埃万妥单抗

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两款核心产品进入医保后销售放量 迪哲医药上半年营收增长74%
Mei Ri Jing Ji Xin Wen· 2025-08-23 20:27
每经记者|许立波 每经编辑|张海妮 其中,舒沃替尼主要针对EGFR二十号外显子插入突变的非小细胞肺癌患者。根据弗若斯特沙利文测算,预计 到2024年和2030年,全球的EGFR Exon20 ins的非小细胞肺癌新发患者人数将分别达到7.4万人和8.6万人,中国 新发患者人数将达到3.5万人和4.2万人。 8月22日晚间,迪哲医药(688192.SH,股价83.3元,市值382.69亿元)发布2025年半年度业绩报告。报告期 内,公司实现营业收入3.55亿元,同比增长74.40%。在医保赋能的推动下,旗下舒沃哲(舒沃替尼片)和高瑞 哲(戈利昔替尼胶囊)销售持续放量。报告期内归属于上市公司股东的净利润为-3.77亿元,去年同期数据 为-3.45亿元。 | 主要会计数据 | 本报告期 (1-6月) | 上年同期 | 本报告期比上年 同期增减(%) | | --- | --- | --- | --- | | 营业收入 | 355,001,420.82 | 203,550,120.00 | 74.40 | | 利润总额 | -378,990,328.00 | -432,296,836.34 | 不适用 | | 归属于 ...
医药生物行业周报:医保、商保初审名单公布,关注后续进展-20250818
Donghai Securities· 2025-08-18 09:04
Investment Rating - The report assigns an "Overweight" rating to the pharmaceutical and biotechnology industry, indicating that the industry index is expected to outperform the CSI 300 index by 10% or more over the next six months [2][34]. Core Insights - The pharmaceutical and biotechnology sector saw an overall increase of 3.08% from August 11 to August 15, 2025, ranking 10th among 31 industries and outperforming the CSI 300 index by 0.71 percentage points. Year-to-date, the sector has risen by 25.02%, ranking 4th among the industries and outperforming the CSI 300 index by 18.22 percentage points [4][14]. - The current PE valuation for the pharmaceutical and biotechnology sector is 31.31 times, which is at the historical median level, with a valuation premium of 145% compared to the CSI 300 index [4][20]. - Key sub-sectors that performed well include medical services, chemical pharmaceuticals, and medical devices, with respective increases of 6.60%, 3.80%, and 2.22% [4][13]. Market Performance - The pharmaceutical and biotechnology sector's performance for the week of August 11-15, 2025, showed a 3.08% increase, ranking 10th among 31 industries, and outperforming the CSI 300 index by 0.71 percentage points. Year-to-date, the sector has increased by 25.02%, ranking 4th among industries and outperforming the CSI 300 index by 18.22 percentage points [4][14]. - The top three performing sub-sectors were medical services, chemical pharmaceuticals, and medical devices, with increases of 6.60%, 3.80%, and 2.22% respectively [4][13]. Industry News - On August 12, 2025, the National Medical Insurance Administration announced the preliminary review list of drugs for the 2025 National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance Drug Directory, with 534 drugs passing the basic medical insurance review and 121 passing the commercial insurance review [5][28]. - On August 15, 2025, the National Medical Insurance Administration issued a temporary management method for disease-based payment, aimed at reforming the payment method primarily based on disease categories [5][29]. - On August 15, 2025, Novo Nordisk announced that the supplemental new drug application for semaglutide (Wegovy) was approved by the FDA for treating metabolic dysfunction-associated fatty liver disease (MASH) in patients with mid-to-late stage liver fibrosis [5][30]. Investment Recommendations - The report suggests that the pharmaceutical and biotechnology sector continues to strengthen after a slight adjustment, outperforming the broader market index. It recommends focusing on investment opportunities in innovative drugs, CXO, medical devices, traditional Chinese medicine, chain pharmacies, and medical services [6][31]. - Recommended stocks include Betta Pharmaceuticals, Teva Pharmaceutical, Kaili Medical, Anjies, and Huaxia Eye Hospital, while stocks to watch include Kelun Pharmaceutical, Qianhong Pharmaceutical, Haier Biomedical, Kangtai Biological, and Baipusais [6][31].
