Core Insights - Rongchang Biopharma (09995) shares increased by approximately 9%, reaching HKD 95.95 with a trading volume of HKD 383 million [1] Financial Performance - For the first half of the year, the company reported revenue of CNY 1.09 billion, representing a year-on-year growth of 48% [1] - The net loss attributable to shareholders was CNY 450 million, which is a reduction in loss by CNY 330 million compared to the previous year [1] Product Performance - The revenue growth is primarily driven by increased sales of its core products, Tai Taisip and Vidi Sima, both of which were included in the medical insurance directory in 2021 [1] - The approval of Tai Taisip for gMG has been granted, with expectations for pSS and IgAN to submit for market approval in the second half of 2025 [1] - Vidi Sima has received approval for treating second-line HER2-positive breast cancer with liver metastasis, and applications for additional indications are underway, which is expected to accelerate commercialization [1]

Group 1 - The company reported a revenue of 1.1 billion yuan (+48%) for the first half of 2025, with a net loss attributable to shareholders of 450 million yuan, meeting expectations [1] - Core products are experiencing continuous growth, with over 1,000 hospitals approved for both autoimmune and oncology treatments. The commercialization team for autoimmune diseases has approximately 900 members, while the oncology team has over 500 members [1] - The company successfully licensed Tai'tasip for the treatment of myasthenia gravis to Vor Bio, receiving an upfront payment of 45 million USD and potential milestone payments totaling up to 4.105 billion USD [2] Group 2 - The company licensed RC28 to Santen China, receiving an upfront payment of 250 million yuan and potential milestone payments totaling up to 525 million yuan [3] - The company expects revenues of 2.21 billion, 2.95 billion, and 4.26 billion yuan for the years 2025, 2026, and 2027, respectively, driven by the continued growth of Tai'tasip and Vidi'simab [3]

Core Viewpoint - The company reported a revenue of 1.09 billion yuan for the first half of 2025, representing a year-on-year growth of 48%, while the net loss attributable to shareholders was 450 million yuan, a reduction in loss by 330 million yuan compared to the previous year, aligning with expectations [1] Group 1: Financial Performance - The company's gross margin reached 84.0% in the first half of 2025, an increase of 5.8 percentage points compared to the same period in 2024 [1] - The sales expense ratio was 47.9%, a decrease of 4.6 percentage points year-on-year, indicating effective cost and expense management [1] - The company reduced its losses by 42.4% year-on-year and by 23.2% quarter-on-quarter in the second quarter of 2025 [1] Group 2: Product Development and Market Potential - The core product, Tai Tasi Pu (泰它西普), has been approved for market launch, with expectations for pSS and IgAN to submit applications in the second half of 2025 [1] - The company has received approval for the use of Vidi Xi Tuo (维迪西妥单抗) in treating second-line HER2-positive breast cancer with liver metastasis, and has submitted applications for other indications [1] - The PD-1/VEGF dual antibody is advancing in global clinical research, with a focus on its potential for international expansion [2] Group 3: Clinical Trials and Regulatory Approvals - Tai Tasi Pu has reached the primary endpoint in the Phase III clinical trial for IgA nephropathy in China, with plans to expedite the application for market approval [2] - The trial included 318 adult patients receiving standard treatment, showing a 55% reduction in the urine protein-to-creatinine ratio after 39 weeks of treatment [2] Group 4: Profit Forecast and Valuation - Based on the semi-annual report and expected potential collaboration funds, the profit forecast for 2025/2026 has been adjusted from a loss of 915 million yuan/333 million yuan to a loss of 345 million yuan and a profit of 34 million yuan, respectively [3] - The target price has been raised by 10.6% to 105.44 HKD, indicating a 20% upside potential from the current stock price [3]

Core Viewpoint - The report from CMB International indicates that Rongchang Biologics (09995) is making significant progress in the research and development of its core products, with the domestic Phase III study of Tai Tasi Pu for the treatment of Sjögren's syndrome reaching its primary endpoint, and a market application is expected to be submitted in the second half of the year [1] Financial Performance - Rongchang Biologics experienced a strong sales growth in Q2, with revenue increasing by 47.6% year-on-year [1] - The gross margin improved by 7.3 percentage points compared to the same period last year, reaching 84.4% [1] - The company recorded a loss of 195 million RMB, which has narrowed both year-on-year and quarter-on-quarter [1] Future Outlook - Management maintains guidance for over 30% growth in product sales for the full year [1] - The company aims to achieve breakeven by next year and expects to become profitable by 2027, excluding BD [1] - CMB International has adjusted its revenue forecast for Rongchang Biologics for 2027 downwards but raised its net profit forecast, increasing the target price to 103 HKD while maintaining a "Buy" rating [1]

Core Viewpoint - The report from CMB International indicates that Rongchang Biologics (09995) is making significant progress in the research and development of its core products both domestically and internationally, particularly with its drug Taitasip for the treatment of Sjögren's syndrome, which has reached its primary endpoint in the domestic Phase III study and is expected to submit a market application in the second half of the year [1] Financial Performance - Rongchang Biologics experienced strong sales growth in the second quarter, with revenue increasing by 47.6% year-on-year [1] - The gross margin improved by 7.3 percentage points compared to the same period last year, reaching 84.4% [1] - The company recorded a loss of 195 million RMB, which has narrowed both year-on-year and quarter-on-quarter [1] Future Outlook - Management maintains guidance for over 30% growth in product sales for the full year [1] - The company aims to achieve breakeven by next year and expects to become profitable by 2027, excluding business development (BD) impacts [1] Target Price Adjustment - CMB International has adjusted its revenue forecast for Rongchang Biologics for 2027 downward due to the licensing of Taitasip but has raised its net profit forecast and increased the target price to 103 HKD while maintaining a "Buy" rating [1]

