Merck & Co. and Cologne Biotech’s sac-TMT has been in the news this week with details or initial reports of three positive Phase 3 trials. Experts say local know-how, proper due diligence and AI will help in closing licensing deals in China. For the first time, a federal jury has found a drug company liable in a late payment lawsuit. moreover.
1. ASCO: Merck and Cologne’s sac-TMT ADC combo outperforms Keytruda by 65% in first-line lung cancer progression
Merck and Cologne sac-TMT scores in endometrial cancer trials
The combination of Merck & Cologne Biotech’s TROP2 antibody-drug conjugate sac-TMT with Keytruda reduced the risk of progression or death by 65% compared with Keytruda alone in first-line PD-L1-positive non-small cell lung cancer, according to the ASCO 2026 abstract detailing the results of the OptiTROP-Lung05 study in China. This data appears competitive compared to Akeso and Summit Therapeutics’ PD-1xVEGF bispecific ivonecicimab as monotherapy.
Meanwhile, Merck’s TroFuse-005 trial met both progression-free survival and overall survival endpoints at interim analysis, and sac-TMT just achieved its first global Phase 3 victory. This study pitted sac-TMT against chemotherapy for previously treated endometrial cancer.
Kelun subsequently announced that the OptiTROP-Breast03 trial in China also showed a “statistically significant and clinically meaningful improvement” in PFS and a “positive trend” in OS for sac-TMT versus chemotherapy at an interim analysis. The first-line triple-negative breast cancer study enrolled patients with PD-L1-negative tumors and patients with PD-L1-positive expression who had previously received early-stage treatment with anti-PD-(L)1 inhibitors.
2. Faced with rising licensing costs in China, biopharmaceutical buyers rely on AI and local know-how to cope
Jeff Meyerson, founder and CEO of Locust Walk, emphasized the importance of having people on the ground when doing biotech deals in China. Sidley Austin attorney Adam Welland emphasized the importance of due diligence, including development strategy. Luba Greenwood, CEO of Mwingir Therapeutics, also said that the explosion of data and candidates in China has made AI a powerful sourcing tool.
3. Takeda Pharmaceutical receives $885 million judgment in antitrust suit
A federal jury in Boston found that Takeda Pharmaceutical conspired with a competitor to delay the release of a generic version of the laxative drug Amitiza, as part of a class action lawsuit brought by purchasers of the drug. The jury ordered the company to pay $885 million in damages, but the final antitrust judgment triples that amount.
4. First, AstraZeneca’s Enhertz receives double FDA approval to treat early-stage breast cancer
Daiichi Sankyo and AstraZeneca’s Enhertz received two simultaneous FDA approvals for early breast cancer, making the HER2 ADC both neoadjuvant and adjuvant therapy. However, the adjuvant label excludes the possibility of continued use of Enhertz in patients already receiving Enhertz in a neoadjuvant setting.
5. Eisai’s slow push towards blockbuster hit with Requembi gains momentum, with $900 million forecast
Lemkebi, the Alzheimer’s disease drug it shares with Biogen, generated sales of 88 billion yen ($555 million) in Japanese yen in Eisai’s fiscal year 2025. Eisai expects sales of anti-amyloid antibodies to reach 143.5 billion yen ($905 million) in fiscal 2026 as the use of blood-based tests increases and more convenient formulations attract new patients.
6. Amgen’s Tabneos faces scrutiny for liver damage; label updated in Japan as patients resume
After Kissei Pharmaceutical Co., Ltd. suspended new patient admissions in Japan for its Amgen-affiliated rare disease drug Tabneos, the company worked with local governments to revise the drug’s label so doctors can resume prescribing it. The move comes after 20 cases of severe liver damage were reported among people taking Tabneos in the country, and comes as similar issues have raised regulatory concerns in both the European Union and the United States.
Other notable news:
7. Novartis terminates plant contract with Chinese CDMO Porton, threatens $64 million legal claim
8. Gilead signs new deal with South Korean API maker Yuhan, this time worth $140 million
9. Vincent Ridge confirms 12.4% weight loss with oral GLP-1, plans to pursue Lilly with Chinese regulators
10. GHO Capital and CBC Group plan to merge to create $21 billion healthcare investment firm
11. Roche signs generic license agreement for Xofluza with pharmaceutical patent pools in 129 countries
12. Otsuka Pharmaceutical cannot overturn generic drug victory in renal drug patent (Bloomberg Law)
13. Singapore court upholds injunction against KBP as arbitration progresses in Novo fraud case (release)
