Home Novo Nordisk Submits NDA for CagriSema, the First GLP-1/Amylin Combination Therapy for Chronic Weight Management

Novo Nordisk Submits NDA for CagriSema, the First GLP-1/Amylin Combination Therapy for Chronic Weight Management

Dec 21, 2025 00:00 CST Updated 00:00
BeOne

Developer of Molecular Targeted and Immune Anti-Tumor Drugs

JW Therapeutics

Developer of Cellular Immunotherapy Products

Harbour BioMed

Antibody Drug Developer

Kelun-Biotech

Innovative Drug Developer

JZJT

Traditional Chinese Medicine Manufacturer

Innovent

High-end Biologics Developer

Sobi

Rare Disease Drug Provider, Specialty Drug Developer and Marketer

Sanofi

Pharmaceutical Manufacturer

GSK

Pharmaceutical R&D Manufacturer

Fosun Pharmaceutical

Healthcare Industry Group

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This week,Investigation into Serious Official Misconduct by Former Director of the National Administration of Traditional Chinese Medicine, Yu Wenming, Concludes; Suspected Bribery Referred to Prosecutors for Prosecution, Illegal Gains ConfiscatedHarbour BioMed Announces Long-term Global Strategic Collaboration and Licensing Agreement with Bristol Myers Squibb to Jointly Develop Next-generation Multi-specific Antibody TherapiesSichuan Kelun-Biotech Biopharmaceutical Co.,LTD(Kelun-Biotech,6990.HK)Announced the settlement agreement with Yilian Biotech to resolve the disputes between the two parties

In terms of policy:United StatesFDA Lifts Real-World Evidence Restrictions for Drug and Device Approvals South Korea to Include Hair Loss Treatment in Health Insurance Advance Issuance of Medical Insurance Subsidy Funds for 2026The Updated National Medical Insurance and Commercial Insurance Innovative Drug List Has Been Clearly ImplementedPublic Solicitation of Comments on the Standardization of Medical Insurance Imaging CloudThree-Year Action Plan for the Liquidation of Medical Insurance Funds Released.

Company Aspect: BeOne Medicines Appoints Wang Lai as New President, Establishing a Dual-President Structure;Kelun-BiotechTermination of ADC Third-Line Approval400 Million Yuan Deal! Jointown Announces Major CollaborationJW Therapeutics Undergoes Major Leadership Change JZJT Announces Name ChangeInnovent Bio's Mastyptide Approved for Marketing in Macao, ChinaDuality Biologics ObtainsFDA Grants Fast Track DesignationJanssen Dual Antibody CombinationLazertinib Approved for First-Line Treatment of Lung CancerFosun Pharmaceutical andClavis Bio has reached a cooperation agreement.

Products:  Sobi Acquires Arthrosi to Obtain URAT1 InhibitorSanofi Inhibitor TreatmentppMS Phase 3 Clinical Trial FailureMabwell Bio Completes First Overseas Commercial Supply of Injectable Solution Enhertu Approved AgainSanofi's Innovative Therapy for Hypertrophic Cardiomyopathy Approved for MarketingGSK's Ultra-Long-Acting Monoclonal Antibody FDA Approved for Severe Asthma Treatment Circular Code Bio Injection Receives Clinical ApprovalYan Sheng Chao Biologics Injection Receives Clinical ApprovalBio-Thera Ophthalmology Anti-VEGF Monoclonal Antibody Submitted for Market ApprovalMerck&Daiichi Sankyo's ADC Phase III Trial Halted.

