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

New Drug Development

Novo Nordisk's Rising Star Amycretin Reports Phase II Success, Higher-Dose Obesity Therapy Advances Simultaneously

On November 24, 2025, Novo Nordisk announced that its Phase 3 trials (EVOKE and EVOKE+) of semaglutide for the treatment of early symptomatic Alzheimer's disease failed to show statistically significant efficacy on the primary endpoint, failing to slow disease progression. On November 25, the company released positive results from a Phase 2 trial of its new drug Amycretin in patients with type 2 diabetes, showing significant reductions in body weight and HbA1c. On November 26, Novo Nordisk submitted a marketing application to the U.S. FDA for a higher dose (7.2mg) of the semaglutide injection Wegovy®, intended for adult obesity patients, which achieved an average weight loss of 20.7% in the Phase 3 trial.

EU Approves Dupilumab for Chronic Spontaneous Urticaria

On November 25, 2025, Regeneron and Sanofi announced that the European Commission had approved Dupixent® (dupilumab) for the treatment of patients aged 12 years and older with moderate-to-severe chronic spontaneous urticaria who are not adequately controlled by antihistamines. This medication becomes the first targeted therapy for the condition in the EU in over a decade, with Phase III trials showing it significantly reduces itching and urticaria symptoms.

Novartis Rare Disease Gene Therapy Itvisma Receives FDA Approval

On November 25, Novartis announced that the US FDA had approved its gene therapy Itvisma for the treatment of spinal muscular atrophy (SMA) patients aged two years and older who have been diagnosed with a mutation in the survival motor neuron 1 gene. The active ingredient in Itvisma is the same as in Novartis' previous therapy Zolgensma, which is approved in the US for treating SMA in patients under two years of age. The wholesale price of the new therapy is $2.59 million, while the old therapy Zolgensma has a wholesale price of $2.1 million.

BeOne Medicines' New Generation BCL2 Inhibitor Sotoclax Receives FDA Priority Review

On November 26, BeOne Medicines announced that its next-generation BCL2 inhibitor, Sotoclax, received Priority Review designation from the FDA for the treatment of relapsed or refractory mantle cell lymphoma in patients who have received BTK inhibitor therapy. The application is based on a Phase 1/2 study, which showed that Sotoclax demonstrated clinically meaningful efficacy in heavily pretreated patients and was well-tolerated.

Innovent Bio's Monoclonal Antibody Approved for Marketing by NMPA

On November 28, Innovent Bio announced that its new monoclonal antibody drug, Xinmeiyue® (Pikangqibai Monoclonal Antibody), was approved for marketing by the NMPA for the treatment of adult patients with moderate to severe plaque psoriasis. The approval was based on a pivotal Phase III study, which showed that the drug demonstrated significantly superior efficacy compared to placebo at week 16, with an overall good safety profile consistent with similar drugs.

InnoCare's Novel TYK2 Inhibitor Soficitinib Completes First Patient Dosing in Global Phase II Clinical Trial for Prurigo Nodularis

On November 28, InnoCare announced that the first patient had been dosed in the global Phase II clinical trial of its novel TYK2 inhibitor, Soficitinib (ICP-332), for the treatment of prurigo nodularis. This drug is a highly potent and selective oral formulation designed to alleviate itching and inflammation by blocking relevant cytokine signaling pathways, thereby treating various autoimmune skin diseases, including prurigo nodularis.

Ascentage Pharma's Nylotinib® Gastrointestinal Stromal Tumor Research Progress Published

On November 25, Ascentage Pharma announced that the translational medicine and Phase Ib clinical research results of its original Class 1 new drug Olverembatinib (trade name:耐立克®) for the treatment of rare SDH-deficient gastrointestinal stromal tumors (GIST) were published in the top journal *Signal Transduction and Targeted Therapy*. This study is the largest prospective clinical trial targeting this subtype, showing significant efficacy of Olverembatinib (clinical benefit rate of 84.6%) and, for the first time, revealing a novel mechanism of its anti-tumor effects through the regulation of lipid metabolism, with good tolerability.

Imfinzi® Fully Approved in China for Consolidation Treatment After Concurrent or Sequential Chemoradiotherapy in Unresectable Stage III Non-Small Cell Lung Cancer

On November 24, AstraZeneca announced that Imfinzi® (Durvalumab) has been approved by the China National Medical Products Administration (NMPA) for the treatment of patients with unresectable Stage III non-small cell lung cancer (NSCLC) who have not progressed following platinum-based concurrent or sequential chemoradiotherapy and do not carry known epidermal growth factor receptor (EGFR) sensitizing mutations or anaplastic lymphoma kinase (ALK) rearrangements.

