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

NewMedicineProgress

Roche's PD-L1 Monoclonal Antibody Atezolizumab Subcutaneous InjectionInjection Approved for Market Launch in China

November 14, the National Medical Products AdministrationNational Medical Products Administration (NMPA)) The official website indicates that the marketing authorization application for Roche’s atezolizumab injection (subcutaneous) has been approved. Atezolizumab is a monoclonal antibody targeting PD-L1, which blocks the interaction between PD-L1 expressed on tumor cells and the PD-1 and B7.1 receptors on immune cells, thereby activating T cells. Since its initial approval in the United States in 2016, the drug has received approval for more than 10 indications, covering non-small cell lung cancer, small cell lung cancer, liver cancer, breast cancer, urothelial carcinoma, melanoma, and other malignancies. The intravenous infusion formulation of atezolizumab (brand name: Tecentriq) was approved for marketing in the United States in May 2016 and has since been approved in multiple regions, including the European Union and Canada. This marks the first imported subcutaneous PD-(L)1 inhibitor approved in China.

Lilly Announces Phase 2 Clinical Trial Data of Selective Amylin Receptor Agonist Eloralintide in Adults with Obesity or Overweight

On November 12, Eli Lilly and Company announced positive results from the Phase 2 clinical trial of eloralintide, an investigational once-weekly selective amylin receptor agonist. The study evaluated the safety and efficacy of eloralintide in 263 adult participants with obesity or overweight accompanied by at least one weight-related comorbidity, excluding those with type 2 diabetes. At week 48, all eloralintide dose groups met the primary endpoint, achieving mean weight reductions ranging from 9.5% to 20.1%, compared with a 0.4% reduction in the placebo group (based on the estimand for efficacy). These findings were presented at Obesity Week 2025 and simultaneously published in The Lancet.

Novo Nordisk Announces New Analysis of Wegovy®: Liver Benefits May Be Independent of Weight Loss Effects

On November 10, Novo Nordisk presented post hoc analysis results from the Phase 3 ESSENCE trial at the annual meeting of the American Association for the Study of Liver Diseases (AASLD). The data showed that in adult patients with MASH (metabolic dysfunction-associated steatohepatitis), semaglutide 2.4 mg (Wegovy®) achieved resolution of liver injury and improvement in fibrosis across subgroups with varying degrees of weight loss. This suggests that the drug’s hepatic benefits may not be entirely dependent on weight reduction, offering new insights into the treatment of MASH.

Boehringer Ingelheim’s Sunvozertinib Receives FDA Priority Review, Poised to Rapidly Benefit Patients with HER2-Mutant Lung Cancer

On November 13, Boehringer Ingelheim announced that its innovative drug zongaitinib, for the treatment of HER2-mutant non-small cell lung cancer (NSCLC), has been granted a Priority Review Voucher by the U.S. FDA. This voucher can significantly shorten the review process to 1–2 months, aiming to accelerate the market launch of this drug, which addresses critical unmet medical needs.

Regeneron Announces Latest Data on Multiple Hematologic Therapies

On November 13, Regeneron presented 14 latest updates from its hematology portfolio at the 66th Annual Meeting of the American Society of Hematology. Highlights included Lynozyfic, a bispecific antibody, as the first monotherapy for newly diagnosed multiple myeloma, and positive results for odronextamab in combination with chemotherapy as a first-line treatment for diffuse large B-cell lymphoma. The company will host an online investor conference on December 10 to provide an in-depth discussion of its multiple myeloma research and development programs.

Transaction Trends

Merck & Co. Acquires Cidara Therapeutics for a Total of $9.3 Billion

On November 15, Merck & Co. (MSD) and Cidara Therapeutics announced that they had signed a definitive agreement under which Merck would acquire Cidara for a total consideration of approximately $9.2 billion. Cidara’s core candidate, CD388, demonstrated a 76% efficacy in preventing influenza at the highest dose in its Phase 2b clinical trial, whereas the average preventive efficacy of traditional influenza vaccines is typically around 40%. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to CD388. The NAVIGATE study met all primary and secondary endpoints related to the prevention of laboratory-confirmed symptomatic influenza in healthy, unvaccinated adults aged 18 to 64 years. Previously, the FDA had granted Fast Track designation to CD388.

