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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…
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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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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…
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Shandong Jincheng Pharmaceutical Group Co., Ltd. (SHE: 300233), China’s largest cephalosporin manufacturer, has announced receiving ethical approval to initiate a Phase II clinical study for its LT-01 (litazolid dry suspension). This development marks a significant step in the advancement of the company’s pipeline. LT-01: A Promising Oxazolidone Antibacterial DrugThe Category…
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China-based Innovent Biologics (HKG: 1801) has published the results of a Phase I clinical study for its IBI351 monotherapy in advanced solid tumors at the American Association for Cancer Research (AACR) annual meeting. IBI351: A KRAS G12C Inhibitor Under AssessmentIBI351 (GFH925), a KRAS G12C inhibitor originated by GenFleet Therapeutics Inc.,…
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XZenith Biopharm, a Chinese company with minority ownership by Sihuan Pharma, has completed patient enrollment in a Phase II clinical study for its in-house developed proton pump inhibitor (PPI). The study focuses on the treatment of adult reflux esophagitis (RE) and the control of related symptoms, such as acid reflux,…
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China-based Adagene Inc. (NASDAQ: ADAG) has announced interim results from its combination dose escalation studies of the masked, anti-CTLA-4 SAFEbody, ADG126, at the AACR Annual Meeting in Orlando, Florida, from April 14-19, 2023. The studies include a Phase Ib/II study for ADG126 as a monotherapy and in combination with toripalimab…
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China-based BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235) and SpringWorks Therapeutics Inc., (NASDAQ: SWTX) have published the latest data from a Phase Ib clinical study assessing the combination of BeiGene’s RAF dimer inhibitor lifirafenib and SpringWorks’ MEK inhibitor mirdametinib in advanced or refractory solid tumors carrying RAS mutations, RAF mutations,…
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Taiwan-based HanchorBio has announced receiving the green light from the US FDA to conduct a multi-region, multi-center clinical study for its innovative fusion protein, HCB101. The non-blind, dose exploration first-in-human trial will be conducted in the US and Taiwan, focusing on assessing the safety, tolerability, pharmacokinetics, and preliminary clinical anti-tumor…
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China-based HutchMed (HKG: 0013, NASDAQ: HCM) has announced that the National Medical Products Administration (NMPA) has accepted a market approval filing for the VEGFR inhibitor Elunate (fruquintinib) in China. The filing focuses on the use of Elunate in combination with paclitaxel as a second-line treatment for advanced gastric or gastroesophageal…