-
China Medical System Licenses Alpha Cognition’s Zunveyl for Dementia Treatment in Asia
•
China Medical System Holdings (CMS; HKG: 0867) has announced a license agreement with Alpha Cognition Inc., obtaining development, regulatory filing, manufacturing, import, export, and commercialization rights to the Canadian firm’s Zunveyl (benzgalantamine delayed-release tablets). The drug targets mild to moderate dementia of Alzheimer’s disease (AD) and is approved for the…
-
Huahai Pharmaceutical to Transfer Rights to Innovative Antidepressant HHT001 via Public Listing
•
China-based Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) is set to transfer the patent and other rights to its hypidone (HHT001), an innovative antidepressant co-developed by the Academy of Military Medical Sciences’ (AMMS) toxicity and drug institute. The transfer will be conducted through a public listing on the China Technology…
-
Mabwell’s 9MW2821 Granted Breakthrough Therapy Designation by CDE for Urothelial Carcinoma
•
China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) to its 9MW2821, an antibody drug conjugate (ADC) targeting Nectin-4. The designation is for the use of 9MW2821 in combination…
-
Kelun Pharmaceutical’s Generic Mulpleta Gains NMPA Approval in China
•
China-based Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its generic version of Japan-based Shionogi’s Mulpleta (lusutrombopag). This Category 4 chemical drug becomes the first generic Mulpleta in China, marking a significant milestone in the…
-
Alloy Therapeutics and Sanofi Collaborate on CNS Drug Development with AntiClastic Antisense Platform
•
US-based Alloy Therapeutics Inc. has announced a target-specific collaboration and license agreement with Sanofi (NASDAQ: SNY), the French pharmaceutical giant. The partnership aims to leverage Alloy’s neuroscience expertise to develop a novel drug targeting the central nervous system (CNS) based on Alloy’s proprietary AntiClastic Antisense Platform. This technology, launched by…
-
Fujian Cosunter’s COVID-19 Therapy GST-HG171/ritonavir Approved in Macau
•
China-based Fujian Cosunter Pharmaceutical Co., Ltd (SHE: 300436) has announced that its Category 1 product, GST-HG171/ritonavir, an oral COVID-19 therapy, has been approved for marketing in Macau. This approval expands the availability of the treatment to patients in the region. Previous NMPA ApprovalThe product previously received conditional approval from the…
-
Medtronic’s Harmony TPV System Gains CE Mark for Minimally Invasive Heart Valve Treatment
•
US-Irish firm Medtronic (NYSE: MDT) has announced that its Harmony Transcatheter Pulmonary Valve (TPV) System has received CE marking, a significant step in expanding its market reach for this minimally invasive alternative to open-heart surgery. The Harmony TPV System is designed for patients with congenital heart disease, specifically those with…
-
Biocytogen and Acepodia Partner to Develop Dual-Payload Bispecific ADCs for Oncology
•
China’s Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (HKG: 2315) has entered into a partnership with Acepodia, a cell therapy specialist operating out of Taipei and California, US. The collaboration aims to provide innovative solutions for tumor heterogeneity and drug resistance through the development of dual-payload bispecific antibody-drug conjugates (BsAD2Cs). Combining ExpertiseThe…
-
Sanofi’s Sarclisa Gains NMPA Approval for Multiple Myeloma Treatment in China
•
French pharmaceutical giant Sanofi (NASDAQ: SNY) has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its Sarclisa (isatuximab) in combination with pomalidomide plus dexamethasone. This approval is for the treatment of adult patients with multiple myeloma who have previously received at least first-line…
-
Araris Biotech and Chugai Pharmaceutical Collaborate on Novel ADC Development
•
Switzerland-based oncology biotech Araris Biotech AG has announced a research collaboration and option to license agreement with Chugai Pharmaceutical Co., Ltd. The partnership will utilize Araris’ proprietary linker-conjugation platform, AraLinQ, to generate novel antibody drug conjugates (ADCs) using antibodies against undisclosed targets provided by the Japanese firm. Deal Terms and…
