Core Viewpoint - The announcement of a 100% tariff on all branded/patented drugs by Trump starting in October is expected to have limited impact on China's innovative drug industry chain, with no excessive concerns warranted [1] Group 1: Impact on Innovative Drugs - Most Chinese innovative drugs that are currently being exported have either established production capacity in the U.S. or have outsourced production to local CMO companies [1] - The majority of domestic innovative drugs are exported using a business development (BD) model, which mitigates the impact of the tariff [1] Group 2: Impact on CXO Sector - The export products in the CXO sector primarily consist of raw materials and biological raw liquids, which are not affected by the new tariff; the proportion of finished dosage forms exported is low [1] - The investment timeline for multinational corporations (MNCs) to build factories in China will take time, leading to limited direct impact on CXO orders in the short term [1] - Long-term policy changes may influence the pace of factory construction by MNCs [1] Group 3: Upcoming Catalysts - The ESMO conference will take place in mid to late October, with a focus on companies like CanSino Biologics (09926), Kelun-Biotech (06990), and Rongchang Biologics (09995) that are expected to release significant data [1] - The results of medical insurance negotiations and the first version of the commercial insurance innovative drug directory are expected to be announced in October-November [1] Group 4: Mid to Long-term Recommendations - Recommended stocks in the innovative drug sector include 3SBio (01530) and Eucure Biopharma-B (06996), which have rich short-term catalysts and their valuations do not yet reflect the core value of major products [2] - Companies like Ascletis Pharma (02096), Hutchison China MediTech (00013), and Legend Biotech are considered undervalued with clear long-term growth logic [2] - In the CXO sector, WuXi AppTec (02268) is highlighted as a leading player benefiting from high downstream demand and improving financing conditions [2]

Group 1 - The core viewpoint is that the new 100% tariff on all branded/patented drugs announced by Trump will have limited impact on China's innovative drug industry chain, and there is no need for excessive concern [1] - For innovative drugs, most products currently being exported are either produced in the U.S. or outsourced to U.S. CMO, and most domestic innovative drugs are exported using the BD model [1] - For CXO, the main export products are raw materials and herbal extracts, which are not affected by the new tariff; the proportion of finished drug exports is low, and the investment timeline for MNC clients to build factories will take time, leading to limited short-term impact on CXO orders [1] Group 2 - Mid to long-term recommendations include innovative drugs such as 3SBio (01530) and Eucure Biopharma-B (06996), which have rich short-term catalysts and their valuations do not yet reflect the core value of major products [2] - Other recommended companies include Ascletis Pharma (02096), Hutchison China MediTech (00013), and Legend Biotech, which are considered significantly undervalued with clear long-term growth logic [2] - For CXO, companies like WuXi AppTec (02268) are expected to benefit from high downstream demand and improving financing conditions [2]

Core Viewpoint - Rongchang Biopharma (09995) saw a stock increase of over 7%, reaching 109.4 HKD with a trading volume of 357 million HKD, following the announcement of its drug Taitasip being prioritized for review for treating adult patients with primary immunoglobulin A (IgA) nephropathy, significantly reducing proteinuria levels [1][1][1] Group 1: Drug Development and Clinical Trials - On September 28, the CDE announced that Taitasip is proposed for priority review for treating IgA nephropathy, which poses a risk of progression [1] - On August 27, Rongchang Biopharma reported that the Phase III study of Taitasip for IgA nephropathy achieved its primary endpoint in Stage A, showing a 55% reduction in the 24-hour urine protein-to-creatinine ratio (UPCR) compared to the placebo group after 39 weeks of treatment [1][1][1] Group 2: Mechanism of Action - Taitasip is currently the only drug that can simultaneously inhibit B lymphocyte stimulator (BLyS) and proliferation-inducing ligand (APRIL), both of which are significantly elevated in IgA nephropathy patients compared to the normal population, acting as key drivers of the disease [1] - By inhibiting these two factors, Taitasip can reduce B cell proliferation, lower plasma cell counts, and decrease the generation of abnormal immunoglobulins, thereby blocking the deposition of immune complexes and alleviating renal immune inflammatory responses [1][1][1]

