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MSD Partners with IDEAYA Biosciences to Develop Combination Therapy for Endometrial Cancer
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced a partnership with IDEAYA Biosciences (NASDAQ: IDYA), a US-based biotechnology company, to clinically develop the combination of MSD’s top-selling anti-PD-1 therapy Keytruda (pembrolizumab) with IDEAYA’s potential first-in-class poly (ADP-ribose) glycohydrolase (PARG) inhibitor IDE161. The collaboration focuses on treating microsatellite instability-high (MSI-high)…
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Bio-Thera Solutions Gets Green Light for Phase Ib/II Study of ADC BAT8008 in Advanced Solid Tumors
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Guangzhou-based Bio-Thera Solutions (SHA: 688177) has announced that it has received approval from the National Medical Products Administration to conduct a Phase Ib/II study for its antibody drug conjugate (ADC) BAT8008 in combination with BAT1308 for the treatment of advanced solid tumors. BAT8008 is an innovative ADC that consists of…
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Betta Pharmaceuticals’ Ensartinib Accepted for FDA Review for First-Line ALK+ NSCLC Treatment
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Betta Pharmaceuticals (SHE: 300558), a pharmaceutical company based in China, has announced that the market filing for its ensartinib, an anaplastic lymphoma kinase (ALK) inhibitor co-developed with its affiliate Xcovery, has been accepted for review by the US Food and Drug Administration (FDA). The drug is intended for the first-line…
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InnoCare Pharma Receives IND Approval in China for BCL2 Inhibitor Combo Therapy
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InnoCare Pharma (HKG: 9969; SHA: 688428), a Beijing-based biotech company, has announced that it has received approval for an Investigational New Drug (IND) clinical trial filing in China. The company is set to initiate a clinical trial for its pipeline B-cell lymphoma-2 (BCL2) inhibitor, ICP-248, in combination with its Bruton’s…
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Simcere Pharmaceutical Gets NMPA Approval for Clinical Study of Trispecific Antibody SIM0500
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Simcere Pharmaceutical Group (HKG: 2096), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for SIM0500, a trispecific antibody targeting GPRC5D, BCMA, and CD3. This molecule is intended for the treatment of recurrent or…
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Kexing Pharmaceutical Secures Rights for Chia Tai Tianqing’s Generic Ibrance in 11 Countries
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Kexing Pharmaceutical (SHA: 688136), based in China, has entered into an international collaboration agreement with fellow Chinese firm Chia Tai Tianqing, securing commercialization rights for Chia Tai’s generic version of Pfizer’s Ibrance (palbociclib). This agreement encompasses an initial batch of 11 countries. Palbociclib, recognized as the world’s first CDK4/6 inhibitor,…
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Kelun-Biotech’s A400 Receives Fast-Track Status from FDA for RET Fusion-Positive NSCLC
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Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) announced that its innovative drug development subsidiary, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), has received fast-track designation from the U.S. Food and Drug Administration (FDA) for its investigational RET inhibitor, A400/EP0031. This drug is being developed for the treatment of RET fusion-positive…
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Sinocelltech Gains NMPA Approval for Clinical Study of SCTB35 in B-Cell Non-Hodgkin’s Lymphoma
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Sinocelltech Group Ltd (SHA: 688520), based in China, has announced that it has received clearance from the National Medical Products Administration (NMPA) to initiate a clinical study for its investigational bispecific antibody (BsAb), SCTB35. This novel molecule targets both CD20 and CD3 and is being evaluated as a treatment for…
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Innovent and HutchMed’s Combination Therapy Set for Priority Review in China for Advanced Endometrial Cancer
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China’s Center for Drug Evaluation (CDE) has indicated that the combination therapy of Innovent Biologics Inc.’s (HKG: 1801) PD-1 inhibitor Tyvyt (sintilimab injection) and HutchMed’s (HKG: 0013, NASDAQ: HCM) Elunate (fruquintinib) is on track to receive priority review status in China. This designation pertains to the treatment of advanced mismatch…
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Simcere Secures FDA Approval for Clinical Study of Trispecific Antibody SIM0500 in Multiple Myeloma
