-
Salubris Pharmaceuticals’ Enarodustat Gains NMPA Approval for Renal Anemia Treatment
•
China’s Shenzhen Salubris Pharmaceuticals Co., Ltd (SHE: 002294) has announced receiving market approval from the National Medical Products Administration (NMPA) for enarodustat, a novel drug candidate specifically targeting renal anemia. Enarodustat is a hypoxia-inducible factor proline hydroxylase inhibitor (HIF-PHI) developed for anemia in non-dialysis adult chronic kidney disease (CKD) patients.…
-
Baheal Pharmaceutical Partners with RabPharma for Commercialization of RAB001 in China
•
China-based health services and distribution giant Baheal Pharmaceutical Group has announced a strategic partnership with compatriot firm RabPharma. The collaboration focuses on the commercialization of RabPharma’s peptide-drug conjugate (PDC), RAB001, which targets osteonecrosis in mainland China. Financial details of the agreement have not been disclosed. RAB001: A Promising Treatment for…
-
CDE Releases 71st Batch of Generic Reference Preparations with Updates and New Injecables
•
The Center for Drug Evaluation (CDE) has released the 71st batch of chemical generic reference preparations, marking a significant update in the generic drug sector. This batch includes 24 new specifications, of which 7 are injectables. Additionally, 33 previously published specifications have been updated, with information on 10 injectables being…
-
Hainan Boao Lecheng Partners with Recordati on Rare Disease Drug Development
•
The Hainan Boao Lecheng International Medical Tourism Pilot Zone has announced a strategic partnership with Italy-based rare disease specialist Recordati’s China unit. This collaboration aims to address the urgent clinical needs for rare disease drugs in China by encompassing medical services, first pilot trials, drug experience accumulation, and other critical…
-
NMPA Approves Shanghai Magic Medicine’s Innovative Multimodal Tumor Treatment System
•
The National Medical Products Administration (NMPA) has granted marketing approval to Shanghai Magic Medicine’s multimodal tumor treatment system, marking it as the 209th novel device approved in China. This approval signifies a significant advancement in the field of oncology treatment options within the country. Integrating Liquid Nitrogen Freezing and Radio…
-
Keymed Biosciences’ CM313 Monoclonal Antibody Shows Promise in Phase I Study for Multiple Myeloma
•
China-based Keymed Biosciences Inc., (HKG: 2162) has announced that the latest results from a Phase I clinical study for its Category 1 drug CM313, a monoclonal antibody (mAb) targeting CD38, have been presented at the 28th European Hematology Association (EHA) annual meeting. The trial focuses on the molecule’s potential use…
-
Eccogene Secures $25 Million in Series B Financing to Advance Metabolic Disease Therapies
•
Sino-US firm Eccogene Inc. has announced the closure of a Series B financing round, raising RMB180 million (USD 25 million). The round was co-led by New Alliance Capital and Zhangjiang Healthcare Venture Capital, with participation from new investors Rockbleu Capital, YuFu Investment, Huajin Capital, and Elikon Venture, as well as…
-
HutchMed Presents Updated Data on Hematological Malignancy Therapies at EHA and ICML
•
HutchMed (China) Ltd (NASDAQ: HCM, HKG: 0013) has announced that new and updated clinical data related to two novel investigational therapies for hematological malignancies, HMPL-306 and amdizalisib, will be presented at the European Hematology Association (EHA) Annual Meeting and the 17th International Conference on Malignant Lymphoma (ICML). HMPL-306: A Dual…
-
Reistone Biopharma’s Ivarmacitinib Accepted for Review by China’s CDE for Atopic Dermatitis
•
Reistone Biopharma Co., Ltd, a company incubated by Hengrui Pharmaceuticals (SHA: 600276) with an investment of USD 100 million in 2018, has announced that the market filing for its JAK1 inhibitor, ivarmacitinib, for the treatment of moderate to severe atopic dermatitis (AD) has been accepted for review by the Center…
-
CDE Indicates Priority Review for Overland ADCT’s Zynlonta and BeiGene’s Brukinsa
•
The Center for Drug Evaluation (CDE) in China has indicated that Overland ADCT BioPharma (CY) Ltd’s Zynlonta (loncastuximab tesirine), an antibody-drug conjugate (ADC) targeting CD19, and BeiGene Ltd’s (NASDAQ: BGNE, HKG: 6160, SHA: 688235) Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib) are on track to receive priority review statuses. Both…
