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中国生物制药“得福组合”击败K药、替雷利珠单抗 国产创新药也成“头对头”挑战对象
Mei Ri Jing Ji Xin Wen· 2025-06-02 08:42
Core Insights - A new Chinese innovative drug combination, "Defu Combination," has outperformed the global leader, Pembrolizumab (K drug), in treating PD-L1 positive advanced non-small cell lung cancer (NSCLC) [2][3] - The results were presented at the 2025 American Society of Clinical Oncology (ASCO) annual meeting, showcasing significant improvements in median progression-free survival (PFS) [2][4] Company Insights - China National Pharmaceutical Group (HK01177) reported that the "Defu Combination" achieved a median PFS of 11 months, surpassing K drug by 3.9 months, with a 30% reduction in the risk of disease progression or death [4] - The "Defu Combination" consists of two first-class innovative drugs: Anlotinib, a multi-targeted anti-angiogenic TKI approved in May 2018, and Bemarituzumab, a PD-L1 monoclonal antibody approved in May 2024 [3][4] Industry Insights - The CAMPASS study, a randomized controlled phase III trial, included 531 PD-L1 positive patients and demonstrated that the "Defu Combination" significantly benefits nearly all subgroups, especially those with high PD-L1 expression (TPS≥50%) [3][4] - The trend of increasing head-to-head clinical trials in China is notable, with domestic companies challenging established drugs like K drug, indicating a competitive landscape for innovative therapies [5][6] - The number of head-to-head trials initiated by domestic companies has risen from 2 in 2020 to 8 in 2023, reflecting a growing commitment to developing competitive treatments [6]
中国生物制药(01177.HK):TQB2868“PD-1/TGF-β双功能融合蛋白”II期研究数据在2025年ASCO年会公布
Ge Long Hui· 2025-05-29 12:30
Core Viewpoint - China Biologic Products (01177.HK) announced preliminary data from a Phase II clinical study of TQB2868, a PD-1/TGF-β dual-function fusion protein, in combination with Anlotinib and AG chemotherapy for first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC) at the 2025 ASCO annual meeting [1][2] Group 1: Clinical Study Results - The TQB2868-ALTN-II-01 study evaluated the efficacy and safety of TQB2868 combined with Anlotinib and AG chemotherapy (Gemcitabine + Albumin-bound Paclitaxel) in mPDAC patients [1] - As of January 2025, 40 patients with stage IV mPDAC were enrolled, with 36 being evaluable; the objective response rate (ORR) was 63.9%, significantly higher than the historical data for AG chemotherapy (23%-36%) [1] - The disease control rate (DCR) reached 100%, compared to 62.3% for AG chemotherapy, and the 6-month progression-free survival (PFS) rate was 86%, double that of AG chemotherapy (43.2%) [1] - The median overall survival (OS) has not yet been reached, but it is expected to exceed one year [1] Group 2: Safety Profile - The safety profile of the TQB2868 combination therapy was favorable, with a rate of grade 3 or higher adverse reactions at 52.5%, lower than the 68.1%-77% range reported for AG chemotherapy [1] Group 3: Future Developments - The company is in communication with the Chinese National Medical Products Administration (NMPA) regarding the registration of a Phase III clinical trial for the TQB2868 combination therapy [2] - This combination therapy is anticipated to become the first-line treatment for pancreatic cancer using immune checkpoint inhibitors, potentially leading to significant improvements in overall survival and quality of life for patients [2]
中国生物制药:TQB2868联合方案在胰腺癌治疗中展现突破性疗效
news flash· 2025-05-29 12:22
Core Viewpoint - The company announced preliminary data from a Phase II clinical study of TQB2868, a PD-1/TGF-β dual-function fusion protein, in combination with Anlotinib and chemotherapy for first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC) at the 2025 ASCO annual meeting [1] Group 1: Clinical Study Results - The study has enrolled 40 patients with stage IV mPDAC, with 36 patients being evaluable as of January 2025 [1] - The objective response rate (ORR) for TQB2868 combined with Anlotinib and AG chemotherapy reached 63.9%, which is 2-3 times higher than historical data for AG chemotherapy [1] - The disease control rate (DCR) was 100%, 1.6 times higher than that of AG chemotherapy [1] - The median progression-free survival (PFS) has not yet been reached, but the 6-month PFS rate is 86%, which is double that of AG chemotherapy [1] - The median overall survival (OS) has not yet been reached, but it is expected to exceed one year [1] Group 2: Safety Profile - The combination therapy demonstrated good safety and tolerability, with a rate of grade 3 or higher adverse reactions at 52.5% [1] - The company is in communication with the Center for Drug Evaluation (CDE) of the National Medical Products Administration regarding the registration of a Phase III clinical trial for the TQB2868 combination therapy [1]
中国生物制药(01177.HK):TQB2102"HER2双抗ADC"I期研究数据在2025年ASCO年会公布
Ge Long Hui· 2025-05-27 09:44
