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Jiangxi Jemincare’s KRAS Inhibitor Earns Breakthrough Designation from China’s CDE for NSCLC
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The China Center for Drug Evaluation (CDE) website has indicated that Jiangxi Jemincare Group’s proprietary small-molecule KRAS inhibitor, JMKX001899, has been granted breakthrough therapy designation (BTD) status for the treatment of advanced or metastatic non-small cell lung cancer (NSCLC) with a KRAS G12C mutation in patients who have previously received…
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CAR T-Cell Therapy Stocks Plunge as FDA Investigates Cancer Reports Linked to Treatments
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Shares of Chimeric Antigen Receptor (CAR) T cell therapy companies plummeted on November 28, 2023, following an announcement from the U.S. FDA regarding an investigation into reports of patients developing cancer as a potential side effect of their treatments. The FDA’s notice highlighted that both clinical trials and post-market surveillance…
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JW Therapeutics Secures Priority Review for Carteyva in Relapsed/Refractory Mantle Cell Lymphoma
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JW Therapeutics (HKG: 2126), based in China, has announced that its CAR-T cell therapy, Carteyva (relmacabtagene autoleucel injection), has received priority review status for the treatment of relapsed or refractory mantle cell lymphoma (r/r MCL). This designation recognizes the drug’s status as a breakthrough therapy. Relmacabtagene autoleucel is an autologous…
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Beijing Konruns Pharmaceutical Launches Phase III Study for KC1036 in Advanced Esophageal Cancer
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Beijing Konruns Pharmaceutical Co., Ltd (SHA: 603590), based in Beijing, has received approval from China’s Center for Drug Evaluation (CDE) to commence a Phase III clinical study for its investigational drug candidate, KC1036. This randomized, controlled, open-label, multi-center Phase III trial aims to evaluate the efficacy and safety of KC1036…
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AbbVie’s Epcoritamab Earns EMA Review and FDA Breakthrough Designation for Follicular Lymphoma
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AbbVie’s (NYSE: ABBV) bispecific antibody (BsAb) Tepkinly/Epkinly (epcoritamab) has been accepted for review by the European Medicines Agency (EMA) and granted breakthrough therapy designation (BTD) by the US Food and Drug Administration (FDA) for the treatment of relapsed or refractory (r/r) follicular lymphoma (FL). These regulatory decisions are backed by…
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Henlius Biotech Gets FDA Clearance for Clinical Study of PD-L1 Targeting ADC HLX43
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Shanghai Henlius Biotech Inc. (HKG: 2696), a Chinese biopharmaceutical company, has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for its antibody drug conjugate (ADC) HLX43, which is co-developed with Suzhou-based Medilink Therapeutics. The molecule is set to be evaluated in patients with…
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CSPC Pharmaceutical Gets NMPA Green Light for SYH2038 Solid Tumor Study
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a Chinese pharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its Category 1 chemical drug, SYH2038, in advanced solid tumors. SYH2038 is a highly selective SOS1 inhibitor, with no similar…
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Abbisko Therapeutics Launches Phase II Trial for Pimocitinib in Advanced Pancreatic Cancer
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Abbisko Therapeutics Co., Ltd (HKG: 2256), a Shanghai-based biotechnology company, has announced the initiation of a Phase II clinical study for its Category 1 innovative drug ABSK021 (pimicotinib) in advanced pancreatic cancer in China, with the first patient now dosed. The multi-center, open-label Phase II study (ABSK021-202) is being conducted…
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Xiamen Inno Medical Partners with Olympus to Advance AI in Digestive Endoscopy
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Xiamen Inno Medical Technology Co., Ltd., a China-based specialist in artificial intelligence (AI) powered digestive endoscopy, has entered into a partnership with Olympus Corporation, a major player in the digestive endoscopy field. The collaboration aims to explore innovative applications and development of AI technology within the digestive endoscopy sector. Financial…
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Coherus Biosciences Sets Price for PD-1 Inhibitor Loqtorzi at $8,892.03, Offering 20% Discount Compared to Keytruda
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Coherus Biosciences Inc. (NASDAQ: CHRS) announced yesterday in an SEC filing the wholesale price for its newly launched PD-1 inhibitor, Loqtorzi (toripalimab), in the U.S. market. The drug, co-developed under license from Shanghai Junshi Biosciences Co., Ltd. (HKG: 1877; SHA: 688180), will retail at $8,892.03 per single-use vial. Loqtorzi received…
