Summary of Conference Call on Bosunji's Developments in Cell Therapy Company Overview - **Company**: Bosunji - **Industry**: Cell Therapy Key Points and Arguments Company and Product Development - Bosunji has established a comprehensive layout in the cell therapy field, with five major platforms including CD7 CAR-T and In vivo CAR-T, and has obtained 85 patents and four registered clinical approvals [2][3][4] - The CD7 CAR-T product targets T-cell malignancies, particularly T-ALL and TLBL, addressing a significant gap in effective treatment options [2][5] - The CD7 CAR-T product has shown promising results in Phase I clinical trials, with an overall response rate of 85% and a complete response rate of 70%, with some patients maintaining complete remission for over two years [2][9] Clinical Trial Results - In Phase I trials, 21 patients were enrolled, showing low rates of CRS (Cytokine Release Syndrome) and no grade 4 CRS cases, indicating good safety [9] - The product has achieved a 95% MRD-negative complete response rate, suggesting potential for bridging to allogeneic transplantation [9][10] Technological Innovations - Bosunji has optimized the CD7 CAR-T manufacturing process through fully automated technology, significantly reducing costs and enhancing competitiveness [2][8] - The company has engineered lentivirus vectors to specifically target T cells or NK cells, improving specificity and safety [2][16][18] Strategic Partnerships and Financing - Anke Bio led a Series B financing round for Bosunji, investing 30 million RMB and signing a strategic agency agreement for the commercialization of the P3-17 product in mainland China [4][28][29] - Bosunji plans to complete key Phase II clinical trial enrollments within a year and submit a pre-NDA application by Q1 2027, while exploring international collaboration opportunities [4][27] Market Potential and Pricing Strategy - The CD7 CAR-T product targets approximately 10,000 suitable patients annually in China, with a preliminary pricing strategy set at no less than 800,000 RMB, aiming for patient out-of-pocket costs not to exceed 300,000 RMB [37] Future Development Plans - Bosunji aims to expand the indications for CD7 CAR-T to include peripheral T-cell lymphoma, NKT lymphoma, and acute myeloid leukemia, while also pursuing international market opportunities [27][34] Challenges and Solutions - The company faced challenges during Phase I trials due to the COVID-19 pandemic, which affected patient enrollment and drug delivery. They adapted by enhancing their clinical operations team and achieving commercial-level production of lentivirus [39][40] Competitive Landscape - Bosunji's CD7 CAR-T product is positioned favorably against competitors, with lower RP2D (Recommended Phase 2 Dose) and a gentler pre-treatment regimen, which may lead to fewer long-term complications for patients [11][12][26] Research Directions - Bosunji is also developing new products targeting autoimmune diseases, including a dual-target in vivo CAR and PD-1 agonists, which are still in early research stages [21][22][24] Additional Important Information - The company has made significant advancements in pharmacokinetics and pharmacodynamics, with CAR-T cells showing prolonged expression in patients and effective tumor clearance [10][19] - Bosunji's innovative lentivirus platform is designed to maximize clinical efficacy while minimizing risks associated with T cell activation [25][26] This summary encapsulates the key developments and strategic directions of Bosunji in the cell therapy industry, highlighting its innovative approaches, clinical trial successes, and future growth plans.

Core Viewpoint - Fosun Pharma's subsidiary, Fosun Kairui, has had its drug registration application for FKC889 accepted by the National Medical Products Administration for treating relapsed or refractory precursor B-cell acute lymphoblastic leukemia in adult patients [1] Group 1: Product Development - FKC889 is a CAR-T cell therapy product targeting CD19, developed through technology transfer from Kite Pharma, a subsidiary of Gilead Sciences [1] - Tecartus, the original product, was approved for market in the US and Europe in July and December 2020 respectively [1] - As of September 24, 2025, FKC889 is in the bridging clinical trial phase for another indication, treating adult patients with relapsed or refractory mantle cell lymphoma after second-line treatment [1] Group 2: Financial Investment - The cumulative R&D investment for FKC889 as of August 2025 is approximately RMB 183 million (unaudited) [2]

Group 1: Company Overview and Investor Relations - The investor relations activity involved a telephone conference with over 130 participants from various financial institutions [2][3]. - Key personnel included the Chairman and Senior Vice President of the company, who addressed investor inquiries [3]. Group 2: Product Development and Clinical Trials - The "AK1012 project" for treating respiratory syncytial virus infections has completed Phase I clinical trials [3]. - "AK2017 injection" has successfully completed Phase II clinical trial enrollment, with discussions for Phase III trials underway [3]. - "HuA21 injection," targeting HER2, has completed Phase Ib/II clinical trials and is preparing for Phase III based on interim analysis [3][10]. - "AK2024 injection," another HER2-targeted drug, has received clinical approval and shows promising preclinical results [3]. - "HK010 injection," a dual-target PD-L1*4-1BB antibody, is progressing well in Phase I trials [3]. Group 3: Collaborations and Innovations - Collaboration with Afana Company on "AFN0328 injection" for HPV precancerous lesions is in Phase I trials, with plans for further mRNA drug development [4]. - The company’s affiliate, Boshengji, has developed the first CAR-T cell therapy targeting CD7, which has been included in a list of breakthrough therapies by the CDE [4][9]. - The "recombinant L-IFN adenovirus injection" developed by Yuansong Bio has received clinical trial approvals from both CDE and FDA for advanced solid tumors [4]. Group 4: Market Potential and Strategic Partnerships - The long-acting growth hormone "Transcon" is expected to outperform existing products, with a significant market opportunity projected at over 4 billion CNY in 2025 for follicle-stimulating hormone [8]. - The partnership with Baoyi Pharmaceutical for "SJ02," a long-acting follicle-stimulating hormone, aims to enhance treatment options in assisted reproductive technology [8]. - The PA3-17 injection has shown an objective response rate (ORR) of 84.6% and a complete remission rate of 95% in clinical trials [9]. Group 5: Future Plans and Regulatory Compliance - The company is actively building production lines compliant with FDA and EU standards, aiming for international market commercialization [11]. - Future clinical plans include launching Phase II trials for PA3-17 and exploring international registration based on Chinese clinical data [9].