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Luzhu Biotechnology’s Herpes Zoster Vaccine LZ901 Concludes Phase II Study
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Beijing Luzhu Biotechnology Co., Ltd (HKG: 2480), a leading maker of human vaccines and therapeutic biologics, has announced the successful conclusion of a Phase II clinical study for its herpes zoster vaccine, LZ901. The drug demonstrated statistically and clinically meaningful data, along with a good safety profile. The company is…
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CMS Receives NMPA Approval for Tildrakizumab for Plaque Psoriasis Treatment
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China Medical System Holdings (CMS; HKG: 0867) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its drug tildrakizumab, which will be used to treat adult patients with moderate to severe plaque psoriasis suitable for systemic therapy or phototherapy. Tildrakizumab: A Humanized Monoclonal Antibody for PsoriasisTildrakizumab…
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CSPC Pharmaceutical’s AlaMab Therapeutics Presents Positive ALMB-0168 Data at ASCO
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that its subsidiary, AlaMab Therapeutics Inc., will present preliminary positive data from a Phase I clinical study of its pipeline candidate ALMB-0168 at the American Society of Clinical Oncology (ASCO) annual meeting. ALMB-0168 is a monoclonal antibody (mAb) that targets connexin…
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Betta Pharmaceuticals Secures Exclusive Rights to C4 Therapeutics’ CFT8919 in Greater China
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China-based Betta Pharmaceuticals Co., Ltd (SHE: 300558) has announced an exclusive licensing agreement with US firm C4 Therapeutics Inc., (NASDAQ: CCCC) focusing on the development and commercialization of C4’s preclinical stage CFT8919 in Greater China, including Hong Kong SAR, Macau SAR, and Taiwan. CFT8919 is an orally bioavailable BiDAC degrader…
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BeiGene’s Brukinsa Receives Canadian Approval for Chronic Lymphocytic Leukemia
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China-based BeiGene Ltd (NASDAQ: BGNE, HKG: 6160, SHA: 688235) has announced that its Bruton’s tyrosine kinase (BTK) inhibitor, Brukinsa (zanubrutinib), has received the latest indication approval in Canada for the treatment of chronic lymphocytic leukemia (CLL). This approval marks the fourth total approved Canadian indication for Brukinsa, following earlier approvals…
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Chia Tai Tianqing’s Biosimilar Rituximab Approved by China’s NMPA for Lymphoma Treatments
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China-based Chia Tai Tianqing has announced receiving a market approval from the National Medical Products Administration (NMPA) for its biosimilar version of Roche’s MabThera (rituximab), which is used for the treatment of follicular lymphoma (FL), CD20 positive diffuse large B-cell lymphoma (DLBCL), and chronic lymphocytic leukemia (CLL). Phase III Study…
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Jiangsu Hengrui Pharmaceuticals Secures NMPA Approvals for SHR-2106 and HRS-1893 Clinical Trials
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has separately announced receiving clinical trial approvals from the National Medical Products Administration (NMPA) for its two drug candidates, SHR-2106 and HRS-1893. SHR-2106: A Pioneering Monoclonal Antibody for Organ TransplantationSHR-2106 is an in-house developed monoclonal antibody (mAb) with no similar product approved…
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AstraZeneca Launches Calquence in China for Mantle Cell Lymphoma Treatment
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UK-based pharmaceutical giant AstraZeneca (AZ, NASDAQ: AZN) has announced the official market launch of Calquence (acalabrutinib), a second-generation Bruton’s tyrosine kinase (BTK) inhibitor, in China. The drug previously received conditional marketing approval in the country in March this year, specifically for the treatment of mantle cell lymphoma (MCL) that has…
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Hisun Pharmaceutical’s SHP2 Inhibitor HS336 Gets NMPA Clinical Trial Approval
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Zhejiang Hisun Pharmaceutical Co., Ltd (SHA: 600267), a China-based pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its investigational drug HS336, intended for the treatment of advanced solid tumors. HS336: A Novel SHP2 Inhibitor for Anti-Tumor TherapyHS336 is a…
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Hubei Leads National Volume-Based Procurement of Patented Traditional Chinese Medicines
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The Healthcare Security Administration (HSA) bureau of Hubei province has released a notification outlining plans to lead a nationwide allied volume-based procurement (VBP) tender focused on patented traditional Chinese medicines (TCMs). This initiative aims to streamline the procurement process for these essential medicines across participating regions. Procurement Cycle and AgreementsThe…
