Core Viewpoint - Shanghai Junshi Biosciences Co., Ltd. has successfully included two of its products, Toripalimab Injection (brand name: Tuoyi) and Engrelistat Injection (brand name: Junshida), in the National Medical Insurance Catalog (2025) under Category B, effective from January 1, 2026 [1][2]. Group 1: Product Information - Toripalimab Injection is the first domestically approved PD-1 monoclonal antibody in China, with 12 indications approved for listing in the National Medical Insurance Catalog, including treatments for renal cancer, triple-negative breast cancer, and melanoma [2][4]. - Engrelistat Injection is a domestically developed PCSK9-targeting drug, newly included in the National Medical Insurance Catalog, specifically for patients intolerant to statins [5][6]. Group 2: Market Impact - The inclusion of these products in the National Medical Insurance Catalog reflects the recognition of their clinical value and innovation by the National Healthcare Security Administration, which supports local innovative pharmaceutical companies [6]. - The listing of all commercialized products in the National Medical Insurance Catalog is expected to enhance affordability and accessibility for patients, thereby promoting market expansion and increasing sales scale for the company [6].

Core Viewpoint - Shanghai Junshi Biosciences Co., Ltd. announced the inclusion of its products Tuoyi (Tremelimumab injection) and Junshida (Angrezi monoclonal antibody injection) in the National Medical Insurance Directory, effective January 1, 2026, highlighting the recognition of their clinical value and innovation by the National Healthcare Security Administration [1][6]. Group 1: Product Information - Tuoyi (Tremelimumab injection) has received approval for 12 indications, all of which are now included in the National Medical Insurance Directory, making it the only PD-1 monoclonal antibody drug listed for the treatment of renal cancer, triple-negative breast cancer, and melanoma [1][2]. - Junshida (Angrezi monoclonal antibody injection) is the only domestic PCSK9-targeted drug included in the new insurance directory for patients intolerant to statins, marking its first inclusion [1][5]. Group 2: Market Impact - The inclusion of both drugs in the National Medical Insurance Directory is expected to enhance patient affordability and accessibility, thereby promoting market expansion and increasing sales scale for the company [6]. - The company plans to actively cooperate with the implementation of insurance policies and expand its market coverage to improve patient access to medications [6]. Group 3: Internationalization - Tuoyi has been approved for marketing in multiple countries and regions, including the United States, European Union, and several others, indicating a strong international presence [3].

Core Viewpoint - Junshi Biosciences (01877) announced the addition of two new indications for its product Toripalimab (brand name: Tuoyi) and the inclusion of its product Engrezt (brand name: Junshida) in the National Medical Insurance Directory, effective January 1, 2026 [1] Group 1 - The product Toripalimab has received approval for 12 indications in mainland China, all of which are included in the National Medical Insurance Directory, making it the only anti-PD-1 monoclonal antibody in the directory for the treatment of renal cancer, triple-negative breast cancer, and melanoma [1] - Engrezt is newly included in the directory and is the only domestic PCSK9-targeted drug for patients intolerant to statins in the updated list [1]

Core Viewpoint - Junshi Biosciences (01877.HK) announced that its products, Toripalimab Injection (brand name: Tuoyi, product code: JS001) and Engreitzumab Injection (brand name: Junshida, product code: JS002), have been included in the National Medical Insurance Catalog (2025) under Category B, effective January 1, 2026 [1] Group 1 - The inclusion of Toripalimab's two new indications and Junshida in the National Medical Insurance Catalog reflects the National Healthcare Security Administration's recognition of the clinical value, patient benefits, and innovation of these drugs [1] - Toripalimab is the only anti-PD-1 monoclonal antibody in the catalog approved for treating renal cancer, triple-negative breast cancer, and melanoma, with all 12 approved indications included [1] - Junshida is the first domestic PCSK9-targeted drug included in the new catalog for patients intolerant to statins [1] Group 2 - All four commercialized products of the company, including Tuoyi, Adalimumab Injection (brand name: Junmaikang, product code: UBP1211), Dexamethasone Hydrochloride Tablets (brand name: Mindewi, product code: VV116/JT001), and Junshida, are now part of the National Medical Insurance Catalog [2] - The inclusion in the catalog is expected to enhance affordability and accessibility for patients, promoting market expansion and increasing sales scale, positively impacting the company's long-term operational development [2] - The company will actively cooperate to implement the medical insurance policy, continue to advance hospital access, and expand coverage in core and broader markets to improve patient access to medications [2]

