Kelun-Biotech and Crescent Forge Strategic Collaboration; Tirzepatide Included in National Reimbursement Drug List for First Time; Regeneron Partners with Tessera

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

New Drug EntryExpand

BioNTech and OncoC4 Lung CancerNew Drug Gotistobart Demonstrates Significant Survival Benefits

On December 6, BioNTech and OncoC4 announced positive results from the global Phase III clinical trial of their selective Treg modulator Gotistobart in previously treated squamous cell carcinoma of the lung patients. The data showed that, compared to standard chemotherapy, Gotistobart reduced the risk of death by 54%, with a significantly better median overall survival than the chemotherapy group. The drug demonstrated manageable safety and has received Fast Track designation from the U.S. FDA.

BMS CAR-T Therapy Breyanzi Receives Fifth FDA Approval in the US

On December 4, Bristol-Myers Squibb announced that its CAR-T cell therapy Breyanzi has been approved by the FDA for the treatment of adult patients with relapsed or refractory marginal zone lymphoma who have received at least two prior lines of therapy. This is the fifth indication for which the therapy has been approved in the United States, with key clinical studies showing a patient response rate of 95.5%.

Johnson & Johnson's Innovative Drug Nirsevimab Approved in the EU for Treating Myasthenia Gravis

On December 1, Johnson & Johnson announced that its FcRn-blocking monoclonal antibody, Nipocalimab (IMAAVY®), received approval from the European Commission for the treatment of generalized myasthenia gravis patients aged 12 years and above. The drug can be used as an add-on therapy to standard treatments, with key Phase III study data demonstrating its sustained efficacy in improving the condition.

Johnson & Johnson's CAR-T Therapy CARVYKTI® Announces Latest Phase III Study Results

On December 7, Johnson & Johnson announced the latest results of its CAR-T therapy CARVYKTI® in the phase III CARTITUDE-4 study. The data showed that as a second-line therapy, the product enabled 80% of patients with standard risk to achieve disease progression-free status for up to 2.5 years without subsequent treatment after the first relapse, demonstrating durable efficacy.

Transaction Trends

Regeneron Collaborates with Tessera to Develop AATD Gene Editing Therapy TSRA-196
On December 1, 2025, Regeneron and Tessera announced a global collaboration on the gene-editing therapy TSRA-196. The therapy aims to precisely correct the genetic mutation causing alpha-1 antitrypsin deficiency in a one-time treatment, with an anticipated clinical trial application submission before the end of the year. Under the agreement, both parties will equally share development costs and future profits, and Tessera will receive an upfront payment of $150 million.

Medical Insurance Access

New Thrombolytic Drug Tenecteplase Included in Medical Insurance

On December 7, the National Healthcare Security Administration released the 2025 National Healthcare Security Drug Catalog, successfully including Boehringer Ingelheim's new-generation thrombolytic drug Tenecteplase. The drug is used to treat acute ischemic stroke, and its convenient single intravenous injection method helps improve treatment efficiency. Experts pointed out that the drug can help more patients achieve good functional recovery. After being included in the healthcare security program, its accessibility will be further improved, assisting in enhancing China’s stroke diagnosis and treatment standards. The new catalog will be implemented on January 1, 2026.

Tirzepatide Included in China's National Medical Insurance for the First Time

On December 7, the 2025 National Basic Medical Insurance, Maternity Insurance, and Work-related Injury Insurance Drug Catalog was announced, with Eli Lilly's tirzepatide injection successfully included. The medical insurance coverage for tirzepatide applies to blood sugar control in adult patients with type 2 diabetes: those whose blood sugar remains poorly controlled despite treatment with metformin and/or sulfonylurea drugs, in addition to diet control and exercise. The new catalog will officially take effect on January 1, 2026.

New Drug Development

Transcenta Pharmaceutical Presents Updated Phase I/II Efficacy Data of Osemitamab Triplet Therapy as First-Line Treatment for Gastric or Gastroesophageal Junction Adenocarcinoma at ESMO Asia

On December 5, Transcenta Holding announced the updated efficacy analysis based on CLDN18.2 and PD-L1 expression from the Phase I/II clinical trial (Transtar102) of osemitamab in combination with nivolumab and CAPOX as a first-line treatment for gastric or gastroesophageal junction adenocarcinoma (TranStar102), Cohort G. The study results were presented as a poster at the ESMO Asia Congress 2025 held in Singapore.

Gmax Biopharm Initiates the World's First Phase III Clinical Trial of Oral KRAS G12D Inhibitor as Monotherapy vs. Chemotherapy
On December 7, GenFleet Therapeutics announced that the pivotal Phase III clinical trial of its oral KRAS G12D inhibitor GFH375 has been initiated at Peking University Cancer Hospital. This study is the world's first single-agent versus chemotherapy Phase III trial targeting KRAS G12D-mutant metastatic pancreatic cancer, marking a critical development phase for this innovative therapy.

China Biopharmaceutical Innovation Analgesic TRD208 Completes First Patient Enrollment in Phase I Clinical Trial

On November 29, the Phase I clinical trial of TRD208, a Class 1 innovative drug independently developed by Beijing Tide Pharmaceutical, a subsidiary of China Biologic Products, has successfully completed its first patient enrollment in China. TRD208 is a non-opioid multi-target multi-modal analgesic innovative drug and a first-in-class (FIC) candidate with the potential to become a blockbuster drug in the field of acute pain.