In the capital market:  Fosun Pharmaceutical Holdings Acquires Green Valley Pharmaceutical Everest Medicines Directors and Major Shareholders Increase Company Shares Zuoli PharmaceuticalAcquisition of Future Bio Asset Group for 356 MillionWuXi AppTec Completes Equity Transfer of Two Subsidiaries$1.365 Billion: GenSci Pharma Authorizes Overseas Licensing Yiming Bio andCircurna Reaches Cooperation Philips AcquisitionAI Vascular Imaging Company $1.04 Billion! Sanofi Boosts Investment in New AD DrugInsilico Medicine Aims for Largest IPO in Hong Kong This YearBiotech IPONovo Nordisk Submits Listing Application

The following is a summary of the key content:


Major Events




   Former Director of the National Administration of Traditional Chinese Medicine, Yu Wenming, Suspected of Bribery and Referred to Prosecutors

On December 16, the Central Commission for Discipline Inspection (CCDI) announced: The investigation into serious official misconduct by Yu Wenming, former director of the National Administration of Traditional Chinese Medicine, has concluded. He is suspected of bribery and has been transferred to the procuratorial organs for prosecution, with his illegal gains confiscated.

Yu WenmingInvestigated in June 2025, it was found that Yu Wenming engaged in covert corruption in the pharmaceuticals sector, profiting from processes such as drug registration and approval to amass substantial wealth, showing no restraint even after the 18th CPC National Congress.

 2   Harbour BioMed and Bristol-Myers Squibb Reach Global Strategic Collaboration

On December 17, Harbour BioMed announced a long-term global strategic collaboration and licensing agreement with Bristol-Myers Squibb to jointly develop a new generation of multispecific antibody therapies.

According to the terms of the agreement, Harbour BioMed will collaborate with Bristol-Myers Squibb to advance and accelerate the multi-specific antibody discovery program. Harbour BioMed will receive a total ofA payment of 90 million US dollars, and if Bristol-Myers Squibb chooses to advance all potential projects, Harbour BioMed could also receive up to 1.035 billion US dollars in development and commercial milestone payments, as well as tiered royalties based on future product net sales.

 3   Kelun-Biotech and Yilian Biotech Reach Settlement in Dispute

On December 17, Sichuan Kelun-Biotech Biopharmaceutical Co.,LTD(Kelun-Biotech, 6990.HK)Announced the settlement agreement with Yilian Biotechnology to resolve the disputes between the two parties. Kelun-Biotech had filed criminal charges against Yilian Biotechnology in 2024 and initiated a civil lawsuit in 2025 over allegations of trade secret infringement and harm to the company's interests.


Policy




 1    United StatesFDA Lifts Real-World Evidence Restrictions for Drug and Device Approvals

On December 15, the U.S. FDA announced the cancellation of the use of real-world evidence in the review of drug and medical device applications.(RWE)One of the key limitations. In a new guideline for submissions targeting specific types of medical devices, the FDA stated that it will accept RWE and no longer require identifiable individual patient data collected from real-world data sources to always be submitted in marketing applications. The FDA also plans to consider updating its guidelines for drugs and biologics.

 2   South Korea to Include Hair Loss Treatment in Health Insurance

On December 16, South Korean President Lee Jae-myung, while receiving work reports from the Ministry of Health and Welfare and other departments, issued an instruction to advance the inclusion of hair loss treatment in health insurance. This move stems from a commitment he made during his 2020 presidential campaign.

 3   Advance Issuance of Medical Insurance Subsidy Funds for 2026

December 17The Ministry of Finance, in collaboration with the National Healthcare Security AdministrationIn AdvanceIssueMedical Insurance Subsidy Fund for 2026416.6 billion yuan, including funds for residents' medical insurance subsidies and medical assistance, provides stable support for pharmaceutical consumption, benefiting medical institutions in stockpiling and pharmaceutical distribution enterprises.

 4   The Implementation of the New National Medical Insurance and Commercial Insurance Innovative Drug Directory is Clear

December 15Issued by the National Healthcare Security Administration2025 Edition of the Medical Insurance Catalog and the First Edition of the Commercial Insurance Innovative Drug Catalog Add 114 New Medicines(Including 50 Class I Innovative Drugs), officially implemented on January 1, 2026ForGuaranteePatientMedicationTheContinuousSex, drugs removed from the medical insurance catalog will be6-month transition period.

