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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.…
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Asieris Pharmaceuticals to Present Phase I Results of APL-1202 Combo at ASCO
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China-based urogenital cancer specialist Asieris Pharmaceuticals (SHA: 688176) has announced that it will publish the results of a Phase I clinical study at the American Society of Clinical Oncology (ASCO) annual meeting. The study combines Asieris’ APL-1202 with BeiGene Ltd’s (NASDAQ: BGNE, HKG: 6160) programmed death-1 (PD-1) inhibitor tislelizumab as…
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Antengene’s ATG-022 Earns FDA Orphan Drug Designations for Gastric and Pancreatic Cancers
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China-based Antengene Corporation Limited (HKG: 6996) has announced that its in-house discovered and developed antibody drug conjugate (ADC), ATG-022, targeting Claudin 18.2, has been granted two Orphan Drug Designations (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of gastric cancer and pancreatic cancer. This brings the…
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Hanx Biopharmaceuticals’ HX009 Receives US IND Approval for Lymphoma Treatment
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Wuhan-based firm Hanx Biopharmaceuticals Inc. has announced the receipt of an Investigational New Drug (IND) approval in the US for its anti-CD47/PD-1 bispecific antibody (BsAb), HX009. The molecule is set to be assessed in a Phase Ib/II study for patients with relapsed/refractory lymphoma who have failed standard therapy. HX009’s Clinical…
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Sino Biopharmaceutical’s TQ-B3525 Files for Market Approval with CDE
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Sino Biopharmaceutical Ltd (HKG: 1177) has announced a market approval filing for its Category 1 anti-tumor drug, TQ-B3525, a phosphatidylinositol3-kinase (PI3-K) α/δ inhibitor. The filing has been accepted for review by China’s Center for Drug Evaluation (CDE), with the intended indication being the treatment of recurrent/refractory follicular lymphoma (FL) as…
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Enhertu, HER2-Targeted ADC, Officially Launched in China for Breast Cancer Treatment
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Enhertu (trastuzumab deruxtecan), a HER2-targeted antibody-drug conjugate (ADC) co-developed by AstraZeneca (AZ, NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568), has been officially launched in the Chinese market. The drug received marketing approval in China in February 2023 and is now available for the treatment of unresectable or metastatic HER2 positive…
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BeiGene’s Tislelizumab Approved in China for First-Line Esophageal Squamous Cell Carcinoma
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BeiGene (NASDAQ: BGNE) has announced that its programmed death-1 (PD-1) inhibitor, tislelizumab, has been approved in China as a first-line therapy for non-resectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC). This approval comes as part of a combination therapy including chemotherapy regimens of paclitaxel and platinum or…
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Bayer’s Copanlisib (Aliqopa) Approved by NMPA for Recurrent Follicular Lymphoma
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The National Medical Products Administration (NMPA) has indicated on its website that Bayer’s (ETR: BAYN) copanlisib (trade name: Aliqopa) has been granted approval as a monotherapy treatment for recurrent or refractory follicular lymphoma (FL) in China. This approval is specifically for patients who have failed at least two previous systemic…
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Shanghai Junshi Biosciences’ Tuoyi Combo for Triple Negative Breast Cancer Accepted for Review
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Shanghai Junshi Biosciences Co., Ltd (HKG: 1877, SHA: 688180) has announced that the regulatory authorities have accepted for review another indication approval filing for its programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab) combined with paclitaxel (albumin bound) for the treatment of PD-L1 positive (CPS ≥ 1) primary metastatic or recurrent metastatic…
