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China Grants Marketing Approval for MSD’s Welireg for von Hippel-Lindau Disease Tumors
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China’s National Medical Products Administration has issued marketing approval for Merck, Sharp & Dohme’s (MSD; NYSE: MRK) oral drug Welireg (belzutifan) as a therapy for von Hippel-Lindau (VHL) disease-related renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastoma, and pancreatic neuroendocrine tumor (pNET) that do not require immediate surgical intervention.…
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Medtronic Reports 5% Organic Revenue Growth in Q2 FY25 with Strong Portfolio Performance
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US-Irish medical device company Medtronic (NYSE: MDT) has announced its financial results for the second quarter (Q2) of fiscal year 2025, which concluded on October 25, 2024. The company reported a total revenue of USD 8.403 billion for the period, marking a 5.0% increase on an organic basis. Cardiovascular Portfolio…
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Pfizer and Flagship Pioneering Expand Partnership with Two New Biotechnology Agreements
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The billion-dollar, multi-program partnership between US pharmaceutical giant Pfizer (NYSE: PFE) and bioplatform innovation company Flagship Pioneering, initiated in July 2023, has expanded with two new additions. Ampersand Biomedicines and Montai Therapeutics, both Flagship-founded biotechs, have entered into agreements to identify targeted molecules aimed at treating obesity and non-small cell…
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Easton Pharmaceutical Secures NMPA Approval for Generic Jakavi and Urocit-K
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Chengdu-based Easton Pharmaceutical Co., Ltd (SHA: 688513) has announced that it has received separate marketing approvals from the National Medical Products Administration (NMPA) for its generic versions of Incyte Corporation’s Jakavi(ruxolitinib) and Missionpharma’s Urocit-K(potassium citrate), marking a significant milestone for the company. Approval of Generic JakaviJakavi, a JAK inhibitor, is…
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Innorna’s mRNA Drug IN015 Earns Orphan Drug Designation for PFIC Treatment
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Shenzhen-based Innorna Co., Ltd, a leading platform company specializing in mRNA technology and LNP (lipid nanoparticle) delivery technology, has announced that it has received Orphan Drug Designation (ODD) from the US Food and Drug Administration (FDA) for its investigational mRNA drug, IN015. The designation is for the treatment of progressive…
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Kura Oncology and Kyowa Kirin Ink Licensing Deal for Menin Inhibitor Ziftomenib
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US-based Kura Oncology, Inc. (NASDAQ: KURA) has entered into a licensing deal with Japan-headquartered Kyowa Kirin Co., Ltd. (TYO: 4151), granting Kyowa Kirin exclusive commercialization rights to Kura’s menin inhibitor ziftomenib outside of the United States. Kura retains the corresponding rights within the US. Financial Terms and MilestonesAccording to the…
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Jiangsu Hengrui Receives NMPA Approval for HRS-6208 Solid Tumor Clinical Study
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has announced that it has received approval from the National Medical Products Administration (NMPA) to commence a clinical study for its investigational drug HRS-6208 as a monotherapy for solid tumors. HRS-6208: A Selective Small Molecule InhibitorThe drug, a selective small molecule inhibitor with…
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CR Pharma’s CR Sanjiu to Sell 51% Stake in Shenghuo for RMB 1.791 Billion
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China Resources Pharmaceutical Group Co., Ltd (HKG: 3320) has announced a significant internal restructuring within its corporate structure. The company’s sub-subsidiary, China Resources Kunming Shenghuo Pharmaceutical CO., Ltd., also known as CR Sanjiu (SHE: 000999), is poised to sell its 51% stake in Shenghuo to another subsidiary of CR Pharma,…
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InxMed’s Ifebemtinib Earns Breakthrough Therapy Designation for NSCLC Treatment in China
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China-based InxMed (Nanjing) Co., Ltd has announced that the Center for Drug Evaluation of the National Medical Products Administration (NMPA) has granted a Breakthrough Therapy Designation (BTD) to its innovative small-molecule ifebemtinib (IN10018). The designation is for the use of ifebemtinib, a focal adhesion kinase (FAK) inhibitor, in combination with…
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Novartis Expands Gene Therapy Portfolio with Acquisition of Kate Therapeutics
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Swiss pharmaceutical company Novartis (NYSE: NVS) has announced the acquisition of US-based Kate Therapeutics, Inc., a pre-clinical biotech firm specializing in adeno-associated virus (AAV)-based gene therapies for muscle and heart diseases, for a substantial USD 1.1 billion. This strategic move allows Novartis to gain access to Kate’s pre-clinical gene therapy…
