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新药周观点:下一个重磅PD-1升级产品PD-1/IL-2α偏向性双抗潜力验证-20250608
Guotou Securities· 2025-06-08 07:03
Investment Rating - The report maintains an investment rating of "Outperform" for the biopharmaceutical sector [7]. Core Insights - The PD-(L)1 monoclonal antibody market is vast, with multiple companies developing PD-1 class upgrade products, including PD-1/VEGF bispecific antibodies and PD-1/IL-2 bispecific antibodies. The IBI363 from Innovent Biologics is expected to be the next significant PD-1 upgrade product following the PD-1/VEGF bispecific antibody [2][21]. - IBI363 has shown excellent data in the treatment of wild-type NSCLC and colorectal cancer, indicating its potential to expand into first-line treatment markets based on its performance in the IO resistant market [2][22]. - The competitive landscape for PD-1/IL-2 bispecific antibodies is favorable for IBI363, as it is the only PD-1/IL-2α bispecific antibody currently in Phase II clinical trials, while most competitors are in earlier stages [3][25]. Summary by Sections Weekly New Drug Market Review - From June 2 to June 6, 2025, the top five companies in the new drug sector by stock performance were Junsheng Tai Pharmaceutical-B (24.29%), Zai Lab (23.28%), Innovent Biologics (18.08%), Maiwei Biopharma (17.72%), and Shenzhou Cell (17.24%). The bottom five were Deqi Pharmaceutical-B (-12.68%), JACOB-B (-11.90%), Heptares Therapeutics-B (-10.86%), CanSino Biologics-B (-10.75%), and WuXi AppTec-B (-8.54%) [1][17]. Weekly New Drug Industry Analysis - The report highlights the potential of IBI363 as a next-generation PD-1 upgrade product, with promising data presented at ASCO 2025. The drug is expected to target multiple tumor types and expand into first-line treatment markets [2][21]. Weekly New Drug Approval & Acceptance Status - This week, 20 new drug or new indication applications were approved in China, including drugs from Zai Lab and Shenzhen Xinlitai. Additionally, 11 new drug applications were accepted, including those from MSD and Eli Lilly [4][28]. Weekly New Drug Clinical Application Approval & Acceptance Status - There were 21 new drug clinical application approvals and 43 new drug clinical applications accepted in the domestic market this week [5].
翰森制药:创新能力持续兑现的制药企业,兼具业绩稳健与创新弹性
Tianfeng Securities· 2025-06-07 00:25
Investment Rating - The report assigns an "Accumulate" rating for the company, marking it as the first coverage with a target price of HKD 29.50, compared to the current price of HKD 27.2 [5]. Core Viewpoints - The company is recognized as a leading innovation-driven pharmaceutical enterprise, focusing on oncology, anti-infection, central nervous system, metabolic diseases, and autoimmune diseases. It is projected to achieve a revenue of HKD 12.26 billion in 2024, representing a 21% year-on-year growth, and a net profit of HKD 4.372 billion, reflecting a 33% increase [1][5]. - The company has successfully launched multiple innovative drugs, with a strong pipeline that is expected to drive future growth. The sales of innovative drugs are anticipated to continue increasing, with a projected revenue of HKD 9.477 billion in 2024, marking a 38.1% year-on-year growth [16][24]. Summary by Sections 1. Innovation and R&D - The company has established a comprehensive R&D system, employing over 1,800 professionals and creating several national-level research institutions. It has been recognized as a key high-tech enterprise and a national technology innovation demonstration enterprise [14][26]. - The company has eight innovative drugs approved for market, including Amelotin (甲磺酸阿美替尼片) and Fluoromethylnitro (甲磺酸氟马替尼片), which are expected to contribute significantly to revenue growth [16][17]. 2. Market Performance - The sales of Amelotin, the first domestic third-generation EGFR TKI, are projected to grow rapidly, with a compound annual growth rate (CAGR) of 214% from 2020 to 2024, capturing approximately 28% of the total sales of third-generation EGFR TKIs by 2024 [2]. - The company has also seen significant sales growth in Fluoromethylnitro, with a 54% increase in 2023 and a projected 36% growth in 2024 [3]. 3. Future Growth Potential - The company has a robust pipeline with several innovative drugs in various stages of clinical trials, including HS-20089 and HS-20093, which have entered phase II and III trials, respectively [4]. - The company is expanding its market presence through collaborations, such as granting global exclusive licensing rights for HS-10535 to Merck, indicating strong potential for future revenue streams [4][5]. 4. Financial Projections - Revenue forecasts for 2025, 2026, and 2027 are projected at HKD 13.741 billion, HKD 15.567 billion, and HKD 17.374 billion, respectively, with net profits expected to reach HKD 4.746 billion, HKD 5.336 billion, and HKD 5.850 billion [5].
