Core Viewpoint - Fosun Pharma's subsidiary, Shanghai Fuhong Hanlin Biotechnology Co., Ltd., received FDA approval for its biosimilar HLX14, which is intended for the treatment of osteoporosis in postmenopausal women at high risk of fractures [1] Group 1: Product Approval and Specifications - HLX14 is a biosimilar of denosumab, with two specifications: 60mg/mL and 120mg/1.7mL [1] - The FDA approval allows HLX14 to be used for treating osteoporosis in postmenopausal women and other indications consistent with the reference drug's label [1] Group 2: Regulatory Progress in Other Regions - In May 2024, HLX14's marketing authorization application (MAA) will be accepted by the European Medicines Agency (EMA), with a positive review opinion expected by July 2025 [1] - In September 2024, HLX14's new drug submission (NDS) will be accepted by Health Canada [1]

Core Viewpoint - Mabwell (Shanghai) Bioscience Co., Ltd. is a biotechnology company focused on innovative drug development, with significant ongoing research and development (R&D) investments, but it is currently not profitable and faces potential risks related to its financial sustainability and operational challenges [1][2][3]. Company Overview - Mabwell has 14 key products in various stages of development, including 10 innovative drugs and 4 biosimilars, primarily targeting oncology and age-related diseases [1]. - The company reported R&D expenditures of 392.09 million yuan in the first half of 2025, a 21.72% increase compared to the same period last year [1]. Financial Performance - For the first half of 2025, the company generated operating revenue of approximately 101.17 million yuan, a decrease of 12.43% from the previous year [9]. - The total profit for the period was a loss of approximately 552.18 million yuan, compared to a loss of 444.34 million yuan in the same period last year [9]. - The net assets attributable to shareholders decreased by 47.86% to approximately 818.07 million yuan compared to the end of the previous year [9]. Industry Context - The global pharmaceutical market is expected to grow significantly, driven by factors such as aging populations, rising chronic disease rates, and increased R&D spending [11]. - The Chinese pharmaceutical market is projected to expand from 1.63 trillion yuan in 2024 to 2.48 trillion yuan by 2032, with a compound annual growth rate (CAGR) of 7.3% [11]. - The oncology drug market is also experiencing rapid growth, with the global market expected to reach approximately 375.9 billion USD by 2028 [13][14]. Regulatory Environment - Recent reforms in China's drug approval processes are aimed at accelerating the development and approval of innovative drugs, which may benefit companies like Mabwell [11]. - The introduction of national centralized procurement for biosimilars may pose challenges to profitability but could also increase market share for these products in the long term [12].

Investment Highlights - The company is covered for the first time by CICC with an "outperform" rating and a target price of HKD 102.91, based on DCF valuation, positioning it as a leading innovative biopharmaceutical enterprise in China [1] - The company has adopted a dual strategy of innovation and internationalization, achieving domestic and international approvals for 6 and 4 products respectively by the end of 2024, establishing itself as a leader in domestic biopharmaceuticals [1] - Revenue has grown significantly from CNY 91 million in 2019 to CNY 5.724 billion, with a CAGR of 129%, while overseas revenue increased from CNY 2.62 million to CNY 678 million, expected to account for 11.9% of total revenue in 2024 [1] Innovation Pipeline - The company has developed a diverse innovation pipeline covering approximately 50 molecules, focusing on cutting-edge areas such as monoclonal antibodies, multi-antibodies, and ADCs [1] - HLX43 is the world's first PD-L1 ADC to enter clinical phase II, offering safety and competitive advantages, with low hematologic toxicity supporting its future use in first-line treatments and combination immunotherapy [1] - HLX22 has entered phase III international multicenter clinical trials for first-line treatment of advanced gastric cancer, with expectations to redefine standard therapies based on efficacy and safety data [1] Biosimilar Development - The company has a rich pipeline of biosimilars, leveraging first-mover advantages in the domestic market, with smooth commercialization progress anticipated [2] - It is expected that the domestic biosimilar procurement price reduction will be rational, allowing the company to achieve volume-based pricing [2] - The company has made strides in internationalization, with overseas revenue from Hanquyou reaching approximately CNY 120 million in 2024, a year-on-year increase of nearly 30%, and FDA approval achieved [2] Financial Forecast and Valuation - The company’s EPS is projected to be CNY 1.46 and CNY 1.55 for 2025 and 2026 respectively, with a CAGR of 1.2% [2] - Using a DCF valuation method with a WACC of 9.0% and a perpetual growth rate of 2.0%, the reasonable valuation for 2025 corresponds to a target price of HKD 102.91, implying an upside potential of 28.6% [2]

