Investment Rating - The report provides a positive outlook on the MASH non-invasive diagnosis technology, suggesting it could accelerate new drug development in the pharmaceutical and biotechnology sector [2]. Core Insights - The pharmaceutical and biotechnology sector experienced a decline of 0.65% from August 25 to August 29, underperforming compared to the Wind All A index (1.9%) and the CSI 300 index (2.71%). Only the medical research outsourcing (4.9%) and other biological products (0.14%) sectors saw gains, while in vitro diagnostics (-4.12%), raw materials (-3.34%), and vaccines (-0.59%) faced significant declines [2][7]. - The FDA has accepted the proposal for using VCTE-LSM as a reasonable alternative endpoint for clinical trials in adults with MASH and moderate to advanced fibrosis. This non-invasive method is expected to enhance patient compliance and could lead to a surge in drug development in the MASH area within the next two to three years [2][13]. - The report emphasizes the potential for domestic companies in China to leverage their cost advantages and forward-looking strategies in the field of non-invasive companion diagnostics, particularly in the MASH drug development competition [2]. Market Weekly Review - The pharmaceutical and biotechnology sector's performance was notably weaker than the broader market indices, with specific sub-sectors like medical research outsourcing and other biological products showing resilience [7][8]. - Individual stocks such as Tianchen Medical (30.1%), Ailis (25.6%), and Maiwei Biotech-U (22.4%) performed well, while stocks like Lifang Pharmaceutical (-13.9%), Yuekang Pharmaceutical (-11.9%), and Kanghua Biotech (-11.1%) faced significant losses [10][12]. Industry News and Key Company Announcements - On August 28, Kangfang Biotech announced that its drug AK112 received approval for treating advanced non-squamous non-small cell lung cancer, with promising clinical trial results expected to be presented at an international conference [12]. - The report highlights various companies' financial performances, with notable revenue changes and profit margins, indicating a mixed outlook across the sector [16][17].

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 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]

在中国，泰它西普获得《乾燥综合征超药品说明书用药中国临床实践指南》《B细胞靶向药物治疗风湿 免疫病中国专家共识》《原发性乾燥综合征多学科诊疗专家共识》等多项权威指南推荐。在国际上，泰 它西普的乾燥综合征适应症已获美国食品药物监督管理局授予的快速通道资格并获准开展全球多中心III 期临床试验。 格隆汇8月14日丨荣昌生物(09995.HK)公布，全球首创BLyS/APRIL双靶点融合蛋白药物泰它西普（商品 名：泰爱®)用于治疗原发性乾燥综合征(pSS)的中国III期临床研究，达到方案设计的临床试验主要研究 终点，将尽快向国家药品监督管理局药品审评中心(CDE)递交上市申请，并择机在国际重大学术会议上 公布具体数据。泰它西普成为治疗乾燥综合征领域全球首个完成III期研究的BLyS/APRIL双靶点融合蛋 白药物。 乾燥综合征是一种慢性炎症性自身免疫性疾病，以淋巴细胞浸润和外分泌腺体损伤为主要特征。除唾液 腺和泪腺功能障碍导致的持续口乾、眼乾外，还可累及多系统器官。中国乾燥综合征的患病率为 0.3%-0.7%，且呈上升趋势，存在巨大尚未被满足的临床需求。 这是一项多中心、随机、双盲、安慰剂对照的III期临床研究，旨 ...

Core Insights - The innovative pharmaceutical company Rongchang Bio reported a significant revenue increase of 58.54% year-on-year, reaching 1.717 billion yuan for 2024, although it still faced a net loss of 1.468 billion yuan [1][3] - The company's two core products, Tai'axip and Vidi'sitomab, are expected to contribute over 90% of total revenue in 2024, with projected revenues of 920 million yuan and 780 million yuan respectively [3][4] - The company is focusing on expanding its international presence, with ongoing clinical trials and partnerships, although it faces challenges in balancing domestic growth with overseas investments [8][9] Financial Performance - Rongchang Bio's revenue for 2024 is projected to be 1.717 billion yuan, a 58.54% increase from the previous year, while the net loss is 1.468 billion yuan [1] - The company’s R&D expenses for 2024 are expected to be 1.541 billion yuan, accounting for 89.69% of its revenue, despite a decrease of 30.93 percentage points from the previous year [6] - Sales expenses reached 830 million yuan in 2024, a 45% increase year-on-year, indicating high marketing costs [9] Product Development - Tai'axip, a dual-target fusion protein, has shown strong growth, with its revenue expected to increase by 62% in 2024, and it has received full approval for rheumatoid arthritis [3][4] - Vidi'sitomab has achieved positive results in clinical trials for various cancers, including a 101% improvement in progression-free survival for HER2-positive breast cancer patients [4] - The company is also developing RC28, an eye drug, which has the potential to capture a market worth over 5 billion yuan [6] Strategic Initiatives - Rongchang Bio is pursuing an "outbound" strategy, licensing its products for international trials and seeking to enhance its global presence [8] - The company has established early collaborations with multinational corporations like Pfizer and Roche, indicating growing recognition of its technology platforms [9] - Despite the positive developments, the departure of a key executive has raised concerns about the company's future direction and operational stability [10]