Core Insights - China Biologic Products (01177.HK) announced preliminary data from the first human Phase I clinical study of TQB2102, a HER2 bispecific antibody-drug conjugate (ADC), presented at the 2025 American Society of Clinical Oncology (ASCO) annual meeting [1] Efficacy Summary - The trial included 181 patients with advanced solid tumors who had no standard treatment options as of October 1, 2024, including both HER2-positive and HER2 low-expressing patients [1] - In terms of efficacy, the objective response rate (ORR) for HER2-positive breast cancer in the 6mg/kg and above dose group was 51.3%, while for HER2 low-expressing breast cancer, the ORR was 51.5% [1] - The ORR for HER2 high-expressing (HER2 IHC 3+) colorectal cancer was 34.8%, and for HER2-positive gastric or gastroesophageal junction adenocarcinoma, the ORR was 70% [1] - Among the subgroup of HER2-positive breast cancer patients with brain metastases, the ORR was 70%, with one case achieving complete resolution of intracranial lesions [1] - 31% of breast cancer patients who were resistant to T-DM1/DS-8201 still responded to TQB2102 treatment [1] Safety Summary - In terms of safety, the main ≥3 grade adverse events (AE) in the overall population included neutropenia (21.7%), decreased white blood cell count (10.6%), anemia (8.9%), and decreased platelet count (6.1%) [2] - Notably, only one case (0.55%) of grade 2 interstitial lung disease (ILD) was reported, which is significantly lower than the incidence seen with similar drug DS-8201 (greater than 10%) [2] - TQB2102 has shown significant clinical benefits across multiple advanced malignancies while maintaining a low incidence of ILD, achieving a balance between efficacy and safety [2] - Currently, TQB2102 is undergoing Phase III clinical trials and has the potential to reshape the treatment landscape for HER2 ADCs [2]
中国生物制药:贝莫苏拜单抗联合安罗替尼一线治疗鳞状非小细胞肺癌III期研究数据在2025年ASCO年会公布
Zhi Tong Cai Jing· 2025-05-23 08:53
Core Viewpoint - China Biologic Products (01177) announced positive results from a Phase III clinical trial comparing Bemesumab injection combined with chemotherapy and Anlotinib hydrochloride capsules against Tislelizumab injection combined with chemotherapy for first-line treatment of advanced squamous non-small cell lung cancer (sq-NSCLC) [1][2] Group 1: Clinical Trial Results - The trial involved 565 patients randomly assigned to treatment and control groups, showing a median progression-free survival (mPFS) of 10.12 months for the trial group compared to 7.79 months for the control group, resulting in a 36% reduction in disease progression risk [2] - The objective response rates (ORR) were 71.9% for the trial group and 65.1% for the control group, with a median duration of response (DoR) of 9.69 months versus 8.34 months, indicating a significant improvement in the trial group [2] - Subgroup analysis revealed benefits across nearly all subgroups, particularly in the PD-L1 expression 1-49% population, with a hazard ratio (HR) of 0.47 [2] Group 2: Clinical Significance - The study addresses unmet clinical needs, as lung cancer has the highest incidence and mortality rates globally, with sq-NSCLC accounting for approximately 30% of all NSCLC cases [3] - The innovative treatment regimen may change existing treatment paradigms for advanced sq-NSCLC patients, who have limited options due to low mutation rates for targeted therapies [3] - The company aims to leverage its innovation and commercialization capabilities to accelerate the global market entry of this product, benefiting more patients [3]
中国生物制药12项临床研究入选ASCO“口头报告” “得福组合”头对头击败对比药物
Zhong Zheng Wang· 2025-05-23 04:04
Group 1 - The core finding of the ASCO annual meeting is the announcement of the phase III clinical trial data for the "Defu Combination" (Bemarituzumab + Anlotinib) as a first-line treatment for locally advanced or metastatic squamous non-small cell lung cancer (sq-NSCLC), showing a median progression-free survival (PFS) of 10.12 months, outperforming the comparative drug [1] - This study represents the first positive phase III clinical research result comparing immune checkpoint (PD-1) inhibitors combined with chemotherapy for the first-line treatment of squamous non-small cell lung cancer [1] - The innovative clinical trial design involved sequential treatment with Bemarituzumab combined with chemotherapy followed by Bemarituzumab combined with Anlotinib, breaking through traditional treatment standards [1] Group 2 - Based on the clinical research results, the company has submitted a new indication application for the "Defu Combination," which was accepted by the National Medical Products Administration (NMPA) on April 22 [2] - Anlotinib has already been approved for 8 indications, with 5 more in the NDA stage, while the "Defu Combination" has received approval for 3 indications and has 3 more in the new drug application stage [2] - The ASCO annual meeting is a highly regarded event in the clinical oncology field, serving as an industry benchmark, with over 70 original research projects from Chinese researchers selected for oral presentations this year, including many "First in Class" and "Best in Class" studies [2]
启明创投邝子平:5年从0到30% 中国生物制药成为全球License-out新高地
Xin Lang Cai Jing· 2025-05-19 07:09