翰森制药(03692):创新能力持续兑现的制药企业,兼具业绩稳健与创新弹性
Tianfeng Securities· 2025-06-06 14:19
Investment Rating - The report assigns an "Accumulate" rating for the company, marking it as the first coverage with a target price of HKD 29.50, compared to the current price of HKD 27.2 [5]. Core Viewpoints - The company is recognized as a leading innovative pharmaceutical enterprise with a focus on oncology, anti-infection, central nervous system, metabolic diseases, and autoimmune diseases. It has shown robust performance with a projected revenue of HKD 12.26 billion for 2024, representing a 21% year-on-year growth, and a net profit of HKD 4.372 billion, reflecting a 33% increase [1][5]. - The company has successfully launched multiple innovative drugs, with significant sales growth in its key products, particularly in the oncology sector, which is expected to account for 66.24% of total revenue by 2024 [17][24]. Summary by Sections 1. Innovation and R&D - The company has established a comprehensive R&D system with over 1,800 professional researchers, focusing on drug discovery and clinical research. It has been recognized as a national high-tech enterprise and a national technology innovation demonstration enterprise [14][26]. - The company has eight innovative drugs approved for market, including Amelotin (甲磺酸阿美替尼片) and Fluoromethine (甲磺酸氟马替尼片), which have shown strong sales performance [16][17]. 2. Sales Performance - The sales of Amelotin are projected to grow at a compound annual growth rate (CAGR) of 214% from 2020 to 2024, capturing approximately 28% of the total sales for third-generation EGFR TKIs by 2024 [2]. - The sales of Fluoromethine increased by 54% in 2023 compared to the previous year, with a projected growth of 36% in 2024 [3]. 3. Future Growth Potential - The company has a robust pipeline with several innovative drugs in various stages of clinical trials, including HS-20089 and HS-20093, which have entered phase II and III trials, respectively [4]. - The company is expanding its market presence with global licensing agreements for its innovative drugs, indicating strong potential for future revenue growth [4][5]. 4. Financial Forecast - The revenue forecast for the company is set at HKD 13.741 billion, HKD 15.567 billion, and HKD 17.374 billion for the years 2025, 2026, and 2027, respectively, with net profits projected at HKD 4.746 billion, HKD 5.336 billion, and HKD 5.850 billion [5].