 5    Public Comments Sought for Medical Insurance Imaging Cloud Standards

December 19China's National Healthcare Security Administration Releases Four Standards to Promote Nationwide Interconnectivity of Imaging Data, Addressing the Challenge of Cross-Hospital Medical Film, Feedback DeadlineDecember 28, Favorable to Medical Information System Manufacturers.

 6   Three-Year Action Plan for the Settlement of Medical Insurance Funds Released

December 15The National Healthcare Security Administration (NHSA) has clarifiedComplete the 2025 annual settlement by the end of May 2026, and starting from 2028, complete the previous year's settlement by the end of March each year, reducing the settlement fund ratio to 3% to improve hospital fund turnover efficiency.


Big Company




 1    BeOne Medicines Appoints Wang Lai as New President, Establishing a Dual-President Structure

December 18, BeOne Medicines(ONC.NS、06160.HK、688235.SH)An announcement regarding the appointment of senior management personnel has sparked market speculation. The announcement states: On December 17, 2025, BeOne Medicines Ltd.("Hereinafter referred to as the 'Company'")The board of directors has reviewed and approved the appointment of Dr. Wang Lai, the company's global R&D head, as the company's president and global R&D head. After the appointment takes effect, Dr. Wang Lai will serve as the company’s president and global R&D head, responsible for managing the company’s R&D, business development, and alliance relationship management functions.

According to media reports, Dr. Wu Xiaobin's position and responsibilities remain unchanged. He continues to serve as the President and Chief Operating Officer of BeOne Medicines and is fully responsible for the company's global commercialization, production, and supply chain operations.

 2    Kelun-Biotech ADC Third-Line Approval Terminated

Recently, according to the public approval information from the National Medical Products Administration (NMPA), Kelun-Biotech's self-developedThe Marketing Authorization Application for HER2-Targeted ADC Drug Bodu Trastuzumab in Third-Line HER2-Positive Breast Cancer Has Been Terminated.

 3    400 Million Yuan Deal! Jointown Announces Major Collaboration

Recently, Quanqing Health, a subsidiary of Jiuzhou Tong, signed a strategic cooperation agreement with Hisun Pharmaceuticals.——Full Engine Health will act as the exclusive agent, fully responsible for the total brand promotion of Hisun Pharma's multiple core products across all retail channels.(CSO)Business: The first-year cooperation deal exceeds 400 million yuan.

 4    JW Therapeutics Undergoes Major Leadership Reshuffle

Recently, JW Therapeutics (Cayman) Co., Ltd.(Stock Code:2126, hereinafter referred to as "JW Therapeutics")Announcement on Core Management and Board RestructuringAn announcement was made to declare a series of adjustments to the core management team and board structure. This change involves the appointment and resignation of the CEO and Chairman of the Board, along with modifications to the composition of board committees and authorized representatives. The aim is to further optimize corporate governance and promote the continuous high-quality development of the business.

 5    JZJT Announces Name Change

On December 13, Jiangzhong Pharmaceutical Co., Ltd. announced that at the tenth meeting of the tenth board of directors, it was decided to change the Chinese name to "China Resources Jiangzhong Pharmaceutical Co., Ltd.", the English name to "China Resources Jiangzhong Pharmaceutical Co., Ltd.", the stock abbreviation to "China Resources Jiangzhong", and the stock code will remain unchanged.

 6     Innovent Bio's Masitopeptide Approved for Marketing in Macao, China

December 15, Innovent Bio(1801.HK)Announcement, Xinerme(Mashiduopeptide Injection)Approved for marketing by the pharmaceutical regulatory authority of the Macao Special Administrative Region, China, for long-term weight control in adult patients with obesity or overweight.

Mashiduo Peptide is a glucagonGCG)/Glucagon-like Peptide-1(GLP-1)Dual receptor agonist, which has been approved for two indications in mainland China, can be used for long-term weight control in adult patients on the basis of diet control and increased physical activity, as well as for blood glucose control in adult patients with type 2 diabetes.