Core Viewpoint - Baotai Biopharmaceutical Co., Ltd. has received approval from the European Commission for Usymro®, a biosimilar drug for treating moderate to severe plaque psoriasis, active psoriatic arthritis, and moderate to severe active Crohn's disease in adults and children, marking a significant milestone for the company [2][3] Company Overview - Baotai is a global biopharmaceutical company based in Guangzhou, China, focused on developing innovative drugs and biosimilars for various diseases, including cancer and autoimmune disorders [2][3] - The company has successfully launched multiple drugs, including Adalimumab and Tocilizumab, in various markets, establishing itself as a leader in antibody drug development [3] Recent Developments - The approval of Usymro® follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in June 2025, highlighting the company's commitment to advancing its biosimilar pipeline [2] - In October 2024, Baotai signed a licensing and commercialization agreement with Gilead Sciences for BAT2206, another biosimilar, covering markets in the EU, UK, Switzerland, and other regions [2]

Financial Performance - Henlius achieved a revenue of RMB 2.82 billion in 2025 H1, representing a 2.7% year-over-year growth[5, 207, 212] - Product sales reached RMB 2.56 billion in 2025 H1, a 3.1% year-over-year increase[6, 207, 212] - The company's net profit was RMB 386 million, with a net profit margin of 13.8%[5, 6] - Net operating cash inflow reached RMB 770 million, showing a 207% year-over-year growth[6] Business Development & Out-licensing - BD contract cash inflow exceeded RMB 1 billion in 2025 H1, a 280% year-over-year growth[6] - Out-licensing deals include HLX13 (Ipilimumab) to Sandoz for up to USD 300 million, HLX15 (daratumumab) to Dr Reddy's for up to USD 131.6 million, and HANSIZHUANG (serplulimab) to Lotus in South Korea for up to USD 112 million[6, 48] - Recent major out-licensing products contributed cash inflow of approximately RMB 670 million in 1H25[47] Key Products Performance - HANSIZHUANG sales reached RMB 0.6 billion in 2025 H1[6] - HANQUYOU global revenue in 1H2025 was RMB 1.44 billion[146] - HANBEITAI revenue in 1H2025 was RMB 116 million[176] - HANNAIJIA revenue in 1H2025 was RMB 97 million[158] - HANLIKANG revenue in 1H2025 was RMB 274 million[186] - HANDAYUAN revenue in 1H2025 was RMB 27 million[186]

Core Viewpoint - Bio-Thera Solutions, Ltd. reported a revenue increase of 9.84% in the first half of 2025, driven by the sales of its products, including Adalimumab injection and Tocilizumab injection, while also noting a significant reduction in net losses compared to the previous year [3][4][5]. Company Overview and Financial Indicators - Bio-Thera Solutions is a biopharmaceutical company focused on the research and development of innovative drugs and biosimilars, classified under the pharmaceutical manufacturing industry [5]. - The company reported a total revenue of approximately CNY 441.89 million in the first half of 2025, compared to CNY 402.29 million in the same period of the previous year [3][4]. - The total profit for the period was a loss of CNY 124.77 million, an improvement from a loss of CNY 236.85 million in the previous year [3][4]. - The net assets attributable to shareholders decreased by 17.65% to CNY 583.12 million compared to the end of the previous year [3][4]. - The company’s R&D expenditure accounted for 78.94% of its revenue, a decrease of 21.12 percentage points from the previous year [4]. Industry Overview - The global pharmaceutical market has grown from USD 1,324.5 billion in 2019 to USD 1,472.3 billion in 2023, with a projected CAGR of 5.0% reaching USD 2,069.4 billion by 2030 [5]. - The Chinese innovative drug market is also on the rise, with a market size expected to grow from USD 132.5 billion in 2019 to USD 159.2 billion by 2024, reflecting a CAGR of 3.7% [5]. - The oncology treatment sector is the largest in the pharmaceutical industry, with significant growth in antibody-drug conjugates (ADC) and bispecific antibodies, showing annual growth rates of approximately 70% and 125%, respectively [6]. - The autoimmune disease drug market is projected to grow from USD 116.9 billion in 2019 to USD 158.5 billion by 2032, with a CAGR of 6.1% from 2019 to 2023 [7][8]. - Cardiovascular diseases are a major health concern in China, with a significant increase in the incidence of acute coronary syndrome (ACS), leading to a projected growth in percutaneous coronary intervention (PCI) procedures [9]. - The aging population is contributing to an increase in eye diseases, particularly age-related macular degeneration (AMD), with the number of patients expected to rise significantly by 2050 [10].

