Merck & Co. unveiled the much-anticipated first look at its PD-1xVEGF bispecific data. China’s Zai Lab is looking to go global. With a pipeline licensed from Hengrui Pharma, Kaleira Therapeutics pulled off a record IPO. And more.
1. AACR: Merck unveils PD-1xVEGF bispecific data in NSCLC, remains tight-lipped on phase 3 plans
Merck & Co. released the first clinical data from its PD-1xVEGF bispecific, licensed from LaNova Medicines, now part of Sino Biopharm. The drug, given at 20 mg/kg once every three weeks, induced an unconfirmed overall response rate of 55% among 11 first-line patients with PD-L1-positive non-small cell lung cancer. The early data suggest the drug has similar efficacy compared with its peers and potentially a slightly better safety profile.
2. AACR: Endeavoring to go global, Zai Lab offers reality check on China’s biotech ascent
Built on a licensing-for-China model, Zai Lab is looking to become a multinational biopharma anchored on novel drugs such its DLL3 antibody-drug conjugate zocilurtatug pelitecan. However, because of limited cash returns on investment in China, licensing deals with Big Pharma will remain the key source of capital for Chinese startups for some time, Josh Smiley, Zai’s president and chief operating officer, told Fierce.
3. Kailera CEO ‘knew we were in a good spot’ before obesity biotech’s record-breaking $625M IPO
Built on a portfolio of GLP-1 drugs licensed from Hengrui Pharma, Kailera Therapeutics has staged a record-breaking $625 million IPO. It was a fast path to the public market after the company emerged in 2024 with $400 million in a series A round. “[Y]ou can tap the pulse of the investment community—and I think we knew we were in a good spot,” Kailera CEO Ron Renaud told Fierce.
4. AACR: FDA vet Pazdur bemoans state of agency, warns of political influence and ‘sense of anxiety’
Speaking about China at the industry partnering event at AACR’s annual meeting, the FDA’s former top drug regulator, Richard Pazdur, M.D, brought up the agency’s Project Orbis, which brings together global authorities so drug applications can be reviewed simultaneously. He would like to see China and other Asian countries brought into such multiregional collaborations.
5. Tortugas comes out of its shell with $106M to fund 4 phase 2-stage neuro drugs licensed from Asia
A neurology-focused startup led by a pair of Sage Therapeutics veterans has emerged with $106 million. The company, Tortugas Neuroscience, boasts a pipeline with a schizophrenia candidate and a GABA receptor-positive allosteric modulator licensed from China’s Hansoh Pharmaceutical, plus GAT-1 inhibitor and a PDE9 inhibitor licensed from Eisai.
Other News of Note:
6. Samsung Biologics posts massive revenue growth as labor union rally sets stage for strike
7. Biogen inks $850M biobucks deal with TJ Biopharma for China rights to late-stage immune antibody
