January 2025 FDA Drug Approvals: A Landmark Month for Oncology, Neurology, and Novel Therapeutics

Feb 26, 2025 09:33 CST Updated 09:33

Amgen

Developer of Treatment Drugs for Serious Diseases

AstraZeneca

Biopharmaceutical Manufacturer

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This article briefly reviews2025Year1MonthFDANew Drug Approval Status: Check Out the Rising Stars in the Pharmaceutical World Bringing New Hope to Life and Health:

2025Year1Month15On [date], Eli Lilly and Company announcedFDAApprovedOmvoh(mirikizumab-mrkz, Mijizumab), used for treatmentModerate to Severe Active Crohn's Disease in Adults(CD). Subsequently2023Year10Approved in [Month] for moderate to severe active ulcerative colitis in adults(UC)The first therapeutic drug thereafter,OmvohNow approved in the U.S. for the treatment of two inflammatory bowel diseases(IBD)。Mirikizumab-mrkzIs a humanizedIgG4Monoclonal antibody that selectively binds to humanIL-23Cytokinesp19Subunit. By blocking withIL-23Receptor interactions,mirikizumabInhibit the release of pro-inflammatory cytokines and chemokines. This is the first to provide two years of Crohn's disease data at the time of approval.3Long-term efficacy data of biologic therapies. The drug aims to reduce inflammation in the gastrointestinal tract, a key aspect of Crohn's disease pathology. Additionally, Eli Lilly has submitted applications in the EU and Japan.OmvohFor the marketing application of Crohn's disease, and stated plans to make more global submissions.

2025Year1Month16Day,FDAApprovedAmgen Inc.TheLumakras (sotorasib), andVectibix(panitumumab)UnitedUsed for treatment via FDA The approved test is determined to be KRAS G12C Mutant metastatic colorectal cancer (mCRC）Adult patients. These patients had previously received chemotherapy based on fluorouracil, oxaliplatin, and irinotecan. At the same time,FDA Also approvedQIAGENCompany's therascreen KRAS RGQ PCRThe kit is used as a companion diagnostic device to identify tumor carriers. KRAS G12CMutated and may meet the criteriaLumakrasAndVectibixColorectal cancer patients under combined treatment conditions.

2024Year1Month16Day,FDA Traditional Approval GrantedAstraZenecaDeveloped Calquence（acalabrutinib) Combined with Bendamustine and Rituximab, for the treatment of previously untreated patients who are ineligible for autologous hematopoietic stem cell transplantation (HSCT`) Conditions`Mantle Cell Lymphoma (MCL）Adult patients.FDAAlso approvedCalquenceAs a single agent for previously treatedMCLAdult patients.CalquencePreviously2017Received accelerated approval in the same year for the same indication. This traditional approval marks that the therapy has met regulatory standards in the risk-benefit assessment.

2025Year1Month17Date, the antibody-drug conjugate jointly developed by AstraZeneca and Daiichi SankyoDatroway(datopotamab deruxtecanOrDato-DXd)Obtained in the United StatesFDAApproved for marketing, for the treatment ofUnresectable or metastatic, hormone receptor(HR)Positive, Human Epidermal Growth Factor Receptor2(HER2)Negative(IHC 0、IHC1+ OrIHC2+/ISH-)Adult Patients with Breast CancerThese patients had previously received endocrine therapy and chemotherapy for unresectable or metastatic disease.DatrowayLast year12Globally approved for the first time in Japan in [Month], for the treatment of hormone receptor(HR)Positive,HER2Negative(IHC 0、IHC 1+OrIHC 2+/ISH-)And adult patients with unresectable or recurrent breast cancer who have received chemotherapy. Currently,DatrowayThe marketing application for the breast cancer treatment is under review in other countries and regions such as the European Union and China. The two companies also stated that they are seeking to expand.DatrowayThe label, used for treating advancedEGFRMutant Non-Small Cell Lung Cancer.DatrowayThe application received priority review earlier this week. It is expected to7Month12The decision was made in Japan.

