Sunvozertinib As Neoadjuvant and Adjuvant Therapy in Stage II-IIIB Non-small-cell Lung Cancer Patients with EGFR Exon 20 Insertion Mutation: a Single-arm, Phase 2 Study (WU-KONG20)

This is a single-arm, phase 2 study to investigate the efficacy and safety of sunvozertinib as neoadjuvant and adjuvant treatment for stage II-IIIB non-small-cell lung cancer patients with EGFR exon20 insertion mutation.

开始日期2025-02-18

申办/合作机构

Tangdu Hospital

[+1]

NCT06786208

/ Not yet recruitingN/AIIT

Real-world Study of Sunvozertinib Treatment in Locally Advanced or Metastatic EGFR-Mutant NSCLC After EGFR-TKI Treatment Failure

Observe the efficacy and safety of sunvozertinib in the real world in the treatment of EGFRm aNSCLC patients with previous EGFR-TKI treatment

开始日期2025-02-01

申办/合作机构

河南省肿瘤医院

ChiCTR2400094167

/ Suspended临床2期IIT

Efficacy and safety of Sunvozertinib for adjuvant treatment of stage IB-IIIB EGFR ex20ins mutated NSCLC after complete resection: a phase II, single-arm clinical study

开始日期2024-12-20

申办/合作机构

上海市肺科医院

100 项与舒沃替尼相关的临床结果

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100 项与舒沃替尼相关的转化医学

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100 项与舒沃替尼相关的专利（医药）

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项与舒沃替尼相关的文献（医药）

2025-01-01·LUNG CANCER

Sunvozertinib monotherapy in EGFR tyrosine kinase inhibitor-resistant non-small cell lung cancer with EGFR mutations

Article

作者: Lee, Chee Khoon ; Zhu, Xuehua ; Yang, Zhenfan ; Yang, James Chih-Hsin ; Su, Wu-Chou ; Gao, Bo ; Jänne, Pasi A ; Huang, Wen-Tsung ; Fang, Jian ; Wang, Mengzhao ; Xu, Yan

BACKGROUND:

Multiple agents can be used to treat patients with EGFR mutated non-small cell lung cancer (NSCLC) who develop resistance to EGFR tyrosine kinase inhibitors (TKIs), but the clinical outcome was not satisfactory, especially in patients with multiple lines of prior therapies. Therefore, there is an unmet medical need for these patients. Sunvozertinib is an oral, potent, irreversible, and mutant-selective EGFR TKI targeting EGFR mutations with weak activity against wild-type EGFR. We investigated the efficacy and safety of sunvozertinib monotherapy in treating EGFR TKI-resistant patients with NSCLC harboring EGFR mutations.

METHODS:

This was a pooled analysis of phase 1 and 2 studies (WU-KONG1, WU-KONG2 and WU-KONG15). Eligible patients received sunvozertinib at doses ranging from 50 mg to 400 mg once daily. Efficacy endpoints included objective response rate (ORR), disease control rate (DCR), duration of response (DoR) and progression free survival (PFS). Safety endpoints included adverse events and serious adverse events. In addition, plasma specimens were collected at baseline to assess EGFR mutation types and genetic alterations in EGFR downstream signaling pathway.

RESULTS:

Forty patients were enrolled. Ninety percent received ≥ 3 prior lines of therapies. The best ORR was 27.5 %, and DCR was 60 %. The median DoR and PFS were 6.5 months and 6 months, respectively. Higher ORR was seen in patients whose last line of treatment was chemotherapy rather than EGFR TKI (31.6 % vs. 14.3 %). Greater responses were seen in patients with EGFR sensitizing and T790M double mutations (ORR: 55.6 %). The safety profile of sunvozertinib was consistent with previous reports.

CONCLUSIONS:

Sunvozertinib has promising activity implying future investigations in the patients with EGFR mutated NSCLC who developed resistance to prior EGFR TKI.

2024-11-01·CTS-Clinical and Translational Science

Serum creatine kinase elevation following tyrosine kinase inhibitor treatment in cancer patients: Symptoms, mechanism, and clinical management

Review

作者: To, Kenneth K. W. ; Zhang, Hang

Abstract:

Molecular targeted tyrosine kinase inhibitors (TKIs) have produced unprecedented treatment response in cancer therapy for patients harboring specific oncogenic mutations. While the TKIs are mostly well tolerated, they were reported to increase serum levels of creatine kinase (CK) and cause muscle metabolism‐related toxicity. CK is an essential enzyme involved in cellular energy metabolism and muscle function. Elevated serum CK levels can arise from both physiological and pathological factors, as well as triggered by specific drug classes. The incidence of serum CK elevation induced by a few approved TKIs (brigatinib, binimetinib, cobimetinib‐vemurafenib combination [Food and Drug Administration, United States]; aumolertinib, and sunvozertinib [only approved by National Medical Products Administration, China]) were over 35%. CK elevation‐related symptoms include myopathy, myositis, inclusion body myositis (IBM), cardiotoxicity, rhabdomyolysis, rash, and acneiform dermatitis. High‐level or severe symptomatic CK elevation may necessitate dose reduction and indirectly dampen TKI efficacy. This review presents an updated summary about the prevalence rate and recent research about mechanisms leading to TKI‐induced serum CK elevation in cancer patients. The utility of monitoring serum CK levels for predicting TKI‐induced adverse effects and their management will also be discussed.

2024-11-01·LUNG CANCER

The prediction of treatment outcome in NSCLC patients harboring an EGFR exon 20 mutation using molecular modeling

Article

作者: Groen, H J M ; van Veggel, B.A.M.H. ; van der Wekken, A J ; Zwierenga, F. ; van der Wekken, A.J. ; Zwierenga, F ; Zhang, L. ; Groves, M R ; Groen, H.J.M. ; Melcr, J ; de Langen, A J ; van Veggel, B A M H ; Schuuring, E. ; Melcr, J. ; Groves, M.R. ; Zhang, L ; Schuuring, E ; de Langen, A.J.