Core Viewpoint - Rongchang Biologics (09995) saw a significant stock increase of over 7%, reaching HKD 109.4 with a trading volume of HKD 357 million, following the announcement of its drug Taitasip being prioritized for review for treating adult patients with primary immunoglobulin A (IgA) nephropathy [1] Group 1: Drug Development and Clinical Trials - On September 28, the CDE website indicated that Taitasip is proposed for inclusion as a priority review product for treating adult patients with IgA nephropathy at risk of progression, significantly reducing proteinuria levels [1] - Previously, on August 27, Rongchang Biologics announced that the Phase III study of Taitasip for IgA nephropathy achieved its primary endpoint in Stage A, showing a 55% reduction in the 24-hour urine protein-to-creatinine ratio (UPCR) compared to the placebo group after 39 weeks of treatment [1] Group 2: Mechanism of Action - Taitasip is currently the only drug that can simultaneously inhibit B lymphocyte stimulator (BLyS) and proliferation-inducing ligand (APRIL), both of which are significantly elevated in IgA nephropathy patients compared to the normal population, serving as key drivers of the disease [1] - By inhibiting these two factors, Taitasip can reduce B cell proliferation, lower plasma cell counts, and decrease the production of abnormal immunoglobulins, thereby blocking the deposition of immune complexes at the source and alleviating renal immune inflammatory responses [1]

每经AI快讯，9月29日，港股荣昌生物(09995.HK)涨超7%，截至发稿，涨7.25%，报109.4港元，成交额 3.57亿港元。 ...

Core Viewpoint - Rongchang Biologics (09995) saw a stock increase of over 7%, reaching HKD 109.4 with a trading volume of HKD 357 million, following the announcement of its drug Taizhisip being prioritized for review for treating adult patients with primary immunoglobulin A (IgA) nephropathy [1] Company Developments - On September 28, the CDE announced that Rongchang Biologics' Taizhisip is proposed for inclusion in the priority review category for treating adult patients with IgA nephropathy at risk of progression, significantly reducing proteinuria levels [1] - On August 27, Rongchang Biologics reported that the Phase III study of Taizhisip for treating IgA nephropathy achieved its primary endpoint in Stage A, showing a 55% reduction in the 24-hour urine protein-to-creatinine ratio (UPCR) compared to the placebo group after 39 weeks of treatment [1] Drug Mechanism - Taizhisip is currently the only drug that can simultaneously inhibit B lymphocyte stimulator (BLyS) and proliferation-inducing ligand (APRIL), both of which are significantly elevated in IgA nephropathy patients compared to the normal population, serving as key drivers of the disease [1] - By inhibiting these two factors, Taizhisip can reduce B cell proliferation, lower plasma cell counts, and decrease abnormal immunoglobulin production, thereby blocking the deposition of immune complexes and alleviating renal immune inflammatory responses [1]

Core Viewpoint - Rongchang Biologics (09995) saw a stock increase of over 7%, currently at 109.4 HKD, with a trading volume of 357 million HKD, following the announcement of its drug Taitasip being prioritized for review for treating adult patients with primary immunoglobulin A (IgA) nephropathy [1] Group 1: Drug Development and Clinical Trials - On September 28, the CDE website indicated that Taitasip is proposed for inclusion in the priority review category for treating adult patients with IgA nephropathy at risk of progression, significantly reducing proteinuria levels [1] - On August 27, Rongchang Biologics announced that the Phase III study of Taitasip for treating IgA nephropathy achieved its primary endpoint in Stage A, showing a 55% reduction in the 24-hour urine protein-to-creatinine ratio (UPCR) compared to the placebo group after 39 weeks of treatment [1] Group 2: Mechanism of Action - Taitasip is currently the only drug that can simultaneously inhibit B lymphocyte stimulator (BLyS) and proliferation-inducing ligand (APRIL), both of which are significantly elevated in IgA nephropathy patients compared to the normal population, serving as key drivers of the disease [1] - By inhibiting these two factors, Taitasip can reduce B cell proliferation, lower plasma cell counts, and decrease the generation of abnormal immunoglobulins, thereby blocking the deposition of immune complexes at the source and alleviating renal immune inflammatory responses [1]

