Akeso Inc. became the fifth company to score an approval for a homegrown PD-1 antibody in China, with penpulimab cleared for relapsed or refractory (r/r) classic Hodgkin’s lymphoma (cHL). The company is seeking more approvals for nasopharyngeal and lung cancers in both China and the U.S. to stand out in the increasingly competitive PD-1 space.
Manufacturing deficiencies were cited in the FDA’s complete response letter (CRL) for Spectrum Pharmaceuticals Inc.’s Rolontis (eflapegrastim), a decision that will further delay to market in the U.S. what could be the *first novel G-CSF drug in more than 15 years to treat chemotherapy-induced neutropenia.
Preliminary real-world data showed that Chinese inactivated vaccines are 63% protective against the COVID-19 Delta variant, China’s top epidemiologist Zhong Nanshan said at the 24th Respiratory Disease Academic Conference of Guangdong Medical Association in Guangzhou.
Burning Rock Biotech Ltd. has formed a global strategic partnership with Impact Therapeutics Inc. to develop companion diagnostics for a pipeline of drugs in the field of synthetic lethality.
Jiangsu Gdk Biotechnology Co. Ltd. will further develop its vaccine pipeline after it started trading on the Shanghai Stock Exchange Star Market on Aug. 2, where it raised ¥1.21 billion ($187 million) through an initial public offering of 22 million shares. The company plans to use the proceeds from the listing to establish a manufacturing plant to produce its quadrivalent influenza vaccine and invest in R&D for other vaccine candidates, as well as replenish working capital and repay bank loans.
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.
Zentera Therapeutics Inc. completed a $75 million series B financing round to help further its candidates in China, as it paves the way for a listing in Hong Kong next year.
Hongyun Biotech Co. Ltd. raised ¥100 million (US$15.5 million) in a series B round to move its new generation EGFR inhibitor, RC-01, to the IND stage in China and the U.S. for non-small-cell lung carcinoma (NSCLC). The plan is to finish the IND filing by the end of this year and start the trial in 2022.
PERTH, Australia – Australia was one of the first nations to slam its borders shut during the pandemic, praising its efforts in containing COVID-19 infections.
Cell and gene therapy have seen much progress in recent times, with the product pipelines in those areas bursting with more than 1,200 therapies. Naturally, the challenges, opportunities and essential development strategies in those fields were the focus on the last day of the BIO Asia-Taiwan Conference 2021.
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