 7     Duality Biologics ObtainsFDA Grants Fast Track Designation

On December 18, Yingen Bio announced that the FDA has granted Fast Track Designation (FTD) to its next-generation HER3-targeted antibody-drug conjugate (ADC) DB-1310 for the treatment of adult patients with advanced/unresectable or metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer. These patients have previously received endocrine therapy and CDK4/6 inhibitor treatment, may or may not have undergone chemotherapy during the unresectable or metastatic disease stage, or experienced disease recurrence within 6 months during or after completing adjuvant chemotherapy. DB-1310 has become the world's first HER3-ADC drug to receive FTD for this indication.

 8     Janssen Dual-Antibody CombinationLazertinib Approved for First-Line Treatment of Lung Cancer

On December 17, Johnson & Johnson announced that the FDA had approved its EGFR/c-Met bispecific antibody amivantamab, in combination with the third-generation brain-penetrant EGFR TKI drug lazertinib, for the first-line treatment of EGFR-mutated non-small cell lung cancer.

 9     Fosun Pharmaceutical and Clavis Bio Reach Cooperation Agreement

On December 18, Fosun Pharmaceutical announced that its holding subsidiary, Fosun Pharmaceutical Industry, had officially signed the "Cooperation and Option Agreement" with Clavis Bio. According to the agreement, during the cooperation period, both parties will jointly select and advance preclinical research and development of candidate compounds targeting potential targets nominated by Clavis Bio.(i.e., collaborative project)This collaboration adopts the "joint R&D + regional decentralization + options" model, which is relatively common in current global innovative drug partnerships.


Product




 1     Sobi Acquires Arthrosi to Obtain URAT1 Inhibitor

On December 13, Sobi announced the acquisition of Arthrosi Therapeutics, whose core pipeline is the new gout drug URAT1 inhibitor AR882, currently in Phase III clinical stage.

 2    Sanofi Inhibitor TreatmentppMS Phase 3 Clinical Trial Failure

On December 15, Sanofi announced that the PERSEUS Phase 3 study results showed that the BTK inhibitor tolirabrutinib did not meet its primary endpoint in delaying the time to 6-month confirmed disability progression in patients with primary progressive multiple sclerosis (PPMS). PPMS patients account for approximately 10% of the overall multiple sclerosis patient population. Based on these results, Sanofi will not pursue regulatory registration of tolirabrutinib for the PPMS indication.

 3    Mabwell Bio Completes First Overseas Commercial Supply of Injectable Solution

On December 16, Mabwell announced that its Denosumab Injection had completed the first batch of commercial supply to overseas markets today, officially entering clinical application in overseas markets.

 4    Enhertu Approved Again

On December 15, Daiichi Sankyo and AstraZeneca announced that the U.S. FDA had approved Trastuzumab Deruxtecan.(Enhertu)A new indication has been approved for marketing, in combination with pertuzumab for the first-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer.

 5     Sanofi's Innovative Therapy for Hypertrophic Cardiomyopathy Approved for Marketing

On December 17, Sanofi announced that Afuketai had been approved by the National Medical Products Administration for marketing in China, intended for treating New York Heart Association...(NYHA)Obstructive Hypertrophic Cardiomyopathy with Cardiac Function Class II-III(HCM)Adult patients, to improve motor function and symptoms.

 6     GSK's Ultra-Long-Acting Monoclonal Antibody FDA Approved for Severe Asthma Treatment

December 16, GSK(GSK)Announced that its ultra-long-acting IL-5 monoclonal antibody Depemokimab(Demochizumab)Approved by the FDA for marketing, this drug boasts the long-acting advantage of being injected once every six months, with an indication for severe asthma.

 7    Circular Code Bio Injection Receives Clinical Approval

On December 17, according to the CDE official website, Huanma Bio's HM2002 injection has been granted clinical approval and is proposed to initiate research for the treatment of chronic coronary syndrome.

