-
Hainan Poly Pharm’s Generic Ganciclovir Approved in Sweden for CMV Retinitis
•
China-based Hainan Poly Pharm Co., Ltd (SHE: 300630) has announced receiving technical review approval from the Medical Products Agency of Sweden for its generic version of Roche’s Cytovene-IV (ganciclovir). The approval is for the treatment of cytomegalovirus (CMV) retinitis in immunocompromised patients, including those with AIDS, and for the prevention…
-
Bio-Thera’s BAT1806 Biosimilar Accepted for Review by European Medicine Agency
•
China-based Bio-Thera Solutions Ltd (SHA: 688177) has announced that a Biologic License Application (BLA) for its BAT1806, a biosimilar version of Roche Holding AG’s (SWX: ROG) Actemra/RoActemra (tocilizumab), has been accepted for review by the European Medicine Agency (EMA). This marks a significant step forward in the global development and…
-
Kactus Biosystems Raises RMB 200M in Series B Financing for Protein and Enzyme Development
•
Kactus Biosystems, a Shanghai-based firm specializing in target proteins and raw enzymes, has raised RMB 200 million (USD 27.6 million) in a Series B financing round. The round was led by New Alliance Capital, with participation from Lingang Group’s healthcare industry fund, GF Capital, and a “famous multinational life science…
-
Shandong Junxiu Biotechnology Secures RMB 45M in Series B Financing
•
Shandong Junxiu Biotechnology Co., Ltd, a China-based maker of implantable regenerative medicine devices, has raised RMB 45 million (USD 6.2 million) in a Series B financing round. The round was led by Shenzhen Capital Group, with participation from Qianhai FOF, Huantong Venture Capital, and other investors. The proceeds will be…
-
Brii Biosciences Reports Positive Phase I Results for HIV Treatments BRII-732 and BRII-778
•
China-based Brii Biosciences Limited (HKG: 2137) has published the latest results of two Phase I clinical studies assessing its long-acting BRII-732 and BRII-778, both being developed to treat HIV infection, in healthy subjects in the US. The results showed that both BRII-732 and BRII-778 produced good safety and tolerability profiles…
-
Bayer to Set Up Shenzhen Unit to Boost Women’s Healthcare in South China
•
Bayer’s (ETR: BAYN) women’s healthcare unit for the South China region is reportedly planning to establish a Shenzhen regional unit, tasked with product promotion in Shenzhen and southern Guangzhou. The move is designed to reinforce Bayer’s prescription drug strategy in China and expand its women’s healthcare segment, according to the…
-
GenScript’s Legend Biotech Reports USD 55M in Carvykti Sales
•
China-based Contract Research Organization (CRO) GenScript Biotech Corporation (HKG: 1548) has revealed that sales of its subsidiary company Legend Biotech Corporation’s (NASDAQ: LEGN) BCMA-directed chimeric antigen receptor T cell (CAR-T) therapy, Carvykti (ciltacabtagene autoleucel), reached USD 55 million as of September 30, 2022. The drug is being commercialized in the…
-
YiChang HEC ChangJiang Pharma’s Insulin Aspart Gains NMPA Approval
•
China-based firm YiChang HEC ChangJiang Pharmaceutical Co., Ltd (HKG: 1558) has announced that its in-house developed insulin aspart (specification 3ml: 300 units, refill) has been approved for marketing by the National Medical Products Administration (NMPA). This approval marks a significant milestone in the company’s efforts to expand its presence in…
-
Henlius Biotech’s Hanbeitai Gains NMPA Approval for Recurrent Glioblastoma
•
Shanghai Henlius Biotech Inc. (HKG: 2696) has announced that a supplementary Biologic License Application (sBLA) for its bevacizumab biosimilar, Hanbeitai, has been approved by the National Medical Products Administration (NMPA). The drug can now be used to treat recurrent glioblastoma (GBM), expanding its therapeutic applications in China. Previous Approvals and…
-
NHSA Responds to Proposal on Dental Implants’ Inclusion in NRDL
•
The National Healthcare Security Administration (NHSA) has responded to the No. 6184 suggestion from the 5th session of the 13th National People’s Congress regarding the inclusion of dental implants in the National Reimbursement Drug List (NRDL). The NHSA clarified that fixed and removable dentures are not covered by the NRDL,…
