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丽珠集团:莱康奇塔单抗银屑病适应症预计最快年底获批
2 1 Shi Ji Jing Ji Bao Dao· 2026-01-22 01:25
Core Viewpoint - The company, Lizhu Group, has announced that its core product, Lakanqita monoclonal antibody, has outperformed Secukinumab in the primary endpoint of a Phase III head-to-head clinical trial for moderate to severe psoriasis, with a PASI 100 response rate at week 12 [1] Group 1 - The product is the first IL-17A/F dual-target inhibitor in China, offering advantages such as less frequent dosing, convenient administration, and excellent safety profile [1] - The company has submitted for market approval and has been included in the CDE's priority review, with the earliest expected approval by the end of 2026 [1] - Cost competitive barriers have been established through the localization of raw materials and process optimization, laying a foundation for future market access and commercialization [1]
健康元药业集团股份有限公司 关于莱康奇塔单抗注射液上市许可申请获受理的提示性公告
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-12-25 01:14
Drug Information - The drug "Lai Kang Qi Ta" monoclonal antibody injection has received acceptance for domestic production registration from the National Medical Products Administration (NMPA) [1] - It is classified as a Class 1 therapeutic biological product and is intended for adult patients with moderate to severe plaque psoriasis suitable for systemic therapy or phototherapy [1] - The drug is a self-developed innovative IL-17A/F dual-target inhibitor, which is the first of its kind in China and the second globally [1][2] Clinical Development - A clinical trial for the drug is set to achieve primary and secondary efficacy endpoints by July 2025, demonstrating superior efficacy compared to the control group [1] - The trial results indicate faster onset, better short-term efficacy, long-lasting effects, and less frequent dosing compared to the control drug [1] - The cumulative R&D investment for the drug is approximately RMB 204.03 million [2] Market Situation - As of the announcement date, there are no approved products in China for psoriasis indications targeting the IL-17A/F dual-target [3] - There are three imported and two domestic products approved for IL-17A and IL-17RA single-target indications [3] - The estimated domestic terminal sales for IL-17A and IL-17RA single-target drugs in 2024 is RMB 2.833 billion [3]
丽珠医药莱康奇塔单抗申报上市 用于治疗斑块状银屑病
智通财经网· 2025-12-24 06:11
Core Viewpoint - Lijun Pharmaceutical and Xinkanghe Biotech have submitted an application for the market approval of Lakanqita Monoclonal Antibody (LZM012/XKH004) for the treatment of plaque psoriasis [2] Group 1: Product Development - Lakanqita Monoclonal Antibody is an IL-17A/IL-17F monoclonal antibody that targets both homodimer IL-17A-A and IL-17F-F, as well as heterodimer IL-17A-F [4] - Lijun Pharmaceutical's subsidiary, Lijun Monoclonal Antibody, has exclusive rights for the global development, registration, production, sales, and sublicensing of this product [4] Group 2: Clinical Trial Results - In July, Lijun Pharmaceutical announced that Lakanqita Monoclonal Antibody (320mg, once every 4 weeks) met the primary endpoint in a Phase III clinical trial compared to Secukinumab (300mg, once every 4 weeks) for moderate to severe plaque psoriasis patients with or without psoriatic arthritis [4] - At week 12 of treatment, the proportion of patients achieving PASI 100 in the Lakanqita group was 49.5%, compared to 40.2% in the Secukinumab group, meeting both non-inferiority and superiority standards [4] - The overall safety profile of Lakanqita Monoclonal Antibody was good, with the incidence of common adverse events comparable to that of the control group [4]
丽珠医药(01513)莱康奇塔单抗申报上市 用于治疗斑块状银屑病
智通财经网· 2025-12-24 06:09
Core Viewpoint - Lijun Pharmaceutical and Xinkanghe Biotech have submitted an application for the market approval of Lakanqita monoclonal antibody (LZM012/XKH004) for the treatment of plaque psoriasis [1] Group 1: Product Development - Lakanqita monoclonal antibody is an IL-17A/IL-17F monoclonal antibody that targets both homodimer IL-17A-A and IL-17F-F, as well as heterodimer IL-17A-F [2] - Lijun Pharmaceutical's subsidiary, Lijun Monoclonal Antibody, has obtained exclusive rights for the global development, registration, production, sales, and sublicensing of this product [2] Group 2: Clinical Trials - In July, Lijun Pharmaceutical announced that Lakanqita monoclonal antibody (320mg, once every 4 weeks) met the primary endpoint in a Phase III clinical trial compared to Secukinumab (300mg, once every 4 weeks) for moderate to severe plaque psoriasis patients with or without psoriatic arthritis [3] - At week 12 of treatment, the proportion of patients achieving PASI 100 in the Lakanqita group was 49.5%, compared to 40.2% in the Secukinumab group, meeting both non-inferiority and superiority standards [3] - The overall safety profile of Lakanqita monoclonal antibody was good, with the incidence of common adverse events comparable to that of the control group [3]