INTRODUCTION:

The structural effect of uncommon heterogenous in-frame deletion and/or insertion mutations within exon 20 (EGFRex20+) in relation to therapy response is poorly understood. This study aims to elucidate the structural alterations caused by EGFRex20+ mutations and correlate these changes with patient responses.

MATERIAL AND METHOD:

We selected EGFRex20+ mutations from advanced NSCLC patients in the Position20 and AFACET studies for computational analysis. Homology models representing both inactive and active conformations of these mutations were generated using the Swiss-Model server. Molecular docking studies with EGFR-TKIs was conducted using smina, followed by Molecular Dynamic (MD) simulations performed with GROMACS. These computational findings were compared with clinical outcomes to evaluate their potential in predicting patient response.

RESULTS:

Our docking studies of 29 EGFRex20+ mutations revealed that the binding energies of afatinib, osimertinib, zipalertinib, and sunvozertinib, compared to the wild type, do not significantly impact either TKI's efficacy. MD simulations for eight EGFRex20+ mutations (A763_Y764insFQEA, A767_V769dup, S768_D770dup, D770_N771insG, D770_P772dup, N771_H773dup, H773_V774insY and H773_V774delinsLM) revealed varying degrees of instability. For six variants, predicted activation based on the αC-helix stability and orientation, as well as TKI sensitivity, aligned well with clinical observations from the Position20 and AFACET studies. Two mutations (D770_N771insG and N771_H773dup) predicted as poor to moderate responders, showed minimal activation of the αC-helix region, warranting further investigation.

CONCLUSION:

In conclusion, MD simulations can effectively predict patient outcomes by connecting computational results with clinical data and advancing our understanding of EGFR mutations and their therapeutic responses.

298

项与舒沃替尼相关的新闻（医药）

2025-03-06

·PRNewswire

TEPMETKO Continues to Strengthens its Position as a Leading METex14 Skipping NSCLC Therapy | DelveInsight

