China

Bayer and 111 Collaborate to Explore the Vast Blue Ocean of Online Healthcare in China

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Shots: The companies will collaborate on drug commercialization initiatives in China, including the commercialization of innovative drugs & healthcare products for chronic disease management, as well as providing reliable and convenient resources for patient education Bayer will leverage 111’s vast network of pharmacies and healthcare… Read More »Bayer and 111 Collaborate to Explore the Vast Blue Ocean of Online Healthcare in China

Bayer Reports the NDA Submission to NMPA for Vericiguat to Treat Chronic Heart Failure in China

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Shots: The NDA submission was submitted to NMPA’s CDE and is based on P-III VICTORIA study, seeking regulatory approval of vericiguat in China In Oct’2014, Bayer and MSD signed a WW agreement for sGC modulators. The therapy is being jointly developed by both the companies… Read More »Bayer Reports the NDA Submission to NMPA for Vericiguat to Treat Chronic Heart Failure in China

BeiGene Signs a License and Supply Agreement with Bio-Thera for BAT1706 (biosimilar, bevacizumab) in China

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Shots: Bio-Thera to receive $165M upfront, regulatory, and commercial milestones and is eligible to receive royalties on sales of the product. BeiGene to get the right to develop, manufacture, and commercialize BAT1706 in China, including Hong Kong, Macau, and Taiwan while Bio-Thera will retain rights… Read More »BeiGene Signs a License and Supply Agreement with Bio-Thera for BAT1706 (biosimilar, bevacizumab) in China

BeiGene Signs a License and Supply Agreement with Bio-Thera for BAT1706 (biosimilar, bevacizumab) in China

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Shots: Bio-Thera to receive $165M upfront, regulatory, and commercial milestones and is eligible to receive royalties on sales of the product. BeiGene to get the right to develop, manufacture, and commercialize BAT1706 in China, including Hong Kong, Macau, and Taiwan while Bio-Thera will retain rights… Read More »BeiGene Signs a License and Supply Agreement with Bio-Thera for BAT1706 (biosimilar, bevacizumab) in China

Henlius’ HLX02 Receives the NMPA’s Approval as the First Trastuzumab Biosimilar in China

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Shots: On Aug 14, 2020, HLX02 (biosimilar, trastuzumab) received NMPA’s approval to treat HER2+ early BC, HER2+ m-BC and HER2+ m-gastric cancer. Additionally, On 27th July, HLX02 has received EC’s approval under the brand name Zercepac Henlius followed the NMPA and EMA’s biosimilar guidelines and… Read More »Henlius’ HLX02 Receives the NMPA’s Approval as the First Trastuzumab Biosimilar in China

Innovent and Eli Lilly Report sNDA Acceptance of Tyvyt (sintilimab) Combination Regimen as 1L Therapy in Squamous Non-Small Cell Lung Cancer in China

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Shots: The NMPA has accepted the sNDA for Tyvyt (sintilimab) in combination with Gemzar (gemcitabine) and platinum as 1L therapy in sq. NSCLC The sNDA is based on P-III ORIENT-12 study assessing sintilimab (200mg) vs PBO in combination with Gemzar and Pt (q3w for up… Read More »Innovent and Eli Lilly Report sNDA Acceptance of Tyvyt (sintilimab) Combination Regimen as 1L Therapy in Squamous Non-Small Cell Lung Cancer in China

Eli Lilly Amends its 2013 Agreement with Chi-Med to Commercialize Elunate (fruquintinib) in China

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Shots: Chi-Med to receive 70%-80% of Elunate sales in the form of royalties, manufacturing costs and service payments with no upfront regarding this amendment. Lilly will maintain the exclusive commercialization rights and will continue to consolidate the sales of Elunate in China while Chi-Med retains… Read More »Eli Lilly Amends its 2013 Agreement with Chi-Med to Commercialize Elunate (fruquintinib) in China

Zai Lab’s Zejula (niraparib) Receives NMPA’s Approval as Maintenance Therapy for Patients with Recurrent Ovarian Cancer in China

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Shots: Zejula (niraparib) is an oral once-daily poly (ADP-ribose) polymerase (PARP) inhibitor used as a maintenance therapy for adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy The NMPA approval of Zejula… Read More »Zai Lab’s Zejula (niraparib) Receives NMPA’s Approval as Maintenance Therapy for Patients with Recurrent Ovarian Cancer in China

Clover Reports Dosing of SCB-808 (biosimilar, etanercept) in P-III Trial in China

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Shots: The P-III study involves assessing of SCB-808 vs Enbrel in patients with AS (axSpA) via SC administration SCB-808 is being developed in the prefilled syringe formulation which is ready for injection and can be self-administered by the patients, thus overwhelming the current Enbrel biosimilar… Read More »Clover Reports Dosing of SCB-808 (biosimilar, etanercept) in P-III Trial in China