Core Viewpoint - The Hang Seng Healthcare Index fell by 1.4% this week, underperforming the market, with internet medicine, CXO, and traditional Chinese medicine sectors showing better performance [1] Group 1: Market Trends - Since September, the proportion of domestic holdings through the Hong Kong Stock Connect has remained stable, while foreign holdings have slightly decreased since mid-year [1] - Both domestic and foreign investors continue to increase their positions in innovative pharmaceutical companies, indicating a consistent long-term strategy [1] Group 2: Investment Recommendations - The report suggests focusing on companies with significant data releases at the upcoming ESMO conference in mid to late October, specifically mentioning Kangfang Biotech (09926), Kelun-Biotech (06990), and Rongchang Biotech (09995) [1] - The importance of timing and stock selection has increased following a broad rise in the innovative drug sector, with recommendations to gradually build positions during market corrections [1] Group 3: Sector Focus - For the innovative drug sector, the report highlights companies such as 3SBio (01530) and Eucure Biopharma-B (06996) as having rich short-term catalysts and undervalued core products, while companies like Ascletis Pharma (02096), Hutchison China MediTech (00013), and Legend Biotech are noted as significantly undervalued with clear long-term growth logic [1] - In the CXO sector, the report points to leading companies benefiting from high downstream demand and marginal recovery in financing, specifically mentioning WuXi AppTec (02268) [1]

Core Viewpoint - The Hang Seng Healthcare Index declined by 1.4% this week, underperforming the market, with internet medicine, CXO, and traditional Chinese medicine sectors showing better performance [1] Group 1: Market Trends - Since September, the proportion of domestic holdings through the Hong Kong Stock Connect has remained stable, while foreign holdings have slightly decreased since mid-year [1] - Both domestic and foreign investors continue to increase their positions in innovative pharmaceutical companies, indicating a consistent long-term strategy [1] Group 2: Investment Opportunities - Domestic investors are focusing on rebound opportunities, while foreign investors are increasing positions in innovative drug targets with high long-term potential and current cost-effectiveness [1] - The innovative drug guarantee model is gradually taking shape, which is expected to alleviate challenges such as hospital access and reimbursement difficulties for companies [1] Group 3: Upcoming Events - The ESMO conference will be held in mid to late October, and the report suggests focusing on companies like CanSino Biologics (09926), Kelun-Biotech (06990), and Rongchang Biologics (09995) that are expected to release significant data [1] Group 4: Stock Recommendations - The importance of timing and stock selection has increased after a broad rise in the innovative drug sector, with recommendations to gradually build positions during sector pullbacks [1] - Specific recommendations include: 1. Innovative drugs: 3SBio (01530), Eucure Biopharma-B (06996) with rich short-term catalysts and undervalued long-term growth logic [1] 2. CXO: Leaders in high-demand segments benefiting from improved financing conditions, such as WuXi AppTec (02268) [1]

