Core Viewpoint - The company has received approval from the National Medical Products Administration for the clinical trial of HSK47388, a drug developed for the treatment of autoimmune diseases [1] Group 1: Drug Development - HSK47388 is an orally administered, potent, and highly selective drug [1] - Preclinical studies have shown significant dose-dependent efficacy in rat models of enteritis [1] - The drug demonstrates good tolerability and a large safety window, indicating strong development potential [1] Group 2: Market Implications - The clinical trial application represents a new indication for HSK47388 in the field of autoimmune diseases [1] - The drug is expected to provide a new treatment option for patients suffering from autoimmune diseases [1]

Group 1 - Company has received the "Drug Clinical Trial Approval Notice" from the National Medical Products Administration for the innovative drug HSK47388, which is intended for the treatment of autoimmune diseases [1] - HSK47388 is an orally administered, potent, and highly selective drug that has shown significant efficacy in preclinical studies, particularly in rat models of enteritis, demonstrating dose-dependent effects and good tolerability [1] - The application for HSK47388 represents a new clinical trial for an additional indication in the field of autoimmune diseases, potentially providing a new treatment option for patients [1] Group 2 - The clinical trial application for HSK47388 was accepted in June 2025, indicating compliance with the relevant drug registration requirements [1] - The drug is classified as a tablet form and is aimed at treating autoimmune diseases, with the registration number CXHL2500600 for domestic production [1]

Core Viewpoint - The company has received approval from the National Medical Products Administration for clinical trials of HSK47388 tablets, a drug developed for the treatment of autoimmune diseases [1] Company Summary - HSK47388 tablets are an orally administered, potent, and highly selective drug developed by the company [1] - The drug has shown significant efficacy in preclinical studies, particularly in a rat model of colitis, demonstrating dose-dependent effects [1] - HSK47388 exhibits good tolerability and a large safety window, indicating its potential for further development [1] Industry Summary - The approval for clinical trials represents a new indication for HSK47388 in the field of autoimmune diseases, potentially providing a new treatment option for patients [1]

Core Viewpoint - The company, HaiSiKe (002653.SZ), has received approval from the National Medical Products Administration for clinical trials of its self-developed drug HSK47388, which is intended for the treatment of autoimmune diseases [1] Group 1: Drug Development - HSK47388 is an oral, potent, and highly selective drug developed by the company [1] - The drug has shown significant dose-dependent efficacy in preclinical studies using rat models of enteritis [1] - HSK47388 demonstrates good tolerability and a large safety window, indicating strong development potential [1] Group 2: Clinical Trial Approval - The approval allows HSK47388 to proceed with clinical trials for a new indication in the field of autoimmune diseases [1] - This development is expected to provide a new treatment option for patients suffering from autoimmune diseases [1]

Investment Rating - The report maintains a "Buy" rating for the company with a target price of 47.30 CNY, reflecting a reasonable market value of 273.54 billion CNY [4][7]. Core Views - The company has shown a narrowing loss with a significant increase in commercial product sales, leading to a 29% year-on-year revenue growth in the first half of 2025, achieving 0.19 billion CNY. The net profit attributable to the parent company was -1.19 billion CNY, a 44% reduction in loss compared to the previous year [12]. - The company is actively expanding the indications for its approved products, with ongoing clinical trials for both Beifutini and Gesorex, which are expected to contribute positively to revenue in the coming years [12]. - The research pipeline is well-structured, with several promising candidates in advanced clinical stages, indicating strong potential for business development opportunities [12]. Financial Summary - The company's revenue is projected to decline from 186 million CNY in 2023 to 141 million CNY in 2025, before rebounding to 323 million CNY in 2026 and 525 million CNY in 2027, reflecting a growth rate of 129.3% and 62.6% respectively [6][15]. - The net profit attributable to the parent company is expected to improve from -284 million CNY in 2023 to -203 million CNY in 2025, with a further reduction to -94 million CNY by 2027 [6][15]. - The gross margin is forecasted to remain high, around 97.2% in 2025, while the net margin is expected to improve significantly from -144.0% in 2025 to -17.8% in 2027 [6][15].