Investment Rating - The report maintains a "Buy" rating for both A-shares and H-shares of the company [4]. Core Insights - The company's core products, Taietisib and Vidisizumab, have seen significant sales growth, contributing to a 48.02% increase in revenue for the first half of 2025 compared to the same period last year [2]. - The company has established a commercial team of approximately 900 sales personnel for autoimmune products and over 500 for oncology, achieving drug access in more than 1,000 hospitals [2]. - The report highlights accelerated clinical trial progress for multiple drug candidates both in China and overseas, with ongoing developments targeting various indications [2]. Financial Forecasts and Valuation - The projected net profit for the company from 2025 to 2027 is estimated at -1.02 billion, -0.43 billion, and +0.175 billion respectively [2]. - Revenue forecasts for the years 2023 to 2027 are 1.083 billion, 1.717 billion, 2.529 billion, 3.389 billion, and 4.278 billion respectively, with growth rates of 40.26%, 58.54%, 47.33%, 33.97%, and 26.25% [3][9]. - The report indicates that the company has strong product innovation capabilities and potential for overseas expansion [2]. Profitability and Financial Metrics - The gross margin is projected to improve from 77.4% in 2023 to 84.7% in 2027 [11]. - The report outlines a significant reduction in net losses, with projections showing a decrease from -1.511 billion in 2023 to a profit of 0.175 billion in 2027 [9][11]. - The company's operating cash flow is expected to improve significantly, moving from -1.503 billion in 2023 to a positive cash flow of 0.301 billion by 2027 [9].

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不就因本公告全部或任何部分內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 IgAN是一種常見的原發性腎小球疾病，該病臨床表現多樣，如反覆發作的鏡下血 尿或肉眼血尿，伴有不同程度蛋白尿，部分患者可以出現嚴重高血壓或者腎功能 異常。IgA腎病也是中國慢性腎臟病和終末期腎病的主要原因之一，高達40%的 IgA腎病患者在診斷後20年內達到終末期腎病，產生對新型藥物迫切的未滿足醫 療需求。目前學術界認為，半乳糖缺乏型IgA1(Gd-IgA1)分泌過多是IgA腎病的發 病的核心及始動因素。 1 RemeGen Co., Ltd.* 榮 昌 生 物 製 藥（ 煙 台 ）股 份 有 限 公 司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：9995） 自願公告 泰它西普（商品名：泰愛®）治療IgA腎病 中國III期臨床研究A階段達到主要終點 本公告由榮昌生物製藥（煙台）股份有限公司（「本公司」）自願作出。 本公司董事會（「董事會」）欣然宣佈，本公司自主研發的全球首創BLyS/APR ...

Group 1 - The core point of the article is that Rongchang Biologics (09995) has achieved the primary endpoint in the Phase III clinical trial of its innovative drug Taitasip (brand name: Tai'ai) for the treatment of IgA nephropathy (IgAN) in China [1] - The Phase III trial was a multicenter, randomized, double-blind, placebo-controlled study involving 318 adult patients with IgAN who had received standard treatment [1] - Taitasip was administered at a dosage of 240mg via subcutaneous injection once a week, showing a 55% reduction in the 24-hour urine protein-to-creatinine ratio (UPCR) compared to the control group after 39 weeks (P<0.0001) [1] Group 2 - IgAN is a common primary glomerular disease that can lead to severe hypertension or renal dysfunction, with up to 40% of patients reaching end-stage renal disease within 20 years of diagnosis [2] - The pathogenesis of IgAN is believed to be linked to the excessive secretion of galactose-deficient IgA1 (Gd-IgA1), with BLyS and APRIL being key cytokines in promoting Gd-IgA1 and its antibodies [2] - Taitasip is a recombinant dual-target fusion protein that inhibits both BLyS and APRIL, preventing abnormal differentiation and maturation of B cells, thereby alleviating pathological immune responses [2]

Core Viewpoint - Rongchang Biopharma (09995.HK) announced that its self-developed innovative drug, Tai Aixin (泰爱®), a world-first BLyS/APRIL dual-target fusion protein, has achieved the primary research endpoint in the Phase III clinical study for treating IgA nephropathy (IgAN) in China [1] Summary by Categories - **Clinical Development** - The Phase III clinical study for Tai Aixin has reached the primary research endpoint [1] - The company plans to submit a New Drug Application (BLA) to the National Medical Products Administration (NMPA) in China as soon as possible [1]

Group 1 - The company Rongchang Biologics (09995) announced that its self-developed innovative drug Tai'aisip (泰爱®), a first-in-class BLyS/APRIL dual-target fusion protein, has met the primary endpoint in the Phase III clinical trial for treating IgA nephropathy (IgAN) in China [1] - The clinical trial was a multi-center, randomized, double-blind, placebo-controlled study involving 318 adult patients with IgAN who had received standard treatment, with a dosage of 240mg administered subcutaneously once a week [1] - Results from the A stage analysis showed that patients in the Tai'aisip group had a 55% reduction in the 24-hour urine protein-to-creatinine ratio (UPCR) compared to the control group at 39 weeks (P<0.0001), demonstrating good tolerability and safety [1] Group 2 - IgAN is a common primary glomerular disease with diverse clinical manifestations, including recurrent microscopic or macroscopic hematuria and varying degrees of proteinuria, and is a major cause of chronic kidney disease and end-stage renal disease in China [2] - Up to 40% of IgAN patients may reach end-stage renal disease within 20 years of diagnosis, indicating a pressing unmet medical need for new therapies [2] - The company’s Tai'aisip targets the underlying mechanisms of IgAN by inhibiting the production of Gd-IgA1 and its antibodies through the dual inhibition of BLyS and APRIL, which are key cytokines in the disease process [2]