Category: (bevacizumab

• The approval is based on P-III IMbrave150 study involves assessing of Tecentriq (atezolizumab, 1200mg) + Avastin (bevacizumab, 15 mg/kg) on day 1 of each 21-day cycle vs sorafenib (400mg, bid) on days 1-21 of each 21-day cycle in 501 patients in a ratio (2:1) with unresectable HCC, prior not treated with systemic therapies
• Result: reduction in the risk of OS (42%); reduction in the risk of disease worsening or death, PFS (41%); showed improvement in both OS and PFS; Grade 3–4 AEs (57% vs 55%), published in the NEJM
• The approval follows an EMA’s CHMP positive opinion received in Sept’2020. The dual regimen also recently included as a class I, A recommendation by the ESMO for unresectable HCC, as well as by many clinical practice guidelines globally

Click here to­ read the full press release/ article | Ref: Roche | Image: National Foundation For Cancer Research

The post Roche’s Tecentriq (atezolizumab) + Avastin (bevacizumab) Receive the EC’s Approval for Unresectable Hepatocellular Carcinoma first appeared on PharmaShots.

• Henlius to receive upfront, regulatory, and commercial milestone payments of ~$43M, eligible to receive $30M for every $1B above the first $600M of the cumulative net sales along with 10% royalties on net sales of the therapy
• Henlius will be responsible for the pre/ clinical development of HLX04, whereas Essex is responsible for regulatory filings and commercialization of HLX04 globally and will be responsible for 80% of all costs and expenses concerning to the development of HLX04. Additionally, Essex has a right to grant a sublicense to third parties, for which Henlius will receive 20% of the related sublicensing revenue
• Henlius is developing HLX04 for ophthalmic diseases, wAMD & DR. Henlius and Essex plan to conduct global clinical trials of HLX04 in China, Australia, EU & the US, & will apply MAA in different countries across the globe

Click here ­to­ read full press release/ article | Ref: Henlius | Image: BioSpectrum Asia

The post Henlius Signs a License Agreement with Essex to Co-develop HLX04 (biosimilar, bevacizumab) for Ophthalmic Diseases first appeared on PharmaShots.

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 for the therapy outside the licensed territory
• The NMPA has recently accepted the BLA for BAT1706. The collaboration allows Bio-Thera to leverage BeiGene’s expertise to accelerate the development and commercialization of BAT1706 as a single agent regimen or as a component of combinational therapies
• BAT1706 is a mAb, a biosimilar referencing Avastin which is a treatment option for solid tumor indications in China such as colorectal, lung, and liver cancers. Additionally, Bio-Thera plans to file for the approval of BAT1706 in the US and EU in the Q4’20

Click here ­to­ read full press release/ article | Ref: BeiGene  Image: JHL Biotech

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 for the therapy outside the licensed territory
• The NMPA has recently accepted the BLA for BAT1706. The collaboration allows Bio-Thera to leverage BeiGene’s expertise to accelerate the development and commercialization of BAT1706 as a single agent regimen or as a component of combinational therapies
• BAT1706 is a mAb, a biosimilar referencing Avastin which is a treatment option for solid tumor indications in China such as colorectal, lung, and liver cancers. Additionally, Bio-Thera plans to file for the approval of BAT1706 in the US and EU in the Q4’20

Click here ­to­ read full press release/ article | Ref: BeiGene  Image: JHL Biotech

Shots:

• The approval is based on P-III IMbrave150 study assessing Tecentriq (1200 mg) + bevacizumab (15 mg/kg, q3w, IV) vs sorafenib (400mg, bid) in 501 patients in a ratio (2:1) with unresectable or metastatic HCC, prior not treated with systemic therapies
• Results: 42% reduction in risk of death (OS); 41% reduction the risk of disease worsening or death (PFS); @primary analysis, median survival follow up time (8.6mos.); 7.6mos. delay in median time to deterioration of patient-reported QoL
• The approval is part of Project Orbis, an initiative of the FDA’s OCE which provides a framework for simultaneous submission and review of oncology products among international partners

Click here ­to­ read full press release/ article | Ref: Roche | Image: SOM

Shots:

• The EMA’s CHMP has adopted a positive opinion recommending the MAA of Centus’ Equidacent (bevacizumab), a biosimilar to Roche’s Avastin to treat carcinoma of the colon or rectum, breast cancer, NSCLC, RCC, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix
• Equidacent will be available as 25 mg/ml as the solution for infusion targeting VEGF and act by inhibiting the binding of VEGF to its receptors on endothelial cell
• The company anticipates EC’s decision in ~60days. The clinical data demonstrated that Equidacent has comparable quality, safety, and efficacy to Avastin

Click here to read full press release/ article | Ref: PRNewswire | Image: PharmaShots