January 10, 2026

Positive results from P3 BREAKWATER study

Pfizer released positive results from P3 BREAKWATER study of BRAFTOVI (encorafenib) + ERBITUX (cetuximab) + FOLFIRI (fluorouracil, leucovorin, and irinotecan) +/- AVASTIN (bevacizumab) for 1L metastatic colorectal cancer (mCRC) with a BRAF V600E mutation

Results:

                                                 P3 BREAKWATER Study Results

This study is expected to be completed in 2027. These data have been presented at ASCO GI 2026.

Source: Pfizer PR Jan 10, 2026

January 13, 2026

Daiichi Initiates First Dose of DATROWAY for NSCLC in P3

The first patient has been dosed in P3 (TROPIONLung17, n=~400) study of DATROWAY (Datopotamab deruxtecan, TROP2 ADC) at 6 mg/kg in patients with TROP2 NMR-positive, adv. non-sq. non-small cell lung cancer (NSCLC) without actionable genomic alterations and previously treated with immunotherapy + pt.CT. The study is assessing DATROWAY vs. docetaxel for PFS & OS as the primary endpoint and ORR, DoR & safety as secondary endpoints across multiple global study sites. Datroway is jointly being developed by Daiichi Sankyo US & AstraZeneca and is being evaluated in 8 other P3 NSCLC trials across lines and with multiple combinations.

Source: Daiichi Sankyo PR Jan 13, 2026

January 15, 2026

AIM Vaccine Completes P3 for High-Efficiency diploid Rabies Vaccine

AIM Vaccine Co.,Ltd. reported that its R&D of the P3 clinical site work of the iterative process for a high-efficiency diploid rabies vaccine has been successfully completed. Animal studies indicate it produces higher protective antibodies than existing diploid rabies vaccines at the same dose. This vaccine supports flexible administration methods such as the “five-dose” and “four-dose” regimens. AIM Vaccine is presently looking to market this vaccine in China and has shown a clear advantage over Vero vaccines too. As per China Insights Consultancy data shows it will grow to RMB 14.8B ($2.12B) by 2030.

Source: PR Newswire Jan 15, 2026

January 02, 2026

BYOOVIZ, Samsung’s Lucentis (Ranibizumab) Biosimilar Commercialization in Europe

Samsung Bioepis has started directly commercializing BYOOVIZ (Ranibizumab bsm), across the EU, following the full transfer of commercial rights from Biogen. BYOOVIZ is Samsung’s fourth product to be directly marketed in the EU, reinforcing Samsung Bioepis’ growing commercial footprint in the region. A new pre-filled syringe (PFS) presentation is expected to enter the EU market in Q2 2026, following a positive opinion from the CHMP in November 2025.

Source: Samsung Bioepis PR Jan 02, 2026

January 06, 2026

NMPA (China) Accepts BLA of LEQEMBI for Early Alzheimer’s Disease

Eisai Co., Ltd. and Biogen got BLA acceptance for SC autoinjector 500 mg QW (two 250 mg injections; time for each autoinjector is ~15 sec) of LEQEMBI in China for the treatment of early Alzheimer’s disease at home, under the brand name “乐意保®” by replacing the current Q2W IV treatments in hospitals. Eisai will be responsible for the distribution in China along with global development and regulatory submissions for LEQEMBI SC, while Biogen will co-commercialize and co-promote along with Eisai globally (ex-China). Eisai estimates that ~17M patients could benefit from LEQEMBI SC in China

Source: Eisai PR Jan 06, 2026

January 08, 2026

US FDA Grant FTD to Enolen for Localized Prostate Cancer

Alessa Therapeutics, Inc. has received Fast Track Designation (FTD) from the US FDA for Enolen, an enzalutamide-releasing implant to treat low- to intermediate-risk, localized prostate cancer. Enolen is being assessed in an ongoing Phase 1 study with expected initial results in 2026. Enolen is expected to deliver already approved enzalutamide directly to the diseased tissue. Preclinical and clinical results have shown positive, durable, and continuous responses.