-
Mirror Biologics and Merck KGaA Collaborate on Phase II Trial for Colorectal Cancer Immunotherapy
•
US-based Mirror Biologics, Inc., an off-the-shelf immunotherapy developer, has announced a clinical trial collaboration and supply agreement with German major Merck KGaA (ETR: MRK). The collaboration aims to jointly conduct a Phase II clinical study assessing the efficacy and safety of Mirror’s immunotherapy AlloStim combined with Merck’s Bavencio (avelumab), an…
-
Johnson & Johnson’s Posdinemab Receives FDA Fast Track Designation for Alzheimer’s Disease
•
US giant Johnson & Johnson (J&J, NYSE: JNJ) has announced that it has received Fast Track designation from the US FDA for its posdinemab, a phosphorylated tau-directed monoclonal antibody (mAb) targeting Alzheimer’s disease (AD). This designation is a significant milestone in the development of posdinemab, which is designed to slow…
-
Boston Scientific Set to Acquire Bolt Medical for Up to USD 900 Million
•
US major Boston Scientific Corporation (NYSE: BSX) is set to acquire Bolt Medical, Inc., a company founded in 2019 with Boston Scientific’s backing, in which it currently holds a 26% stake. The transaction is structured to include an upfront payment of USD 43 million for the remaining 74% ownership that…
-
China’s Central Committee and State Council Outline Reforms for Elderly Care Services
•
The Communist Party of China (CPC) Central Committee and State Council have released the Opinions on Deepening the Reform and Development of Elderly Care Services. The aim is to accelerate the construction of an elderly care service system suitable for China’s national conditions, ensuring that the elderly have a sense…
-
Xtalpi’s Ailux Biologics Partners with UCB for AI-Driven Drug Discovery
•
Shenzhen-based QuantumPharm Inc. (HKG: 2228), better known as Xtalpi Inc., has announced that its subsidiary Ailux Biologics has struck a partnership with UCB (EBR: UCB), granting the Belgian biopharma commercial rights to utilize Ailux’s XtalFold AI platform for the discovery and engineering design of macromolecular drugs. No financial details were…
-
Shanghai Opens Door to Wholly Foreign-Owned Hospitals in Key Areas
•
The Shanghai Municipal Health Commission, along with three other bureaus, has jointly released the “Work Plan for Deepening the Pilot of Opening up Wholly Foreign Owned Hospital Sector in Shanghai.” The plan allows the establishment of wholly foreign-owned hospitals in Shanghai, excluding traditional Chinese medicine hospitals and mergers and acquisitions…
-
NHSA Strengthens Medical Security Rights for Workers in China
•
China’s National Healthcare Security Administration (NHSA) has released the “Notice on Further Strengthening the Protection of Workers’ Medical Security Rights and Interests.” The notice suggests that all localities promote megacities to completely eliminate registered residence restrictions on flexible employment personnel to participate in insurance in the place of employment, ensuring…
-
Duality Biologics and Avenzo Ink Exclusive License for DB-1418/AVZO-1418
•
On January 8, Duality Biologics, Inc. (Duality Bio) and Avenzo Therapeutics, Inc. (Avenzo) jointly announced that they have entered into an exclusive license agreement. Under the agreement, Avenzo will obtain exclusive rights to develop, manufacture, and commercialize DB-1418/AVZO-1418 globally, excluding Greater China. DB-1418/AVZO-1418 is an EGFR/HER3 bispecific antibody-drug conjugate (ADC)…
-
MSD’s Gardasil Vaccine Gains NMPA Approval for Use in Males Aged 9 to 26
•
US major Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its recombinant human papillomavirus (HPV) quadrivalent vaccine, Gardasil, for use in males aged 9 to 26. This approval expands the vaccine’s application to include prevention…
-
Bayer’s Nubeqa Seeks NMPA Approval for New Prostate Cancer Indication
•
Bayer AG (ETR: BAYN) has announced the submission of a supplemental new drug application (sNDA) for its Nubeqa (darolutamide) to the National Medical Products Administration (NMPA) in China. The German pharmaceutical giant is seeking approval for its androgen receptor inhibitor (ARi) combined with androgen deprivation therapy (ADT) for the treatment…