石药集团(01093)发布公告，本集团开发的度普利尤单抗注射液(该产品)已获中国国家药品监督管理局批 准，可在中国开展临床试验。 该产品是一种靶向IL-4Rα的重组全人源单克隆抗体药物，为达必妥的生物类似药，按照治疗用生物制品 3.3类申报，适用于治疗成人中重度特应性皮炎。 该产品的研发遵循生物类似药相关研究指南。药学及非临床研究结果显示，该产品与原研参照药在质 量、安全性和有效性方面高度相似，支持开展后续临床研究。 ...

Group 1 - The core point of the article is that CSPC Pharmaceutical Group (01093) has received approval from the National Medical Products Administration of China to conduct clinical trials for its drug Dupilumab Injection [1] - The product is a recombinant fully human monoclonal antibody targeting IL-4Rα and is a biosimilar to Dupixent, classified under Category 3.3 for therapeutic biological products [1] - The drug is intended for the treatment of moderate to severe atopic dermatitis in adults [1] Group 2 - The development of the product follows the relevant research guidelines for biosimilars [1] - Pharmaceutical and non-clinical research results indicate that the product is highly similar to the reference drug in terms of quality, safety, and efficacy, supporting the initiation of subsequent clinical studies [1]

Core Viewpoint - Jiuyuan Gene (02566) saw a nearly 24% increase in stock price, attributed to the upcoming board meeting to approve mid-term performance and the potential of its biosimilar drug Semaglutide in the domestic market [1] Company Developments - Jiuyuan Gene's stock rose by 23.72% to HKD 15.28, with a trading volume of HKD 41.215 million [1] - The company plans to hold a board meeting on August 18 to approve its mid-term performance [1] - Jiuyuan Gene is focusing on the metabolic field, particularly with its potential first domestic biosimilar of Semaglutide [1] Market Strategy - The company aims to leverage its first-mover advantage in the hospital market and expand accessibility through pharmacy networks and strategic partnerships with e-commerce platforms [1] - Jiuyuan Gene has granted overseas rights for Semaglutide to other domestic pharmaceutical companies, including a unique licensing agreement with Sinovac Biotech for major Latin American countries [1] - A product licensing agreement with Fosun Pharma allows them exclusive rights for clinical development, registration, and commercialization of Semaglutide and other products in the Middle East, North Africa, sub-Saharan Africa, and parts of ASEAN countries [1] - New drug applications for Semaglutide are expected to be submitted to Brazil and Saudi Arabia by 2025 [1]

Core Insights - The stock of Boan Biotech (06955) has increased by over 3%, currently trading at 18.88 HKD with a transaction volume of 313 million HKD [1] Group 1: Product Approval - Boan Biotech announced that its self-developed product, Bo You Ping® (Dulaglutide injection), has received approval from the National Medical Products Administration for market launch, aimed at blood sugar control in adult patients with type 2 diabetes [1] - Bo You Ping® is the world's first and currently the only approved biosimilar to Trulicity® (the English brand name), with no other domestic dulaglutide injections having entered the Biologics License Application (BLA) stage in China [1] Group 2: Commercialization and Collaboration - The commercialization of Bo You Ping® in mainland China will be conducted in collaboration with Shanghai Pharmaceuticals Holding Co., Ltd [1] Group 3: Technical Expertise - The development of dulaglutide, as a peptide-Fc fusion protein, involves complex processes, and the biosimilar's pharmaceutical (CMC) development is challenging [1] - The company possesses extensive technical expertise and experience in the CMC field, with an advanced process development platform that effectively controls critical quality attributes [1] - The innovative analytical platform has successfully developed control methods for key quality attributes, overcoming CMC technical challenges and facilitating the early approval of Bo You Ping® [1] Group 4: Clinical Trials - Beyond the Chinese market, Bo You Ping® has also been approved to conduct clinical trials in the United States [1]