多款百万一针抗癌药,入围商保创新药目录初审名单
2 1 Shi Ji Jing Ji Bao Dao· 2025-08-13 07:24
Core Insights - The National Healthcare Security Administration (NHSA) announced the preliminary review results for the 2025 National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance drug catalog, revealing 534 drugs passed the review, with 121 drugs included in the commercial insurance innovative drug catalog [1][2] - This year marks the first implementation of a "dual-track system" for the drug catalog, focusing on basic insurance for essential drugs and providing supplementary coverage for "exclusive new drugs" or "rare disease medications" through commercial insurance [1][2] - The number of drugs passing the preliminary review has significantly increased compared to last year, with the number of drug names outside the catalog rising from 249 in 2024 to 310 [1] Drug Categories and Highlights - Over 98% of the drugs in the announced list are Western medicines, with only two traditional Chinese medicines included [3] - CAR-T therapies, which are at the forefront of cancer treatment, have gained attention, with several priced over 1 million yuan per injection, including products from Fosun Kite, Kintor Pharmaceutical, and Reindeer Biologics [1][2] - Notable entries in the list include innovative drugs from domestic companies, such as Shanghai Xinnian Pharmaceutical's hemophilia B gene therapy and Hengrui Medicine's PD-1 monoclonal antibody [3] Review and Approval Process - Passing the preliminary review does not guarantee inclusion in the basic medical insurance or commercial insurance innovative drug catalog, as further expert evaluations and price negotiations are required [3] - Approximately 80 drug varieties passed the preliminary review for both the basic medical insurance and commercial insurance catalogs, indicating potential for simultaneous negotiations [3]
多款百万一针抗癌药,入围商保创新药目录初审名单
21世纪经济报道· 2025-08-13 07:18
Core Insights - The article discusses the announcement by the National Medical Insurance Administration regarding the preliminary review of 534 drugs for the 2025 National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance drug catalog, along with 121 drugs included in the commercial insurance innovative drug catalog [1][2]. Group 1: Drug Catalog Adjustments - The 2025 drug catalog adjustments implement a "dual-track system," focusing on basic insurance for essential drugs while providing supplementary coverage for "exclusive new drugs" or "rare disease medications" through the commercial insurance innovative drug catalog [1][2]. - A total of 718 applications were received for the basic medical insurance catalog, with 534 approved, while 141 applications were received for the commercial insurance innovative drug catalog, with 121 approved [1][2]. Group 2: CAR-T Therapies - CAR-T therapies, which are personalized cancer treatments, have gained attention due to their high costs, with prices exceeding 1 million yuan per injection for several products [1][2]. - The article highlights that CAR-T therapies are among the first specialty drugs to be included in commercial insurance coverage, with various regions like Jiangsu and Shanghai incorporating them into their insurance plans [2]. Group 3: Drug Composition and Approval Process - The approved drugs are predominantly Western medicines, with over 98% of the list, and only two traditional Chinese medicines included [3]. - The approval of drugs through preliminary review does not guarantee inclusion in the basic medical insurance or commercial insurance catalogs, as further expert evaluations and price negotiations are required [3]. Group 4: Pricing and Negotiation - Approximately 80 drug varieties passed the preliminary review for both the basic medical insurance and commercial insurance catalogs, indicating potential for simultaneous negotiations [3]. - Drugs that exceed the basic insurance pricing limits may still qualify for the next evaluation stage, but their final inclusion depends on successful negotiations [3].
商保创新药目录药品初审名单公布,多款百万抗癌药在列
2 1 Shi Ji Jing Ji Bao Dao· 2025-08-13 05:43
Core Insights - The National Healthcare Security Administration (NHSA) announced the preliminary review results for the 2025 National Basic Medical Insurance, Maternity Insurance, and Work Injury Insurance drug catalog, revealing 534 drugs passed the review, with 121 drugs included in the commercial insurance innovative drug catalog [1][2] Group 1: Drug Catalog Adjustments - The 2025 adjustments mark the first implementation of a "dual-track system," focusing on basic insurance for essential drugs while providing supplementary coverage for "exclusive new drugs" or "rare disease medications" through the commercial insurance innovative drug catalog [1][2] - A total of 718 submissions were received for the basic insurance catalog, with 534 approved, while 141 submissions were made for the commercial insurance catalog, with 121 approved [1][2] - The number of drug names excluded from the catalog increased from 249 in 2024 to 310 [1] Group 2: CAR-T Therapies - CAR-T therapies, which are personalized cancer treatments, have gained attention due to their high costs, with prices exceeding 1 million yuan per injection for several products [1][2] - The