Investment Rating - The report maintains an "Accumulate" rating for the pharmaceutical and biotechnology sector [8]. Core Viewpoints - The report expresses strong confidence in the innovative drug sector, particularly highlighting the progress of the PD-1/VEGF bispecific antibody drug, Ivosidenib, in its international multicenter Phase III clinical trials for high PD-L1 expressing NSCLC [2][22]. - Ivosidenib has shown significant overall survival (OS) benefits in the HARMONi-A study, confirming its clinical value beyond progression-free survival (PFS) [2][23]. - The report suggests that Ivosidenib's efficacy and safety are consistent across different ethnicities and regions, enhancing its international market potential [2][23]. Summary by Sections Market Review - Last week, the A-share pharmaceutical and biotechnology index fell by 0.65%, underperforming the CSI 300 index by 3.37 percentage points [1][17]. - The Hong Kong Hang Seng Medical Health Index dropped by 3.41%, lagging behind the Hang Seng Index by 1.96 percentage points [1][17]. Company Updates - Recent clinical applications include new undertakings for AK152 injection by Kangfang Biopharma and 9MW3811 injection by Maiwei Biopharma [33]. - Ongoing Phase III clinical trials include HS-20094 by Hansoh Pharmaceutical and TaiTasi by Rongchang Biopharma [33]. Clinical Research Progress - Ivosidenib is expanding its clinical research into various tumor types, including first-line treatments for high-incidence cancers and immune-resistant indications [3][31]. - The report recommends focusing on innovative companies involved in VEGF bispecific antibodies, such as Sanofi, Rongchang Biopharma, Junshi Biosciences, and Innovent Biologics [3]. Investment Strategy for 2025 - The report emphasizes a structural selection of investment opportunities based on payment willingness and ability, focusing on three payment channels: hospital payments, out-of-pocket payments, and overseas payments [3]. - Key recommendations include Heng Rui Medicine, Mindray Medical, United Imaging Healthcare, and Yuyue Medical [3].

Investment Rating - The report maintains a "Recommended" investment rating for the company [1][7][10] Core Views - The company is experiencing short-term pressure on performance, with a notable decline in revenue and net profit for the first half of 2025 [4][7] - Despite the current challenges, the company is making continuous progress in innovative research and development, with several drugs in various stages of clinical trials [7][8] Summary by Relevant Sections Financial Performance - For the first half of 2025, the company reported revenue of 1.642 billion yuan, a decrease of 27.29% year-on-year, and a net profit of 142 million yuan, down 40.12% year-on-year [4] - The second quarter of 2025 saw revenue of 764 million yuan, a decline of 15.09% year-on-year, with a net profit of 59 million yuan, down 42.43% year-on-year [4] - The company's gross margin for the first half of 2025 was 70.88%, a decrease of 3.67 percentage points year-on-year [7] Product Line Performance - Revenue from the injection segment was 506 million yuan, down 39.73% year-on-year, while the capsule segment generated 383 million yuan, down 4.78% [7] - Oral liquid revenue fell to 279 million yuan, down 48.78%, while tablet revenue increased by 12.26% to 190 million yuan [7] Future Projections - The company has revised its revenue forecasts for 2025 and 2026, now expecting 3.573 billion yuan and 3.901 billion yuan respectively, down from previous estimates of 5.139 billion yuan and 5.948 billion yuan [8] - The projected net profit for 2025 and 2026 is now 402 million yuan and 453 million yuan, respectively, down from earlier forecasts of 618 million yuan and 772 million yuan [8] R&D Progress - The company is advancing its innovative drug pipeline, with several products in clinical trials, including treatments for Alzheimer's disease and other conditions [7][8]