JACOBIO's KRAS G12C and SHP2 Inhibitor Combination Therapy Results Published in The Lancet
On December 1, JACOBIO announced that the Phase I/IIa clinical research results of its KRAS G12C inhibitor Golrelesor combined with SHP2 inhibitor were officially published in The Lancet Respiratory Medicine. In the first-line treatment of patients with KRAS G12C-mutant non-small cell lung cancer, the study achieved an objective response rate of 71%, demonstrating significant efficacy.

Ascentage Pharma's Orelabartib Approved for Global Phase III Clinical Trials in the US and Europe
On December 5, Ascentage Pharma announced that the global Phase III registration study of its original drug Olverembatinib (trade name: Nulua®) combined with chemotherapy for the treatment of newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia has been approved by the U.S. FDA and the European EMA, which will accelerate its market launch process in Europe and the United States.

Research on KRAS G12C Inhibitor Golaresec for Advanced Colorectal Cancer Published in The Lancet

On December 5, Ailis Pharmaceutical announced that the combined analysis results of two Phase I/II clinical studies on its KRAS G12C inhibitor, Golaresec, for the treatment of advanced colorectal cancer were officially published in the prestigious international medical journal, The Lancet Gastroenterology & Hepatology. The data showed that the objective response rate of Golaresec in combination with Cetuximab reached 50%, offering a new therapeutic direction for this difficult-to-treat patient population.

Transaction Trends

Kelun Biotech and Crescent Reach Strategic Cooperation

On December 5, Kelun Biotech and Crescent Biopharma reached a collaboration to jointly develop the novel oncology drugs SKB105 (ADC) and CR-001 (bispecific antibody). Both parties will accelerate the advancement of drug research and development, explore monotherapy and combination therapies, and share global market development rights.

Simcere Pharmaceutical's Anti-RSV New Drug Introduction and Anti-Tumor Drug Inclusion in Medical Insurance Announced on the Same Day

On December 3, Simcere Pharmaceutical reached a cooperation agreement with Wangshan Wangshui on the broad-spectrum antiviral drug Dihydrobromide Deuterated Remdesivir, obtaining exclusive rights to its dry suspension for the treatment of RSV and HMPV infections in the Greater China region. The drug has received breakthrough therapy designation from the CDE. On December 7, Simcere Zaiming, under the group, announced that its first-class new anti-tumor drug Enzesu® (Suvexitant Monoclonal Antibody) was successfully included in the 2025 National Medical Insurance Catalog and will be implemented on January 1, 2026.

Medical Insurance Access

3SBio's Oral Paclitaxel Solution Successfully Included in China's 2025 National Medical Insurance Catalog

On December 7, the oral paclitaxel solution developed through the collaboration between 3SBio and Haihe Biopharma was included in the National Medical Insurance Catalog. This medication overcomes the challenge of oral absorption, providing a convenient and cost-effective at-home oral treatment option for patients with advanced gastric cancer.

Luye Pharma's Five Innovative Drugs Successfully Included in the 2025 National Medical Insurance and Commercial Insurance Innovative Drug List

On December 7, Luye Pharma announced that five of its innovative products have been successfully included in the 2025 National Medical Insurance Drug List or the Commercial Insurance Innovative Drug List. Among them, the new analgesic Memeixin® and the schizophrenia drug Ruibailai® have entered the medical insurance for the first time; the new lung cancer drug Zanbika® has been selected for the commercial insurance list; Botuowei® and Ruikekuo®, which were already included in the medical insurance, have been successfully renewed. This move will enhance patient access to medications and reduce the burden of treatment.

Chipscreen Biosciences' Globally First-in-Class Drug Chidamide Included in China's National Medical Insurance Regular Category B Management
On December 7, MicroCore Biotech announced that its globally pioneering original drug, Chidamide (Aipusha®), has been officially included in the Class B management of the National Medical Insurance Catalog. The drug is suitable for patients with relapsed or refractory peripheral T-cell lymphoma and MYC/BCL2-positive diffuse large B-cell lymphoma. This inclusion will further enhance the accessibility of the drug, providing patients with long-term stable medication security.

Zai Lab's Three Innovative Drugs Successfully Renewed in China's 2025 National Reimbursement Drug List
On December 7, Zai Lab announced that three of its innovative products had successfully renewed their inclusion in the 2025 National Medical Insurance Catalog. Vyvgart® (Efgartigimod α) for the treatment of myasthenia gravis, Nuzyra® (Omadacycline) for bacterial infections, and Zejula® (Niraparib) for ovarian cancer treatment have all been renewed, continuing to benefit a wide range of patients.

First China-produced KRAS G12C inhibitor Fuzoraden (Dabot®) included in the new National Medical Insurance Drug Catalog

Gmax Biopharm Announces that its First Commercial Product, Fuzoraden (Dabot®, KRAS G12C Inhibitor), Has Been Included in the National Basic Medical Insurance, Work-related Injury Insurance, and Maternity Insurance Drug List (2025) (National Medical Insurance Drug List) for the Treatment of Adult Patients with KRAS G12C Mutation-positive Advanced Non-Small Cell Lung Cancer (NSCLC) Who Have Received at Least One Systemic Therapy. The Product Successfully Entered the National Medical Insurance Drug List in Its First Negotiation Attempt, and the New Edition of the List Will Officially Take Effect on January 1, 2026.