With increasing biomarker-driven cancer treatments, TEPMETKO benefits from growing adoption in precision oncology. Competition from other MET inhibitors like TABRECTA (capmatinib) exists, but TEPMETKO's once-daily dosing and efficacy profile offer differentiation. LAS VEGAS, March 6, 2025 /PRNewswire/ -- DelveInsight's " TEPMETKO Market Size, Forecast, and Market Insight Report" highlights the details around TEPMETKO, a kinase inhibitor indicated for the treatment of adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of TEPMETKO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. EMD Serono's TEPMETKO (tepotinib) Overview TEPMETKO is a kinase inhibitor prescribed for adult patients with metastatic non-small cell lung cancer (NSCLC) carrying MET exon 14 skipping alterations. The active component is Tepotinib (as hydrochloride monohydrate), administered orally. Patients should be cautioned about the heightened risk of severe or fatal interstitial lung disease/pneumonitis, liver toxicity, and potential embryo-fetal toxicity, necessitating effective contraception during and shortly after treatment. Tepotinib specifically targets MET, including variants with exon 14 skipping mutations. It blocks HGF-dependent and independent MET phosphorylation, disrupting MET-driven signaling pathways. Additionally, at clinically relevant concentrations, Tepotinib inhibits melatonin 2 and imidazoline 1 receptors. In vitro studies show that it suppresses tumor cell proliferation, anchorage-independent growth, and migration of MET-dependent cancer cells. In mouse models with MET-driven tumors, including those with MET exon 14 skipping alterations, Tepotinib reduced tumor growth, sustained MET phosphorylation inhibition, and, in one case, decreased metastasis formation. The recommended dose of TEPMETKO is 450 mg taken orally once daily until disease progression or intolerable toxicity occurs. Patients should take it at the same time each day, swallowing tablets whole without chewing, crushing, or splitting them. If a dose is missed and less than eight hours remain until the next scheduled dose, patients should skip it. In cases of vomiting after taking TEPMETKO, the next dose should be taken at the usual time. Learn more about TEPMETKO projected market size for NSCLC @ TEPMETKO Market Potential Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for 81% of all diagnosed cases. Early detection greatly improves outcomes, but diagnosing NSCLC and other lung cancers is challenging because their symptoms are often mistaken for common illnesses or the long-term effects of smoking. Consequently, 80% of NSCLC cases are already at advanced stages by the time they are identified, making treatment more difficult. Around 80% of EGFR mutations in NSCLC involve either exon 19 deletions or the exon 21 L858R substitution, both of which are classified as sensitizing mutations. Until the last decade, chemotherapy was the primary treatment for advanced and metastatic lung cancer. However, this changed in 2015 with the approval of the first immune checkpoint inhibitor (ICI), KEYTRUDA (pembrolizumab), as a second-line therapy for advanced cases. This was followed by TECENTRIQ (atezolizumab) in 2016. Both therapies were later approved for first-line treatment, broadening their use to a larger patient population. In 2020, the combination of OPDIVO (nivolumab) and ipilimumab also received approval as a first-line treatment for metastatic NSCLC. According to DelveInsight, the NSCLC market size across the 7MM is projected to grow from USD 30 billion in 2024, with a substantial CAGR through 2034. This growth is largely driven by the introduction of emerging therapies during the forecast period (2025–2034). Discover more about the NSCLC market in detail @ Non-small Cell Lung Cancer Market Report Emerging Competitors of TEPMETKO The NSCLC pipeline is very robust with the promising therapies such as Telisotuzumab vedotin (AbbVie), Patritumab deruxtecan (Daiichi Sankyo/AstraZeneca), Datopotamab deruxtecan (Daiichi Sankyo/AstraZeneca), Eftilagimod alpha (Immutep), BNT311/GEN1046 (acasunlimab) (Genmab), V940 (mRNA-4157) + Pembrolizumab (Moderna Therapeutics/Merck), Plinabulin + Docetaxel (BeyondSpring), Olomorasib (LY3537982) (Eli Lilly and Company), Zipalertinib (Cullinan Oncology/Taiho Pharma), Ceralasertib (AZD6738) (AstraZeneca), TEDOPI (EP-2101; IDM 2101; OSE-2101) (OSE Immuno-therapeutics), Sigvotatug vedotin (PF08046047) (Pfizer), ANKTIVA (N-803) (ImmunityBio), Aumolertinib/Almonertinib/HS-10206 (Jiangsu Hansoh Pharmaceutical), Niraparib (GSK), Savolitinib (AstraZeneca/Hutchison MediPharma), TRODELVY (Gilead Sciences), Pyrotinib (Jiangsu HengRui Medicine), Ociperlimab (BGB-A1217) (BieGene), Volrustomig (AstraZeneca), Gotistobart (BNT316/ONC-392) (OncoC4/BioNTech), Ivonescimab (AK112/SMT112) (Akeso Biopharma/Summit Therapeutics), ZYNYZ (retifanlimab/INCMGA00012) (Incyte/Macrogenics), Divarasib (GDC-6036) (Roche/Genentech), Tiragolumab (RG6058) (Roche), Sacituzumab Tirumotecan (Merck and Kelun-Biotech), JEMPERLI (dostarlimab/TSR-042) (GSK and AnaptysBio), Zongertinib (BI-1810631) (Boehringer Ingelheim), BAY 2927088 (Bayer), Serplulimab (HLX10) (Shanghai Henlius Biotech), Rilvegostomig (AZD2936) (AstraZeneca), MK-1084 (Merck, Taiho Pharmaceutical, and Astex), Domvanalimab (Arcus Biosciences and Gilead Sciences), OPDUALAG (nivolumab and relatlimab) (Bristol-Myers Squibb), Belrestotug + JEMPERLI (iTeos Therapeutics and GSK), Firmonertinib (ArriVent BioPharma), Sunvozertinib (DZD9008) (Dizal Pharmaceutical), Cobolimab (GSK), Livmoniplimab (AbbVie), Fianlimab (REGN3767) (Regeneron Pharmaceuticals), BNT327/PM8002 (Biotheus/BioNTech), HS-20117 (Hansoh BioMedical), IO102-IO103 + Pembrolizumab (IO Biotech), Naptumomab estafenatox (NeoTX Therapeutics/Active Biotech), FF-10832 (FUJIFILM Corporation), BNT116 (BioNTechSE/Regeneron Pharmaceuticals), CAN-2409 (Candel Therapeutics), Mecbotamab Vedotin (BA3011/CAB-AXL-ADC) (BioAtla), Bemcentinib (BGB 324/BGB-3234/R-428) (BerGenBio/Rigel Pharmaceuticals), DOVBLERON (taletrectinib/AB-106/IBI-344) (Nuvation Bio/Innovent Biologics/Daiichi Sankyo/Nippon Kayaku), Lifileucel (Iovance Biotherapeutics), IBI363 (Innovent Biologics), Sotevtamab (AB-16B5) (Alethia Biotherapeutics), Avutometinib (VS6766) (Verastem Oncology), Vebreltinib (APL-101) (Apollomics), LP-300 (Lantern Pharma), JNJ-90301900 (Johnson & Johnson Innovative Medicine), AMG 193 (Amgen), Luveltamab tazevibulin (Sutro Biopharma), PRT3789 (Prelude Therapeutics), Disitamab vedotin (Seagen), PADCEV (enfortumab vedotin) (Astellas Pharma), RP1 (Replimune), TIVDAK (tisotumab vedotin) (Seagen), Zanidatamab (Jazz Pharmaceuticals), Utidelone injectable (UTD1) (Beijing Biostar Pharmaceuticals), REGN5093-M114 (Regeneron Pharmaceuticals), SLC-391 (SignalChem Lifesciences), fulzerasib (GenFleet), Davutamig (REGN5093) (Regeneron Pharmaceuticals), TAS3351 (Taiho Oncology), H002 (RedCloud Bio), JIN-A02 (J INTS BIO), FWD1509 (Forward Pharma), Sabestomig (AZD7789) (AstraZeneca), Sasanlimab (Pfizer), Selvigaltin (GB1211) (Galecto Biotech), Vepafestinib Helsinn (Healthcare/Taiho Pharmaceutical), EP0031 (A400/ KL590586) (Ellipses Pharma/Kelun-Biotech), Pamvatamig (MCLA-129) (Merus), Zidesamtinib (NVL-520) (Nuvalent), NVL-655 (Nuvalent), RMC-4630 (Revolution Medicines), REQORSA (quaratusugene ozeplasmid) (Genprex), PDC*lung01 (PDC*line Pharma), Evalstotug (BA3071) (BioAtla and BeiGene), PT-112 (Promontory Therapeutics), MRT-2359 (Monte Rosa Therapeutics), GAIA-102 (GAIA BioMedicine), Rigosertib (Traws Pharma), HMBD-001 (Hummingbird Bioscience), PLB1004 (Avistone Biotechnology), ANS03 (Avistone Biotechnology), MYTX-011 (Mythic Therapeutics), A166 (Sichuan Kelun-Biotech Bio-pharmaceutical), Atamparib (BN-2397) (Ribon Therapeutics), DELTACEL (KB-GDT-01) (Kiromic BioPharma), Carotuximab (ENV-105) (Kairos Pharma), YL202 (MediLink Therapeutics), and others. To know more about the number of competing drugs in development, visit @ TEPMETKO Market Positioning Compared to Other Drugs Key Milestones of TEPMETKO In February 2024, the FDA granted traditional approval to TEPMETKO for adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. In February 2022, the EC approved TEPMETKO as monotherapy for the treatment of adult patients with advanced NSCLC harboring alterations leading to METex14 skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy. In February 2021, Merck announced that the US FDA has approved TEPMETKO following priority review for the treatment of adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. This indication was approved under accelerated approval based on ORR and DOR. In October 2020, TEPMETKO received ODD for treating NSCLC with MET genomic tumor aberrations In March 2020, EMD Serono (the biopharmaceutical business of Merck KGaA), announced that the MHLW approved TEPMETKO for the treatment of patients with unresectable, advanced, or recurrent NSCLC with METex14 skipping alterations. In September 2019, the US FDA granted BTD for tepotinib in patients with metastatic NSCLC harboring METex14 skipping alterations who progressed following platinum-based cancer therapy Discover how TEPMETKO is shaping the NSCLC treatment landscape @ TEPMETKO NSCLC TEPMETKO Market Dynamics TEPMETKO competes in a growing but highly specialized market where MET-targeted therapies are gaining traction due to their efficacy in addressing MET-altered tumors. The market for MET inhibitors is expanding as precision oncology advances and molecular diagnostics become more widely available, enabling better identification of patients who would benefit from targeted treatments like TEPMETKO. A key factor shaping TEPMETKO's market dynamics is competition. It directly competes with Novartis' TABRECTA (capmatinib), another MET inhibitor approved for the same indication. While TEPMETKO offers the advantage of once-daily dosing compared to TABRECTA's twice-daily regimen, both drugs have similar efficacy profiles, making physician and patient preference an important differentiator. Additionally, broader competition from next-generation MET inhibitors and combination therapies in clinical trials could impact TEPMETKO's long-term market position. Regulatory approvals and market access play a crucial role in TEPMETKO's adoption. The drug has been approved in multiple regions, including the U.S., Europe, and Japan, but reimbursement and pricing strategies vary by market. Payer policies, along with the cost-benefit analysis of MET inhibitors compared to other targeted therapies, influence prescription trends. Furthermore, real-world evidence and post-marketing studies will be critical in demonstrating TEPMETKO's sustained effectiveness and safety, which could support expanded indications and increased market penetration. Looking ahead, the MET inhibitor market is expected to grow with advances in biomarker-driven therapy, further refining patient selection. TEPMETKO's success will depend on continued clinical development, potential label expansions, and strategic partnerships to strengthen its competitive edge. As new entrants emerge, Merck KGaA's ability to differentiate TEPMETKO through combination strategies or enhanced formulations may determine its long-term sustainability in this evolving landscape. Dive deeper to get more insight into TEPMETKO's strengths & weaknesses relative to competitors @ TEPMETKO Market Drug Report Table of Contents Related Reports Non-small Cell Lung Cancer Market Non-small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key NSCLC companies including Daiichi Sankyo, AstraZeneca, Gilead Sciences, BieGene, AbbVie, Roche, Merck, Novartis, Pfizer, Takeda Pharmaceuticals, Eli Lilly, BerGenBio, GlaxoSmithKline, Duality biologics, among others. Non-small Cell Lung Cancer Pipeline Non-small Cell Lung Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key non-small cell lung cancer companies, including BridgeBio Pharma, Daiichi Sankyo, EMD Serono, Merck, BridgeBio Pharma, Abbvie, Pfizer, Eli Lilly and Company BioNTech SE, Shenzhen TargetRx, Taiho Pharmaceutical, Chong Kun Dang, Bristol Myers Squibb, Innovent Biologics, Xuanzhu Biopharmaceutical, Bayer, GeneScience Pharmaceuticals, InventisBio, Apollomics, Imugene, Ono Pharmaceutical, Pierre Fabre, Jiangsu Hengrui Medicine Co., Bristol-Myers Squibb, Surface Oncology, Inhibrx, Sinocelltech, Mirati Therapeutics, REVOLUTION Medicines, Yong Shun Technology Development, Iovance Biotherapeutics, Galecto Biotech, among others. C-MET Metastatic Non-small Cell Lung Cancer Market C-MET Metastatic Non-small Cell Lung Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key C-MET mNSCLC companies, including Novartis, Merck, EMD Serono, AbbVie, Regeneron Pharmaceuticals, Mythic Therapeutics, Apollomics, Johnson & Johnson Innovation, Haihe Biopharma, among others. C-MET Non-small Cell Lung Cancer Pipeline C-MET Non-small Cell Lung Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key C-MET non-small cell lung cancer companies, including AbbVie, Janssen Research & Development, Beijing Pearl Biotechnology Limited Liability Company, Novartis, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