2025Year1Month21Day,FDAApprovedJohnson & JohnsonDevelopedSpravato（esketamine）CIIINew Drug Application Supplement for Nasal Spray (sNDA), making itThe first and only treatment for major depressive disorder (MDD) patients who have had an inadequate response to at least two oral antidepressants (MDD) Monotherapy for adult patients。MDDOne of the most common mental illnesses, with approximately2100Among thousands of adult patients, about one-third respond poorly to oral antidepressants, significantly impacting their quality of life.MDDThe economic burden is heavy, with nearly half of it attributed to refractory depression (TRD). This approval was based on the positive results of a randomized, double-blind, multicenter, placebo-controlled study, which obtainedFDAPriority Review Status (Priority Review）。

2025Year1Month22Day,MedexusPharmaceutical Company AnnouncesFDAApprovedGrafapex(treosulfan, Qu Ao Shu Fan)Used in combination with Fludarabine, asAllogeneic Hematopoietic Stem Cell Transplantation(alloHSCT)Preparation Plan, used for1Years and above with acute myeloid leukemia(AML)Or myelodysplastic syndrome(MDS)Adult and pediatric patients.treosulfanIt is an alkylating agent, used as a treatment in patients undergoing a process known as“Allogeneic Hematopoietic Stem Cell Transplantation”The drug given to patients before bone marrow transplantation. It is used as“Regulation”Treatment to clear the patient's bone marrow and make room for the transplanted bone marrow cells, which can then produce healthy blood cells.

2025Year1Month26Day,FDAApprovedEisai Co., Ltd. And Biogen Inc. TheLeqembi（lecanemab-irmb) Every four weeks, a supplemental Biologics License Application (BLA) for intravenous injection maintenance dosing (sBLA）。LEQEMBIFor the treatment within the United StatesAlzheimer's Disease (AD) Patients with Mild Cognitive Impairment (MCI) or mild dementia(collectively referred to asEarly StageAD), upon completion of the18Every month2Week1After the initial treatment, a transition to every4Week1Time10 mg/kgThe maintenance dose regimen, or continue with every2Week1Time10 mg/kgThe treatment plan. This approval is based onLEQEMBIThe2Phase Research (Study 201) and its long-term extension study (LTE) andClarity ADResearch (Study 301) and itsLTEModeling Analysis of Observational Data in the Study.LEQEMBIIn2023Year1Approved in the month through the accelerated approval pathway, followed by validation based on a confirmatory trial.LEQEMBIClinical benefits,FDAAnnounced that it will be converted from accelerated approval to traditional approval,LEQEMBIAnd thus became the first to transition from accelerated approval to traditional approval for the treatment ofADTheβAmyloid Antibody Drug.

2025Year1Month27On [Date], the U.S. Food and Drug Administration (FDA)(FDA)AstraZeneca and Daiichi Sankyo's collaboration has been approvedEnhertu (fam-trastuzumab deruxtecan-nxki), this is a specially designedHER2GuidanceDXdAntibody-Drug Conjugates(ADC), used for treatmentPatients with unresectable or metastatic hormone receptor(HR)Positive, Human Epidermal Growth Factor Receptor2(HER2)-Low(Immunohistochemistry[IHC] 1+OrIHC 2+/In Situ Hybridization[ISH])OrHER2-Ultra-low(IHC 0, Membrane Staining)Breast CancerAdult patients, afterFDAThe approved trial determined that the patient had already1One or more endocrine therapies have resulted in metastasis. Approval is based onDESTINY-Breast06Results of the Phase III Trial.

2025Year1Month28Day,FDAApprovedNovo NordiskTheOzempicInjection (semaglutide，0.5 mg、1 mgOr2 mg), used forReduce the incidence of2Type 2 Diabetes and Chronic Kidney Disease (CKD) in adult patients with worsening kidney disease, kidney failure (end-stage kidney disease), and the risk of death from cardiovascular disease. This approval enablesOzempicBecoming the Glucagon-Like Peptide with the Widest Range of Indications in Its Class-1Receptor Agonist (GLP-1 RA), its approved indications also include improving2Blood glucose control in adult patients with type diabetes, as well as reducing the risk for those with heart disease2Risk of Major Cardiovascular Events in Adult Patients with Type Diabetes.

2025Year1Month30Day,FDAApprovedAxsome Therapeutics TheSymbravo（meloxicam and rizatriptan) Used forAcute Treatment of Migraine With or Without Aura in Adults。SYMBRAVOAn innovative multi-mechanism treatment approach was adopted, effectively targeting multiple pathophysiologic pathways of migraine attacks. It can rapidly eliminate migraine pain and help patients restore normal function, with efficacy sustained after a single dose.24To48Hour.SYMBRAVOThe efficacy has been validated in multiple types of patients, including those with mild pain in the early stages of migraine, those with moderate to severe migraine pain, and those with varied responses to previous acute treatments.

