Core Insights - Rongchang Biopharmaceutical (09995.HK) announced that its dual-target fusion protein drug, Taitasip (brand name: Tai'ai®), has successfully completed Phase III clinical trials for the treatment of primary Sjögren's syndrome (pSS) in China, achieving the primary endpoint of the study [1] - The company plans to submit a marketing application to the National Medical Products Administration (NMPA) and will present detailed data at major international academic conferences [1] - Taitasip is the first dual-target fusion protein drug to complete Phase III trials in the field of Sjögren's syndrome treatment [1] Clinical Study Details - The Phase III clinical study was a multicenter, randomized, double-blind, placebo-controlled trial aimed at evaluating the efficacy and safety of Taitasip in patients with primary Sjögren's syndrome [2] - The primary endpoint was the change in ESSDAI score at week 24, which is the gold standard for measuring disease activity in Sjögren's syndrome [1] - Results indicated that Taitasip significantly and sustainably improved clinical symptoms in patients, demonstrating good efficacy and safety [1] Disease Background and Market Potential - Sjögren's syndrome is a chronic inflammatory autoimmune disease characterized by lymphocytic infiltration and damage to exocrine glands, leading to persistent dryness of the mouth and eyes, and potentially affecting multiple organ systems [1] - The prevalence of Sjögren's syndrome in China is estimated to be between 0.3% and 0.7%, with an increasing trend, indicating a significant unmet clinical need [1] Mechanism of Action - Research indicates that the overactivation of autoreactive B cells is a key pathological basis for the onset of Sjögren's syndrome [2] - Taitasip is a novel dual-target fusion protein developed by the company that simultaneously inhibits the overexpression of B lymphocyte stimulator (BLyS) and proliferation-inducing ligand (APRIL), effectively preventing abnormal differentiation and maturation of B cells [2] - Taitasip has received multiple authoritative guideline recommendations in China, including the "Clinical Practice Guidelines for Sjögren's Syndrome" and the "Expert Consensus on B Cell Targeted Therapy for Rheumatic and Immune Diseases" [2]

Core Viewpoint - Rongchang Biologics (09995) has announced that its innovative BLyS/APRIL dual-target fusion protein drug, Taisip, has successfully met the primary endpoint of its Phase III clinical trial for treating primary Sjögren's syndrome (pSS) in China, marking it as the first of its kind globally to complete such a study [1][2] Group 1: Clinical Trial Details - The Phase III clinical trial was a multicenter, randomized, double-blind, placebo-controlled study aimed at evaluating the efficacy and safety of Taisip in patients with primary Sjögren's syndrome [1] - The primary endpoint was the change in ESSDAI score at week 24, which is the gold standard for measuring disease activity in Sjögren's syndrome [1] - Results indicated that Taisip can sustainably and effectively improve clinical symptoms in patients, demonstrating good efficacy and safety [1] Group 2: Disease Background and Market Potential - Primary Sjögren's syndrome is a chronic inflammatory autoimmune disease characterized by lymphocytic infiltration and damage to exocrine glands, leading to persistent dry mouth and dry eyes, and can affect multiple organ systems [1] - The prevalence of Sjögren's syndrome in China is estimated to be between 0.3% and 0.7%, with an increasing trend, indicating a significant unmet clinical need [1] Group 3: Drug Development and Recognition - Taisip is a novel dual-target fusion protein developed by the company, designed to simultaneously inhibit the overexpression of B lymphocyte stimulator (BLyS) and proliferation-inducing ligand (APRIL), effectively preventing abnormal differentiation and maturation of B cells [2] - In China, Taisip has received recommendations from several authoritative guidelines, including the "Chinese Clinical Practice Guidelines for Sjögren's Syndrome" and the "Expert Consensus on B Cell Targeted Therapy for Rheumatic and Immune Diseases" [2] - Internationally, Taisip has been granted Fast Track designation by the U.S. Food and Drug Administration and has been approved to conduct global multicenter Phase III clinical trials for its indication in Sjögren's syndrome [2]