港股收盘(06.06) | 恒指收跌0.48% 有色、创新药走高 快手-W(01024)逆市涨超8%
智通财经网· 2025-06-06 08:57
Market Overview - The Hong Kong stock market indices collectively declined, with the Hang Seng Index stopping a three-day rise, closing down 0.48% at 23,792.54 points, with a total turnover of HKD 235.62 billion [1] - The Hang Seng China Enterprises Index fell 0.63% to 8,629.75 points, and the Hang Seng Tech Index also dropped 0.63% to 5,286.52 points [1] - For the week, the Hang Seng Index rose 2.16%, the China Enterprises Index increased by 2.34%, and the Tech Index gained 2.25% [1] Blue Chip Performance - Kuaishou-W (01024) continued its upward trend, rising 8.44% to HKD 59.1, contributing 22.8 points to the Hang Seng Index [2] - The annualized revenue run rate for Kuaishou's AI product exceeded USD 100 million as of March, with monthly payments surpassing RMB 100 million in April and May [2] - Other blue-chip stocks included CSPC Pharmaceutical Group (01093) up 12.72%, Hansoh Pharmaceutical (03692) up 2.84%, while SMIC (00981) fell 4.85% and Trip.com Group (09961) dropped 3.31% [2] Sector Highlights - Large tech stocks generally declined, with Xiaomi down over 2% and Alibaba down over 1%, while Kuaishou rose over 8% [3] - Precious metals saw gains, with China Silver Group rising 26% and silver prices reaching a 13-year high, driven by industrial demand [3] - The innovative drug sector saw gains, with CSPC Pharmaceutical up 12.72% and other biotech firms also performing well, indicating a positive outlook for the sector [4] Stablecoin Sector - The stablecoin sector experienced a pullback after Circle's successful NYSE listing, with China Everbright Holdings (00165) dropping 17.2% [5] - The Hong Kong government announced the implementation of the Stablecoin Regulation on August 1, 2025, which aims to reshape the regulatory framework for stablecoins [6] Automotive Sector - Automotive stocks declined, with XPeng Motors (09868) down 1.77% and Great Wall Motors (02333) down 1.76% [6] - Concerns over a price war in the automotive industry were raised, with profit margins for the sector declining [6] Notable Stocks - WanGuo Gold Group (03939) reached a new high, rising 11.73% to HKD 30, supported by positive mining contracts [7] - Xinyi Energy (03868) increased by 7.07% as it submitted listing materials for a solar power infrastructure REIT in China [8] - Juzhibio (02367) faced pressure, down 3.04%, amid ongoing controversies regarding its product composition [9]
对外授权交易频现 创新药出海加速
Group 1 - Hansoh Pharmaceutical granted Regeneron Pharmaceuticals exclusive overseas licensing for its GLP-1/GIP dual receptor agonist HS-20094, which has completed multiple Phase II clinical trials and is currently in Phase III trials in China [1][2] - The licensing agreement includes an upfront payment of $80 million, potential milestone payments of up to $1.93 billion, and double-digit royalties on future sales [2][3] - Recent licensing deals by Chinese pharmaceutical companies indicate a growing trend, with 33 license-out transactions completed in Q1 2025, totaling $36.633 billion, a year-on-year increase of approximately 258% [1][6] Group 2 - The licensing deal with Pfizer for the PD-1/VEGF dual antibody SSGJ-707 includes a record upfront payment of $1.25 billion, with potential milestone payments reaching $4.8 billion [3] - Other companies, such as Sinovant and Ansai, have also announced licensing agreements, indicating a robust market for Chinese pharmaceutical innovations [3][4] - The 2025 ASCO annual meeting showcased over 70 original research results from China, highlighting the international competitiveness of Chinese innovative drugs [4][5] Group 3 - The overall trend shows that Chinese innovative drugs are gaining global value, with a significant increase in licensing transactions and amounts [6][7] - The pharmaceutical industry is expected to see steady recovery, driven by the growing demand for innovative therapies and the improvement in the quality and quantity of domestic innovative drugs [7]
翰森制药的肺癌靶向药首入海外市场
Xin Lang Cai Jing· 2025-06-04 13:03
Core Viewpoint - Hansoh Pharmaceutical's innovative drug, Amivantamab (Aumseqa®), has been approved for marketing in the UK, marking it as the first innovative drug from the company to enter the overseas market and the first Chinese-origin EGFR-TKI to be launched internationally [1][2]. Group 1: Drug Approval and Market Entry - Amivantamab is approved for use as a first-line treatment for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activated EGFR mutations, as well as for patients with T790M mutation-positive NSCLC [1]. - The drug has already been approved for four indications in China, making it the most approved indication for a Chinese-origin third-generation EGFR-TKI [2]. Group 2: Market Context and Competitors - As of March 2025, there are seven third-generation EGFR-TKI products available in China, including Amivantamab and others like Osimertinib and Furmonertinib [3]. - The market for NSCLC treatments is significant, with lung cancer accounting for 18.7% of global cancer deaths in 2022, and NSCLC being the most common type, representing approximately 85% of all lung cancer cases [4]. Group 3: Historical Context and Future Prospects - The first-generation EGFR-TKI, Gefitinib, was launched in the early 2000s, followed by second-generation drugs that also faced resistance issues, leading to the development of third-generation EGFR-TKIs like Osimertinib [5]. - Current research is focused on addressing resistance issues associated with third-generation EGFR-TKIs, with innovations such as EGFR/C-MET dual antibodies and ADC drugs being explored [6].