Investment Rating - The investment rating for the company is "Buy" with a target price of 144.48 RMB [7][5]. Core Views - The company's revenue for 1H25 was 6.603 billion RMB, with a net profit attributable to the parent company of 0.983 billion RMB, reflecting a year-on-year decline of 0.5% and 42.85% respectively. The revenue stability is attributed to steady sales of growth hormone and stable performance in the real estate sector, while the profit decline is mainly due to increased sales, management, and R&D expenses during the innovation transition [1][5]. - The company is expected to stabilize its revenue in 2025, driven by an increase in long-acting growth hormone revenue and the expansion of non-growth hormone product sales. The approval and rapid market entry of IL-1β is also anticipated to contribute positively [1][5]. - The long-term growth trajectory is supported by the commercialization of pipelines in various therapeutic areas, including oncology, autoimmune diseases, pediatrics, and gynecology [1][5]. Summary by Sections Financial Performance - In 1H25, the company reported revenue of 6.603 billion RMB and a net profit of 0.983 billion RMB, with a year-on-year decline of 0.5% and 42.85% respectively. The decline in profit is primarily due to increased expenses related to the company's innovation transition [1][5]. - The company expects revenue to stabilize in 2025, with a projected net profit decline due to ongoing investments in sales and management during the transition period [1][5]. Product Development - The company has established multiple technology platforms for drug development, including ADC, small nucleic acids, long-acting release, and dual antibodies/multifunctional macromolecules. Currently, 8 molecules across 11 indications are in clinical III phase and NDA stages [3]. - Key therapeutic areas for future growth include endocrine disorders, immunology, and oncology, with several promising candidates in the pipeline [3]. Market Outlook - The company anticipates steady revenue growth in 2025, driven by the expansion of growth hormone sales and the introduction of new products in gynecology, pediatrics, and oncology [2][5]. - The approval of the IL-1β drug is expected to generate significant sales in its first year, with further growth anticipated as additional indications are pursued [2][5].

Group 1 - The World Lung Cancer Conference (WCLC) will be held from September 6 to September 9, and the European Society for Medical Oncology (ESMO) annual meeting will take place from October 17 to October 21, which is expected to catalyze the market with excellent data releases [1] - The domestic innovative drug industry is entering a turning point phase where innovative results are being realized after ten years of development, benefiting from the rapid growth of revenue in biotech companies driven by innovative drug launches and overseas licensing deals [1] - The third-generation EGFR-TKI drug, Furmonertinib, along with CAR-T therapy, PD-1, Tislelizumab, and bispecific antibodies, are driving rapid performance growth for companies in the sector [1] Group 2 - The innovative drug sector is currently the most clearly defined sub-industry within the pharmaceutical sector, with significant future growth potential, and is expected to remain the main investment theme for the year [1] - The Guotai Innovative Drug ETF (517110) tracks the SHS Innovative Drug (RMB) Index (931409), which selects listed companies involved in innovative drug research and biopharmaceuticals from the Chinese A-share market [2] - The index constituents exhibit high growth and volatility characteristics, with a high industry concentration, focusing on capturing investment opportunities in the innovative drug field [2]

Core Viewpoint - Nocera Biopharma reported a significant revenue increase of 74.26% year-on-year, reaching 730 million yuan in the first half of 2025, with a reduction in losses to 36 million yuan, a decrease of 86.7% compared to the previous year. The core product, Oubatinib, generated sales of 637 million yuan, marking a 52.48% increase year-on-year [1][10]. Financial Performance - The company achieved total revenue of 730 million yuan in H1 2025, a 74.26% increase, primarily driven by the sales of Oubatinib and an upfront payment from a licensing agreement with Prolium. Drug sales reached 640 million yuan, up 53.47%, with Oubatinib sales contributing 637 million yuan, reflecting a 52.48% growth [1][10]. - R&D expenses for H1 2025 were 450 million yuan, a 6.9% increase, while sales expenses rose by 55.31% to 240 million yuan due to intensified commercialization efforts. Management expenses decreased by 1.61% to 83 million yuan [11]. Product Development and Pipeline - Oubatinib's sales growth is attributed to its approval for first-line treatment of CLL/SLL and its potential in autoimmune diseases. The company is advancing multiple Phase III clinical trials, including for ITP and multiple sclerosis [5][6]. - The company is also focusing on expanding its pipeline in hematological malignancies with products like Tafasitamab and Mesutoclax, which are showing promising clinical results [2][3][4]. Market Position and Strategy - Nocera Biopharma is strengthening its leadership in the hematological oncology field through its three main products: Oubatinib, Tafasitamab, and Mesutoclax. The company aims to enhance its competitive edge in this area [2]. - The company is actively pursuing new indications for Oubatinib in autoimmune diseases, with ongoing Phase III trials for conditions like primary progressive multiple sclerosis and immune thrombocytopenic purpura [5][6]. Future Outlook - The company anticipates continued revenue growth, projecting a 35% increase in Oubatinib sales for the full year 2025. The establishment of a commercialization team is expected to enhance market penetration [12]. - Revenue forecasts for 2025, 2026, and 2027 are estimated at 1.444 billion yuan, 1.889 billion yuan, and 2.414 billion yuan, respectively, with corresponding growth rates of 43%, 30.87%, and 27.81% [12].