 8     Yanshengtide Biological Injection Receives Clinical Approval

On December 17, according to the CDE website, Yanshengchao Bio's YSC001 Injection received clinical approval and is proposed to initiate research for the treatment of rheumatoid arthritis.

 9   Bio-Thera Ophthalmology Anti-VEGF Monoclonal Antibody Submitted for Market Approval

Monoclonal AntibodyBAT5906)The listing application has been accepted by the National Medical Products Administration, with the indication for neovascularization.(Wet)Age-related Macular Degeneration(nAMD/wAMD). This drug is the first domestically produced ophthalmic anti-VEGF monoclonal antibody to be submitted for marketing approval in China.

 10     Merck & Daiichi Sankyo's ADC Phase III Trial Halted

On December 18, according to media reports: Daiichi Sankyo(Daiichi Sankyo)With MSD(Merck & Co.)The antibody-drug conjugate (ADC) targeting B7-H3, co-developed — ifinatamab deruxtecan(abbreviated as I-DXd)Its global Phase III clinical trial, IDeate-Lung02, was partially placed on clinical hold by the U.S. FDA due to unexpected death cases.


Capital Market



 1    Fosun Pharmaceutical Holdings Acquires Green Valley Pharmaceutical

On December 15, Fosun Pharmaceutical announced that its subsidiary, Fosun Pharmaceutical Industry, signed an investment agreement with Green Valley Pharmaceutical and its existing shareholders. Fosun Pharmaceutical plans to invest approximately RMB 1.412 billion to acquire a controlling stake in Green Valley Pharmaceutical. After the completion of this acquisition, Green Valley Pharmaceutical will become a subsidiary of Fosun Pharmaceutical, and its core drug, Sodium Oligomannate Capsules, will be included in Fosun Pharmaceutical's innovative drug pipeline, mainly used for treating mild to moderate Alzheimer's disease.

 2    Everest Medicines Directors and Major Shareholders Increase Their Stake in the Company

On December 15, Everest Medicines announced that on December 12, 2025, Mr. Wei Fu, Non-Executive Director, Honorary Chairman of the Board, and a major shareholder of the company; Mr. Yifang Wu, Executive Director and Chairman of the Board; Mr. Yongqing Luo, Executive Director and Chief Executive Officer of the company; and Mr. Ying He, Executive Director, President, and Chief Financial Officer of the company, collectively purchased 846,659 ordinary shares of the company through the open market. The total amount involved exceeded 38 million Hong Kong dollars, with an average price of approximately HKD 45.01 per share. In addition, CBC Group, a major shareholder of the company, has further committed to increasing its shareholding by no more than 1% cumulatively over the next three to six months, subject to market conditions and applicable legal and regulatory restrictions.

 3     Zuoli PharmaceuticalAcquisition of Future Bio Asset Group for 356 Million

On December 14, Zole Pharmaceutical announced: The company signed the "Asset Group Acquisition Agreement for Multi-Trace Element Injection" with Tibet Future Biomedical Co., Ltd. and its two wholly-owned subsidiaries, acquiring the multi-trace element injection asset group of Future Biotech for a total price of 3.56 billion yuan.

 4    WuXi AppTec Completes Equity Transfer of Two Subsidiaries

On December 15, WuXi AppTec announced that the equity transfer transactions of its two subsidiaries have been completed.

The Transferor has received the first tranche of the equity transfer payment paid in full by the Transferee in accordance with the "Equity Transfer Agreement".RMB 1.54 billion, all closing conditions have been met. After the completion of the transaction, Shanghai Concord CRO Co., Ltd. and Shanghai Wuxi Jinshi Pharmaceutical Technology Co., Ltd. will no longer be included in the consolidated financial statements of WuXi AppTec.