上市批准免疫疗法优先审批

2025-03-04

·汇聚南药

中国毛利率最高的10家医药公司

在医药产业这片充满机遇与挑战的沃土上，毛利率不仅是衡量企业盈利能力的重要指标，也是投资者评估企业价值的关键因素。一、毛利率榜单概览根据《南方财富网趋势选股系统》财报工具数据整理，以及市场公开信息，截至2024年第二季度，医药生物上市公司毛利率榜单前十名依次如下（注：由于数据时效性，以下排名及数据可能随时间有所变动，但旨在提供分析框架）： NO.1、迪哲医药：97.78% 　　公司所在地：江苏　　所属行业：化学制药　　2024年第二季度季报显示，迪哲医药实现总营收1.22亿元，毛利率97.78%。 NO.2、神州细胞：96.52% 　　公司所在地：北京　　所属行业：生物制品　　2024年第二季度季报显示，神州细胞实现总营收6.92亿元，毛利率96.52%。 NO.3、西藏药业：96.36% 　　公司所在地：西藏　　所属行业：生物制品　　2024年第二季度季报显示，西藏药业公司实现营业总收入9.1亿元，毛利率96.36%，净利润为2.89亿元。 NO.4、艾力斯：95.81% 　　公司所在地：上海　　所属行业：医药制造　　艾力斯2024年第二季度，公司实现总营收8.34亿，毛利率95.81% NO.5、欧林生物：95.53% 　　公司所在地：四川　　所属行业：生物制品　　欧林生物2024年第二季度公司总营收1.55亿，毛利率95.53%。 NO.6、爱美客：95.26% 　　公司所在地：北京　　所属行业：医美护理　　爱美客2024年第二季度公司总营收8.49亿，毛利率95.26%。 NO.7、我武生物：94.71% 　　公司所在地：浙江　　所属行业：生物制品　　我武生物2024年第二季度季报显示，公司实现总营收2.13亿，毛利率94.71%。 NO.8、上海谊众：94.62% 　　公司所在地：上海　　所属行业：医药制造　　上海谊众2024年第二季度公司总营收5321.89万，毛利率94.62%。 NO.9、特宝生物：93.61% 　　公司所在地：福建　　所属行业：生物制品　　公司2024年第二季度季报显示，特宝生物总营收6.45亿，毛利率93.61%。 NO.10、康华生物：93.6% 　　公司所在地：四川　　所属行业：生物制品　　公司2024年第二季度季报显示，2024年第二季度总营收4.3亿，毛利率93.6%。二、深度剖析1. 迪哲医药：两款核心产品降价50%进入医保，高毛利或难以维持在2024年的半年报中，迪哲医药以高达97.78%的毛利率位居榜首，可能主要是受益于两款以上市药物戈利昔替尼胶囊医保谈判前价格为33900元/盒（0.15g*30粒）以及舒沃替尼片医保谈判前价格为9040元/盒（150 mg*14片）。上述两款药品皆已经通过国家医保谈判被纳入新版国家医保药品目录，并于2025年1月1日起正式实施。据网上披露：戈利昔替尼胶囊在医保谈判后的价格为15360元/盒，舒沃替尼片在医保谈判后的价格为4160元/盒。（见：58款替尼进入新一轮医保目录）随着上述两款核心产品以降价50%进入国家医保目录，迪哲医药高毛利或许难以维持。2. 神州细胞与生物制品的高毛利率神州细胞以96.52%的毛利率紧随其后，展现了生物制品领域的高盈利能力。近日，神州细胞发布2024年业绩快报。神州细胞2024年营业总收入25.13亿元，同比增长33.13%。营业利润达到5.68亿元，同比增长8829.33%，归属于母公司所有者的净利润为1.12亿元，成功扭亏为盈。神州细胞2024年营业总收入与营业利润大幅增长，主要系公司核心产品安佳因(重组凝血八因子产品、注射用重组人凝血因子Ⅷ)销售额增长，以及其他上市产品销售收入增加。3. 中药与生物制品的并驾齐驱在榜单中，西藏药业和多家生物制品企业占据了重要位置。西藏药业以96.36%的毛利率展现了中药领域的盈利能力。随着国家对中医药产业的支持和消费者健康意识的提高，中药市场有望迎来新的发展机遇。同时，生物制品领域的高毛利率也反映了该领域的竞争力和发展潜力。4. 投资视角下的高毛利率企业从投资角度来看，高毛利率企业往往具有更强的盈利能力和抗风险能力。在医药产业中，高毛利率企业通常拥有独特的产品线、强大的研发实力或广阔的市场前景。因此，投资者在关注医药企业时，应重点关注企业的毛利率水平及其背后的驱动力。三、医药产业与投资趋势展望1. 医药产业的创新趋势随着医药技术的不断进步和消费者健康意识的提高，医药产业正呈现出明显的创新趋势。创新药、生物制品等高附加值产品将成为未来医药市场的主流。同时，医药产业也将更加注重个性化治疗和精准医疗的发展。2. 投资视角下的医药板块从投资角度来看，医药板块因其独特的行业属性和广阔的市场前景而备受关注。投资者在关注医药企业时，应重点关注企业的研发实力、产品线、市场前景和盈利能力等方面。同时，也应关注国家政策、市场环境和行业趋势等因素对企业的影响。四、结语中国毛利率最高的10家医药公司不仅展现了医药产业的盈利能力和发展潜力，也为投资者提供了有价值的参考。随着医药技术的不断进步和消费者健康意识的提高，医药产业正迎来新的发展机遇。投资者应密切关注医药企业的动态和市场变化，把握投资机会。同时，医药企业也应不断加强研发实力和市场拓展能力，以应对日益激烈的市场竞争和不断变化的市场需求。喜欢我们文章的朋友点个“在看”和“赞”吧，不然微信推送规则改变，有可能每天都会错过我们哦~ 免责声明 “汇聚南药”公众号所转载文章来源于其他公众号平台，主要目的在于分享行业相关知识，传递当前最新资讯。图片、文章版权均属于原作者所有，如有侵权，请在留言栏及时告知，我们会在24小时内删除相关信息。信息来源：医药财经往期推荐本平台不对转载文章的观点负责，文章所包含内容的准确性、可靠性或完整性提供任何明示暗示的保证。

