Core Viewpoint - The approval of the Upaftin sustained-release tablet application by Shijiazhuang Four Medicines adds to the competitive landscape of the JAK1 inhibitor market, which is rapidly growing and attracting local pharmaceutical companies [1]. Group 1: Market Potential - Upaftin sustained-release tablets, developed by AbbVie, are projected to reach nearly $6 billion in global sales by 2024, with a significant presence in the Chinese market after being included in the national medical insurance list [1][2]. - The sales of Upaftin in the Chinese hospital market are expected to exceed 300 million yuan in 2024, marking a year-on-year growth of 278.02%. By the first three quarters of 2025, sales are anticipated to surpass 400 million yuan, reflecting a staggering year-on-year increase of 104.03% [1][2]. Group 2: Patent Challenges - The core compound and composition patents for Upaftin were originally set to expire in 2030. However, a significant turning point occurred at the end of 2022 when Sichuan Guowei initiated a patent challenge targeting the compound patent [4][7]. - In July 2023, the National Intellectual Property Administration declared the compound patent invalid, significantly opening the pathway for generic manufacturers six years earlier than expected [7]. Group 3: Competitive Landscape - Over 35 companies, including Shijiazhuang Four Medicines, have submitted applications for the generic version of Upaftin, indicating intense competition among leading generic drug manufacturers [8]. - Despite early submissions by companies like Sichuan Guowei and Tiandi Hengyi, no local company has yet successfully launched a generic version, with AbbVie still holding a dominant position in the market [10][12].

Group 1 - The core point of the article is that the company, Furuida, is preparing to submit its research product, Upatinib sustained-release tablets, for approval after completing all necessary research work [2] - Upon passing the review, the company will obtain a drug production license, allowing the product to be available for clinical use [2]

Market Performance - The pharmaceutical sector experienced a slight increase of +0.14% on November 28, 2025, underperforming the CSI 300 index by 0.11 percentage points, ranking 27th among 31 sub-industries in the Shenwan classification [1] - Among sub-industries, medical devices (+1.53%), hospitals (+0.95%), and other biological products (+0.70%) performed well, while offline pharmacies (-0.55%), vaccines (-0.46%), and medical research outsourcing (-0.33%) lagged behind [1] - Top three gainers in individual stocks were Haiwang Pharmaceutical (+10.03%), Baihua Pharmaceutical (+10.01%), and Hefei China (+7.49%); the top three decliners were Yue Wannianqing (-13.71%), Zhongsheng Pharmaceutical (-10.00%), and Guangji Pharmaceutical (-9.98%) [1] Industry News - The CDE announced that AbbVie's Upadacitinib extended-release tablets are proposed for priority review, targeting severe alopecia areata in adults and adolescents aged 12 and above [2] - Upadacitinib is a JAK inhibitor effective for various immune-mediated inflammatory diseases, with a stronger inhibitory effect on JAK1 compared to JAK2, JAK3, and TYK2; this priority review in China suggests accelerated access for alopecia patients [2] Company News - Guobang Pharmaceutical (605507) announced an employee stock ownership plan involving 270 employees, aiming to raise up to 185 million yuan, with a stock cap of 10% of total equity and a duration of 24 months, including a 12-month lock-up period [3] - Tianen Kang (301263) reported that its subsidiary Shandong Huabo Kaisheng received a drug registration certificate for Baricitinib tablets from the National Medical Products Administration, confirming compliance with registration requirements [3] - Yipinhong (300723) announced that its subsidiary Guangzhou Yipinhong received approval for Esomeprazole Magnesium Enteric-Coated Suspension from the National Medical Products Administration, meeting registration standards [3] - Enhua Pharmaceutical (002262) stated that it received a drug registration certificate for Oxycodone Hydrochloride Extended-Release Tablets from the National Medical Products Administration, confirming compliance with registration requirements [3]

Core Viewpoint - The acceptance of the market application for the generic drug Upadacitinib extended-release tablets by Shandong Nuohuo Kang Pharmaceutical Co., Ltd. marks a significant development in the competitive landscape of the JAK inhibitor market, which is projected to reach $8 billion in annual sales by 2026 [1][5][17]. Group 1: Market Dynamics - Upadacitinib, developed by AbbVie, has seen explosive sales growth since its FDA approval in August 2019, with sales increasing from $47 million in its initial year to approximately $2.7 billion in 2023 [3][5]. - The global market demand for Upadacitinib is rapidly increasing, with a projected annual sales figure nearing $8 billion by 2026 [5]. - In China, the sales of Upadacitinib have surged, with a reported increase of over 9271% in 2023, reaching sales of 81.71 million yuan, and further projected growth of 12098% in the first half of 2024 [9]. Group 2: Competitive Landscape - A total of 15 generic pharmaceutical companies have submitted applications for Upadacitinib, indicating a highly competitive environment for the first generic version [11]. - The patent landscape has shifted, with the core compound patent for Upadacitinib declared invalid in China, allowing generic manufacturers to enter the market sooner than expected [14][16]. - The ongoing patent disputes and the approval of new indications for Upadacitinib are expected to intensify competition among generic manufacturers [17].