fistula stenosis in hemodialysis patients. Product…
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China-based chimeric antigen receptor (CAR)-T cell specialist, CARSgen Therapeutics Holdings Ltd (HKG: 2171), has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its pipeline candidate, CT041. The therapy will be assessed as a post-operative adjuvant treatment for Claudin18.2 (CLDN18.2)-positive pancreatic cancer. Potential First-In-Class CAR-T Therapy:…
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Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 product candidate, ZG2001. ZG2001: An Oral Pan-KRAS Mutation InhibitorZG2001, an in-house developed oral pan-KRAS mutation inhibitor, is under development for the treatment of…
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Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) has announced receiving clinical trial approval for its Category 1 biologic product ASKG915 from the National Medical Products Administration (NMPA). The study will initially assess the therapy in patients with general advanced solid tumors. ASKG915: A Bifunctional Fusion Protein Targeting PD-1 and IL-15ASKG915…
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China-based InnoCare Pharma (HKG: 9969, SHA: 688428) has announced receiving another indication approval from the National Medical Products Administration (NMPA) for its Bruton’s tyrosine kinase (BTK) inhibitor, orelabrutinib. The drug can now be used to treat recurrent/refractory marginal zone lymphoma (MZL), marking it as the first BTK inhibitor for that…
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China’s Walvax Biotechnology Co., Ltd (SHE: 300142) has announced the efficacy interim results of a Phase III clinical study for its RQ3013, a bivalent mRNA vaccine based on the S protein chimera of Alpha/Beta SARS-CoV-2 variants. The study provides crucial data on the vaccine’s performance as a sequential booster in…
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The National Medical Products Administration (NMPA) has released its “Annual Drug Supervision and Administration Statistics (2022)”, offering insights into the drug and device administrative system for the 2022 calendar year. Yearly Increase in Clinical Trials and Market FilingsDuring the period, the NMPA accepted a total of 2,403 clinical trial filings,…
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The National Medical Products Administration (NMPA) has granted import approval to US firm Alcon Laboratories, Inc. for its innovative intraocular lens, marking it as the 197th innovative medical device to be approved by the bureau. Product Features and BenefitsThe product in question is a one-piece posterior chamber intraocular lens that…
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Biosyngen Pte Ltd, a cell and gene therapy (CGT) biotech with operations in Singapore and Guangzhou, China, has announced receiving Investigational New Drug (IND) approval from the US FDA for its second pipeline product, a T-cell redirection therapy designed for the treatment of EBV-positive lymphoma. This approval follows closely on…