Amgen added to uncertainty surrounding the OX40 drug class by returning an autoimmune candidate to Kyowa Kirin. Roche penned a deal worth up to $1.7 billion for an RNA interference program from SanegeneBio. Daiichi Sankyo stopped development of its first non-DXd candidate. And more.
1. Amgen jilts Kyowa, exiting $400M autoimmune pact after running vast pivotal program
The prospect of the OX40 class for autoimmune disease is suddenly looking bleak. After Sanofi reported mixed phase 3 atopic dermatitis data on amlitelimab, including a case of Kaposi’s sarcoma, Amgen has terminated its rocatinlimab collaboration with Kyowa Kirin. While Kyowa attributed the decision to portfolio reasons at Amgen, the Japanese pharma later disclosed a case of Kaposi’s sarcoma as well.
2. Roche's return to RNA continues with $1.7B deal for Sanegene program
Roche is paying $200 million upfront for an RNA interference program from Sino-American biotech SanegeneBio. The target and disease area were not disclosed. Sanegene could be in line for up to $1.5 billion in development and sales milestones. The deal came as Roche and another RNAi partner, Alnylam Pharmaceuticals, moved their hypertension candidate zilebesiran into phase 3 testing.
3. Daiichi stops internal development of next-wave ADC as key Datroway readout delayed again
Daiichi Sankyo has discontinued internal development of DS-9606, the first candidate based on the company’s second antibody-drug conjugate platform using a modified pyrrolobenzodiazepine (mPBD) payload. Daiichi suggested the CLDN6-directed candidate has shown some good early data in the germ cell tumor setting that has “confirmed the utility” of the mPBD platform.
4. India will invest $1.1B to boost development of biologics, biosimilars
India is launching the Biopharma Strategy for Healthcare Advancement through Knowledge, Technology and Innovation (SHAKTI) initiative, which is designed to support the domestic development of biologics. The country will invest 100 billion rupees ($1.1 billion) over the next five years to increase research and production of biologic drugs.
5. Chugai drops only AI-assisted antibody from pipeline but still holds high hopes for tech
Roche’s Chugai has nixed its only clinical candidate that was discovered with the help of an in-house artificial intelligence tool called Malexa. The phase 1 chronic disease antibody BRY10 was dropped from the pipeline “based on a comprehensive review” of data, a Chugai spokesperson said. The spokesperson said the discontinuation was unrelated to Malexa itself.
6. Astellas tops expectations as Vyloy sales surge outshines trial setback
Astellas’ quarterly sales beat analysts’ consensus by 8% thanks to strong performance from cancer drugs Padcev and Vyloy. As the first FDA-approved CLDN18.2 agent, Vyloy saw sales quadruple to about $125 million in the last three months of 2025, even as the drug hit a midstage setback in pancreatic cancer. Astellas also discontinued a KRAS G12D protein degrader in favor of another.
Other News of Note:
7. Roche diagnostics business nudges up 2% in '25 as China headwinds buffet Asia-Pacific sales
8. FDA emphasizes drug ingredients, production pledges as it debuts PreCheck manufacturing program
9. AZ, Daiichi nab priority review tag as Datroway homes in on next FDA nod (regulatory tracker)
10. Sun Pharma marks Super Bowl ‘SUNday’ with skin cancer awareness drive
11. China's Newsoara pens $135M deal for remaining rights to vTv's inflammation drug
12. Eisai nabs rights to sell Henlius’ PD-1 in Japan for $75M upfront (release)