Clinical Breakthroughs by Everest Medicines, BeiGene, and Innovent Lead the Way; Chipscreen Biosciences Enters AI-Driven Drug Discovery

Li Jiaying Author: Interns Chen Chuan, Zheng Ao, He Duo

NewMedicineProgress

Regeneron Announces New EU and FDA Approvals for Libtayo and EYLEA HD on the Same Day

On November 19, Regeneron announced two significant approvals: the EU approved its PD-1 inhibitor Libtayo® to reduce the risk of recurrence after surgery for high-risk cutaneous squamous cell carcinoma; meanwhile, the U.S. FDA approved EYLEA HD® for treating macular edema associated with retinal vein occlusion, adding a new monthly dosing option.

Lilly's Alzheimer's Drug Remdulane® Approved for New Dosing Regimen in China

On November 20, Lilly China announced that the new dosage instructions for its Alzheimer's disease treatment drug Jienengda® (Donanemab) had been approved by the China National Medical Products Administration. The new regimen significantly reduced the risk of specific brain edema in clinical studies while maintaining similar amyloid plaque clearance effects.

AbbVie Announces FDA Approval of EPKINLY® Combination Regimen for the Treatment of Relapsed or Refractory Follicular Lymphoma

On November 18, AbbVie announced that the FDA had approved its subcutaneous bispecific antibody EPKINLY® in combination with rituximab and lenalidomide for the treatment of adult patients with relapsed or refractory follicular lymphoma. The approval was based on positive results from a pivotal Phase 3 study.

Merck's Once-Daily Oral HIV Medication Phase 3 Trial Results Announced

On November 19 local time, Merck announced that its once-daily oral two-drug combination regimen DOR/ISL achieved the primary endpoint in a pivotal Phase 3 clinical trial targeting treatment-naïve HIV-1 infected individuals. The results showed that its viral suppression rate at 48 weeks was comparable to the control group, with a consistent safety profile.

Transaction Trends

Johnson & Johnson Acquires Halda Therapeutics for Over $3 Billion

On November 17, Johnson & Johnson announced that it would acquire Halda Therapeutics, a clinical-stage biotechnology company, for $3.05 billion in cash. The acquisition aims to obtain its proprietary RIPTAC™ platform and core prostate cancer therapy HLD-0915, to expand Johnson & Johnson's innovative product pipeline in the oncology field.

Roche Signs Commercialization Agreement with Freenome for Blood Test in Colorectal Cancer

On November 18, Freenome, an early cancer detection company, announced a strategic partnership with Roche to jointly commercialize its blood-based cancer screening technology in markets outside the United States. Roche will pay over $200 million, including a $75 million equity investment and future sales royalties.

New Drug Development

Everest Medicines' Universal Cancer Vaccine EVM14 Administers First Patient Dose in the U.S.

On November 20, Everest Medicines announced that the first patient has been dosed in the U.S. as part of the global multicenter Phase I clinical trial for its universal off-the-shelf therapeutic cancer vaccine EVM14. The vaccine targets five tumor-associated antigens and is intended for the treatment of squamous cell carcinomas such as non-small cell lung squamous cell carcinoma.

BeOne Medicines' Brihane® Combined with Briezum® and Chemotherapy Achieves Positive Results in Phase 3 Clinical Study

On November 17, BeOne Medicines announced that its HER2-targeted bispecific antibody Zenidatamab achieved positive results in a Phase 3 study for the first-line treatment of HER2-positive gastric and esophageal adenocarcinoma. Compared with the existing standard therapy, both of its combination regimens significantly improved patients' progression-free survival and several key secondary endpoints.

Innovent Biologics Announces Phase III Clinical Trial Results of Masmidotide Injection

On November 20, Innovent Biologics announced that its GCG/GLP-1 dual receptor agonist, mazdutide 9mg, achieved all endpoints in a Phase III study among Chinese patients with moderate to severe obesity. After 60 weeks of treatment, the average weight loss of participants reached 18.55%. The company plans to submit an application for marketing approval for this indication soon.

Transaction Trends

MicroCore Biotech Partners with StoneWise for AI-Driven Drug Discovery

On November 19, Shenzhen Chipscreen Biosciences announced a collaboration with StoneWise to introduce its MolVado platform AI molecule generation and computational validation solutions. This partnership aims to enhance the efficiency and accuracy of Chipscreen Biosciences in the early-stage research and development of small-molecule drugs, jointly exploring a new AI-driven drug discovery model.

China Resources Pharmaceutical Issues 1.1 Billion Yuan in TechnologyInnovative Bonds

On November 18, CR Pharmaceutical successfully issued 1.1 billion yuan of "25 Runya K3" bonds with a term of 3 years and a coupon rate of 1.78%, receiving active subscriptions from the market.