Financial Performance - Revenue for the six months ended June 30, 2025, reached RMB 1,091,976 thousand, a significant increase of 47.6% from RMB 739,656 thousand in the same period of 2024[9]. - Gross profit for the first half of 2025 was RMB 921,848 thousand, up 61.5% from RMB 570,385 thousand in the prior year[9]. - RemeGen's pre-tax loss for the first half of 2025 was RMB 449,568 thousand, an improvement from a loss of RMB 780,460 thousand in the same period of 2024[9]. - The net loss for the period was RMB 449,568 thousand, an improvement from a net loss of RMB 780,460 thousand in the prior year, showing a 42.4% reduction in losses[132]. - The basic loss per share improved to RMB (0.83) from RMB (1.45) year-over-year, indicating better performance on a per-share basis[132]. - The total comprehensive loss for the period was RMB 419,557 thousand, which includes other comprehensive income of RMB 29,011 thousand[138]. Assets and Liabilities - Total assets increased to RMB 5,850,358 thousand as of June 30, 2025, compared to RMB 5,498,519 thousand as of December 31, 2024, reflecting a growth of approximately 6.4%[9]. - The total liabilities as of June 30, 2025, were RMB 3,492,867 thousand, a slight decrease from RMB 3,512,318 thousand as of December 31, 2024[9]. - The total equity increased to RMB 2,357,491 thousand as of June 30, 2025, compared to RMB 1,986,201 thousand as of December 31, 2024, representing a growth of approximately 18.6%[9]. - Cash and cash equivalents increased significantly to RMB 1,271,002 thousand from RMB 759,530 thousand, representing a 67.3% increase[135]. - The group's debt-to-asset ratio improved from 63.9% as of December 31, 2024, to 59.7% as of June 30, 2025[58]. Research and Development - Research and development expenses decreased to RMB 647,216 thousand in the first half of 2025 from RMB 806,233 thousand in the same period of 2024, indicating a reduction of approximately 19.7%[9]. - The company has developed over ten drug candidates, with seven currently in clinical development targeting more than twenty indications[10]. - The company is developing a rich pipeline of candidates, including Taitasip for various autoimmune diseases and other indications[14]. - The company is actively exploring additional indications for Taitasip, planning to initiate multiple Phase II/III clinical trials domestically[19]. Clinical Trials and Product Development - The company initiated a Phase III clinical trial for Taitasip (RC18) in China for the treatment of generalized myasthenia gravis (gMG) in the first half of 2023, with the trial expected to reach its primary endpoint by August 2024[15]. - In the Phase III trial, Taitasip demonstrated a significant reduction in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score by 5.74 points compared to a 0.91 point reduction in the placebo group, with 98.1% of patients showing improvement of ≥3 points[16]. - A licensing agreement was established with Vor Biopharma Inc. for the development and commercialization of Taitasip outside Greater China, with a total value of $125 million, including an upfront payment of $45 million[19]. - Vor Biopharma is conducting a global Phase III clinical trial for Taitasip in gMG patients, having received orphan drug designation from the FDA in October 2022[20]. - The company has developed Vidisicimab, a leading antibody-drug conjugate (ADC) candidate, which is the first domestically approved ADC in China for treating HER2-expressing solid tumors, including low-expressing types[22]. Market and Sales - The company has commercialized two products, RC18 (brand name: Tai'ai®) and RC48 (brand name: Aidiqi®), which are undergoing clinical trials in China and the United States for over twenty indications[10]. - The company aims to become a leading player in the global biopharmaceutical industry, focusing on innovative and differentiated biologics for unmet medical needs[10]. - Revenue increased from RMB 739.7 million for the six months ended June 30, 2024, to RMB 1,092.0 million for the six months ended June 30, 2025, driven by strong sales of the autoimmune product Taitasip and the oncology product Vidisizumab[42]. Shareholder and Equity Information - As of June 30, 2025, the company had a total of 563,608,243 shares, including 208,581,239 H-shares and 355,027,004 A-shares[75]. - Mr. Wang Weidong holds a 43.25% equity interest in A-shares through controlled entities, representing 27.24% of the total shares[71]. - The company has established a consortium agreement among key stakeholders to ensure unified action in management and decision-making[73]. - The company issued 54,426,301 new A-shares at RMB 48.00 per share, raising approximately RMB 2,612.4 million, with net proceeds of about RMB 2,505.9 million after deducting issuance costs[68]. Incentive Plans - The company has implemented the first H-share plan to enhance its compensation system and ensure a balance of interests among stakeholders[82]. - The second phase of the H-share plan allows for the purchase of up to 27,213,150 H-shares, representing approximately 13.05% of the total issued H-shares and about 4.83% of the total share capital as of the report date[96]. - The 2022 A-share plan aims to enhance the company's long-term incentive mechanism, attracting and retaining talent while aligning the interests of shareholders, the company, and core team members[105]. - The maximum number of shares that any incentive recipient can receive will not exceed 1% of the total shares as of the announcement date[105]. Corporate Governance - The company has complied with all applicable corporate governance codes as of June 30, 2025[122]. - The independent auditor has reviewed the interim financial information in accordance with the relevant standards, confirming compliance with applicable accounting standards and regulations[124].