Akeso and Summit Therapeutics' PD-1xVEGF drug has delivered its first overall survival win in a phase 3 trial. Fosun Pharma out-licensed another immune disease candidate. Hutchmed's CEO took medical leave. And more.
1. Akeso, Summit's PD-1xVEGF drug meets overall survival goal for the first time in a lung cancer trial
For the first time, Akeso and Summit Therapeutics’ ivonescimab has hit the overall survival goal in a phase 3 trial. The study, HARMONi-A, tested the PD-1xVEGF drug alongside chemo in patients with previously treated EGFR-mutated nonsquamous non-small cell lung cancer in China. The success of the trial increases the chances that its global version, HARMONi, could meet its overall survival goal, too, Evercore ISI analysts said.
2. Sitala, backed by Forbion and OrbiMed, seals $670M deal for Fosun immune disease drug
Fosun Pharma has signed its second immune-related disease deal in about two weeks. For up to $670 million, the Chinese biopharma is granting Britain’s Sitala Bio ex-China rights to its drug coded FXS6837. Existing therapies for the candidate’s targeted indications generated $3.8 billion in global revenue last year, Fosun said, citing IQVIA data.
3. Hutchmed names interim chief as CEO Weiguo Su takes medical leave
Hutchmed CEO Weiguo Su, Ph.D., is taking a leave of absence due to health reasons, the company said Monday. The firm’s chief financial officer Johnny Cheng has been named acting CEO to oversee day-to-day operations and management of the company. “This has been a very difficult decision to make, but at this time my focus must be on my health,” Su said in a statement.
4. Akeso scores twice in pair of phase 3 trials, teeing up regulatory submission in China
Akeso is more than just an oncology company. The company just recorded two positive phase 3 readouts for two of its inflammatory disease candidates. The two drugs, the anti-IL-17A agent gumokimab and the anti-IL-4Rα med manfidokimab, were successful in their respective Chinese trials in active ankylosing spondylitis and atopic dermatitis. Akeso is now planning regulatory submissions in China.
5. RemeGen and Vor score again with telitacicept, this time in IgA nephropathy
RemeGen’s telitacicept has pulled off another China phase 3 win. The IgA nephropathy study met its primary endpoint, linking the BLyS/APRIL dual-target agent to a 55% reduction in 24-hour urine protein-to-creatinine ratio at 39 weeks compared with placebo. RemeGen recently partnered with Vor Bio on the drug outside of China.
Other News of Note:
6. Nippon Kayaku, Formiica, CBC form Singapore JV to license drugs in Asia (release)
7. Nasdaq-listed LakeShore receives buyout offer from investment consortium (release)
8. Chinese CRO ChemPartner gets ready to debut new Boston research facility