 5     $1.365 Billion: GenSci Pharma Licenses Overseas

On December 15, Jin Sai Pharmaceutical, a subsidiary of Changchun High-Tech, announced that Saizeng Medical had officially signed an exclusive licensing agreement with U.S.-based biopharmaceutical company Yarrow Bioscience, Inc.("Agreement" hereinafter)According to the agreement, Yarrow has obtained the humanized thyroid-stimulating hormone receptor independently developed by GenSci Pharma.(TSHR)Antagonistic Monoclonal Antibody GenSci098(YB-101)Global exclusive rights for development, production, and commercialization outside of Greater China. According to the agreement, Ascletis will receive a $120 million upfront payment and near-term development milestone payments.(Including a non-refundable and non-creditable upfront payment of 70 million US dollars and subsequent near-term development milestone payments of 50 million US dollars)According to the progress made by GenSci098 in clinical development, registration, and commercialization, Saizen Healthcare will be entitled to receive up to $1.365 billion in milestone payments under this exclusive license. After the subsequent product launch, Saizen Healthcare will also be eligible to receive sales royalties exceeding 10% of net sales.

 6     Yiming Bio andCircurna Partnership Reached

On December 16, Yiming Bio announced a partnership with a company focused on the next generation of circular RNA.(circRNA)Circurna, a biotechnology company focused on therapy development, has reached a strategic cooperation with Innovent Bio. According to the cooperation agreement, Innovent Bio will provide end-to-end services for Circurna’s circular RNA active pharmaceutical ingredients and formulations, including process and analytical method development, scaled production, and GMP-level manufacturing and delivery. This collaboration will also fully leverage Innovent Bio's expanding global manufacturing network and cross-regional regulatory registration experience to ensure that Circurna’s products have a robust quality system, repeatable processes, and meet the submission requirements of multiple countries.

 7    Philips AcquisitionAI Vascular Imaging Company

On December 15, Philips announced that it had reached an agreement to acquire SpectraWave, a U.S.-based AI imaging technology company. The company focuses on coronary artery-enhanced vascular imaging.(Enhanced Vascular Imaging, EVI)And angiography-based physiological evaluation technology. The specific amount of this transaction was not disclosed.

 8    $1.04 Billion! Sanofi Boosts Investment in New AD Drug

On December 16, South Korean biotechnology company ADEL announced that it had reached a strategic cooperation agreement worth up to $1.04 billion with French pharmaceutical giant Sanofi. The two parties will work together to advance the development and commercialization of an early-stage Alzheimer's experimental therapy under ADEL’s portfolio.

 9   Insilico Medicine Aims for Largest AI-driven Drug Discovery IPO in Hong Kong This YearBiotech IPO

Holding the fastest global progressAI Drug's Insilico Intelligence to Launch IPO on HKEX from December 18 to December 23. This IPO plans to issue 94,690,500 shares, with 10% allocated for the Hong Kong public offering and 90% for international placement. The share price is set at HKD 24.05 per share, with a board lot of 500 shares, and the minimum subscription fee is HKD 12,146.27. The company is expected to be listed and commence trading on December 30, which is anticipated to be the largest Biotech IPO in the Hong Kong stock market in 2025.

 10   Novo NordiskNew Weight Loss DrugSubmit an application for listing

On December 18, Novo Nordisk announced the submission of the marketing application for CagriSema to the FDA. This marks the world's first GLP-1+Amylin combination therapy.

Novo Nordisk has fallen behind Eli Lilly in the competition for weight loss.CagriSema will compete with tirzepatide to a certain extent after its approval.The competition for iterative products is even more intense.Lilly inGLP-1/GIP/GCG Triple TargetsSmall MoleculesGLP-1BiasAmylinActRIIA/B Antibody Takes the Lead, Novo NordiskIs actively developingGLP-1/AmylinGLP-1/GIP/GCGGLP-1/GIP/Amylin

Disclaimer: The information in this WeChat article is for general reference only and should not be directly used as decision-making content. BioSentinel assumes no responsibility for any losses incurred by any party due to the use of the content herein. If there are any objections, please contact the editor via the backstage for modifications.

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