Core Viewpoint - Rongchang Biologics (09995) shares rose over 5%, reaching a price of HKD 96.45, following the announcement of positive Phase III clinical trial results for Taitasip in treating systemic lupus erythematosus (SLE) published in the New England Journal of Medicine (NEJM) [1] Group 1: Clinical Trial Results - The Phase III trial achieved its primary endpoint, with 67.1% of patients in the Taitasip group showing significant improvement in disease activity, compared to 32.7% in the placebo group [1] - Taitasip is confirmed as a transformative B-cell therapy targeting BLyS/APRIL dual pathways, highlighting its advantages in treating SLE [1] Group 2: Disease Context and Treatment Landscape - Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that can affect multiple organs and lead to irreversible damage, with over half of patients experiencing organ damage within 2-6 years of diagnosis [1] - Despite existing treatment options such as corticosteroids, antimalarials, immunosuppressants, and biologics, many patients still face challenges with disease activity, indicating a pressing need for new therapies [1] - Taitasip was approved for SLE treatment in China in March 2021 and was included in the national medical insurance drug list by the end of the same year, marking it as the world's first dual-target biologic new drug for SLE [1]

Core Viewpoint - Rongchang Biologics (09995) shares rose over 5%, currently up 5.7% at HKD 96.45, with a trading volume of HKD 205 million, following the announcement of positive Phase III clinical trial results for Taitasip in treating systemic lupus erythematosus (SLE) published in the New England Journal of Medicine (NEJM) [1][1][1] Group 1 - The Phase III trial achieved its primary endpoint, with 67.1% of patients in the Taitasip group showing significant improvement in disease activity compared to 32.7% in the placebo group [1][1][1] - Taitasip, a dual-target biologic therapy for B cells, is highlighted as a transformative treatment for SLE, showcasing its advantages in this therapeutic area [1][1][1] Group 2 - Systemic lupus erythematosus (SLE) is a chronic autoimmune disease that can affect multiple organs and lead to irreversible damage, with over half of patients experiencing organ damage within 2-6 years of diagnosis [1][1][1] - Despite existing treatment options such as corticosteroids, antimalarials, immunosuppressants, and biologics, many patients still face challenges with disease activity, indicating a pressing need for new therapies [1][1][1] - Taitasip was approved for SLE treatment in China in March 2021 and entered the national medical insurance drug list by the end of the same year, marking it as the world's first dual-target biologic new drug for SLE [1][1][1]

Core Viewpoint - Rongchang Bio (09995) has entered into an agreement with SPD Bank Yantai Branch to invest a total of RMB 5 billion in wealth management products, utilizing both idle self-owned funds and idle raised funds [1] Group 1 - The company will invest RMB 400 million of its idle self-owned funds in the wealth management products [1] - The company will also invest RMB 100 million of its idle raised funds in the wealth management products [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的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並表明概不就因本公告全部或任何部份內容而產生或因依賴該等 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） 須予披露交易 購買理財產品 購買理財產品 本公司第二屆董事會第二十一次會議已於2025年3月27日，(1)審議批准了關 於使用自有資金進行現金管理的決議，根據該決議本公司可使用不超過人民幣 500.0百萬元額度的部分閒置自有資金購買保本型銀行理財產品，以及(2)審議批 准了關於使用閒置募集資金進行現金管理的決議，根據該決議本公司可使用不 超過人民幣140.0百萬元額度的部分閒置募集資金購買保本型銀行理財產品。 董事會宣佈，於2025年10月15日，本公司與浦發銀行煙台分行訂立浦發銀行理 財產品協議，據此本公司同意(1)以人民幣400.0百萬元的閒置自有資金向浦發銀 行煙台分行購買理財產品，以及(2)以人民幣100.0百萬元的閒置募集資金向浦發 銀 ...

Group 1 - Company Rongchang Bio (09995) announced an agreement with Pudong Development Bank Yantai Branch to purchase wealth management products [1] - The company will invest a total of RMB 5 billion, consisting of RMB 4 billion of idle self-owned funds and RMB 1 billion of idle raised funds [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的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並表明概不就因本公告全部或任何部份內容而產生或因依賴該等 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） 須予披露交易 購買理財產品 購買理財產品 本公司第二屆董事會第二十一次會議已於2025年3月27日，(1)審議批准了關 於使用自有資金進行現金管理的決議，根據該決議本公司可使用不超過人民幣 500.0百萬元額度的部分閒置自有資金購買保本型銀行理財產品，以及(2)審議批 准了關於使用閒置募集資金進行現金管理的決議，根據該決議本公司可使用不 超過人民幣140.0百萬元額度的部分閒置募集資金購買保本型銀行理財產品。 董事會宣佈，於2025年10月15日，本公司與浦發銀行煙台分行訂立浦發銀行理 財產品協議，據此本公司同意(1)以人民幣400.0百萬元的閒置自有資金向浦發銀 行煙台分行購買理財產品，以及(2)以人民幣100.0百萬元的閒置募集資金向浦發 銀 ...