Core Viewpoint - Rongchang Biopharmaceutical (09995) announced that its innovative BLyS/APRIL dual-target fusion protein drug, Tai'aisip (泰爱), has successfully completed the primary endpoint of a Phase III clinical trial for the treatment of primary Sjögren's syndrome (pSS) in China, and the company plans to submit a marketing application to the National Medical Products Administration (NMPA) soon [1][2] Group 1 - Tai'aisip is the first BLyS/APRIL dual-target fusion protein drug globally to complete Phase III research for the treatment of Sjögren's syndrome [1] - The Phase III clinical study is a multi-center, randomized, double-blind, placebo-controlled trial aimed at evaluating the efficacy and safety of Tai'aisip in pSS patients, with the primary endpoint being the change in ESSDAI score at week 24 [1] - The results indicate that Tai'aisip can sustainably and effectively improve clinical symptoms in pSS patients, demonstrating good efficacy and safety [1] Group 2 - Primary Sjögren's syndrome is a chronic inflammatory autoimmune disease characterized by lymphocyte infiltration and damage to exocrine glands, leading to persistent dry mouth and dry eyes, and can affect multiple organ systems [1] - The prevalence of Sjögren's syndrome in China is estimated to be between 0.3% and 0.7%, with an increasing trend, indicating a significant unmet clinical need [1] - The overactivation of autoreactive B cells is a key pathological basis for the onset of Sjögren's syndrome, and Tai'aisip effectively inhibits the overexpression of BLyS and APRIL, preventing abnormal differentiation and maturation of B cells [2] Group 3 - Tai'aisip has received multiple authoritative guideline recommendations in China, including the "Clinical Practice Guidelines for the Use of Super Drugs in Sjögren's Syndrome" and the "Expert Consensus on B Cell Targeted Therapy for Rheumatic and Immune Diseases" [2] - Internationally, Tai'aisip has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for its indication in Sjögren's syndrome and has been approved to conduct global multi-center Phase III clinical trials [2]

Core Insights - Rongchang Biopharmaceutical (09995.HK) announced that its dual-target fusion protein drug, Taitasip (brand name: Tai'ai®), has successfully completed Phase III clinical trials for the treatment of primary Sjögren's syndrome (pSS) in China, achieving the primary endpoint of the study [1][2] - The company plans to submit a marketing application to the National Medical Products Administration (NMPA) and will present detailed data at major international academic conferences [1] - Taitasip is the first dual-target fusion protein drug to complete Phase III trials in the field of Sjögren's syndrome treatment globally [1] Clinical Study Details - The Phase III clinical study was a multicenter, randomized, double-blind, placebo-controlled trial aimed at evaluating the efficacy and safety of Taitasip in pSS patients [1] - The primary endpoint was the change in ESSDAI score at week 24, which is the gold standard for measuring disease activity in Sjögren's syndrome [1] - Results indicated that Taitasip significantly and sustainably improved clinical symptoms in pSS patients, demonstrating good efficacy and safety [1] Disease Background - Sjögren's syndrome is a chronic inflammatory autoimmune disease characterized by lymphocytic infiltration and damage to exocrine glands, leading to persistent dry mouth and dry eyes, and can affect multiple organ systems [1] - The prevalence of Sjögren's syndrome in China is estimated to be between 0.3% and 0.7%, with an increasing trend, indicating a significant unmet clinical need [1] Mechanism of Action - Research indicates that the overactivation of autoreactive B cells is a key pathological basis for the development of Sjögren's syndrome [2] - Taitasip is a novel dual-target fusion protein developed by the company that simultaneously inhibits the overexpression of B lymphocyte stimulator (BLyS) and proliferation-inducing ligand (APRIL), effectively preventing abnormal differentiation and maturation of B cells [2] - Taitasip has received multiple authoritative guideline recommendations in China, including the "Clinical Practice Guidelines for the Use of Sjögren's Syndrome Super Drug" and the "Expert Consensus on B Cell Targeted Therapy for Rheumatic and Immune Diseases" [2]

Core Viewpoint - Rongchang Biologics announced that its dual-target fusion protein drug, Taisip (brand name: Tai'ai), has achieved the primary endpoint of its Phase III clinical trial for the treatment of primary Sjögren's syndrome (pSS) in China [1] Group 1 - The drug Taisip is the world's first BLyS/APRIL dual-target fusion protein [1] - The company plans to submit a marketing application to the National Medical Products Administration (NMPA) as soon as possible [1] - Specific data from the clinical trial will be presented at major international academic conferences at an appropriate time [1]

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。 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®）治療原發性乾燥綜合徵 中國III期臨床研究達到主要終點 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，全球首創BLyS/APRIL雙靶點融合蛋白藥物 泰它西普（商品名：泰愛®)用於治療原發性乾燥綜合徵(pSS)的中國III期臨床研 究，達到方案設計的臨床試驗主要研究終點，將盡快向國家藥品監督管理局藥品 審評中心(CDE)遞交上市申請，並擇機在國際重大學術會議上公佈具體數據。泰 它西普成為治療乾燥綜合徵領域全球首個完成III期研究的BLyS/APRIL雙靶點融 合蛋白藥物。 1 在中國，泰它西普獲得《乾燥綜合徵超藥品說明書用藥中國臨床實踐指南》《B細 ...