2025Year1Month30Day,FDAApprovedVertex Pharmaceuticals DevelopedFirst Non-Opioid AnalgesicJournavx（suzetrigine）50 mgOral tablets, for treatmentModerate to Severe Acute Pain in Adults. This drug blocks the transmission of pain signals by targeting the sodium ion channel pathways in the peripheral nervous system, interrupting the signal before it reaches the brain. It has become the first approved therapy with such a mechanism of action. The application has receivedFDABreakthrough therapy, fast track, and priority review designation. This approval provides a new option for alternatives to opioid medications.

Ref:FDAOfficial Website

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The conference recommends that the actual time and schedule on-site shall prevail.

Agenda updating, subject to the conference site.

09:00-09:25

Trends and Opportunities in the Development of Innovative Drugs in 2025

Wang XingliFosun Pharma, Executive President & Co-CEO of Innovative Drug Division

09:25-09:50

Commercialization Pathways for Innovative Drugs/Modified New Drugs in the Context of Centralized Procurement and National Negotiations (Proposed)

Liu QianGeneral Manager of AstraZeneca China, Respiratory and Gastrointestinal Business Unit

09:50-10:15

How Will CR Pharmaceutical Address the Uncertainty of 2025

Cui XingpinChina Resources Pharmaceutical, Vice President

10:15-10:40

Tea Break

10:40-11:05

Accelerate Innovation, Embrace the World, and Open a New Chapter of Growth

Xie XinChina Biopharmaceuticals, Executive Director, Senior Vice President

11:05-11:30

Through AI and Big Data: Future Insights and Innovation Prospects in Biomedical R&D

Gong YuanxiangPresident of Hengqin Haomai Technology Co., Ltd., Zhuhai

11:30-12:00

Roundtable: Cooperation + Going Global, Pushing Chinese Innovation onto the World Stage

1. What are the impacts of the NewCo model's popularity on pharmaceutical R&D? What effects has it brought to China's innovative drug capital market?

2. Key Points for Choosing the Path of Product Pipeline Overseas Expansion

3. Project transfer overseas, newco, formulation export, and API export: What are the pain points and obstacles for each (e.g., economic cycles, trade protectionism, local competition, trust issues, etc.)?

Zhao XiaolinLilly China Innovation Collaboration Center, Senior Advisor for External Innovation Collaboration

Wang JunLinko Pharmaceuticals, CSO

Cui HaifengJemincare Group Shanghai Jiyu Pharmaceutical, VP&CSO

Hong JunVice President of Global Business Development, I-Mab Biopharma

Cao FeiYing Shi Bio, Co-Founder/Chief Operating Officer

Wang XinguangFormer GSK, Head of Communications, Government Affairs and Market Access

12:00-13:30

Lunch

13:30-13:55

USP Quality Standards for Therapeutic Monoclonal Antibodies

Cen GuoshanUSP, Vice President and General Manager of Greater China

13:55-14:20

Research and Development of Tumor Immunostimulants and Multi-Antibody Prodrug Molecules

Jiang WeidongKangkang Bio, CEO

14:20-14:45

How to Design the Next Generation of ADCs to Improve the Therapeutic Window

Gao ChangshouAlice Pharmaceuticals, Chief Technology Officer

14:45-15:10

Nonclinical Safety Evaluation Strategies and Case Studies for ADC Drugs

Zhou LiTianqin Biotech, Executive Vice President; Chairman of the Reproductive Toxicology Professional Committee of the Chinese Society of Toxicology

15:10-15:35

Iterative Updates of ADC Extracellular Cleavable Linkers

Cai JiaqiangSuzhou Yilink Biotechnology, Co-Founder, CSO

15:35-16:00

Frontier Exploration of Radiopharmaceuticals in Clinical Applications

Single WaveCEO of Suzhou Borui Chuanghe

16:00-16:25

Research Challenges and Application Prospects of Multispecific Antibody Drugs

AmgenImmune Ark, Founder, Chairman and CEO

16:25-16:50

Application of BioAI Models in the Early Research of Antibody Drugs

Liu JianghaiShengshi Junlian, Founder & General Manager

16:50-17:15

Sixin Pharmaceuticals

17:15-17:40

The Epic Transformation of One-Click Large Model Writing for Any Pharmaceutical Development Report

Li XingBeijing Deep Intelligence Technology Co., Ltd., CEO

09:00-09:25

From the Blossoms of JPM, Seeking Survival and Development Strategies for Biotech Startups: The Overseas Expansion Chapter

Cai XuejunFormer BMS, Global Vice President of R&D

09:25-09:50

Breaking the Deadlock and Reflections on the Overseas Expansion of Innovative Drugs