commercial insurance catalog will include CAR-T therapies in upgraded coverage plans in various regions, with Shanghai's "Huibao" covering up to 500,000 yuan for patients [2] - Over the past three years, more than 80 lymphoma patients have received treatment through this channel, with total reimbursements exceeding 40 million yuan [2] Group 3: Drug Composition and Approval Process - The approved drugs are predominantly Western medicines, with over 98% representation, and only two traditional Chinese medicines included [3] - Notable cancer drugs include those from major pharmaceutical companies, alongside innovative domestic products like gene therapy for hemophilia B and PD-1 monoclonal antibodies [3] - Passing the preliminary review does not guarantee inclusion in the final catalog, as further expert evaluations and price negotiations are required [3][4] Group 4: Submission Conditions - Unique drugs meeting specific criteria can apply for both the commercial insurance innovative drug catalog and the basic catalog simultaneously [4]
医药生物行业投资策略周报:重视幽门螺杆菌疫苗胃癌防治的作用-20250811
CAITONG SECURITIES· 2025-08-11 14:30
Core Insights - Gastric cancer remains a significant global health issue, ranking fifth in cancer-related deaths according to GLOBOCAN 2022 data from the IARC, with a particularly heavy burden in Asia, Latin America, and parts of Africa [6][7] - Approximately 76% of gastric cancer cases globally are attributed to Helicobacter pylori infection, with higher attribution rates in specific regions, such as 82% in African women and 71% in Asian men [7][8] - The rising incidence of gastric cancer among individuals under 50 years old is concerning, potentially reversing previous trends of declining rates [6][7] - Implementing effective H. pylori screening and treatment strategies could reduce gastric cancer cases by up to 75% globally, highlighting the importance of developing and promoting H. pylori vaccines as a preventive measure [8][9] - The report suggests a positive outlook for innovative drug companies, particularly those with true innovation capabilities, and highlights potential investment opportunities in sectors such as CXO services and AI healthcare [9][10] Industry Overview - The pharmaceutical and biotechnology sector's TTM-PE ratio is currently at 50.25, representing a 106% increase from its historical low of 24.38 [11] - The sector's premium over the CSI 300 index is 278%, significantly higher than the historical average of 241% over the past decade [11] - The healthcare sector has experienced a decline of 0.84% in the past week, ranking last among 27 sub-industries [20][22] - Notable individual stock performances include Hai Chen Pharmaceutical with a 41.29% increase and Qi Zheng Tibetan Medicine with a 16.11% decrease [22][24] Industry Dynamics - Recent approvals in the industry include AstraZeneca's long-acting C5 complement inhibitor and the first biosimilar of dulaglutide for diabetes management [25][28] - The report emphasizes the ongoing trend of innovative drug approvals and the potential for significant market opportunities in the pharmaceutical sector [25][28][29]
医药生物行业周报(8月第2周):关注减肥药潜在BD机会-20250811
Century Securities· 2025-08-11 00:52
Investment Rating - The report indicates a focus on potential business development opportunities in the weight loss drug sector, suggesting a positive outlook for innovative drug companies in this area [1][2]. Core Insights - The pharmaceutical and biotechnology sector experienced a decline of 0.84% from August 4 to August 8, underperforming compared to the Wind All A index (1.94%) and the CSI 300 index (1.23%) [7][9]. - Notable sub-sectors that performed well include medical consumables (3.93%), in vitro diagnostics (2.55%), and medical devices (1.94%), while medical research outsourcing (-3.56%), chemical preparations (-2.04%), and traditional Chinese medicine (-1.88%) saw significant declines [8][10]. - The report highlights the competitive landscape in the weight loss drug pipeline, with Eli Lilly reaffirming the feasibility of oral GLP-1 drugs, while other multinational corporations (MNCs) may seek external products to enhance competitiveness [2][12]. - The report also discusses the initiative by seven government departments to promote innovation in the brain-computer interface industry, aiming for breakthroughs in key technologies by 2027 [2][12]. Summary by Sections Market Weekly Review - The pharmaceutical and biotechnology sector saw a decline of 0.84% during the week, with significant internal rotation and underperformance compared to broader indices [7][9]. - Medical consumables, in vitro diagnostics, and medical devices were the top-performing sub-sectors, while medical research outsourcing and chemical preparations faced the largest declines [8][10]. Industry News and Key Company Announcements - The report notes several key industry events, including the approval of a biosimilar drug by Boan Biotech and the joint initiative by multiple government departments to foster the brain-computer interface industry [11][12]. - Significant company announcements include the approval of new indications for existing drugs and the launch of new products, indicating ongoing innovation within the sector [15][16].