烧钱23年却无产品上市 和美药业赴港IPO求生
Bei Jing Shang Bao· 2025-12-03 16:01
Core Viewpoint - He Mei Pharmaceutical is urgently seeking an IPO after 23 years of product development, with its first drug Mufemilast recently approved, amidst a highly competitive market for psoriasis treatments [1][4]. Company Overview - Founded in 2002, He Mei Pharmaceutical has raised over 1.2 billion yuan and incurred losses exceeding 1.1 billion yuan, achieving a valuation of 3.9 billion yuan without any products on the market [1][3]. - The company has been in a continuous state of high cash burn, with significant R&D expenditures primarily focused on Mufemilast, which has taken over 16 years to develop [2][3]. Product Development - Mufemilast's development timeline began in 2009, with clinical trials starting in 2012, and it received approval for treating moderate to severe plaque psoriasis in September 2025 [2]. - The R&D costs for Mufemilast accounted for 60% of the total R&D expenses from 2023 to mid-2025, reflecting the heavy investment required for its development [2]. Market Competition - The psoriasis drug market in China is highly competitive, with 18 approved targeted therapies, including 5 small molecules and 13 biologics, leading to a fierce price war [4][5]. - Major competitors include established products from international pharmaceutical giants, which have already captured significant market shares [4][5]. Pricing Strategy - He Mei Pharmaceutical plans to set Mufemilast's initial annual treatment cost between 52,700 and 119,900 yuan, positioning it above some small molecule competitors but below the price of leading biologics [7]. - The relatively high pricing strategy may hinder Mufemilast's competitiveness, especially among price-sensitive patients requiring long-term treatment [7][8]. Commercialization Challenges - The commercialization of Mufemilast is expected to be slow due to the nature of psoriasis as a chronic disease, which requires extensive academic promotion and trust-building among healthcare professionals [8]. - Even if Mufemilast successfully launches, it may not generate significant revenue quickly enough to offset the company's ongoing losses [8].
烧钱23年零产品,和美药业赴港IPO求生
Bei Jing Shang Bao· 2025-12-03 11:56
Core Viewpoint - He Mei Pharmaceutical is urgently seeking an IPO after 23 years of product development, with its first drug Mufemilast recently approved, amidst a highly competitive market for psoriasis treatments [1][6]. Company Overview - Founded in 2002, He Mei Pharmaceutical has raised over 1.2 billion RMB and incurred losses exceeding 1.1 billion RMB, achieving a valuation of 3.9 billion RMB despite having no products on the market [1][5]. - The company has been heavily reliant on external financing, completing six rounds of funding from 2021 to the end of 2024, with a post-investment valuation reaching 3.9 billion RMB after the E round [5]. Product Development - The development of Mufemilast has taken 16 years, starting from preclinical research in 2009 to receiving approval for treating moderate to severe plaque psoriasis in September 2025 [3]. - Research and development expenses for Mufemilast accounted for 60% of the total R&D costs, with losses reported at 156.4 million RMB for 2023 and projected losses of 123.4 million RMB for 2024 [3][4]. Market Competition - The psoriasis drug market in China is projected to grow from 18.2 billion RMB in 2024 to 48.3 billion RMB by 2028, with 18 approved targeted therapies already available, including 13 biologics [6][7]. - He Mei Pharmaceutical faces intense competition from established players like Novartis and Eli Lilly, which have already captured significant market shares with their products [6][7]. Pricing Strategy - He Mei Pharmaceutical plans to price Mufemilast between 52,700 RMB and 119,900 RMB annually, positioning it above some small molecule competitors but below the price of established biologics [8]. - The higher pricing strategy may hinder Mufemilast's competitiveness in a market where patients are sensitive to treatment costs, especially for chronic conditions requiring long-term medication [8][9]. Commercialization Challenges - The commercialization of Mufemilast is expected to be slow due to the need for long-term academic promotion and building trust among healthcare professionals [9]. - Even with successful market entry, Mufemilast is unlikely to generate significant revenue quickly, making it difficult for He Mei Pharmaceutical to reverse its overall loss situation [9].