财报

2025-03-02

·阿基米德Biotech

悬崖边上，惊天逆转

创新药企2024Q4国内业绩，几乎没有亮点。这造就一种畸形的体格。早期创新已是世界巨人，据医药魔方数据，从专利布局看，截至2024年8月，中国在全球创新药管线中的占比已达36%；后期商业化却是矮子，10亿美元分子仍是内需市场无望触及的白月光，国产高增长大单品仅剩的一根独苗——三代EGFR-TKI，也面临天花板困境。过去4年，拯救Biotech的是行业特殊的商业模式。不同于传统制造业以成品为王，创新药在成药前的每个阶段，从临床前候选化合物到临床I期、II期、III期，都可以通过BD实现商业化。据Insight数据库，2024年中国药企BD 交易总额达 635 亿美元。所以，我们不难理解，为何今年前两个月以国际化逻辑为主导的恒生生物科技指数上涨17.14%，而以内需市场为驱动的中证医药指数却下跌0.39%？从传统药企到新兴Biotech，国内商业化都退到了悬崖边上。这推动支付政策进行改革，预计从现在到9月医保谈判结果公布为止，控费力度边际放松、激励创新力度加大，都会有持续不断的催化剂。在国际化、支付政策的推动下，医药修复行情（中药例外）有望贯穿全年，虽然不时会受到外部冲击（关税、脱钩）干扰。 01 绝地创新药国内商业模式仍没有跑通。 A 股创新药企整体合计收入增长从2023年开始加速（YOY+51%）， 2024-2026 年收入增速有望维持在25~40%区间，但收入体量增大，来自于创新药供给扩大，据Insight数据库，国产新药NDA获批数量从2019年的11件快速增长至2023年的86件，2024H1已获批88件。核心单品平均销售峰值，才决定着创新药企的体感温度。迪哲医药舒沃替尼（2023年8月获批上市）、戈利昔替尼（2024年6月获批上市），应该还处于生命周期早期，却已暮气沉沉。公司2024Q3营收环比爬坡不明显，Q4营收仅有0.22亿元，因产品进入国家医保药品目录后，价格有较大幅度下降，在 2024 年末对经销商的库存进行医保价格差价补偿，影响当季收入约 5200 万元。加回因差额补偿影响的收入，Q4营收仍然环比滑坡。 2024年前三季度营收3.4亿元，而销售费用3.2亿元。这是创新药企的一个经典挑战，核心单品必须不断环比放量，远超销售费用，进而覆盖研发费用，最终要为既往无数的失败买单，也要支撑下一波可能失败无数次的研发，形成创新循环。如果国内商业化之路走不通，迪哲仍存国际化预期。中国创新药企先行者微芯生物的问题更为典型，商业化已逾10年，还没有收获一个10亿人民币分子。2024年营收6.58亿元，亏损1.15亿元，其中2024Q4营收1.77亿元，环比下降1%。再鼎医药2024Q4产品收入净额为1.085亿美元，环比增长6.6%，其中，则乐产品收入净额为4840万美元，环比增长0.4%，基本停止爬坡，卫伟迦和卫力迦产品收入净额为3000万美元，环比增长9.9%，进一步放缓。再鼎预计2025Q4实现非GAAP经营利润盈利，存在较大挑战，目前SG&A费用率高达75%，参考百济神州，2024年实现非GAAP经营利润为正，SG&A费用率为48%。石药集团2024Q4净利润5.68亿元，环比下降25%，同比下降59%。抗肿瘤业务2024年收入同比下降约28%，津优力及多美素价格于京津冀「3 + N」联盟药品集采中分别下调约58 %和23 %，到账销售额有显著下滑。心血管业务2024年收入同比下降约15 %，玄宁落选2023年国家第八批集采，使其在严格执行集中采购的医院的销售受到较大的冲击。唯一狂飙突进的创新药大单品是艾力斯三代EGFR-TKI伏美替尼，2024年销售额达到35.1亿元，也接近天花板了。艾力斯2024Q4净利润3.61亿元，环比下降11%，营收10.24亿元，环比增长7%。营收环比增速首次跌破两位数，国内创新药“30亿魔咒”生效了。伏美替尼本来会更早熄火，被奥希替尼短期让出市场份额扶了一把。受人事动荡影响，阿斯利康中国取消医药代表2024Q4销售指标，Q1-Q4同比增速分别为12%、18%、15%、-3%，其中呼吸类产品和奥希替尼下滑明显。当阿斯利康缓过神来又将怎样？从个体命运回到时代大背景。2024年，全国一般公共预算支出284612亿元，比上年增长3.6%，其中，卫生健康支出20348亿元，比上年下降9.1%，在10项主要支出科目中降幅最大。 2024年国内与全球医药交易TOP10项目对比（单位：百万美元） 02 逢生单一支付体系独木难支，穷则思变。多元化支付体系势必将在年内初步建立。药品市场形成价格分层的格局，仿制药继续集采，承担普惠的社会责任，创新药愿意降价可以进医保，不愿意降价进商保，不同支付能力的患者，都有相应层次的药物可供选择。据国盛证券，2022年，商业健康险保费8653亿元，赔款3600亿元，在卫生总费用中占比仅5%，发展空间巨大。若占比提至20%，赔付率达80%，保费收入将逼近两万亿，能为医疗费用注入近万亿增量，有效缓解支付难题。据传出的文件，创新药定价将得到优化，合理确定创新药医保支付标准，加强医保谈判测算专家能力培训，规范支付标准测算程序，充分体现药品的临床价值，支持符合条件的创新药在上市初期获得与高投入、高风险相符的收益回报。这有望抬高大单品收入天花板，稳定创新药企中长期估值水平。虽然科创板未盈利生物科技IPO“只听楼梯响，不见人下来”，但国内外投融资都在回暖。据动脉橙数据，2025年1月，全球医疗健康产业投融资总额约80.04亿美元，同比增长88.7% ，环比增长100.5%；据财联社创投通数据，2025年1月中国医疗健康产业融资额约53.04亿元，同比下滑约23.57%，环比增长14.11%，自2024Q4起月度环比持续改善。虽然PE/VC“已死”，但耐心资本地方国资登上了时代的舞台。2023年以来，以上海市、广东省、江苏省、湖南省、湖北省为代表的地方政府先后成立十亿甚至百亿级别的生物医药产业投资基金，通过市场化运作机制引导社会资本向早期研发、临床转化的高风险环节倾斜，以“资本+政策”双轮驱动模式重塑中国生物医药创新生态。国内支付端、融资端迎来破局之年，改善仍然是细微的，算是一个宏大叙事的开端。创新药当前主导逻辑是国际化，难以被地缘关系的干扰撼动，BD不受关税直接影响，而且与CDMO类似，脱钩也不具备可行性。 MNC购买创新药管线绕不开中国市场。中国成为医药创新主要发源地。据Pharmaprojects和Citeline的数据，2024年中国有6280种药物处于研发阶段，与十年前相比增长了1200%。从目前管线项目数来看，中国管线的增速已超过美国，整体管线数目约为美国研发药物总数的三分之二。 Biotech是全球重磅药物的主要来源。Nature发表数据显示，2015-2021年TOP20 MNC获批138款创新药，其中65%来自外部许可或并购，仅28%为自主研发，5%为合作推出，尤其在生物药领域，Biotech输出比例达到63%。中国Biotech以更低的研发成本（约为美国的1/3至1/5）、更快的研发速度、更优化的分子，在BIC领域已经碾压海外Biotech，让MNC能够在中国以更低价格找到具有竞争力的产品，倾向于在中国完成概念验证（POC）后，随即将管线资产引入海外进行后期开发。中国本土药物创新能力获得MNC认可。据DealForma数据，2024 年大约 31% MNC引进的创新药候选分子来自中国，后续随着这些管线推进，获批上市，中国创新药将共享全球1.6万亿美元（2023 年数据）的份额。在MNC主导的5000万美元以上预付款合作中，中国项目占比从2020年低于5%提升至2024年约30%。据医药魔方统计，2024年实现授权TOP MNC的国产项目超过30个，对比2024年国内与全球医药交易规模，恒瑞医药、舶望制药和礼新医药已进入全球榜单TOP10。中国药企全面布局美国市场。据复旦大学药学院数据，2007-2023年期间，共有177家中国本土药企的350款原研创新药在美国开展针对499个适应症的691项临床试验，包括I期临床试验399项（49%），II期临床试验269项（39%）和III期临床试验83项（12%）。中国创新药在美国开展的临床研究大部分（82%）于2019-2023年启动，数量增长快速。也许2024Q4是医药的最后一个冬天。