Sheng YanciHenlius, General Manager of Global Strategy and Project Management

09:50-10:15

Progress in Small Molecule New Drugs

Hu YonghanCinovent, CTO

10:15-10:30

Coffee Break

10:30-10:55

Analysis of Key Factors in Clinical Development and Registration for Innovative Drugs Going Overseas

Shen XiaoHaisen Bio, Chief Medical Officer

10:55-11:20

Global Progress in the Development of New Anti-Influenza Virus Drugs

Chen XiaoxinZhongsheng Ruichuang, Co-Founder, Director, President

11:20-12:00

Roundtable Dialogue: Layout and Development Trends of Small Molecule Innovative Drug R&D

Zhang HanchengYingchuang Pharmaceuticals, Chairman & President

Cai XuejunFormer BMS, Global Vice President of R&D

Sheng YanciHenlius, General Manager of Global Strategy and Project Management

Hu YonghanXinnuowei, CTO

Xiao ShenHaisen Bio, Chief Medical Officer

12:00-13:30

Lunch

Showcase of High-Potential Pharmaceutical Enterprises

13:30-13:55

From Single-Cell Technology to Disruptive Treatment Strategies

Xu XuanhaoBioRay Laboratories, Single-Cell Medical Scientist

13:55-14:20

Development of Innovative Drugs for Chronic Pain Based on the Concept of Multimodal Analgesia

Wang YouxinLidao Pharmaceuticals, Chairman and CEO

14:20-14:45

NPTXR: New First in class target receptor for platform therapy of Solid tumors

Chen BozhouCali Biotech, Co-founder and CEO

14:45-15:10

EP4 Antagonist: Paving a New Path for Cartilage Regeneration in Osteoarthritis

Deng YongqiKaif Pharma, Founder & CEO

15:10-15:30

Guest Itinerary Confirmation in Progress

15:30-15:55

Tea Break

15:55-16:20

Exploring the Etiology of Autoimmune Diseases to Develop New Drugs for Fundamental Treatment

Fan GuohuangAmephi Bio, Chairman

16:20-16:45

From Best-in-Class to First-in-Class (Indication): Development Strategy for a Potent Dual Selective JAK Inhibitor

Shen WangVivoryon Biosciences, CEO

16:45-17:10

Development of IKZF1/3 Molecular Glue Degraders

Liwén ZhàoChaoyang Pharmaceutical, CEO

17:10-17:35

PolysaccharideInnovative Drug Platform GlycoTDS™ and Targeted Anti-Tumor New Drug Industrialization

Wang SiSuzhou Shengduolikang Pharmaceutical Co., Ltd., Founder/CEO

13:30-14:00

Case Study: SINOVAC Biotech's Collaboration with China's Biopharmaceutical Enterprises for International Expansion

Shao KeSinovac Biotech Ltd., Vice President

14:00-14:30

Shanghai Pharmaceutical's Experience Sharing in Expanding into Southeast Asia, Middle East and North Africa Markets

Yan JunGeneral Manager of Shanghai Pharmaceutical International Business Division

14:30-15:00

Pharmaceutical Companies Going Global: The Role of the FDA and Regulatory Requirements

Wang YapingFormer FDA Review Expert; Blue Magpie Bio, CMO of Therapeutic Products

15:00-15:30

Quality Assurance and Regulatory Requirements for Innovative Drug Products Going Overseas

Du XinEglin, Co-founder & CEO

15:30-15:55

Tea Break

15:55-16:25

Current Status and Opportunities in BD for the Biopharmaceutical Industry and Protein Degradation Field in Recent Years

Zhou FengHangzhou Hezheng Pharmaceutical, Chief Strategy Officer

16:25-16:55

EU Pharmaceutical Regulatory Policies and Regulations

16:55-17:30

Roundtable Dialogue: Opportunities and Challenges for Pharmaceutical Companies Going Global (Policy, Market, Clinical)

Cai XuejunFormer BMS, Global R&D Vice President (Moderator)

Shao KeSinovac Biotech, VP

Yan JunGeneral Manager of Shanghai Pharmaceuticals International Business Division

Zhou FengHangzhou Hezheng Pharmaceutical, Chief Strategy Officer

09:00-09:25

Design of Lipid Nanocarriers and Their Exploration in RNA Drug Development

Zhang XueqingRongcan Bio, Chief Scientist

09:25-09:50

A Novel Small Nucleic Acid Delivery System: QTsome™

Lin JialiangHaichang Bio, Head of Delivery System Research and Development at the New Drug Research and Development Center