Transaction Trends

BioNTech's Equity Swap Offer for CureVac to Expire on December 3

On November 26, 2025, BioNTech announced progress in its share exchange offer for all outstanding shares of CureVac. At a special meeting held on November 25, CureVac shareholders approved the relevant resolution with support exceeding 99.16%.

The offer will finally expire at 15:00 (CET) on December 3. To ensure processing efficiency, shareholders need to submit their CureVac shares before 0:00 on the expiration date. The final exchange ratio is confirmed to be 0.05363 BioNTech American Depositary Shares (ADS) for every 1 share of CureVac.

New Drug Progress

Hutchmed to Announce Latest Clinical Data for Multiple Cancer Drugs in December

On November 27, 2025, HUTCHMED announced that the latest clinical data of several of its self-developed anti-cancer drugs will be presented at the ESMO Asia Annual Meeting and the American Society of Hematology (ASH) Annual Meeting to be held in December.

Key highlights include the first human trial results of the anti-CD47 antibody HMPL-A83, registration study data of fruquintinib for renal cancer treatment, and Phase III long-term results of orelabrutinib for immune thrombocytopenia. These data cover multiple high-incidence cancer types, including lung cancer, renal cancer, and pancreatic cancer.

Hengrui's New Drug Application for Sulima Almatinib Sulfate Tablets Accepted for Review

On November 24, Hengrui Medicine received the "Acceptance Notice" issued by the National Medical Products Administration. The marketing authorization application for the company's self-developed Class 1 new drug, Ivarmacitinib Sulfate Tablets (Aisuda®), has been accepted. Indication: This product is indicated for adult patients with active radiographic negative axial spondyloarthritis who have an inadequate response or intolerance to non-steroidal anti-inflammatory drugs (NSAIDs) and exhibit objective signs of inflammation (characterized by elevated C-reactive protein [CRP] and/or abnormal magnetic resonance imaging [MRI]).

Betta Pharmaceuticals' Ensartinib European Marketing Application Accepted

On November 28, 2025, Betta Pharmaceuticals announced that the marketing authorization application for Ensartinib Hydrochloride Capsules submitted by its subsidiary, U.S.-based Xcovery, has been accepted by the European Medicines Agency (EMA). The drug is intended for the treatment of adult patients with ALK-positive locally advanced or metastatic non-small cell lung cancer. Ensartinib, a next-generation ALK inhibitor independently developed by Betta Pharmaceuticals, was previously approved for marketing in China and entered the U.S. market in 2024. The acceptance by EMA marks another step forward in the global expansion of this drug.

Bo'an Biologics' Aflibercept Intravitreal Injection Solution Approved for Marketing in China

On November 26, 2025, Biosan Bio, a wholly-owned subsidiary of Luye Pharma Group, announced that its self-developed aflibercept intravitreal injection solution, Boyoujing®, has officially been approved for marketing by the China National Medical Products Administration (NMPA) for the treatment of neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) in adults. This product is the second approved biosimilar of aflibercept in China.

HEC Pharmaceuticals Launches Large-Scale Drug Synthesis Model HEC-SynAI

On November 28, 2025, Dongyang Guangya Pharmaceutical announced the launch of its self-developed drug synthesis large model, HEC-SynAI. This model integrates large language models with agent technology, featuring multi-modal parsing capabilities that enable intelligent decision-making across the entire process, from retrosynthetic analysis, reaction condition recommendations, to literature citations. Internal testing has shown that its multi-step synthesis route prediction accuracy significantly outperforms existing methods, aiming to enhance drug synthesis efficiency and drive the digital and intelligent transformation of synthetic process development.

World's First KRAS G12C InhibitorCombined SHP2 Inhibitor ResearchAchievements Reach the Top of The Lancet

On November 29, 2025, the results of a Phase I/IIa clinical study led by Professor Wang Jie's team from the Cancer Hospital of the Chinese Academy of Medical Sciences were published in The Lancet Respiratory Medicine. The study demonstrated for the first time that the combination of KRAS G12C inhibitor gorelarsen and SHP2 inhibitor AST24082 showed remarkable efficacy in the first-line treatment of advanced non-small cell lung cancer with KRAS G12C mutations, achieving a median progression-free survival of 12.2 months, an objective response rate of 71%, and manageable safety. This establishes a new paradigm for oral dual-target combination therapy.