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Simcere Pharmaceutical Group (HKG: 2096), based in China, has received approval from the U.S. Food and Drug Administration (FDA) to initiate a clinical study for its trispecific antibody, SIM0500, which targets GPRC5D, BCMA, and CD3. This innovative molecule is being evaluated as a treatment for recurrent or refractory multiple myeloma…
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Lepu Biotechnology’s MRG004A ADC Gains Fast Track Designation for Pancreatic Cancer
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Lepu Biotechnology Co., Ltd. (HKG: 2157), based in China, has announced that its in-house developed antibody-drug conjugate (ADC) MRG004A has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. This indication previously secured the ADC an orphan drug designation (ODD)…
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Merck’s 2023 Annual Report: A Mixed Bag Amid Global Challenges
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Merck KGaA (ETR: MRK), a leading German chemical, reported a 5.6% decline in its global net sales for the fiscal year 2023, amounting to €21.0 billion ($23.0 billion). This contraction was partially attributed to the adverse impact of foreign exchange rates. The company’s Healthcare division, however, posted a 2.7% increase…
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BMS’s Opdivo Secures FDA Approval for First-Line Urothelial Carcinoma Treatment
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The US Food and Drug Administration (FDA) has granted Bristol Myers Squibb (BMS; NYSE: BMY) an indication extension approval for its anti-PD-1 drug Opdivo (nivolumab). The drug is now approved in combination with cisplatin and gemcitabine for the first-line treatment of unresectable or metastatic urothelial carcinoma (UC) in adults. The…
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Shanghai Fosun Pharma Gets NMPA Green Light for Universal NK Cell Therapy GCK-01 Clinical Study
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), a leading pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a Phase I clinical study for its universal NK cell therapy, GCK-01. This Category 1 innovative therapeutic…
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Shanghai Fosun Pharma Gets NMPA Green Light for XS-02 Solid Tumor Clinical Study
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196, HKG: 2196), a leading pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its drug candidate XS-02 in patients with advanced solid tumors. XS-02 is a…
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Luye Pharma Launches Small-Cell Lung Cancer Treatment Zepzelca in Hong Kong and Macau
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Luye Pharma Group (HKG: 2186), a China-based pharmaceutical company, has announced the official market launch of Zepzelca (lurbinectedin), a novel drug for the treatment of small-cell lung cancer (SCLC), in Hong Kong and Macau. Lurbinectedin, discovered and developed by Spain-based Pharma Mar, S.A. (MCE: PHM), is a selective inhibitor of…
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Proviva Therapeutics Secures $18 Million in Series A Financing to Advance PTX-912
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Proviva Therapeutics, a Shanghai-based clinical-stage biotechnology company, has reportedly secured USD 18 million in a Series A financing round led by Lapam Capital, Ennovation Ventures, and Sangel Capital. The funds raised will be directed towards the clinical advancement of the company’s core product, PTX-912. Specializing in the development of next-generation…
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CARsgen Launches BCMA-Targeted CAR-T Therapy in China with High Price Point
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China-based CAR-T cell therapy specialist CARsgen Therapeutics Holdings Ltd. (HKG: 2171) has launched its BCMA-targeted CAR-T cell therapy, CT053 (zevorcabtagene autoleucel; zevor-cel), with a price tag of RMB 1.15 million (USD 160,000), as reported by The Paper, a local media outlet. The company anticipates that the drug’s annual end sales…
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EMA Reviews J&J’s Darzalex Subcutaneous Formulation for Newly Diagnosed Multiple Myeloma
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The European Medicines Agency (EMA) has this week received an indication extension filing from Johnson & Johnson (J&J; NYSE: JNJ) for a subcutaneous formulation of its anti-CD38 drug Darzalex (daratumumab). The filing seeks approval for the combination therapy with bortezomib, lenalidomide, and dexamethasone as a treatment for newly diagnosed multiple…
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Gilead and Merus Form Strategic Oncology Alliance to Develop Trispecific T-Cell Engagers
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Gilead Sciences Inc., (NASDAQ: GILD), has entered into a strategic partnership with Netherlands-based Merus N.V. (NASDAQ: MRUS) to discover two to three trispecific T-cell engagers in the field of oncology. Merus is set to receive an upfront payment of $56 million, an equity investment worth $25 million, and is eligible…