Pfizer Completes Dollar-Denominated Acquisition of Metsera

On November 13, Pfizer announced on its official website the successful completion of its acquisition of Metsera. Metsera is a clinical-stage biopharmaceutical company dedicated to accelerating the development of next-generation therapies for obesity and cardiometabolic diseases. Through this acquisition, Pfizer has added a portfolio of promising therapeutic candidates that complement its internal medicine R&D pipeline, including: MET-097i, a GLP-1 receptor agonist (RA) poised to initiate Phase 3 clinical trials; and MET-233i, an amylin analog candidate currently being evaluated in Phase 1 clinical trials for its efficacy as a monotherapy and in combination with MET-097i. Pfizer acquired all outstanding common shares of Metsera for $65.60 per share in cash, implying an enterprise value of approximately $7 billion. Additionally, each share is eligible for contingent value rights (CVRs) worth up to $20.65 per share (approximately $2.2 billion in aggregate), tied to the achievement of three specified clinical and regulatory milestones. The total transaction value is approximately $9.2 billion. Upon closing, Metsera became a wholly owned subsidiary of Pfizer.

New Drug Developments

CanSino Biologics’ Inhaled Tuberculosis Vaccine Launches Phase I Clinical Trial in Indonesia

On November 13, CanSino Biologics announced that its globally innovative inhaled tuberculosis vaccine has initiated Phase I clinical trials in Indonesia, with the first participant successfully enrolled. Utilizing nebulized inhalation technology, this vaccine aims to enhance protection against tuberculosis by eliciting pulmonary immune responses, offering a novel solution for global TB prevention and control.

Simcere Pharmaceuticals’ IL-2 Mutant Fusion Protein Initiates Phase II Clinical Trial, Targeting Tregs for the Treatment of Atopic Dermatitis

On November 10, Simcere Pharmaceutical announced that SIM0278, its regulatory T cell (Treg)-preferential IL-2 mutant fusion protein, has initiated a Phase II clinical trial in China for the treatment of moderate-to-severe atopic dermatitis, with the first patient dosed at Hangzhou First People’s Hospital. This innovative therapy aims to restore immune balance by selectively activating Tregs, offering a potential new option for the treatment of autoimmune diseases.

Kelun Pharmaceutical’s Paliperidone Palmitate Injection Approved, Offering a New Long-Acting Treatment Option for Schizophrenia

On November 14, Kelun Pharmaceutical announced that its self-developed paliperidone palmitate injection (brand name: Anyueda) has officially received marketing approval from the National Medical Products Administration (NMPA) for the treatment of schizophrenia in both the acute and maintenance phases. As a long-acting microcrystalline formulation administered once monthly, this product enhances treatment adherence through steady drug release, is expected to reduce the risk of relapse, and provides a new therapeutic option for nearly 8 million patients in China.

Zai Lab’s Partner Announces Data on Novel Kidney Disease Drug, Demonstrating Best-in-Class Potential

On November 10, at the annual meeting of the American Society of Nephrology, Vertex, a partner of Zai Lab, presented 48-week data on its investigational drug povetacicept for the treatment of IgA nephropathy and primary membranous nephropathy. The results showed that proteinuria decreased by 64% and 82% from baseline, respectively, while renal function remained stable. The drug has received FDA Breakthrough Therapy designation and is expected to have a marketing application submitted within the year.

Everest Medicines Announces New Data from China Study of Nefecon®, Confirming Significant Efficacy in Special Populations and Early-Stage Patients

On November 13, Everest Medicines presented multiple Chinese study datasets for Tarpeyo® (budesonide delayed-release capsules) at the American Society of Nephrology Annual Meeting. The results demonstrated that the drug significantly reduced proteinuria and improved renal function in patients with severe renal impairment as well as in pediatric patients with IgA nephropathy, with a favorable safety profile. Furthermore, the studies confirmed that even patients with lower levels of proteinuria could benefit from the treatment, providing important evidence-based support for early and long-term etiological therapy.