第三季度亏损大幅收窄 智翔金泰业绩回暖待盈利
Xin Lang Cai Jing· 2025-11-28 11:29
Core Viewpoint - The company Zhixiang Jintai (688443.SH) is gaining attention as it progresses towards commercializing its core product, the Sairiqi monoclonal antibody injection, despite its initial poor stock performance and ongoing losses. Investors are keen to understand when the company will achieve profitability as it moves into a phase of revenue realization [1][4]. Financial Performance - In the third quarter, Zhixiang Jintai reported a revenue of 162.16 million yuan, a year-on-year increase of 1199.88%, while the net profit attributable to shareholders was a loss of 53.28 million yuan, significantly narrowing from a loss of 187 million yuan in the same period last year [3][4]. - For the first three quarters, the company achieved a total revenue of 208 million yuan, reflecting a year-on-year increase of 1562.05%, with the net loss narrowing from 550 million yuan to 370 million yuan, a reduction of 32.73% [4]. Product Development and Market Position - Zhixiang Jintai focuses on the development of monoclonal and bispecific antibodies for autoimmune, infectious diseases, and oncology. Currently, only one product has been approved for sale, and the company has incurred a cumulative net loss of 2.869 billion yuan from 2020 to 2024 [5][7]. - The Sairiqi monoclonal antibody injection has been approved for two indications and is expected to contribute significantly to revenue, having generated 45.38 million yuan in sales in the first half of the year [7][8]. - The company is facing competition from multiple IL-17A targeted drugs, including Novartis's Secukinumab, which has established a strong market presence with sales reaching 2.08 billion yuan in 2022 and increasing to 2.75 billion yuan in 2023 [8][9]. Research and Development - Zhixiang Jintai has over ten products in its research pipeline, with three currently under review for approval. The company has invested heavily in R&D, with expenditures of 4.54 billion yuan, 6.20 billion yuan, and 6.10 billion yuan over the last three years, totaling 16.85 billion yuan [10][11]. - Recent collaborations have provided short-term financial relief, including a partnership with Cullinan Therapeutics that brought in a $20 million upfront payment and potential milestone payments totaling $692 million [12][13]. Future Outlook - The company aims to enhance its product pipeline and market presence through innovative drug discovery technologies and expanding its therapeutic targets. However, long-term sustainability will depend on the success of its proprietary products in generating consistent revenue [13].
国信证券晨会纪要-20251128
Guoxin Securities· 2025-11-28 01:30
Group 1: AI Empowerment in Asset Allocation - The report discusses the performance of three representative AI asset management products: AIEQ, ProPicks, and QRFT, evaluating whether AI can provide excess returns to investors [8] - AIEQ, an actively managed ETF, has underperformed SPY due to high market sentiment volatility and cost erosion from high turnover rates [8] - ProPicks has shown strong returns during favorable tech periods but is highly sensitive to execution discipline and slippage, making actual replication challenging [8] - QRFT has closely tracked the S&P 500 over the long term, showing significant phase differentiation, indicating a focus on narrow enhancements rather than stable high alpha [8] Group 2: Pharmaceutical and Biotechnology Sector - The pharmaceutical sector underperformed the overall market, with a 4.32% decline in the A-share market, and the biopharmaceutical sector fell by 6.88% [10] - The report highlights the treatment options for Hidradenitis Suppurativa (HS), noting that the prevalence in Western populations is approximately 1%, with around 320,000 diagnosed patients in the U.S. [11] - First-line therapies for HS primarily involve antibiotics, while second-line biological treatments include Adalimumab and IL-17A inhibitors, which have gained market share due to their efficacy and safety [11] Group 3: Atour (ATAT.O) Financial Performance - Atour reported a 38% year-on-year revenue growth in Q3 2025, raising its full-year revenue growth guidance from 30% to 35% [13] - The company’s retail business saw a remarkable 76% revenue growth, significantly contributing to the overall performance [13] - The number of hotels in operation increased by 27% year-on-year, with a total of 1,948 hotels by the end of Q3 2025 [14] Group 4: Hars (002615.SZ) Industry Leadership - Hars is a leading company in the cup and kettle industry, with a projected revenue compound annual growth rate (CAGR) of 25% from 2021 to 2024, reaching 3.3 billion [17] - The company operates both OEM/ODM and proprietary brand businesses, maintaining stable partnerships with international brands like YETI and PMI [17] - The domestic market for insulated cups is expected to replicate overseas trends, with significant growth potential driven by IP collaborations and social media marketing [18]
