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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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Sanofi’s Commitment to China: Expansion, Digital Innovation, and Local R&D
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Wayne Shi, president of France-based Sanofi’s (NASDAQ: SNY) Greater China business, has been discussing the firm’s ongoing commitment to the China market with local media. Speaking to China Daily, Shi emphasized that Sanofi has “always been optimistic about the Chinese market and will continuously expand our investment in China.” Sanofi…
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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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Galvanize Therapeutics Partners with Energenx Medical for Greater China Expansion
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US-based Galvanize Therapeutics Inc. has revealed a licensing deal with Shanghai-based Energenx Medical Ltd, which will see Energenx develop and commercialize Galvanize’s products in Greater China, including Hong Kong, Taiwan, and Macau. Financial details of the agreement have not been disclosed. Energenx was established by Galvanize in collaboration with founding…
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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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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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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…
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Sichuan Kelun Pharmaceutical to Present Clinical Data on RET Inhibitor and ADC at ASCO
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Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422), a China-based pharmaceutical company, has unveiled plans to present clinical trial data for two of its drugs at the upcoming American Society of Clinical Oncology (ASCO) annual meeting. The company will showcase a Phase I clinical trial for its RET inhibitor, KL590586, in…
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Lancet Study Reveals Dalian’s Cancer Survival Rates Compared to US
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A recent study published in The Lancet has conducted a comparative analysis of cancer mortality rates between the United States and Dalian city in Liaoning province, China. The research utilized Dalian cancer registry data from 2015 to 2020, revealing insights into age-standardized 5-year survival rates for all cancer patients, which…
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BioRay Pharmaceutical’s LIV-1 Targeted ADC BRY812 Files IND in China
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Shanghai-based BioRay Pharmaceutical Co., Ltd has announced that an investigational new drug (IND) filing has been submitted in China for its pipeline antibody drug conjugate (ADC), BRY812. The National Medical Products Administration (NMPA) has accepted the filing, marking a step forward in the potential approval of the LIV-1-targeted ADC for…
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Mabwell Bioscience’s 9MW3811 Receives NMPA Approval for Clinical Trials in Oncology and Fibrosis
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China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its in-house developed IL-11 monoclonal antibody (mAb), 9MW3811. The drug is intended for the treatment of various advanced malignant tumors and fibrotic diseases. Therapeutic Potential…
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Roche’s Rozlytrek on Track for Priority Review for Pediatric NTRK Fusion Tumor Treatment
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The Center for Drug Evaluation (CDE) website has indicated that Roche’s (SWX: ROG) Rozlytrek (entrectinib) is likely to receive priority review status for the treatment of children with NTRK fusion positive locally advanced or metastatic solid tumors. This priority review status is justified by the drug’s eligibility for conditional approval.…