Core Viewpoint - The 2025 Global Investor Conference emphasizes the new productive forces in China and the investment opportunities in Shenzhen's open innovation market, particularly in the biopharmaceutical sector and technology advancements [1][4]. Biopharmaceutical Industry - China's biopharmaceutical sector is rapidly advancing, producing world-class products at lower costs. By 2024, 30% of global big pharma's License-in deals will come from Chinese biotech startups, a significant increase from 0% in 2019 [1][7]. - The shift from being a License-in country to a License-out origin indicates China's growing influence in the global pharmaceutical landscape [7]. Technology and AI Development - The emergence of DeepSeek, a leading AI company, showcases China's capabilities in AI, with its models achieving results comparable to international counterparts at a fraction of the cost [5][6]. - The global perception of China's AI capabilities has shifted, with reports indicating that the gap between Chinese and leading international AI technologies has narrowed to just a few months [6]. Globalization of Chinese Tech Companies - Chinese tech companies are increasingly expanding their international presence, with notable examples including BYD, CATL, ByteDance, Alibaba, and Xiaomi, all showing rising overseas revenue proportions [8][9]. - Smaller tech firms, such as Stone Technology and Insta360, are also achieving significant global market shares, demonstrating the competitive strength of Chinese innovation [10]. Investment Opportunities - The venture capital industry in China plays a crucial role in supporting technological innovation, with a focus on sectors like AI, advanced manufacturing, healthcare, and renewable energy [11][12]. - The potential for investment in Chinese technology is underscored by the fact that six out of seven companies founded after 2010 that have reached a market value of over $100 billion are from China [12]. Future Growth Areas - Key areas for future investment include artificial intelligence, biopharmaceuticals, and renewable energy, driven by demographic changes and technological advancements [13]. - The expectation is that by 2025, AI will significantly empower various industries, creating substantial investment opportunities [13].
京东健康与中国生物制药达成战略合作 全网首发新药德瑞妥®和得舒平®
Zheng Quan Ri Bao Wang· 2025-05-07 13:48
Core Insights - JD Health and China National Pharmaceutical Group have signed a strategic cooperation agreement to enhance the accessibility of quality medical resources and promote health technology [1][2] - The partnership aims to launch innovative pharmaceutical products, including the first domestically approved tolvaptan patch and a sodium loxoprofen gel patch, through JD Health's online channels [1][2] Group 1: Strategic Partnership - JD Health and China National Pharmaceutical Group will collaborate in disease knowledge dissemination and new product launches [1] - The partnership is expected to leverage JD Health's online platform to improve public access to healthcare services [1][2] Group 2: Product Launches - JD Health will exclusively distribute the 2mg tolvaptan patch online, which is designed to alleviate symptoms of bronchial asthma and other obstructive airway diseases [1] - Another product, sodium loxoprofen gel patch, is the first in China to complete phase III clinical trials and is aimed at treating inflammation and pain from osteoarthritis and muscle injuries [1] Group 3: Market Trends - JD Health is positioned as the leading online health consumption platform, with e-commerce channels projected to account for 12.9% of the pharmaceutical retail market by 2024 [2] - The company employs a comprehensive "B2C + O2O + offline store" model to integrate supply chain, logistics, and medical resources effectively [2] Group 4: Future Collaboration - The partnership will expand to cover various disease areas, including oncology, rheumatology, and cardiovascular health, utilizing JD Health's internet hospital resources [2] - Both companies aim to transform authoritative medical knowledge into accessible content for the public, enhancing health education and chronic disease management [2]
中国生物制药与京东健康深化战略合作,借数字医疗打破信息壁垒
Bei Ke Cai Jing· 2025-05-07 08:43
Group 1 - The core viewpoint of the articles is the strategic partnership between China National Pharmaceutical Group and JD Health, aimed at enhancing the supply chain, retail channels, and innovative marketing models in the pharmaceutical sector [1][2] - The collaboration is seen as a key initiative to bridge the "last mile" in drug accessibility, leveraging digital healthcare to eliminate information barriers and geographical limitations, allowing patients to access quality medications more quickly [1] - The partnership will expand to cover various disease areas including oncology, rheumatology, surgery/pain management, liver disease, respiratory, cardiovascular, and endocrine disorders, utilizing resources from JD Health's internet hospital and expert doctors [1] Group 2 - China National Pharmaceutical Group launched two new products: Loxoprofen Sodium Gel Patch (brand name: Deshu Ping) and Torasemide Patch (brand name: Deruituo), with over 70 innovative drugs currently in development and plans to launch more than 50 innovative drugs in the next decade [2] - The collaboration will focus on three strategic directions: creating a "drug zone for all treatment areas," establishing an "innovative drug digital incubation platform," and innovating a comprehensive health management model that shifts from "passive treatment" to "proactive health management" [2] - The aim is to enhance patient health levels through a patient-centered service model, integrating medical education, medication guidance, and patient recruitment systems [2]
