Semaglutide(Hainan Zhonghe)

Datroway's phase 3 triple-negative breast cancer win, InnoCare Pharma and Zenas BioPharma's autoimmune licensing deal and Lupin's planned investment in Florida made our news this week. AstraZeneca and Daiichi Sankyo are teeing up a TROP2 showdown with Gilead Sciences in first-line triple-negative breast cancer. China's InnoCare Pharma agreed to out-license three autoimmune candidates to Zenas BioPharma. Lupin plans to invest $250 million to build a new plant in Florida. And more.1. AZ, Daiichi score 'landmark' results for ADC Datroway in triple-negative breast cancerAstraZeneca and Daiichi Sankyo said their TROP2 antibody-drug conjugate Datroway extended overall survival against chemotherapy when used as a treatment for first-line triple-negative breast cancer in patients who are not up for immunotherapy. The phase 3 Tropion-Breast02 win sets up likely competition with Gilead Sciences' Trodelvy, which is not yet able to tout an overall survival benefit from its own Ascent-03 trial.2. Zenas makes big bet on MS drug, striking $2B licensing deal with InnoCareZenas BioPharma has signed a licensing deal to obtain three autoimmune disease assets from China’s InnoCare Pharma. For $100 million upfront and near-term milestone payments, Zenas gained development and commercial rights to orelabrutinib in multiple sclerosis globally and in non-oncology indications in certain territories. The drug is approved in China for the treatment of certain blood cancers. The potential $2 billion deal also includes an IL-17AA/AF inhibitor and a TYK2 inhibitor.3. Lupin rides the onshoring wave, pledging $250M to build new respiratory production plant in Fla.Lupin plans to build a new manufacturing plant in Coral Springs, Florida, with capacity to produce more than 25 critical respiratory medicines. The Indian pharma expects to invest $250 million across R&D, infrastructure and capital expenditures at the site over five years. The company has acquired more than five acres of land to construct the planned 70,000-square-foot site.4. Novo vs. KBP Chapter 2: 'Anomalous' trial resultsThe second chapter of Fierce Biotech's deep dive into the showdown between Novo Nordisk and KBP Biosciences focuses on the outsized treatment effect observed at a Bulgaria site in both the phase 2 and phase 3 trials of ocedurenone. Novo alleged that the “anomalous” data were indication of possible fraud, while KBP argued that Novo was trying to obtain worse clinical outcomes to allegedly cover up its own wrong decision to terminate the program.5. Expedition resupplies for phase 2 COPD voyage with $165M series AExpedition Therapeutics, which is built on a model of in-licensing drugs from China, has raised $165 million in a series A round led by Sofinnova Investments and Novo Holdings. The proceeds will go toward a global phase 2 study for the biotech’s lead candidate, EXPD-101, in chronic obstructive pulmonary disease. Expedition got the DPP1 inhibitor from Fosun Pharma.6. Eli Lilly earmarks $1B-plus for contract manufacturing partnerships in IndiaEli Lilly plans to invest more than $1 billion in contract manufacturing partnerships in India. The investment will help boost the supply of the Illinois pharma’s drugs for obesity, diabetes, Alzheimer’s disease, cancer and autoimmune conditions through local manufacturers. Part of the investment will be used on a facility in Hyderabad to oversee the local network of contractors.Other News of Note:7. Ono's BMS-partnered EP4 antagonist improves progression-free survival in phase 2 gastric cancer test8. FDA launches generics pilot program, advances facility PreCheck proposal in bid to incentivize US drug manufacturing9. Trump excludes generics from Big Pharma tariff plan (The Wall Street Journal)10. AviadoBio secures option to rare eye disease gene therapy that could bring Chinese biotech $413M11. Olympus, W.L. Gore link on global distribution deal for endoscopic placement tool12. Lotus signs semaglutide generic deal with Adalvo (release)