豪掷20亿美元交易达成!翰森授权再生元巨大潜力药物!
Ge Long Hui· 2025-06-04 10:16
Core Insights - The collaboration between Hansoh Pharmaceutical and Regeneron involves a deal worth over $2 billion, including an $80 million upfront payment and potential milestone payments of up to $1.93 billion, along with double-digit royalties on future sales [2][9][16] Group 1: HS-20094 Drug Overview - HS-20094 is an innovative GLP-1/GIP dual receptor agonist that has shown promising efficacy and safety data in multiple Phase II clinical trials [3][5] - The drug works by selectively activating GLP-1 and GIP receptors, promoting insulin secretion, delaying gastric emptying, and suppressing appetite, leading to improved glycemic control and weight loss [3][5] - The administration method is a once-weekly subcutaneous injection, enhancing patient convenience [3][4] Group 2: Clinical Trial Progress - In a Phase II study, HS-20094 demonstrated significant reductions in HbA1c levels compared to baseline, with reductions of -0.63%, -0.75%, and -0.84% for the 5mg, 10mg, and 15mg doses, respectively [5] - Weight loss was also observed in HS-20094 groups, with reductions of -1.27%, -2.51%, and -4.41%, showing a dose-dependent effect and outperforming the placebo group [5] - HS-20094 is currently undergoing Phase III clinical trials in China for obesity and Phase IIb trials for diabetes [5] Group 3: Strategic Importance for Companies - The partnership with Regeneron marks a significant strategic move for Hansoh Pharmaceutical, enhancing its global presence and financial returns while showcasing its R&D capabilities [9][11] - Regeneron aims to leverage HS-20094 to diversify its obesity treatment portfolio and explore combinations with its proprietary drugs to address obesity-related complications [6][7] Group 4: Market Context - The GLP-1R/GIPR agonist market is rapidly growing due to increasing obesity and diabetes rates, with only Eli Lilly's Mounjaro currently approved, generating sales of $16.4 billion in 2024 [12][13] - Domestic companies are quickly advancing in the GLP-1R/GIPR space, with several candidates in Phase III trials, including Hansoh's HS-20094 [12][14][15] Group 5: Financial Performance of Regeneron - Regeneron reported revenues of $647.07 million for the second quarter of 2024, with a net profit of $215.43 million, indicating strong financial health [8]
6月4日电,翰森制药公告称,甲磺酸阿美替尼片获英国药品与保健品监管局批准上市。
news flash· 2025-06-04 04:09
Group 1 - The core point of the article is that Hansoh Pharmaceutical has received approval from the UK Medicines and Healthcare products Regulatory Agency for the marketing of Amivantamab tablets [1]
速递|20.1亿灭元!翰森制药GLP-1双靶点药物授权再生元
GLP1减重宝典· 2025-06-03 09:47
整理 | GLP1减重宝典内容团队 再生元制药公司(NASDAQ: REGN)宣布与翰森制药集团有限公司("翰森制药")达成许可协议,再生元获得GLP-1/GIP双重受体激动剂 (HS-20094)在中国大陆、香港和澳门以外地区的独家临床开发和商业化权利。 该候选药物目前正处于三期临床试验阶段,作为每周一次的皮下注射方案,已在超过1,000名患者中进行测试,显示出良好的安全性和疗效,其 表现与目前美国FDA唯一批准的GLP-1/GIP双重受体激动剂相似。目前,该药正在中国进行一项治疗肥胖的三期临床试验以及一项糖尿病二期b 试验。 根据协议条款,再生元将向翰森制药支付8000万美元的预付款,并在开发、监管及销售里程碑达成时,可能额外支付最高19.3亿美元。此外,在 协议指定地区以外的全球销售收入中,翰森制药还将获得低双位数百分比的销售提成。 再生元内科临床开发高级副总裁Boaz Hirshberg医学博士补充道:"获得这一处于后期开发阶段的药物,使我们有机会将其与自有在研药物进行 联合探索,进一步解决肌肉流失以及心血管疾病、肝脏疾病和糖尿病等肥胖并发症。这也与我们在肥胖治疗领域的整体战略相一致,例如我们正 在进 ...
