Shots: 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 […]Read More
Shots: The P-III HLX04-mCRC03 study involve assessing of HLX04 (7.5mg/kg, q3w, when combined with XELOX or 5mg/kg, q2w when combined with mFOLFOX6) vs reference bevacizumab + CT (XELOX or mFOLFOX6) as a 1L treatment in 675 patients in a ratio (1:1) with mCRC Results: PFSR36wk (46.4% vs 50.7%); no difference in 2EPs including OS, PFS, ORR, […]Read More
Shots: The exploratory analyses of the P-III study evaluate the equivalent efficacy of Aybintio vs reference bevacizumab in combination with paclitaxel & carboplatin, q3w up to 6 cycles followed by Aybintio or reference bevacizumab as maintenance monothx. in 665 patients with metastatic/recurrent nsq. NSCLC Results: previous analysis demonstrate ORR in PPS (50.1% vs 44.8%); expanded […]Read More
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 […]Read More
Shots: The EMA’s CHMP positive opinion was provided in June and is the fifth product which received the EU approval for autoimmune diseases and tumor diseases The P-III study results of Abincio which involves 763 patients non-small cell lung cancer (NSCLC) patients and demonstrated the risk ratio of ORR vs original product, also presented at […]Read More
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 […]Read More
Shots: The CHMP has recommended the approval of Aybintio in the EU to treat mCRC, mBC, NSCLC, mRCC, epithelial ovarian, fallopian tube and primary peritoneal cancer and cervical cancer. The EC will review the CHMP’s positive opinion to grant marketing authorization for the therapy The MAA is based on analytical, PK, clinical data, pharmacology, and […]Read More
Shots: The NMPA has approved Byvasda for the treatment of patients with NSCLC and metastatic colorectal cancer. The approval follows TYVYT (sintilimab injection) approval, indicated to treat patients with Hodgkin’s lymphoma, granted in Dec’2018 The launch of Byvasda will provide Chinese patients with high-quality and relatively more affordable bevacizumab biosimilar injection In Jan’2020, Innovent granted […]Read More
Shots: HLX04 is a biosimilar that binds to vascular endothelial growth factor (VEGF) for inhibiting angiogenesis where VEGF acts for promoting growth of blood vessels can inhibit tumor angiogenesis further preventing tumor growth or metastasis. The biosimilar was developed under Chinese biosimilar guideline The P-III HLX04-mCRC03 trial involves assessing of HLX04 (biosimilar, bevacizumab) or Avastin […]Read More
Shots: The P-III IMbrave150 study involves assessing Tecentriq (IV, 1200mg) + Avastin (IV, 15mg/kg) vs Sorafenib (400mg, bid) in 501 (194 from China) patients in a ratio (2:1) in patients with unresectable HCC, prior not treated with systemic therapy The Chinese patients demonstrated a 56% improvement in OS, 40% reduction in PFS and is well […]Read More
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