Sinocelltech Group Ltd. has received marketing approval for its recombinant chimeric anti-CD20 monoclonal antibody, ripertamab (SCT-400), from China’s NMPA to treat patients with CD20-positive diffuse large B-cell lymphoma. The country’s first homegrown anti-CD20 therapy, ripertamab has been shown to have similar efficacy to global blockbuster rituximab but with a superior safety profile.
Sinocelltech Group Ltd. has received marketing approval for its recombinant chimeric anti-CD20 monoclonal antibody, ripertamab (SCT-400), from China’s NMPA to treat patients with CD20-positive diffuse large B-cell lymphoma. The country’s first homegrown anti-CD20 therapy, ripertamab has been shown to have similar efficacy to global blockbuster rituximab but with a superior safety profile.
Researchers from Biomea Fusion Inc. presented preclinical data for the novel covalent menin inhibitor, BMF-219, after being evaluated in models of diffuse large B-cell lymphoma (DLBCL) and multiple myeloma (MM).
In a new licensing deal cut with Swedish Orphan Biovitrum AB (Sobi), ADC Therapeutics SA is getting a $55 million up-front payment and could receive $50 million more upon regulatory approval of Zynlonta (loncastuximab tesirine) in third-line diffuse large B-cell lymphoma by the European Commission.
Antengene Corp. Ltd. has gained the first greenlight in Asia for the oral exportin 1 (XPO1) inhibitor selinexor, in-licensed from Karyopharm Therapeutics Inc., after South Korea’s Ministry of Food and Drug Safety gave the thumbs up for its NDA.
Antengene Corp. Ltd. has gained the first greenlight in Asia for the oral exportin 1 (XPO1) inhibitor selinexor, in-licensed from Karyopharm Therapeutics Inc., after South Korea’s Ministry of Food and Drug Safety gave the thumbs up for its NDA. The drug has been approved in Korea to treat relapsed or refractory multiple myeloma (MM) and relapsed and refractory diffuse large B-cell lymphoma (DLBCL) in combination with dexamethasone.
China’s drug regulator granted a first CAR T therapy approval to Fosun Kite Biotechnology Co. Ltd.’s FKC-876. Marketed as Yescarta (axicabtagene ciloleucel) in the U.S. and EU, the approval by the National Medical Production Administration for the CD19-directed CAR T therapy came 3.5 years after the FDA nod.
HONG KONG – Chugai Pharmaceutical Co. Ltd. has obtained Ministry of Health, Labor and Welfare (MHLW) approval for a combination regimen containing antimicrotubule binding anti-CD79b monoclonal antibody Polivy (polatuzumab vedotin), bendamustine and Mabthera (rituximab) to treat relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL).
HONG KONG – Daejeon, South Korea-based Curocell Inc. has received the first IND approval for a CAR T therapy in South Korea from the Ministry of Food and Drug Safety (MFDS).
HONG KONG – Overland Pharmaceuticals Inc., a company created to bring innovative medicines to China, this week revealed the formation of two joint ventures intended to deliver on that mission, one with ADC Therapeutics SA and another with Allogene Therapeutics Inc.
