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Germany’s Merck KGaA (ETR: MRK), a leading player in the global pharmaceutical industry, has this week unveiled its strategic plans for the US healthcare market. The company, which currently commercializes two cancer treatments in the US, is gearing up to launch two additional drugs by 2025. Furthermore, Merck anticipates continuing…
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The Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has issued a positive opinion regarding the approval of Tecentriq SC (atezolizumab), the subcutaneous version of Roche’s (SWX: ROG) PD-L1 inhibitor Tecentriq. This development is a significant step forward for patients with various types of…
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China-based Legend Biotech Corp., (NASDAQ: LEGN) has secured a second multinational partnership for its chimeric antigen receptor (CAR) T cell therapies with Novartis Pharma AG (NYSE: NVS) in a landmark USD 1.1 billion deal. The Swiss pharmaceutical giant has acquired exclusive global development, manufacturing, and commercialization rights to certain assets…
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Bristol Myers Squibb (BMS; NYSE: BMY) has made a significant move in the field of oncology by purchasing ORM-6151, a potential first-in-class antibody-drug conjugate (ADC) from US-based Orum Therapeutics. The acquisition includes approval from the local regulator for ORM-6151 to enter a Phase I study for acute myeloid leukemia (AML)…
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Germany-based pharmaceutical major Bayer (ETR: BAYN) has announced its decision to withdraw the filing for the kinase inhibitor Aliqopa (copanlisib) with the US Food and Drug Administration (FDA). Aliqopa, which received accelerated approval in 2017 for the treatment of relapsed follicular lymphoma (FL), failed to meet the primary endpoint of…
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AnchorDx Medical Co., Ltd, a specialist in methylation high-throughput sequencing based in China, has entered into a partnership with DiaCarta, Ltd, a US-based precision molecular diagnostics company. The collaboration aims to focus on the development and commercialization of cancer screening products, leveraging their proprietary technologies in DNA methylation and mutation…
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Immupeutics Medicine, a Beijing-based developer in the field of tumor immunotherapy, has reportedly secured tens of millions of renminbi in a pre-Series A+ financing round. The funding round was led by Beijing state-owned Capital Operation and Management Center, with additional investments from Junshi Bio, Alwin Capital, and the company’s founder.…
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France-based pharmaceutical company Servier has announced that the US Food and Drug Administration (FDA) has granted market approval for its drug Tibsovo (ivosidenib) for the treatment of recurrent or refractory (R/R) myelodysplastic syndrome (MDS) with IDH1 mutation. This marks the fifth indication for the drug in the IDH1 mutant cancer…
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The National Medical Products Administration (NMPA) of China has indicated on its website that it has approved AstraZeneca’s (AZ, NASDAQ: AZN) programmed death-ligand 1 (PD-L1) inhibitor, Imfinzi (durvalumab), for use in combination with chemotherapy for the treatment of first-line locally advanced or metastatic cholangiocarcinoma (BTC). This marks a significant expansion…
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Germany-headquartered Bayer (ETR: BAYN) has announced a significant modification to its 2020 drug discovery collaboration with US biotechnology firm Recursion Pharmaceuticals (NASDAQ: RXRX). The partnership, which was initially focused on fibrosis, will now shift its attention to precision oncology. This strategic move will see the initiation of up to seven…
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Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755), a Chinese pharmaceutical company, has announced that the China National Medical Products Administration (NMPA) has accepted a clinical trial application for the combination of two pipeline candidates, ASKC202 tablets and ASK120067 tablets. The company is seeking to evaluate this combination therapy in adults…
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The National Medical Products Administration (NMPA) has conditionally approved the marketing of inaticabtagene autoleucel (CNCT 19), a chimeric antigen receptor (CAR)-T cell therapy developed by Chinese firm Juventas Cell Therapy Ltd. The drug is indicated for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) in China. Inaticabtagene Autoleucel’s…
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US-based science and technology services giant Danaher Corporation (NYSE: DHR) has entered into a partnership with the hospital management unit of the China Health Economics Association (CHEA). The collaboration aims to promote the development of oncology prevention and control centers at the county hospital level in China, with no financial…
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China-based Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) has announced receiving approval from the Health Sciences Authority (HSA) in Singapore to conduct a Phase I clinical study for its investigational drug, 177Lu-LNC1003. 177Lu-LNC1003: A Radiopharmaceutical for Advanced Prostate Cancer177Lu-LNC1003 is a radioactive in vivo therapeutic drug that targets prostate…
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Shenzhen-based biotechnology company ImmVira has announced the successful completion of Phase I clinical studies in the United States for its intravenous oncolytic virus product, MVR-T3011 IV. The trial, which focuses on late stage patients with various tumor types, yielded “exceptional” safety results and demonstrated initial efficacy for certain indicationsThe study…
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China-based CStone Pharmaceuticals (HKG: 2616) has announced a licensing agreement with Allist Pharmaceuticals Co., Ltd, granting the Shanghai-based biotech exclusive commercial promotion rights to Gavreto (pralsetinib) in mainland China. CStone retains development, regulatory filing, and other rights excluding promotion in mainland China. Under the agreement, CStone will receive an undisclosed…
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Swiss pharmaceutical giant Roche (SWX: ROG) has announced that it has received market approval from the National Medical Products Administration (NMPA) in China for its novel lymphoma therapy, Columvi (glofitamab). The drug is now approved to treat adult patients with recurrent or refractory diffuse large B-cell lymphoma (DLBCL) who have…
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) has announced that it has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for its investigational drug timdarpacept (IMM01). This marks a significant milestone for the company’s first SIRPαFc fusion protein targeting CD47, which was designed in China.…
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Shanghai-based biotech Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase I clinical study for its next-generation CD73 inhibitor, ABSK051, in China. This first-in-human (FIH), multi-center, open-label study will evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD),…
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The US Food and Drug Administration (FDA) has granted approval to HutchMed (NASDAQ: HCM) and its partner Takeda (NYSE: TAK, TYO: 4502) for their oral tyrosine kinase inhibitor Fruzaqla (fruquintinib), marking the second approval this year for a China-developed innovative drug. The drug is indicated for adult patients with previously…