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Hua Medicine and Bayer AG Terminate Co-promotion Agreement for HuaTangNing
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China-based Hua Medicine (HKG: 2552) has announced the termination of its co-promotion agreement with German pharmaceutical giant Bayer AG (ETR: BAYN) regarding HuaTangNing (dorzagliatin tablets, HMS5552), effective January 1, 2025. The agreement, which began in August 2020, focused on the promotion and distribution of the drug in China. Dorzagliatin’s Impact…
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United Imaging Installs AI-Powered uMR OMEGA at XRANM’s Breast Health Center
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Shanghai-based United Imaging Healthcare Co., Ltd. has announced the installation of an ultra-wide-bore AI-empowered uMR OMEGA at XRANM’s Breast Health & Imaging Center in New Mexico, United States. This cutting-edge installation marks a significant advancement in patient care and comfort in the field of medical imaging. The uMR OMEGA: Combining…
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Sino Biopharmaceutical Submits NDA for Anlotinib and Penpulimab Combo in HCC to NMPA
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China-based Sino Biopharmaceutical Ltd (HKG: 1177) has announced the submission of a New Drug Application (NDA) to the National Medical Products Administration (NMPA) for its combination therapy of anlotinib and penpulimab in first-line advanced hepatocellular carcinoma (HCC). Phase III Study Data Supports NDA FilingThe filing is supported by data from…
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Sihuan Pharmaceutical’s Huisheng Pharm Strikes Exclusive Deal for Semaglutide Biosimilar in China
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China’s Sihuan Pharmaceutical Holdings Group Ltd (HKG: 0460) has announced an exclusive licensing agreement between its subsidiary Huisheng Pharm and MEIYOUNG. The deal pertains to Huisheng’s biosimilar version of Denmark-based Novo Nordisk’s (NYSE: NVO) weight loss drug semaglutide (Ozempic/Wegovy) for the treatment of overweight or obesity in China. Terms of…
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Innovent Biologics’ IBI354 Earns Breakthrough Therapy Designation for Ovarian Cancer Treatment
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The Center for Drug Evaluation (CDE) website has indicated that China-based Innovent Biologics, Inc. (HKG: 1801) is set to obtain breakthrough therapy designation (BTD) for its antibody drug conjugate (ADC) IBI354, which targets HER2, for the treatment of platinum-resistant ovarian cancer. Phase I/II Clinical Study ResultsThe Phase I/II clinical study…
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CDE Includes Double-Crane’s Hydroxocobalamine and Sanofi Genzyme’s Fitusiran in Rare Disease Care Plan
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China’s Center for Drug Evaluation (CDE) has announced the inclusion of China Resources Double-Crane Pharmaceutical Co., Ltd’s (SHA: 600062) hydroxocobalamine and Sanofi (NASDAQ: SNY) Genzyme’s fitusiran in its patient-centered rare disease drug development pilot program, known as the Care Plan. Hydroxocobalamine for Metabolic Disorders in Children with MMAHydroxocobalamine, also referred…
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Apeiron Therapeutics Initiates Phase Ia/B Study for GTA182 in Solid Tumors with MTAP Deficiency
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Apeiron Therapeutics, a biomarker-driven cancer therapy developer with operations in Shanghai, China, and San Francisco, US, has announced the enrollment of the first patient in the Phase Ia/B study for its investigational drug GTA182. The dosage escalation study aims to assess the safety, efficacy, and pharmacokinetics of the small molecule…
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BI Partners with Sinopharm for Promotion of Sifrol and Pradaxa in China
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German pharmaceutical major Boehringer Ingelheim (BI) has entered into a partnership with China-based Sinopharm Group Co., Ltd (HKG: 1099), granting the latter the rights to promote Boehringer Ingelheim’s Sifrol (pramipexole) and Pradaxa (dabigatran) in China effective from January 1, 2025. Boehringer Ingelheim will retain ownership and manufacturing responsibilities for both…
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Medtronic Receives US Approval for InPen App with Missed Meal Dose Detection
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US-Irish firm Medtronic (NYSE: MDT) has announced US market approval for its new InPen app, which features missed meal dose detection. This innovation marks a significant step in the launch of Medtronic’s Smart MDI system, integrated with the Simplera continuous glucose monitor (CGM). InPen App: A Pioneer in Real-Time Insulin…
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CStone Pharmaceuticals Partners with Pharmalink for Suemalimab Commercialization in MENA and South Africa
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China-based CStone Pharmaceuticals (HKG: 2616) has announced a strategic commercial collaboration with Pharmalink Store – L.L.C – O.P.C (Pharmalink), a prominent pharmaceutical company based in the United Arab Emirates (UAE), concerning its anti-PD-L1 monoclonal antibody (mAb) sugemalimab. Commercial Rights and Deal TermsUnder the agreement, Pharmalink will acquire the commercial rights…