临床3期上市批准财报

100 项与舒沃替尼相关的药物交易

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研发状态

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10 条最早获批的记录,

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适应症	国家/地区	公司	日期
EGFR 20号外显子插入突变非小细胞肺癌	中国	迪哲（江苏）医药股份有限公司	2023-08-22

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适应症	最高研发状态	国家/地区	公司	日期
非小细胞肺癌IIIB期	临床2期	中国	迪哲（江苏）医药股份有限公司	2025-02-18
HER2突变型非小细胞肺癌	临床2期	美国	迪哲（江苏）医药股份有限公司	2023-01-10
HER2突变型非小细胞肺癌	临床2期	中国	迪哲（江苏）医药股份有限公司	2023-01-10
HER2突变型非小细胞肺癌	临床2期	中国台湾	迪哲（江苏）医药股份有限公司	2023-01-10
转移性非小细胞肺癌	临床2期	美国	迪哲（江苏）医药股份有限公司	2023-01-10
转移性非小细胞肺癌	临床2期	中国	迪哲（江苏）医药股份有限公司	2023-01-10
转移性非小细胞肺癌	临床2期	中国台湾	迪哲（江苏）医药股份有限公司	2023-01-10
EGFR突变的非小细胞肺癌	临床2期	中国	迪哲（江苏）医药股份有限公司	2022-12-27
边缘区B细胞淋巴瘤	临床2期	中国	迪哲（江苏）医药股份有限公司	2021-08-01
局部晚期非小细胞肺癌	临床2期	美国	迪哲（江苏）医药股份有限公司	2019-07-09