中国生物制药(01177) - 2024 - 年度财报
2025-04-29 09:43
Company Performance - The company reported a strong performance with a continuous presence in the top 50 global pharmaceutical companies for six consecutive years from 2019 to 2024[19]. - The company has been recognized as one of the top 50 best companies in Asia-Pacific by Forbes for three consecutive years from 2016 to 2018[16]. - The company recorded revenue of approximately RMB 28,866.16 million, representing a year-on-year growth of about 10.2% compared to RMB 26,199.41 million in the previous year[73]. - Gross profit was approximately RMB 23,529.94 million, an increase of about 10.9% from RMB 21,209.53 million in the previous year[73]. - Profit attributable to equity holders of the parent company was approximately RMB 3,499.83 million, reflecting a significant year-on-year increase of about 50.1%[74]. Financial Highlights - Total revenue for 2024 reached RMB 28,866,159 thousand, a 10.1% increase from RMB 26,199,409 thousand in 2023[26]. - Gross profit for 2024 was RMB 23,529,941 thousand, up from RMB 21,209,532 thousand in 2023, reflecting a gross margin improvement[26]. - Operating profit for 2024 was RMB 5,739,924 thousand, showing a significant increase compared to RMB 4,209,634 thousand in 2023[29]. - The company reported a net profit of RMB 6,364,682 thousand for 2024, compared to RMB 5,097,398 thousand in 2023, marking a 24.9% year-over-year growth[26]. - The total assets of the company reached RMB 65,408,069 thousand in 2024, up from RMB 63,604,819 thousand in 2023[26]. Research and Development - Research and development expenses for 2024 amounted to RMB 5,089,203 thousand, an increase from RMB 4,402,973 thousand in 2023, indicating a focus on innovation[26]. - The company has established multiple R&D centers recognized by Jiangsu Province, focusing on oncology and other therapeutic areas[12]. - The company is actively involved in expanding its market presence and enhancing its product offerings through strategic R&D initiatives[11]. - The company has 70 innovative drugs in development, including 39 for oncology, 7 for liver diseases, 13 for respiratory diseases, and 6 for surgical/pain relief[102]. Product Portfolio and Innovations - The company has a diverse product portfolio, including various biopharmaceuticals and chemical drugs, with a strong market position in oncology, liver disease, respiratory, and surgical/pain relief[11]. - The company plans to launch new innovative products within the next five years, focusing on original innovation rather than imitation[38]. - The company received approval for 6 innovative products from the NMPA, including 4 Class 1 innovative drugs, achieving a revenue of RMB 12.06 billion from innovative products in 2024, a year-on-year increase of 21.9%[46]. - Revenue from new products launched within the last 5 years reached RMB 10.09 billion in 2024, reflecting a year-on-year growth of 25.4%[46]. Market and Strategic Initiatives - The company aims to become a leading global pharmaceutical enterprise, emphasizing innovation and patient service[11]. - The government has implemented policies to encourage pharmaceutical innovation, which is expected to positively impact the company's growth trajectory[44]. - The company is actively pursuing multiple indications for Gosorese, aiming to establish it as a key product in the oncology field[50]. - The company is focusing on clinical research to provide more academic evidence for the clinical use of its products[56]. Corporate Governance and Management - The board of directors focuses on overall corporate strategy and financial performance, emphasizing sustainable development[123]. - The company has established various committees, including an executive committee and an audit committee, to enhance board efficiency and oversight[125]. - The company emphasizes compliance with legal and regulatory requirements in its governance practices[133]. - The company has adopted a code of conduct for securities trading by directors and senior management, ensuring compliance with the standards set forth in the Listing Rules[162]. ESG and Sustainability - The company received an MSCI ESG rating of A for two consecutive years and improved its S&P CSA score to the top 4% in the global pharmaceutical industry[121]. - The company has implemented a carbon neutrality goal and pathway plan, with annual sustainable energy usage continuously increasing and carbon emission density decreasing[117]. - The company invested a total of RMB 60.11 million in community initiatives, with community service hours totaling 3,213 hours during the year[120]. - The company achieved a 96% pass rate in supplier ESG management self-assessments, identifying 13 key risks and achieving a 100% improvement plan formulation rate[120].