异动盘点0603|光大控股此前投资稳定币巨头,狂飙21%;汽车股回暖、医药股走强;BioNTech获91亿天价并购
贝塔投资智库· 2025-06-03 04:00
Group 1: Stock Movements and Market Reactions - JunDa Co., Ltd. (02865) fell by 12.69% due to weak fundamentals, expected shareholder sell-off, and cash flow concerns [1] - Rongchang Biopharmaceutical (09995) rose by 4.61% after ASCO announced positive data for RC108 combined with vorinostat, enhancing its commercialization prospects [1] - Datang Gold (08299) increased by 7.27% as it partnered with Wuxi to develop AI mining applications, benefiting from gold's safe-haven demand [1] - Kanglong Chemical (03759) gained 4.35% by investing in a biopharmaceutical fund, strengthening its investment ecosystem [1] - Automotive stocks surged following a significant increase in May's new energy vehicle sales, with Li Auto (2015) rising nearly 6% and Great Wall Motors (2333) up over 3% [1] - Gold stocks led the market as COMEX gold prices returned to $3,400, with Goldman Sachs predicting $4,200, driven by geopolitical tensions [1] Group 2: Company-Specific Developments - Changfei Optical Fiber (06869) rose by 8.34% as its Wuhan base began mass production of 6-inch silicon carbide wafers, achieving a 97% yield rate [2] - China Shipbuilding Defense (00317) increased by 7.58% after securing the highest global new orders from January to April, with Q1 net profit up 1,099% [2] - Hengrui Medicine (00013) rose by 5.09% as SACHI III phase data met expectations, opening up market space for MET amplification lung cancer treatment [2] - Lepu Medical Technology (02157) gained 5.76% following positive ASCO data for its ADC drug MRG003, boosting approval expectations for nasopharyngeal carcinoma [2] - Aidi Kang Holdings (09860) increased by 5.2% after acquiring Suzhou Yuande Youqin to enhance blood disease diagnostics [2] - NetDragon (00777) rose by 5.82% due to its collaboration with Thailand on an AI education platform, attracting investor interest [2] Group 3: Notable Market Trends - China Everbright Holdings (00165) surged over 21% following the enactment of Hong Kong's stablecoin regulations, with Circle's IPO expectations boosting related equity valuations [3] - iFlytek Medical (02506) rose by 6.62% as its medical AI model demonstrated superior accuracy, supported by favorable policies [3] - MicroPort NeuroTech (02172) increased by 9.59% as it initiated clinical research on brain-machine interfaces, benefiting from policy incentives [3] - Longpan Technology (02465) rose by 14.9% after its subsidiary signed a $7.1 billion contract with Yiwei Lithium Energy for lithium iron phosphate [4] - Hansoh Pharmaceutical (03692) gained 3.85% after reaching a global licensing agreement with Regeneron, receiving an $80 million upfront payment [4] Group 4: U.S. Market Highlights - Steel and aluminum stocks surged over 10%-28% as Trump proposed increasing steel tariffs to 50%, benefiting domestic companies [5] - Blueprint Medicines (BPMC.US) rose by 26% following Sanofi's $9.1 billion acquisition, enhancing its rare disease pipeline [5] - BioNTech (BNTX.US) increased by 18% due to a collaboration with Bristol-Myers Squibb, securing a $1.5 billion upfront payment [5] - Applied Digital (APLD.US) surged by 48.46% after signing a $7 billion AI data center lease, validating its business model [5] - Tempus AI (TEM.US) rose by 15% as it launched an AI medical innovation plan, attracting investor interest [7]