Merck & Co. announces the long-awaited first publication of PD-1xVEGF bispecific data. China’s Zai Lab is aiming for global expansion. With a pipeline licensed from Hengrui Pharma, Kaleira Therapeutics achieved a record IPO. moreover.
1. AACR: Merck releases PD-1xVEGF bispecific data in NSCLC, remains tight-lipped about Phase 3 plans
Merck & Co. announced the first clinical data from the PD-1xVEGF bispecific, licensed from LaNova Medicines, now part of Sino Biopharm. The drug, given at 20 mg/kg once every three weeks, produced an unconfirmed overall response rate of 55% in 11 first-line patients with PD-L1-positive non-small cell lung cancer. Early data suggests the drug may have similar efficacy and a slightly better safety profile compared to other drugs.
2. AACR: Zai Lab aims to expand globally, provides reality check on China’s biotech breakthrough
Built on a licensing model for China, Xylab aims to become a multinational biopharmaceutical company focused on new drugs such as the DLL3 antibody drug conjugate zosyllutatagperitecan. But cash returns from investing in China are limited, so licensing deals with big drug companies will remain an important source of funding for Chinese startups for some time, Josh Smiley, Zai’s president and chief operating officer, told Fierce.
3. Kailera CEO: ‘We knew we were in a good position’ ahead of obesity biotech’s record-breaking $625 million IPO
Kailera Therapeutics, built on a portfolio of GLP-1 drugs licensed from Hengrui Pharma, conducted a record $625 million IPO. After the company emerged in 2024 with a $400 million Series A round, it was on the fast track to going public. “You can have your finger on the pulse of the investment community, and I think we knew we were in a good position,” Kailera CEO Ron Renaud told Fierce.
4. AACR: FDA veteran Pazdur laments current state of agency, warns of political influence and ‘feeling of insecurity’
Richard Pazdul, M.D., the FDA’s former top drug regulator, spoke about China at an industry partnership event at the AACR Annual Meeting and brought up the FDA’s Project Orbis, which brings together regulators around the world to review drug applications simultaneously. He hopes that China and other Asian countries will participate in such multiregional cooperation.
5. Tortugas comes out of its shell with $106 million to fund four-phase, two-step nerve drug licensed from Asia
A neurology-focused startup led by two Sage Therapeutics veterans has been launched with $106 million. The company, Tortugas Neurosciences, boasts a pipeline of drug candidates for schizophrenia and GABA receptor-positive allosteric modulators licensed from China’s Hansoh Pharmaceutical, as well as GAT-1 and PDE9 inhibitors licensed from Eisai.
Other notable news:
6. Samsung Biologics records significant revenue increase as union rallies gear up for strike
7. Biogen Inc. signs $850 million bioback deal with TJ BioPharma for rights to Chinese late-stage immune antibodies