强生(JNJ.US)宣布EGFR/c-MET双抗“埃万妥单抗”在国内获批一项新适应症
智通财经网· 2025-08-08 13:24
Core Viewpoint - Johnson & Johnson's Amivantamab has received approval for a new indication in China for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations [1][2] Group 1: Drug Approval Details - Amivantamab is now approved in combination with Lenzatinib for first-line treatment of NSCLC patients with EGFR 19 exon deletions or L858R mutations [1] - This marks the third indication for Amivantamab in China, following its initial approval for EGFRex20ins mutation NSCLC in February 2025 and a subsequent approval for use with chemotherapy in April 2025 [2] Group 2: Global Approval History - Amivantamab was first granted accelerated approval in the United States in May 2021 [2] - To date, Amivantamab has received a total of four indications globally for the treatment of non-small cell lung cancer [2]
医药生物行业双周报2025 年第16 期总第139期:上半年中国创新药BD交易总额突破600亿美元,关注真创新平台化国际化企业-20250805
Great Wall Glory Securities· 2025-08-05 08:47
Investment Rating - The investment rating for the pharmaceutical and biotechnology industry is "Positive" and the rating has been maintained [2] Core Insights - The pharmaceutical and biotechnology industry index increased by 4.90%, ranking third among 31 primary industries, outperforming the CSI 300 index, which decreased by 0.09% [4][15] - The sub-industries of medical research outsourcing and vaccines saw significant gains of 12.70% and 6.59%, respectively, while blood products and offline pharmacies lagged with increases of only 0.35% and 2.41% [4][15] - As of August 1, 2025, the overall PE (TTM) for the pharmaceutical and biotechnology industry was 30.97x, up from 30.09x in the previous period, indicating an upward valuation trend [4][21] - The top three sub-industries by PE (TTM) are vaccines (62.06x), hospitals (38.94x), and other biological products (38.44x), while the lowest valuation is in pharmaceutical circulation (16.12x) [4][21] Industry Review - The National Medical Products Administration (NMPA) is seeking public opinion on the "Regulations on the Filing Management of Internet Drug and Medical Device Information Services" [6] - The State Council's news office held a press conference discussing multiple measures for drug price management [6] - Bristol-Myers Squibb's "Nivolumab Injection" combined with "Ipilimumab Injection" received NMPA approval, marking it as China's first approved dual immune therapy for lung cancer [6] - The total transaction amount for innovative drug BD in China exceeded 60 billion USD in the first half of 2025, indicating a significant market shift towards platform-based pipeline output [7] Investment Recommendations - The National Healthcare Security Administration (NHSA) has clarified a "reverse inward competition" direction in the 11th batch of centralized procurement, promoting a shift from price competition to a quality-first and reasonably priced ecosystem [7] - The report suggests focusing on companies with "true innovation" capabilities, strong barriers (complex formulations/high-end device domestic replacements), platform-based operations, and internationalization [7]
双抗巨变的时代已经来临?
Ge Long Hui· 2025-07-26 20:38
Core Insights - The dual antibody (dual-target) market is experiencing explosive growth in 2023, with major multinational corporations (MNCs) like Roche and Johnson & Johnson leading the charge [1][17] - Roche has successfully launched several dual antibodies in the Chinese market, including Glofitamab and Faricimab, while Johnson & Johnson's Amivantamab targets a $5 billion market in non-small cell lung cancer (NSCLC) [2][13] Group 1: Dual Antibodies in Hematological Malignancies - The dual antibody market began in 2014 with the FDA's accelerated approval of Blincyto for treating acute lymphoblastic leukemia, which generated $583 million in sales in 2022 [5] - Currently, most approved dual antibodies are focused on hematological malignancies, with a significant number targeting CD3 in various combinations [6][8] - The competition between dual antibodies and CAR-T therapies is intensifying, particularly in the CD3/CD20 target combination, which has over 10 candidates in development globally [8][9] Group 2: Broadening Applications in Solid Tumors - Dual antibodies are expanding into various indications, including genetic diseases and solid tumors, with significant potential in the latter [11] - Amivantamab, the first dual antibody approved for solid tumors, is projected to reach peak sales of $5 billion, supported by positive clinical data [13][15] - Roche's Faricimab has also made strides in ophthalmology, achieving $1.788 billion in sales in the first three quarters of 2023 due to its long-lasting efficacy [15] Group 3: Domestic Dual Antibody Development - The domestic dual antibody market is expected to enter a concentrated harvest period in 3-5 years, with over 20 candidates currently in development [18] - Domestic companies are increasingly pursuing international collaborations, with notable deals exceeding $1 billion in potential total transaction value [19] - The first domestic dual antibody, Kadofili monoclonal antibody, was approved in 2022, generating significant revenue and expanding its indications [21][22]