Core Viewpoint - Rongchang Biopharma is attempting to raise funds through H-share placement despite showing high revenue growth, as it struggles with persistent losses and financial challenges [2][4][6]. Financial Performance - The company reported a revenue of 5.26 billion yuan in Q1 2025, a 59.2% year-on-year increase, but faced a net loss of 2.54 billion yuan [4]. - In 2024, the total revenue reached 17.17 billion yuan, up 58.54% year-on-year, yet the net loss was 14.68 billion yuan [6]. - The two main products, Taitasip and Vidisizumab, accounted for over 90% of the revenue, with sales of 9.7 billion yuan and 7.2 billion yuan respectively [7]. Cost Structure - The company's sales, management, and financial expenses totaled 13.35 billion yuan, representing 77.75% of its revenue [10]. - Taitasip's gross margin was 73.92%, below the industry average of 83.45%, indicating competitive pressure [8]. Cash Flow and Receivables - Accounts receivable surged by 28.79% year-on-year, leading to a significant cash flow outflow of 11.14 billion yuan [8]. - The company’s cash flow situation is concerning, with a cash-to-current liabilities ratio of only 37.82% [14]. Debt and Financing - As of March 2025, the company had 7.22 billion yuan in cash against short-term borrowings of 10.84 billion yuan and long-term borrowings of 14.82 billion yuan, covering only 67% of short-term debts [11]. - The debt ratio increased to 63.88% by the end of 2024, significantly higher than the industry average [11][12]. Regulatory Attention - Regulatory bodies have expressed concern over the company's financial health, particularly regarding its liquidity and debt levels [13][14]. - The company has been asked to clarify its revenue recognition and debt management strategies in response to regulatory inquiries [14]. Future Challenges - The company faces the challenge of breaking the cycle of relying on financing to cover losses while needing to improve its profitability and cash flow management [2][15].

Core Insights - The company has successfully completed a Phase III clinical trial for its innovative drug, Tai'ai (RC18), targeting primary Sjögren's syndrome, achieving the primary endpoints as per the study design [1][3] Group 1: Drug Development and Clinical Research - Tai'ai is a dual-target fusion protein developed by the company, designed to inhibit the overactivation of autoreactive B cells, which is a significant pathological basis for the onset of Sjögren's syndrome [2] - The Phase III clinical trial was a multi-center, randomized, double-blind, placebo-controlled study aimed at evaluating the efficacy and safety of Tai'ai in patients with primary Sjögren's syndrome [1][3] - Results from the clinical study indicate that Tai'ai can sustainably and effectively improve clinical symptoms in patients, demonstrating good efficacy and safety [3] Group 2: Market and Clinical Need - Primary Sjögren's syndrome is a chronic inflammatory autoimmune disease with a prevalence rate in China ranging from 0.3% to 0.7%, indicating a growing unmet clinical need [1] - The company plans to submit a marketing application to the National Medical Products Administration (NMPA) in China, with detailed data expected to be presented at major international academic conferences [3]

Investment Rating - The report maintains a "Buy" rating for the company [5]. Core Insights - The company has achieved the primary endpoint in the Phase III clinical trial of its innovative drug, Taitasip (BLyS/APRIL dual-target fusion protein), for the treatment of primary Sjögren's syndrome (pSS) and plans to submit a marketing application to the National Medical Products Administration (NMPA) [2]. - There is a large patient base for Sjögren's syndrome in China, with an estimated prevalence of 0.3%-0.7%, translating to approximately 4.2 to 9.8 million patients, and the demand for effective treatments is significant due to the limited availability of specialized therapies [3]. - The company is progressing rapidly in the development of Taitasip, which has a clear first-mover advantage in the domestic market, as it is among the few innovative therapies for Sjögren's syndrome currently in clinical trials [3]. - Taitasip has demonstrated good efficacy and safety in its Phase II clinical trial, with no deaths or serious adverse events reported [3]. - The company is also advancing its PD-1/VEGF dual antibody, RC148, which has received FDA IND approval and is expected to enter international Phase II clinical trials [4]. Financial Forecast and Valuation - The company is projected to achieve revenues of 2.339 billion RMB, 3.247 billion RMB, and 4.597 billion RMB in 2025, 2026, and 2027, respectively, with a net profit of -855 million RMB, -90 million RMB, and 362 million RMB in the same years [5][9]. - The revenue growth rates are expected to be 40.26%, 58.54%, 36.26%, 38.78%, and 41.58% from 2023 to 2027 [9].

Group 1 - The core viewpoint of the news highlights the performance of the Sci-Tech Innovation Board, with Rongchang Biologics leading the gains at 9.77% and the overall market showing mixed results [1] - Rongchang Biologics announced the successful completion of the primary endpoint in the Phase III clinical trial of its innovative drug, RC18 (brand name: Tai Ai®), for the treatment of primary Sjögren's syndrome (pSS) [1] - Jianghai Securities emphasizes that innovation-driven growth and internationalization are the main themes in the industry, with increased policy support for innovative drugs and enhanced R&D capabilities of domestic pharmaceutical companies [1] Group 2 - The Sci-Tech 100 ETF (588800) closely tracks the Sci-Tech 100 Index, which is the first and only mid-cap style index on the Sci-Tech Innovation Board, focusing on high-growth tech companies in the semiconductor, pharmaceutical, and new energy sectors [2]