-
Kexing Pharmaceutical Secures Commercial Rights for Convalife’s Neratinib Generic Outside China
•
China-based Kexing Pharmaceutical (SHA: 688136) has announced a licensing agreement with compatriot firm Convalife, securing commercial rights to the latter’s generic version of Puma Biotechnology Inc’s neratinib in six countries outside China. This move expands access to the oral irreversible small molecule pan-HER tyrosine kinase inhibitor (TKI) for patients in…
-
Lee’s Pharmaceutical Secures Rights to Eyedetec’s Dry Eye Device in Asia-Pacific
•
China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) through its subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622) has announced a licensing, supply, and distribution agreement with US medical device firm Eyedetec Medical Inc. The agreement grants Zhaoke regulatory filing, import, promotion, distribution, sales, and marketing rights to Eyedetec’s dry eye device, Eye…
-
NMPA Approves Betta Pharmaceuticals’ Vorolanib for Second-Line RCC Treatment in Combination with Everolimus
•
The National Medical Products Administration (NMPA) has granted approval for Betta Pharmaceuticals Co., Ltd’s (SHE: 300558) Category 1 drug vorolanib to be used in combination with everolimus for the second-line treatment of advanced renal cell carcinoma (RCC). This approval follows the market filing submitted in January last year and marks…
-
Zelgen Biopharmaceuticals’ ZGGS15 Earns FDA Approval for Advanced Solid Tumor Clinical Trial
•
Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266) has announced that it has received clinical trial approval from the US FDA for its bispecific antibody (BsAb), ZGGS15, which targets LAG-3 and TIGIT in advanced solid tumors. This marks ZGGS15 as the world’s first BsAb of its kind to reach the clinical…
-
CSPC Pharmaceutical’s CPO301 Receives Health Canada Approval for Phase I Study
•
China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received the green light from Health Canada to initiate a Phase I clinical study. The study will assess the safety, pharmacokinetics, and preliminary efficacy of its in-house developed antibody-drug conjugate (ADC), CPO301, in patients with advanced solid tumors,…
-
Shanghai Fosun High Technology Partners with NICE for Joint Innovation Centers
•
China-based conglomerate Shanghai Fosun High Technology (Group) Co., Ltd has entered into a partnership with the National Innovation Center par Excellence (NICE), a comprehensive national technology innovation center approved by the Ministry of Science and Technology (MOST). This collaboration aims to strengthen production, education, and research ties between the entities.…
-
Samyang Holdings Partners with Yxintent for Lafullen Dermal Filler in China
•
South Korea-based Samyang Holdings Biopharm Group has secured a partnership with Hangzhou-based Yxintent, a specialist in medical devices and aesthetics, for its dermal filler product Lafullen. The partnership deal grants Yxintent the development and commercialization rights to Lafullen in China, marking a significant step for Samyang as it expands into…
-
Sequoia Capital to Split into Three Units, Including Independent China and India/SEA Divisions
•
US-based investment fund Sequoia Capital has declared plans to reorganize its business into three distinct units, effective from March 2024. This strategic move includes the establishment of a separate China unit to be renamed Hongshan, an India/South-east Asia unit, and the US/Europe division which will retain the Sequoia Capital name.…
-
Jacobio Pharma Gets Green Light for Phase I/IIa Study of PARP7 Inhibitor JAB-26766
•
China-based Jacobio Pharma (HKG: 1167) has announced receiving approval in China to initiate a Phase I/IIa clinical study for its in-house developed PARP7 inhibitor, JAB-26766, targeting advanced solid tumors. JAB-26766: A Potential Treatment for Squamous CancersThe oral small molecule PARP7 inhibitor is under development for the treatment of squamous non-small…
-
BioMarin Pharmaceutical to Discontinue Vimizim Import License in China
•
BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) has announced its decision not to renew the Import Drug License (IDL) for Vimizim (elosulfase alfa) in China when it expires in May 2024. The company is currently exploring feasible ways to ensure a continuous supply to patients currently undergoing treatment. Challenges in China’s Market…