医药生物周报(25年第46周):化脓性汗腺炎治疗药物梳理-20251127
Guoxin Securities· 2025-11-27 09:35
Investment Rating - The report maintains an "Outperform" rating for the pharmaceutical and biotechnology sector [5] Core Insights - The pharmaceutical sector has underperformed the overall market, with a significant decline in various sub-sectors, including a 6.88% drop in the biotechnology sector [1][32] - Hidradenitis Suppurativa (HS) is identified as a chronic, recurrent inflammatory skin disease with a low prevalence in China and the U.S., highlighting the potential market for treatment options [2][10] - The report emphasizes the increasing market share of new biologics targeting IL-17A and IL-17A/F, which are expected to outperform traditional therapies like Adalimumab [17][18][22] Summary by Sections Market Performance - The overall A-share market declined by 4.32%, with the biotechnology sector falling by 6.88%, indicating a weaker performance compared to the broader market [1][32] - Specific declines were noted in chemical pharmaceuticals (7.02%), biological products (7.46%), and medical services (6.90%) [1][32] Hidradenitis Suppurativa (HS) Overview - HS affects approximately 0.03% of the population in China, with around 400,000 cases, and has been included in the rare disease directory [2][10] - The disease's complex pathogenesis involves multiple immune pathways, making it a target for various therapeutic approaches [11][27] Investment Strategy - The report suggests focusing on undervalued stocks in the medical device and pharmacy sectors, which have already priced in risks from policy changes [42][43] - It highlights the potential for growth in the CXO sector, particularly in CDMO and clinical CRO segments, as they continue to show strong performance despite market challenges [42][43] Recommended Stocks - The report lists several companies with strong growth potential, including Mindray Medical, WuXi AppTec, and Aier Eye Hospital, all rated as "Outperform" [4][44] - Mindray Medical is noted for its robust R&D and international expansion, while WuXi AppTec is recognized for its comprehensive drug development services [44]
医药生物周报(25 年第46 周):化脓性汗腺炎治疗药物梳理-20251127
Guoxin Securities· 2025-11-27 05:13
Investment Rating - The report maintains an "Outperform" rating for the pharmaceutical and biotechnology sector [5][4]. Core Insights - The pharmaceutical sector has underperformed the overall market, with a significant decline in various sub-sectors, including a 6.88% drop in the biotechnology sector [1][32]. - Hidradenitis Suppurativa (HS) is identified as a chronic, recurrent inflammatory skin disease with a low prevalence in China and the U.S., highlighting the potential market for treatment options [2][10]. - The report emphasizes the increasing market share of new biologics targeting IL-17A and IL-17A/F, which are expected to outperform traditional therapies like Adalimumab [2][18]. Summary by Sections Market Performance - The overall A-share market declined by 4.32%, with the biotechnology sector falling by 6.88%, indicating a weaker performance compared to the broader market [1][32]. - Specific declines were noted in chemical pharmaceuticals (7.02%), biological products (7.46%), and medical services (6.90%) [1][32]. Hidradenitis Suppurativa Treatment Overview - HS affects approximately 0.03% of the population in China, with around 400,000 cases, and has been included in the rare disease directory [2][10]. - First-line treatments primarily involve antibiotics, while second-line therapies include biologics such as Adalimumab and newer agents targeting IL-17A and IL-17A/F [2][10]. Company Earnings Forecast and Investment Ratings - Key companies such as Mindray Medical, WuXi AppTec, and Aier Eye Hospital are rated as "Outperform," with projected net profits for 2024 ranging from 1.4 billion to 116.7 billion CNY [4][42]. - The report highlights the strong growth potential in the CXO sector, particularly in CDMO and clinical CRO services, driven by new orders and emerging business lines [42][43]. Investment Strategy - The report suggests focusing on undervalued stocks in the medical device and pharmacy sectors, which have already priced in various policy risks [42]. - It also emphasizes the importance of monitoring the clinical progress of innovative drugs in overseas markets, as this can significantly impact their commercialization potential [43][42]. Recommended Stocks - Mindray Medical is noted for its strong R&D and sales capabilities, benefiting from domestic healthcare infrastructure development [44]. - WuXi AppTec is recognized for its comprehensive service capabilities across the new drug development chain, poised to benefit from the global outsourcing market [44]. - Aier Eye Hospital is highlighted for its scale and commitment to introducing international standards in eye care [44].