Core Insights - Rongchang Biopharma (09995) shares rose over 8%, reaching HKD 115 with a trading volume of HKD 222 million [1] Group 1: Clinical Development - On September 18, Rongchang Biopharma announced that its self-developed innovative drug, RC18 (brand name: Tai'ai®), targeting both BLyS and APRIL, has successfully completed a 48-week open-label extension study for the treatment of generalized Myasthenia Gravis (gMG) [1] - The long-term efficacy data from this study has been selected for an oral presentation at the 2025 American Association of Neuromuscular and Electrodiagnostic Medicine (AANEM) annual meeting, scheduled for October 29 to November 1 in San Francisco, California [1] Group 2: Strategic Partnerships - Rongchang Biopharma disclosed during its earnings briefing that in August 2021, it entered into a global exclusive licensing agreement with Seattle Genetics (now acquired by Pfizer Inc.) for the global development and commercialization rights of RC48 outside of its region (excluding Japan and Singapore) [1] - Currently, the clinical trials for RC48 are being advanced as planned by Pfizer in overseas markets [1]

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]

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]

Core Viewpoint - Rongchang Biologics (09995) experienced a nearly 5% increase in opening price, currently up 4.7% at HKD 71.35, with a trading volume of HKD 11.84 million [1] Group 1: Clinical Research Announcement - The company announced that its self-developed BLyS/APRIL dual-target fusion protein innovative drug, Tai'aisip (RC18), has successfully completed Phase III clinical trials for the treatment of primary Sjögren's syndrome (pSS), achieving the primary endpoint as per the study design [1] - The clinical research results indicate that Tai'aisip can sustainably and effectively improve the clinical symptoms of patients with Sjögren's syndrome, demonstrating good efficacy and safety [1] - The company plans to submit a marketing application to the National Medical Products Administration (NMPA) Drug Evaluation Center (CDE) as soon as possible, with detailed data to be presented at major international academic conferences [1]

Core Points - The company is holding its annual general meeting to discuss various proposals, including financial reports and governance changes [1][3][19] - The meeting will take place on June 26, 2025, at 14:00 in Yantai, China, with both on-site and online voting options available [4][5][6] Meeting Procedures - Attendees must register and verify their identity to participate in the meeting [1][2] - Shareholders have the right to speak, ask questions, and vote on proposals, but must adhere to the meeting's agenda and time limits [2][3] - The meeting will be conducted in an orderly manner, with the chairman having the authority to manage discussions and responses to questions [2][3][4] Agenda Items - The meeting will review and vote on several key proposals, including: - The 2024 annual board report [8][10] - The 2024 annual supervisory report [10] - The 2024 financial settlement report, which has been audited and approved [11] - The 2024 annual report and its summary [12] - A proposal for profit distribution, indicating no distribution for 2024 [13] - The reappointment of accounting firms for 2025 [13] - Confirmation of director and supervisor remuneration for 2024 [14][18] - A proposal for general authorization to issue new shares [15][16] - Changes to the company's registered capital and governance structure, including the abolition of the supervisory board [17][21] - Amendments to the company's articles of association and meeting rules [19][20][22] Financial Performance - The company reported significant sales growth, particularly from its products, with a revenue of 1.699 billion yuan from one of its drugs [24] - The company is focused on maintaining high R&D investment while reducing net losses compared to previous years [24]