Core Insights - Rongchang Biologics announced that its self-developed dual-target fusion protein innovative drug, Tai'axi, has received acceptance for its marketing application for the treatment of primary immunoglobulin A (IgA) nephropathy by the National Medical Products Administration (NMPA) and is included in the priority review process [1] - The application is based on positive results from the Phase III clinical study (Stage A) of Tai'axi for treating IgA nephropathy, which involved 318 adult patients receiving standard treatment [1] Group 1 - The Phase III clinical trial was a multi-center, randomized, double-blind, placebo-controlled study, where patients received a dosage of 240mg of Tai'axi via subcutaneous injection once a week [1] - The primary endpoint was achieved, showing that the Tai'axi group had a 55% reduction in the 24-hour urine protein-to-creatinine ratio (UPCR) compared to the placebo group after 39 weeks of treatment (P<0.0001) [1] - The drug demonstrated good tolerability and safety, with detailed data to be presented at an upcoming major international academic conference [1] Group 2 - IgA nephropathy is one of the most common primary glomerular diseases globally, with an estimated 10.16 million patients by 2030, including 2.37 million in China [2] - In China, IgA nephropathy patients account for approximately 54.3% of all renal biopsy cases, with 30% to 40% of these patients progressing to end-stage renal disease (ESRD), severely impacting their quality of life [2] - There is a significant unmet clinical need for effective treatments for IgA nephropathy, as current therapeutic options are very limited [2] - Besides IgA nephropathy, Tai'axi is also undergoing Phase II/III clinical studies for lupus nephritis and membranous nephropathy in China [2]

Core Viewpoint - The A-share market is experiencing a rebound, particularly in the innovative drug sector, with significant inflows into the ETF focused on this area, indicating growing investor interest and confidence in the sector [1][5]. Group 1: Market Performance - As of 10:23 on October 15, the Kexin Innovative Drug ETF (589120) saw a rise of nearly 3%, currently up over 2% [1]. - The ETF recorded a net inflow of over 6 million yuan for the day, with a cumulative inflow of over 56 million yuan in the past 10 days [1]. Group 2: Stock Performance - Most component stocks of the Kexin Innovative Drug ETF experienced gains, with Rongchang Bio rising over 6%, Maiwei Bio over 5%, and several others including Ailis and Borui Pharma rising over 3% [3]. - The top-performing stocks by estimated weight include Baiji Shenzhou (9.89%), Ailis (8.60%), and Baili Tianheng (8.16%) [4]. Group 3: Industry Developments - Rongchang Bio announced that its innovative drug, Tai Tasi Pi, for treating primary immunoglobulin A nephropathy, has received acceptance for market application from the National Medical Products Administration (NMPA) [5]. - The upcoming European Society for Medical Oncology (ESMO) conference from October 17 to 21 in Berlin is anticipated to showcase new data on domestic innovative drugs, which could create new business development (BD) opportunities [5][6]. Group 4: Regulatory and Market Insights - Analysts suggest that the impact of tariff policies on China's pharmaceutical industry is limited, with the market having already priced in the effects of drug tariffs [5]. - The number of overseas BD transactions by Chinese innovative drug companies is expected to continue growing, with significant increases in both the number and total transaction value from 2022 to 2025 [6].

Core Viewpoint - Rongchang Biologics (09995) has seen a nearly 5% increase in stock price following the acceptance of its innovative drug, Taitasip, for the treatment of primary immunoglobulin A (IgA) nephropathy by the National Medical Products Administration (NMPA) of China, marking it as the first domestically developed new drug in this field [1] Group 1 - Rongchang Biologics' stock price rose by 4.75% to HKD 93.75, with a trading volume of HKD 226 million [1] - The drug Taitasip, a dual-target fusion protein, has been accepted for priority review by the NMPA, making it the first domestic original new drug submitted for IgA nephropathy [1] - VorBio, the overseas partner of Rongchang Biologics, appointed Dr. Navid Z.Khan as CMO, who has extensive experience in global drug development in the neurology and autoimmune fields [1] Group 2 - Huatai Securities expressed optimism about Taitasip's global development prospects, citing its strong competitive edge and potential in treating MG and being the first innovative drug reported in the pSS field [1] - The combination of Taitasip's innovative profile and Dr. Khan's experience is expected to enhance its global competitiveness [1]

Core Viewpoint - Rongchang Biopharma (09995) saw a nearly 5% increase in stock price, currently trading at 93.75 HKD, following the acceptance of its innovative drug Tai'aisip for the treatment of primary immunoglobulin A (IgA) nephropathy by the National Medical Products Administration (NMPA) [1] Company Developments - The drug Tai'aisip, a dual-target fusion protein targeting BLyS/APRIL, is the first domestically developed innovative drug submitted for market approval in the IgA nephropathy field [1] - The company has entered a priority review process for Tai'aisip, indicating a faster evaluation timeline by regulatory authorities [1] Strategic Partnerships - VorBio, the overseas partner of Rongchang Biopharma, appointed Dr. Navid Z. Khan as Chief Medical Officer (CMO) on September 23 [1] - Dr. Khan has extensive experience in global development of innovative drugs, having previously led the development of drugs like Efigatuzumab in the neurology and autoimmune fields [1] Market Outlook - Huatai Securities expresses optimism regarding the global development prospects of Tai'aisip, citing its strong competitive position and potential in treating myasthenia gravis (MG) and being the first innovative drug reported in the primary Sjögren's syndrome (pSS) field [1] - The firm maintains a "buy" rating for both A-shares and H-shares of Rongchang Biopharma [1]