Hansoh Pharma’s B7-H4 ADC Phase II Study Results in Platinum-Resistant Ovarian Cancer Selected for Oral Presentation

On November 11, Hansoh Pharma announced that the Phase II study results of HS-20089, a B7-H4-targeting antibody-drug conjugate (ADC) independently developed by the company for the treatment of patients with platinum-resistant ovarian cancer, were presented as an oral report at the 2025 International Gynecologic Cancer Society (IGCS) Global Meeting, held from November 5 to 7, 2025, at the Century City Conference Centre in Cape Town, South Africa. These findings had previously been first disclosed at the 2025 European Society for Medical Oncology (ESMO) Annual Meeting.

Innovent Biologics and Saint-Gene Biotech Jointly Announce Phase I Clinical Study Results of IBI3016 (AGT siRNA)

On November 10, Innovent Biologics and Sanegene Bio USA Inc. (“Sanegene Bio”) jointly announced that the primary results from the first-in-human (FIH) Phase I clinical study of IBI3016, a small interfering RNA (siRNA) therapeutic targeting angiotensinogen (AGT), were presented in the digital poster session at the 2025 American Heart Association (AHA) Scientific Sessions. This study was a randomized, double-blind, placebo-controlled, single-ascending-dose trial conducted in healthy subjects and patients with mild hypertension, designed to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of subcutaneously administered IBI3016. The results demonstrated that a single dose of IBI3016 achieved sustained and potent reduction in AGT levels along with initial blood pressure lowering, exhibited a favorable safety and tolerability profile, and revealed no unexpected safety signals.

KangFang Biologics’ Personalized mRNA Vaccine for Pancreatic Cancer Completes First Dosing in Phase I Clinical Trial

On November 10, Akeso announced on its official website that the first patient has been dosed in a Phase I clinical study evaluating its first self-developed personalized mRNA vaccine, AK154, as monotherapy or in combination with cadonilimab (a PD-1/CTLA-4 bispecific antibody) or ivonescimab (a PD-1/VEGF bispecific antibody), for adjuvant treatment of pancreatic cancer after surgery.

Transaction Trends

CanSino Biologics Licenses Three-Component LNP Technology in Deal Valued at Over RMB 100 Million

On November 10, CanSino Biologics announced that it had licensed its independently developed novel three-component lipid nanoparticle (LNP) delivery system to Panru Bio for the global research, development, and commercialization of the latter’s mRNA vaccine for prostate cancer. The total value of the agreement exceeds RMB 100 million, marking a significant step forward for CanSino Biologics in breakthrough delivery technology.

Legend Biotech’s CAR-T Therapy Surpasses 9,000 Patients Globally

On November 12, Legend Biotech announced its financial results for the third quarter of 2025. Its flagship product, the BCMA CAR-T therapy CARVYKTI®, demonstrated strong commercial performance, having been launched in 14 markets globally and administered to over 9,000 patients. The company also announced the initiation of a new clinical trial aimed at expanding the use of this therapy to patients with newly diagnosed multiple myeloma. The financial report revealed robust collaboration revenue and ample cash reserves for the period.

Financial Report Information

InnoCare Pharma’s Total Revenue Rises 60% in the First Three Quarters, with Full-Year Break-Even Expected

On November 13, InnoCare Pharma released its financial report for the third quarter of 2025. Total revenue for the first three quarters increased by 59.8% year-on-year to RMB 1.12 billion, primarily driven by the continued growth in sales of the company’s core product, the BTK inhibitor orelabrutinib, and the upfront payment received from the licensing agreement with Prolium. Revenue from orelabrutinib rose by 45.8% year-on-year to RMB 1.01 billion during the first three quarters, surpassing the full-year revenue of the previous year. This performance was mainly attributable to the increasing volume of orelabrutinib sales for its exclusive indication, marginal zone lymphoma (MZL), as well as the approval and market launch of a new indication for first-line treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). Meanwhile, the company’s net loss for the first three quarters narrowed significantly by 74.8%, decreasing to RMB 70 million. The substantial reduction in losses was driven by rapid revenue growth and further improvements in cost efficiency.