The U.S. FDA approved the country’s first two interchangeable biosimilars, or copy products, of Regeneron Pharmaceuticals Inc./Bayer AG’s Eylea (aflibercept) on May 20, to treat four eye-related conditions. The FDA granted the approvals to U.S.- and India-based Johnson & Johnson Services Inc./Biocon Biologics Ltd.’s Yesafili (aflibercept-jbvf; M-710) and South Korea’s Samsung Bioepis Co. Ltd.’s Opuviz (aflibercept-yszy; SB-15).
Zai Lab Ltd., of Shanghai and Cambridge, Mass., has been on a regulatory roll in China, gaining approval of Bristol Myers Squibb Co.’s Augtyro (repotrectinib) for lung cancer on May 12 and NMPA acceptance of subcutaneous Vyvgart‘s (efgartigimod alfa SC) supplemental BLA with priority review on May 14.
South Korea’s HLB Co. Ltd. saw its stock (KOSDAQ:028300) drop nearly 30% on May 17 as CEO Jin Yang-gon announced the U.S. FDA’s complete response letter (CRL) to its NDA seeking approval of its rivoceranib and camrelizumab (Airtuika, Jiangsu Hengrui Pharmaceutical Co. Ltd.) combo for liver cancer.
To strengthen its cancer pipeline, South Korea’s Dong-A ST Co. Ltd. made a strategic investment of ₩25 billion (US$18.45 million) in Seocho-gu, Seoul-based Idience Co. Ltd., a cancer-focused subsidiary of Ildong Pharmaceutical Co. Ltd. on May 20.
Shaking up corporate and pipeline structure, San Diego-based cancer developer Erasca Inc. in-licensed two assets from China-based biopharmas in all-cash deals, while laying off 18% of its workforce, primarily in drug discovery. The flurry of announcements made on May 16, which included $160 million raised in private placement, showed that Erasca would scrap three existing pipeline assets – ERAS-007, ERAS-801 and ERAS-4 – and reshape development to a RAS-targeting franchise.
To strengthen its cancer pipeline, South Korea’s Dong-A ST Co. Ltd. made a strategic investment of ₩25 billion (US$18.45 million) in Seocho-gu, Seoul-based Idience Co. Ltd., a cancer-focused subsidiary of Ildong Pharmaceutical Co. Ltd. on May 20. The equity buyout makes Dongdaemun-gu, Seoul-based Dong-A ST the second largest shareholder of Idience, following Ildong Pharmaceutical. The two companies also shook on a co-development deal for Idience’s lead cancer asset, venadaparib (IDX-1197).
Shaking up corporate and pipeline structure, San Diego-based cancer developer Erasca Inc. in-licensed two assets from China-based biopharmas in all-cash deals, while laying off 18% of its workforce, primarily in drug discovery. The flurry of announcements made on May 16, which included $160 million raised in private placement, showed that Erasca would scrap three existing pipeline assets – ERAS-007, ERAS-801 and ERAS-4 – and reshape development to a RAS-targeting franchise.
After Novosis Putty gained U.S. FDA breakthrough device designation of bio-fusion spine implantation device, South Korea’s Cgbio Co. Ltd. posted positive findings of similar ceramic bone graft, Novosis, to lay groundwork for U.S. market entry.
South Korea’s HLB Co. Ltd. saw its stock (KOSDAQ:028300) drop nearly 30% on May 17 as CEO Jin Yang-gon announced the U.S. FDA’s complete response letter (CRL) to its NDA seeking approval of its rivoceranib and camrelizumab (Airtuika, Jiangsu Hengrui Pharmaceutical Co. Ltd.) combo for liver cancer.
Denver-based Arcscan Inc. gained Chinese approval of its computer-controlled, ultra-high frequency ultrasound diagnostic imaging solution for myopia called Insight 100, expanding its reach beyond the U.S. and Europe.
