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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a China-based pharmaceutical company, has announced receiving approval from the National Medical Products Administration (NMPA) to conduct two clinical studies. One study will investigate the combination of its drug candidate BL-B01D1 with osimertinib (Tagrisso) for the treatment of locally advanced or metastatic non-small…
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Jiangsu Hengrui Pharmaceuticals (SHA: 600276), a leading China-based pharmaceutical company, has announced receiving another indication approval from the National Medical Products Administration (NMPA) for its small-molecule HER2 inhibitor, pyrotinib. The drug is now approved for use in combination with Herceptin (trastuzumab) plus chemotherapy to treat recurrent or metastatic breast cancer…
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Suzhou Evopoint Biosciences Co., Ltd., a China-based pharmaceutical company, has announced receiving approval from the Center for Drug Evaluation (CDE) to conduct a Phase I/II clinical study for its antibody-drug conjugate (ADC), XNW27011. The study will focus on locally advanced unresectable or metastatic malignant solid tumors expressing Claudin 18.2 (CLDN18.2).…
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ChengDu ShengNuo Biotech Co., Ltd (SHA: 688117), a China-based polypeptide specialist, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of Shire’s Firazyr (icatibant). This marks a significant milestone as the company becomes the first manufacturer to file for Drug…
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Reistone Biopharma Co., Ltd, a company incubated by Hengrui Pharmaceuticals (SHA: 600276) with an investment of USD 100 million in 2018, has obtained clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 drug, RSS0343, intended to treat non-cystic fibrosis bronchiectasis (NCFB). Understanding Non-Cystic Fibrosis Bronchiectasis…
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Nanjing-based Neurodawn Pharmaceutical Co., Ltd has announced that its Category 1 drug, injectable Y-1, has obtained clinical trial approval from the National Medical Products Administration (NMPA) for the treatment of primary intracranial malignant tumors. TRPML1 Inhibitor’s Non-Clinical Study ResultsNon-clinical studies have demonstrated that the TRPML1 inhibitor, Y-1, can effectively inhibit…
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China-based Contract Research Organization (CRO) GenScript Biotech Corporation (HKG: 1548) has announced that its subsidiary, Legend Biotech Corporation (NASDAQ: LEGN), has filed a 6-K with the US Securities and Exchange Commission and published clinical studies with the European Hematology Association (EHA) regarding its chimeric antigen receptor (CAR)-T therapies. The release…
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The 2023 edition of the American Association for Cancer Research (AACR) annual meeting has concluded, highlighting the latest trends in clinical cancer research. The event featured a range of CAR-T cell therapies under development, including Allogene Therapeutics’ (NASDAQ: ALLO) CD70-targeting allogeneic treatment ALLO-316, as well as anti-CD19/CD20 and anti-TACI/BCMA bispecific…
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U.S.-based pharmaceutical giant Pfizer (NYSE: PFE) has reported receiving an additional indication approval from the National Medical Products Administration (NMPA) for its globally successful vaccine, Prevenar 13. The approval extends the vaccine’s use to infants and children aged between 6 weeks to 5 years (before the 6th birthday), expanding the…
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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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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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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 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…