Core Insights - Junshi Biosciences (君实生物) announced the inclusion of two new indications for its product Toripalimab injection (brand name: Tuoyi) and the successful addition of its product Engreztinib injection (brand name: Junshida) to the National Medical Insurance Catalog for 2025 [1] Group 1: Product Developments - Toripalimab has now been approved for all 12 indications in mainland China and is the only anti-PD-1 monoclonal antibody in the catalog for the treatment of renal cancer, triple-negative breast cancer, and melanoma [1] - Junshida is newly included in the catalog and is the only domestic PCSK9-targeted drug for patients intolerant to statins in the updated list [1] Group 2: Market Position - As of the announcement date, four commercialized products from Junshi Biosciences, including Tuoyi, Adalimumab injection (brand name: Junmaikang), Dexamethasone Hydrochloride tablets (brand name: Mindewi), and Junshida, have been included in the National Medical Insurance Catalog [1]

Core Viewpoint - Junshi Biosciences reported a significant revenue growth of 49% year-on-year for the first half of 2025, with total revenue reaching 1.168 billion yuan, while the net loss attributable to shareholders decreased by 36% to 413 million yuan [1][4]. Group 1: Financial Performance - The company achieved a total revenue of 1.168 billion yuan in H1 2025, with drug sales contributing 1.059 billion yuan [1]. - The net loss attributable to shareholders was reduced to 413 million yuan, marking a 36% decrease compared to the previous year [1]. Group 2: Product Commercialization - The sales of Toripalimab (Tuoyi) accelerated, generating 954 million yuan in domestic sales, a 42% increase year-on-year, with two new indications approved in H1 2025 [1]. - The company’s commercial network has expanded to over 80 countries and regions globally, with Toripalimab approved in 40 countries, establishing it as one of the most widely covered domestic PD-1 products [2]. Group 3: R&D Pipeline - Junshi Biosciences has over 50 product pipelines across five therapeutic areas, with nearly 30 in clinical stages and over 20 in preclinical stages [3]. - Key products include JS207 (PD-1/VEGF bispecific antibody) and Tifcemalimab (first BTLA monoclonal antibody in clinical development), with several ongoing Phase II and III studies [3]. Group 4: Profit Forecast - The company forecasts net losses of 771 million yuan, 307 million yuan, and a profit of 534 million yuan for the years 2025 to 2027, with corresponding EPS of -0.75 yuan, -0.30 yuan, and 0.52 yuan [4].

Core Viewpoint - Junshi Bioscience plans to raise approximately HKD 1.039 billion through the placement of 41 million new H-shares at a price of HKD 25.35 per share, which represents an 11.52% discount to the closing price on June 12 [1] Group 1: Fundraising and Use of Proceeds - The company intends to allocate 70% of the raised funds for innovative drug development, focusing on dual-specific antibodies such as JS207 (PD-1/VEGF), JS212 (EGFR/HER3), and JS213 (PD-1/IL-2) [1] - The remaining funds will be used to supplement working capital [1] - Junshi Bioscience previously announced an investment of CNY 767 million in the PD-1/VEGF dual antibody (JS207) [1] Group 2: Clinical Development and Market Position - JS207 is currently in Phase II clinical trials, with plans to conduct key clinical trials for lung cancer, breast cancer, liver cancer, colorectal cancer, and other advanced solid tumors [1] - Junshi Bioscience, established in December 2012, was the first domestic company to receive approval for a PD-1 monoclonal antibody, but its product, Toripalimab, has faced stiff competition from later entrants [4] - Toripalimab remains the company's leading product, generating CNY 1.501 billion in domestic sales in 2024, accounting for 77% of total revenue of CNY 1.948 billion [4] Group 3: Financial Performance and Market Trends - Despite not yet achieving profitability, the company's losses have significantly narrowed in 2024, with Q1 revenue and net loss reported at CNY 500 million and CNY 235 million, respectively [4] - The PD-1/VEGF dual antibody field has gained traction, with significant competitive developments, including a head-to-head trial where a competitor's product outperformed the leading PD-1 drug [5] - The innovative drug sector has seen a strong performance in the A-share market, with a 12.72% increase in May and a total increase of over 22% from April to June [6]