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Harbour Biomed’s Porustobart Combo Shows Promise in HCC Treatment, ASCO Presentation Reveals
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China-based Harbour Biomed (HKG: 2142) has announced the publication of results from a Phase Ib clinical study of its CTLA-4 antibody porustobart (HBM4003) in combination with Junshi Biosciences’ (HKG: 1877, SHA: 688180) PD-1 inhibitor toripalimab for the treatment of hepatocellular carcinoma (HCC) at the American Society of Clinical Oncology (ASCO)…
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Ascentage Pharma’s Olverembatinib Earns Breakthrough Designation for SDH-Deficient GIST
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The China’s Center for Drug Evaluation (CDE) has granted breakthrough therapy designation (BTD) to olverembatinib, a Category 1 drug developed by Suzhou Ascentage Pharma Co., Ltd’s (HKG: 6855) wholly-owned subsidiary, Guangzhou Shunjian Biopharmaceutical Technology Co., Ltd. The designation targets succinate dehydrogenase (SDH) deficient gastrointestinal stromal tumors (GIST) that have received…
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Abbisko Therapeutics Reports Positive Phase Ib Results for ABSK021 at ASCO
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) is poised to announce positive results from a Phase Ib clinical study of its drug ABSK021 (pimicotinib) in the treatment of tenosynovial giant cell tumor (TGCT) at the American Society of Clinical Oncology (ASCO) annual meeting. Impressive Objective Response Rates for PimicotinibThe…
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Shanghai Yizhong’s Paclitaxel Micelles Data to be Presented at ASCO Annual Meeting
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Shanghai Yizhong Pharmaceutical Co., Ltd (SHA: 688091), a China-based pharmaceutical company, has announced that clinical data for its paclitaxel polymer micelles will be presented at the prestigious American Society of Clinical Oncology (ASCO) annual meeting. Clinical Data from Retrospective Study in NSCLC TreatmentThe data originates from a retrospective study examining…
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Ascentage Pharma to Present Clinical Results of Four Oncology Drugs at Medical Conference
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Suzhou-based Ascentage Pharma (HKG: 6855) has announced its intention to present the clinical results of its four oncology drugs, including olverembatinib, Bcl-2 inhibitor APG-2575, MDM2-p53 inhibitor APG-115, and FAK/ALK/ROS1 triple inhibitor APG-2449, at an upcoming medical conference. Phase I Study for APG-2449 in Solid TumorsAn open, multicenter, dose escalation, and…
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BeiGene Presents Groundbreaking Clinical Data at ASCO Annual Meeting
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China-based BeiGene (NASDAQ: BGNE, HKG: 6160, SHA: 688235) announced the presentation of new data at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The data highlights the range of BeiGene’s research expertise and the productivity of one of the industry’s largest research and development teams. The…
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Chia Tai Tianqing’s TQ-B3525 Heads for Priority Review for Recurrent Follicular Lymphoma
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The Center for Drug Evaluation (CDE) website has indicated that Chia Tai Tianqing’s TQ-B3525, a phosphatidylinositol 3-kinase (PI3-K) α/δ inhibitor, is set to receive priority review status for the treatment of recurrent/refractory follicular lymphoma (FL) as a third-line or later treatment option. TQ-B3525: A Dual Inhibitor Addressing Drug ResistanceTQ-B3525 is…
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Sanofi Launches Soliqua for Type 2 Diabetes Treatment in China
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French pharmaceutical major Sanofi (NASDAQ: SNY) has announced the official market launch of Soliqua (insulin glargine, lixisenatide) in China, targeting adults with type 2 diabetes (T2DM) who struggle with poor blood glucose control. This product can be integrated with other oral hypoglycemic drugs, along with diet and exercise, to enhance…
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GenScript’s Legend Biotech Files Type II Variation Application for Carvykti with EMA
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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 submitted a Type II variation application to the European Medicines Agency (EMA) for its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy, Carvykti (ciltacabtagene autoleucel). The application is supported…
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Takeda and HutchMed’s Fruquintinib Receives Priority Review Status from FDA
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Takeda (TYO: 4502) and HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) have provided an update on the New Drug Application (NDA) filing for Elunate (fruquintinib) with the US FDA. The FDA has granted the filing priority review status and set a Prescription Drug User Fee Act (PDUFA) date for November…