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DxVx Secures License for OVM-200 Anti-Cancer Vaccine from Oxford Vacmedix
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South Korea-based DxVx is poised to license OVM-200 from Oxford Vacmedix (OVM), with plans to further develop the anti-cancer vaccine. OVM is anticipated to initiate a Phase Ib study for the vaccine in the UK in the near future, while DxVx will launch a study in Asia, encompassing South Korea…
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KingWise Partners with Truking Technology for Gynecological Tumor Gene Therapy Facilities
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KingWise, a Wuhan-based specialist in gynecological tumor diagnostics, has entered into a partnership with local firm Truking Technology Ltd (SHE: 300358) concerning KingWise’s facilities for gynecological tumor gene therapy products. Truking will offer KingWise a comprehensive end-to-end (EPC) solution for biopharmaceutical front-end processes, including factory design, purification engineering, water distribution…
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Sichuan Kelun Pharmaceutical’s RET Inhibitor A400 Earns FDA Orphan Drug Designation
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Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422), a Chinese pharmaceutical company, through its innovative drug development subsidiary Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), has announced that it has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its RET inhibitor A400/EP0031 in the treatment…
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Jiangxi Jemincare Group Secures NMPA Approval for Generic Ibrance Capsules
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Jiangxi Jemincare Group, a Chinese pharmaceutical company, has announced that it has received market approval from the National Medical Products Administration (NMPA) for its generic version of Pfizer’s (NYSE: PFE) Ibrance (palbociclib). This follows the company’s earlier approval for its active pharmaceutical ingredients (APIs) of palbociclib in China. Palbociclib, initially…
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Jiangsu Hengrui Pharmaceuticals Receives NMPA Approval for Phase Ib/II Study of Dalpiciclib and HRS-8080
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced that it received approval from the National Medical Products Administration (NMPA) to initiate a Phase Ib/II clinical study. This trial will evaluate the combination of dalpiciclib (SHR6390) and HRS-8080 in patients with ER+/HER2- irresectable or metastatic breast cancer. HRS-8080: A…
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Pyrotech Biotechnology’s PTT-936 Gets US FDA Clinical Trial Approval
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Pyrotech (Beijing) Biotechnology Co., Ltd, a China-based biotech firm, has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its in-house developed innate immune agonist, PTT-936. The specific targeted indication for this trial remains undisclosed. Mechanism of Action and Preclinical Success PTT-936…
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SCG Cell Therapy’s SCG101 Receives Tacit Approval for Cholangiocarcinoma Clinical Trial in China
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China’s Center for Drug Evaluation (CDE) website has indicated that SCG Cell Therapy Pte. Ltd’s SCG101 autologous T cell therapy has obtained tacit clinical trial approval in China. This marks a world-first clinical indication for the treatment of cholangiocarcinoma. SCG101’s Expanding Clinical IndicationsSCG101, a TCR-T cell therapy, targets specific hepatitis…
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Akeso Biopharma’s Cadonilimab Meets Primary Endpoint in Phase III Cervical Cancer Study
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China-based Akeso Biopharma (HKG: 9926) has announced that its Phase III AK104-303 study for cadonilimab (AK104), an innovative bispecific antibody targeting programmed death-1 (PD-1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), has achieved its primary endpoint. The study combines the antibody with chemotherapy and optional bevacizumab for the first-line treatment of…
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Boehringer Ingelheim Acquires T3 Pharmaceuticals to Boost Immuno-Oncology Portfolio
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Germany’s Boehringer Ingelheim has announced the purchase of Switzerland-based biotechnology firm T3 Pharmaceuticals this week, in a strategic move to expand its immuno-oncology pipeline. The transaction is valued at up to CHF 450 million (USD 510 million), highlighting Boehringer Ingelheim’s commitment to advancing cancer treatments. T3 Pharmaceuticals’ Innovative Approach to…
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AnHeart Therapeutics and Innovent Biologics File Taletrectinib for Marketing Approval in China
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China’s Center for Drug Evaluation (CDE) has indicated on its website that taletrectinib, an ROS1/NTRK inhibitor co-developed by AnHeart Therapeutics and Innovent Biologics Inc. (HKG: 1801), has been filed for marketing approval. The drug is intended to treat ROS1 fusion positive non-small cell lung cancer (NSCLC) in patients who have…