09:50-10:15

Crossing the CGT Original Innovation Death Valley through Open Innovation - A Case Study of Targeted Integration of Large Gene Fragments in Cell Therapy

Xie XuanhuiReindeer Bio, Chief Innovation and Investment Officer

10:15-10:35

Tea Break

10:35-11:00

The Practice of AI in Efficiently Discovering Clinical Candidate Drugs

Xing LiLangrui Bio, CEO

11:00-11:25

Key Points for IND Submission of Nucleic Acid Vaccines

Lu HangJIAYI Bio, CEO

11:25-11:50

Development of In vivo CAR-T Therapy Based on LNP-mRNA Technology

Hu RongkuanXingrui Pharmaceuticals, Chairman and CEO

11:50-13:30

Lunch

13:30-13:55

Rational Design of Nucleic Acid Drug Sequences Sharing
Pan JuanEdding Pharma, Preclinical R&D Director

13:55-14:20

Obesity/Weight Loss Drug Development (Proposed)

Jing ShuqianGloria Biosciences, Founder, Chairman and CEO

14:20-14:45

Case Study on the Identification of Semaglutide and Tirzepatide Impurities

Liu GuozhuChenchen Pharmaceuticals, Founder & Chairman

14:45-15:10

Research on Artificial Intelligence-Based Protein Drug Design Methods and GLP-1 Peptide Drug Practice

Chen HaifengProfessor at Shanghai Jiao Tong University; Co-founder of Zhiyao Yuanchuang

15:10-15:35

Development of New Drugs Based on Survival Strategy Animal Toxin Peptides

Rong MingqiangPed Bio, Chairman

15:35-16:00

Stability Modification and Pharmacokinetic Analysis Methods of FGF21 Analogues

Zhou ZhenxingDoer Biologics, Senior Director of Bioanalysis

16:00-16:25

Medical Concept Validation and Minimally Invasive Intervention Drug Delivery Technology Platform

Li YongyongTongji University, School of Medicine, Professor

09:00-09:30

Protein Degradation Dual Platform (GlueTacs^®) Driven Tumor and Immunotherapy Drug Development

Yang XiaobaoBiaoxin Bio, Founder, Chairman, CEO

09:30-10:00

Advances in Transdermal Delivery Technology and New Drug Development

Sheng XiaoxiaLeading Pharma, CEO

10:00-10:30

Late-stage CMC and NDA Submission Practice for Small Molecule Innovative Drugs (Tentative)
Liu Juntao
BeiGene, Director of Process Development

10:30-10:50

A Good Process Is Important for Small Molecule New Drugs
Fu Peng
Hibiscus Chemical, CEO

10:50-11:20

Mitochondrial Uncouplers and Their Applications in the Field of Metabolic Diseases

Ma TianweiPresident of JunShengTai Pharmaceutical Translational Science Academy

11:20-11:50

Pharmaceutical Considerations in the Clinical Translation of Small Molecule Innovative Drugs

Li YongguoJiayue Pharmaceuticals, Chairman & CSO

11:50-12:10

ACT001 Combined with Radiotherapy: A Breakthrough Treatment for Brain Metastases in Small Cell Lung Cancer in China

Chen Yue Shangde Pharmaceutical, Founder & Chairman

12:10-13:30

Lunch

13:30-14:00

Current Status and Future Directions in Pain Management Drug Development
Chen Bozhou
Calithera Biosciences, Co-Founder and CEO

14:00-14:30

Discovery of Novel A2aR/A2bR Antagonists for Cancer Immunotherapy (Proposed)

Wang Yonghui
Fudan University, Distinguished Professor; Lead Discovery Pharma, Co-Founder and Chief Scientific Officer

14:30-15:00

In-situ Neural Regeneration Technology in the Brain and Clinical Translation

Chen GongDirector of the Brain Repair Center, Jinan University; Founder and Chairman of NeuroX Biotech

15:00-15:30

Development and Challenges of Proteolysis Targeting Chimeras (PROTAC) Drugs

Lei ZengHepharma, CEO

15:30-16:00

Research on FLT3-ITD Inhibitor Resistance Mechanisms and Development of Innovative Targeted Intervention Strategies

Yang GuangNankai University, College of Pharmacy, Professor & Doctoral Supervisor

16:00-16:30

Progress in Anti-Aging Research and Opportunities for Clinical Innovation Drug Development

Zhang JianGeneral Manager of Jiangsu Lead Biotech

16:30-17:00

Synthetic Lethal Drugs: Opportunities, Challenges, and Development Trends

Chen XuxingYouli Biologics, Founder, CEO