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05559645 \| NCT03974022 \| CTR20192097 (WU-KONG15, Pubmed) 人工标引	N/A	EGFR突变的非小细胞肺癌 EGFR Mutation	40	Sunvozertinib	顧齋窪膚獵鬱遞艱壓鏇(遞積憲鹹淵糧範顧窪夢) = 網鏇網獵願鏇醖壓蓋窪憲顧簾襯獵構築顧醖憲 (齋窪糧蓋鬱鏇衊憲襯範 ) 更多	积极	2024-12-02
NCT03974022 (WU-KONG1B, ESMO2024) 人工标引	临床2期	EGFR 20号外显子插入突变非小细胞肺癌二线 EGFR Exon 20 Mutation	107	Sunvozertinib 300 mg	艱鬱鏇廠願鑰顧廠簾願(窪鹹齋糧餘繭鹹構鑰齋) = 糧膚顧簾觸鹽窪築淵築簾艱醖積蓋襯範糧夢淵 (鏇製構鏇範艱獵餘積顧 )	积极	2024-09-14
NCT03974022 (WU-KONG1B, PRNewswire) 人工标引	临床2期	非小细胞肺癌 EGFR Exon 20 Insertion	111	舒沃哲 300mg	衊鹽膚衊襯觸鏇淵糧簾(衊壓膚膚獵範簾簾窪膚) = 憲獵鑰艱範網齋鹽網糧淵窪製範蓋鏇觸積襯獵 (網壓糧鏇淵積夢膚醖廠 ) 更多	积极	2024-06-02
WU-KONG (ASCO2024) 人工标引	临床1/2期	EGFR 20号外显子插入突变非小细胞肺癌 EGFR Exon 20 Insertion	121	Sunvozertinib	壓鏇觸積壓遞齋鏇築範(構膚顧衊顧壓鹽壓廠憲) = 廠壓簾蓋餘鑰鏇鑰齋顧醖遞遞鹽蓋遞鏇艱網網 (餘獵壓繭繭積繭構範淵 ) 更多	积极	2024-05-24
WU-KONG (ASCO2024) 人工标引	临床1/2期	EGFR 20号外显子插入突变非小细胞肺癌 EGFR Exon 20 Insertion	121	sunvozertinib	壓鏇觸積壓遞齋鏇築範(構膚顧衊顧壓鹽壓廠憲) = 淵膚窪繭艱獵廠繭鹹範醖遞遞鹽蓋遞鏇艱網網 (餘獵壓繭繭積繭構範淵 ) 更多	积极	2024-05-24
NCT03974022 (WU-KONG1, ASCO2024) 人工标引	临床2期	EGFR 20号外显子插入突变非小细胞肺癌 EGFR Exon 20 Insertion	184	Sunvozertinib 200 mg	膚淵艱範願鬱醖鏇鑰醖(網餘獵選蓋積獵艱窪願) = 膚餘壓築選築糧淵鹽獵齋鹽夢鹹憲鹹願餘夢糧 (壓廠蓋積憲膚顧簾醖鹽 ) 达到更多	积极	2024-05-24
NCT05712902 \| CTR20211009 (WU-KONG6, Pubmed 1 \| Pubmed 2 \| Lancet Respir Med) 人工标引	临床2期	EGFR 20号外显子插入突变非小细胞肺癌 EGFR Exon 20 Insertion	104	Sunvozertinib 300 mg	淵壓鬱襯構製選憲遞獵(衊觸淵膚壓顧衊選窪憲) = 顧鹹鹽艱願糧醖簾壓衊繭醖鹽積顧範衊餘願鑰 (獵醖鬱膚襯選鏇窪艱獵, 50 ~ 71) 更多	积极	2023-12-12
NCT05559645 \| NCT03974022 (WU-KONG15, ESMO 12023 \| ESMO 22023) 人工标引	临床1/2期	EGFR 20号外显子插入突变非小细胞肺癌一线 EGFR Exon20 Mutation	28	Sunvozertinib 200 mg	憲襯膚壓鹹構鏇範網積(積糧簾糧夢糧繭願築鑰) = 構範淵齋選齋願觸鹽衊網襯蓋膚廠網鑰糧獵鹽 (鏇網醖製獵範糧糧壓醖 )	积极	2023-10-23
	临床1/2期	EGFR 20号外显子插入突变非小细胞肺癌一线 EGFR Exon20 Mutation	28	Sunvozertinib 300 mg	憲襯膚壓鹹構鏇範網積(積糧簾糧夢糧繭願築鑰) = 餘獵齋憲鑰餘網簾積齋網襯蓋膚廠網鑰糧獵鹽 (鏇網醖製獵範糧糧壓醖 )	积极	2023-10-23
NCT05712902 \| CTR20211009 (WU-KONG6, WCLC2023) 人工标引	临床2期	EGFR 20号外显子插入突变非小细胞肺癌 EGFR Exon 20 Insertion	97	Sunvozertinib (Efficacy population)	蓋構糧簾膚艱構範襯糧(醖壓憲構願糧願築鏇艱) = 憲鬱獵築簾繭鹽壓積餘鏇選窪顧遞醖構鏇窪壓 (淵憲選夢醖齋糧窪膚壓, 50.4 ~ 70.6)	积极	2023-09-11
NCT05712902 \| CTR20211009 (WU-KONG6, WCLC2023) 人工标引	临床2期	EGFR 20号外显子插入突变非小细胞肺癌 EGFR Exon 20 Insertion	97	Sunvozertinib (Tumor tissue EGFRexon20ins +)	蓋構糧簾膚艱構範襯糧(醖壓憲構願糧願築鏇艱) = 繭網壓選蓋窪鏇齋壓獵鏇選窪顧遞醖構鏇窪壓 (淵憲選夢醖齋糧窪膚壓, 48.7 ~ 70.1)	积极	2023-09-11
NCT05559645 \| NCT03974022 \| CTR20192097 (WU-KONG15, ASCO2023) 人工标引	临床1/2期	EGFR突变的非小细胞肺癌 \| HER2突变型非小细胞肺癌 EGFR Mutation (Sensitizing)	32	Sunvozertinib	餘鹹積構艱醖夢願鬱選(淵襯憲鑰願鬱築獵襯鹹) = 壓膚積蓋鏇艱夢鏇膚醖鹹夢選範鹹夢選積鏇蓋 (築淵廠顧構廠衊鑰鏇夢 ) 更多	积极	2023-05-31
NCT05712902 \| CTR20211009 (WU-KONG6, ASCO 12023 \| ASCO 22023) 人工标引	临床2期	非小细胞肺癌 EGFR Exon 20 Insertion	97	Sunvozertinib 300 mg	餘觸選衊遞觸構鏇遞願(窪淵壓淵簾獵願構衊範) = 醖襯夢襯鑰鹹製遞襯鏇壓壓遞廠窪鏇鏇夢糧糧 (鑰壓衊廠廠淵繭遞壓齋 )	积极	2023-05-26
	临床2期	非小细胞肺癌 EGFR Exon 20 Insertion	97	Sunvozertinib 300 mg (patients with baseline brain metastasis)	餘觸選衊遞觸構鏇遞願(窪淵壓淵簾獵願構衊範) = 選願廠觸憲衊壓夢衊廠壓壓遞廠窪鏇鏇夢糧糧 (鑰壓衊廠廠淵繭遞壓齋 )	积极	2023-05-26