Source: Alessa PR Jan 08, 2026

January 08, 2026

IND Acceptance by FDA for Late-Onset Pompe Disease

AskBio Inc. announced that the US FDA accepted the IND application of AB-1009 (AAV gene therapy) for the treatment of late-onset Pompe disease. This advances the program to the P1/2 (PROGRESS-GT LOPD) clinical study in the US, evaluating safety. The company plans to enroll its first patient in early 2026. In Sep 2024, AskBio partnered with Belief BioMed (BBM), which sublicensed its proprietary AAV capsid for AB-1009 and provided vector production support, key factors in achieving IND clearance. Additionally, AB-1009 (AAV version) received FTD & ODD from the US FDA

Source: AskBio PR Jan 08, 2026

January 05, 2026

Sanofi and Earendil Labs Collaboration for Autoimmune Disease

Earendil Labs has entered into a strategic collaboration with Sanofi to utilize Earendil’s AI-driven discovery platform for the development of bispecific antibody drugs targeting multiple autoimmune and inflammatory diseases. Under this collaboration, Sanofi will handle global development and commercialization. The total potential deal value is up to $2.56B (incl. $160M upfront + milestones) + low double-digit sales royalties.

Source: PR Newswire Jan 05, 2026

January 09, 2026

MediLink Collaborates with Roche for YL201

MediLink Therapeutics granted Roche an exclusive license for YL201, targeting solid tumors, for development, manufacturing, and commercialization worldwide except mainland China, Hong Kong, and Macau. Roche will provide $570M in upfront and near-term milestone payments, with additional development, regulatory, and commercial milestone payments + tiered royalties on net sales in licensed territories post-approval.

Source: MediLink PR Jan 09, 2026

January 11, 2026

Royalty Pharma Fund Teva for Vitiligo Treatment

Teva Pharmaceuticals received funding of ~$500M from Royalty Pharma to support clinical development of Teva’s TEV-408 (Anti-IL2 mAb) for the treatment of vitiligo. The initial $75M to support the P2b trial is expected to initiate in 2026, and Royalty Pharma holds an option to provide an additional $425M to help in P3, contingent on P2b positive results. Royalty Pharma is expected to receive milestone payments and royalties on global net sales post approval and future sales. TEV-408 is currently assessed in P1b for the treatment of vitiligo, whereas results are expected in 2026 from the P2a celiac disease trial.

Source: Teva PR Jan 11, 2026

January 12, 2026

AbbVie and RemeGen Collaborate for RC148

RemeGen Biosciences granted AbbVie an exclusive license for RC148 targeting advanced solid tumors for a total of $5.6B, for global development, manufacturing, and commercialization (excl. Greater China). AbbVie will pay $650M in upfront and $4.95B for development, regulatory, and commercial milestone payments, along with tiered, double-digit royalties on net sales.

Source: AbbVie PR Jan 12, 2026

January 07, 2026

Rakuten Medical Raises $100M in Oversubscribed Series F Funding for U.S. Regulatory Approval Development

Rakuten Medical closed a $100M Series F funding round, with $70M from new investors and $30M from converted notes plus interest. Series F will support U.S. regulatory approval of ASP-1929, a photoimmunotherapy, currently being evaluated in a global P3 trial (NCT06699212) in combination with pembrolizumab, treating recurrent head and neck cancer. The fund will help increase patient enrollment in several countries, including the U.S., Taiwan, Japan, Ukraine, and Poland, and plans for a U.S. FDA BLA filing in 2028. The round, led by TaiAx Life Science Fund, involved Japanese firms like Daiwa Securities, Mitsui Sumitomo Insurance, and Sumitomo Mitsui Banking, plus ABIES Capital, Nexus CVC, OEP Group, and existing investors, including SBI Group, Rakuten Group, Inc.

Source: Rakuten Medical PR Jan 07, 2026