-
Johnson & Johnson Reports Q3 Sales Growth, Maintains Full-Year Guidance
•
US giant Johnson & Johnson (J&J, NYSE: JNJ) released its Q3 2022 financial report, showing global sales growth of 1.9% year-on-year (YOY) in reported terms to USD 23.8 billion. However, operational sales, excluding acquisitions, divestitures, and currency impacts, grew by 8.2%. This performance prompted the company to maintain its 2022…
-
Sichuan Biokin Pharma Plans IPO on STAR Board to Raise RMB 1.422 Billion
•
China-based Sichuan Biokin Pharmaceutical Co., Ltd is set to conduct an initial public offering (IPO) of 40.1 million shares on the Shanghai Stock Exchange’s Sci-Tech Innovation Board (STAR). The offering is expected to raise a total of RMB 1.422 billion (USD 196.6 million). The proceeds will be allocated towards the…
-
Mabwell Bioscience’s 9MW3011 Accepted for Review by China’s NMPA
•
China-based Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced that its clinical filing for the Category 1 drug candidate 9MW3011 in β-Thalassemia and polycythemia vera has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step forward in the development of innovative treatments…
-
Zhiyi Biotechnology Receives FDA Clearance for SK10 in Chemotherapy-Induced Diarrhea
•
Guangzhou-based Zhiyi Biotechnology has announced receiving clearance from the US FDA for a clinical study of its SK10 (inactivated Bacteroides fragilis) in chemotherapy-induced diarrhea (CID). This marks a significant milestone in the development of live biotherapeutic products (LBPs) for addressing unmet medical needs. First-in-Class IND ApprovalNotably, this is the world’s…
-
Shanghai’s Hrain Biotechnology Plans IPO on STAR Board to Raise RMB 2.539 Billion
•
Shanghai-based Hrain Biotechnology Co., Ltd, a specialist in tumor immunotherapy, plans to conduct an initial public offering (IPO) of 50 million shares on the Shanghai Stock Exchange’s Sci-Tech Innovation Board (STAR). The offering is expected to raise RMB 2.539 billion (USD 352.6 million). The proceeds will be allocated towards cell…
-
Eucure Biopharma Partners with Syncromune on Intratumoral Immunotherapy
•
Eucure Biopharma, a wholly-owned subsidiary of Sino-US contract research organization (CRO) Biocytogen, has entered into an agreement with US firm Syncromune, an innovative pharma company focused on the development of next-generation tumor immunotherapies via intratumoral delivery. The collaboration aims to advance the development and commercialization of intratumoral immunotherapy based on…
-
Abogen Biosciences Receives UAE Clinical Trial Approval for Omicron BA.4/5 mRNA Vaccine
•
China’s Abogen Biosciences Co., Ltd, a developer of messenger ribonucleic acid (mRNA) drugs, has announced receiving clinical trial approval in the United Arab Emirates (UAE) for its mRNA COVID-19 vaccine targeting the Omicron BA.4/5 variants. This approval marks a significant step in the global fight against the evolving COVID-19 pandemic.…
-
Shenzhen GeneBioHealth Secures USD 15M for Bio-Business Expansion
•
Shenzhen GeneBioHealth Co., Ltd, a China-based in-vitro diagnostic (IVD) medical device developer, has reportedly raised USD 15 million in a Series B+ financing round. The funds will be used to support bio-business development and product pipeline research and development (R&D). This investment underscores the company’s commitment to advancing its diagnostic…
-
CSPC’s Generic Xofluza Gains NMPA Approval Amid Roche Patent Dispute
•
China-based CSPC Pharmaceutical Group Co., Ltd (HKG: 1093) has obtained market approval from the National Medical Products Administration (NMPA) for its generic version of Roche’s (SWX: ROG) Xofluza (baloxavir marboxil) on October 11, 2022. This approval marks a significant development in the availability of generic influenza treatments in China. However,…
-
Gracell Biotechnologies Initiates Phase II Dosing for GC007g in B-ALL Patients
•
China-based Gracell Biotechnologies Inc. has announced the first patient dosing in the Phase II portion of its registrational Phase I/II clinical study assessing GC007g for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) in China. This milestone marks a significant step forward in the development of innovative treatments…
