Product Development and Clinical Trials - In 2022, the company issued 165 prescriptions for Beiduo Da® and completed 141 infusions for r/r LBCL patients, demonstrating strong efficacy in real-world applications[14]. - The two-year overall survival (OS) rate for Beiduo Da® as a third-line treatment for LBCL was reported at 69.3% with no new safety signals identified[3]. - Beiduo Da® achieved a 100.0% objective response rate (ORR) and a 92.6% complete response rate (CRR) based on a median follow-up of 11.7 months from 28 treated subjects[3]. - The company received breakthrough therapy designation for Beiduo Da® for MCL patients who have undergone several lines of prior treatment in April 2022[3]. - The company initiated a study in March 2023 to evaluate Beiduo Da® as a first-line treatment for high-risk LBCL patients, completing the first patient infusion[4]. - The company aims to develop Beiduo Da® as a treatment for systemic lupus erythematosus (SLE), having initiated an investigator-initiated trial in March 2023[6]. - Clinical development for Beiduo Da® in treating solid tumors has commenced, with the first patient infusion completed for JWATM204 and JWATM214 targeting hepatocellular carcinoma (HCC)[24]. - The company initiated a clinical study for Beiduo Da® in March 2023 to treat moderate to severe active systemic lupus erythematosus (SLE), completing the first patient infusion[24]. - The company has developed a differentiated cell immunotherapy product pipeline, with opportunities to expand into emerging solid tumors and autoimmune diseases[24]. - The company has partnered with 2seventy bio, Inc. for the development and commercialization of a cell therapy product targeting MAGE-A4 in Greater China[24]. - The company has initiated clinical trials for JWATM204 and JWATM214 for the treatment of solid tumors, expanding its pipeline in autoimmune diseases[153]. Financial Performance - Revenue for the year ended December 31, 2022, was RMB 145.7 million, a significant increase from RMB 30.8 million for the year ended December 31, 2021, representing a growth of 372%[102]. - Gross profit for the year ended December 31, 2022, was RMB 58.8 million, with a gross margin of 40.3%, compared to RMB 9.0 million and a gross margin of 29.4% for the year ended December 31, 2021[106]. - The company reported a net loss of RMB 846.1 million for the year ended December 31, 2022, compared to a net loss of RMB 702.3 million for the year ended December 31, 2021[96]. - The company achieved a gross margin increase from 29.4% in 2021 to 40.3% in 2022 due to successful cost reduction initiatives[123]. - Adjusted losses decreased from RMB 679.0 million for the year ended December 31, 2021, to RMB 605.1 million for the year ended December 31, 2022, primarily due to increased revenue and gross profit from the sale of the product Beiduo Da®[198]. - The company experienced an increase in revenue and gross profit from the sales of its product, Yescarta, which partially offset the losses incurred[185]. Strategic Partnerships and Alliances - The company has established a strategic alliance with 2seventy bio, Inc. for the development and commercialization of cell therapy products targeting MAGE-A4[7]. - The company has strengthened its relationship with Juno to develop DLL3 targeted cell therapy products in Greater China, capitalizing on the significant market potential[69]. - Strategic alliances were established with 2seventy bio, Inc. and Juno to enhance the pipeline for solid tumor therapies, demonstrating the company's reputation as a preferred partner in cell therapy[126]. Cost Management and Operational Efficiency - The company successfully executed a cost reduction plan in 2022, increasing gross margin from 29.4% in 2021 to 40.3% in 2022 by reducing the cost of goods sold per batch[18]. - The company has implemented a strategy to reduce manufacturing costs, including the use of domestic raw materials to replace imports, aiming for further cost reductions in the medium term[18]. - The company has established a dedicated commercial team for the commercialization of Beiduo Da® in China, consisting of approximately 88 employees as of February 2023, enhancing operational efficiency and market promotion capabilities[16]. - The company achieved a 98% production success rate for Beiduo Da® in 2022, maintaining high levels achieved during LBCL registration clinical trials[9]. Regulatory Approvals and Market Position - The company received approval for a supplemental new drug application for Beiduo Da® to treat relapsed/refractory follicular lymphoma (r/r FL), marking a significant milestone in clinical development[24]. - As of December 31, 2022, Beiduo Da® has been included in 56 commercial insurance products and 75 local government supplementary medical insurance plans, with 24% of patients receiving insurance compensation[17]. - The company is positioned favorably in the growing CAR-T market in China, with expectations of strong growth until 2030 due to unmet treatment needs[13]. - The company contributed to the development of new CAR-T therapy management guidelines in China, enhancing its role in the ecosystem of cell therapy products[123]. Research and Development - The company has strengthened its internal R&D capabilities by appointing Dr. Cordoba as Chief Scientific Officer, who holds the third-highest number of CAR technology-related patents globally[92]. - The company plans to leverage its proprietary technology platform and clinical track record to focus on high-growth opportunities in the cell therapy field, including novel cell targets for cancer treatment[93]. - The company is focused on expanding its product offerings and enhancing its research and development capabilities in the biopharmaceutical sector[198]. Corporate Governance - The board of directors consists of one executive director, five non-executive directors, and three independent non-executive directors as of the date of the report[186]. - The company continues to review and monitor its corporate governance practices to ensure compliance with the corporate governance code[173]. - The company has established three board committees, including the audit committee, remuneration committee, and nomination committee, to oversee specific aspects of its affairs[176].

Financial Performance - Gross profit increased by 549.6% from RMB 9.0 million for the year ended December 31, 2021, to RMB 58.8 million for the year ended December 31, 2022, with a gross margin rising from 29.4% to 40.3%[2] - The company reported a net loss of RMB 846.1 million for the year ended December 31, 2022, compared to RMB 702.3 million for the year ended December 31, 2021, primarily due to increased unrealized foreign exchange losses and the absence of one-time non-cash income from a terminated agreement with Juno Therapeutics[28] - Adjusted losses decreased from RMB 679.0 million for the year ended December 31, 2021, to RMB 605.1 million for the year ended December 31, 2022, driven by increased revenue and gross profit from the sales of the product, reduced general and administrative expenses, and increased other income and net financial income[28] - The company reported a pre-tax loss of RMB 846.1 million for the year ended December 31, 2022, compared to a loss of RMB 702.3 million for the year ended December 31, 2021[71] - The company reported a gross profit of RMB 58.8 million for the year ended December 31, 2022, compared to RMB 9.0 million in 2021, representing a significant increase[114] Research and Development - Research and development expenses decreased by RMB 6.6 million to RMB 407.8 million for the year ended December 31, 2022, primarily due to cost reduction initiatives and fewer research batches[2] - The company has established an internal early discovery and preclinical research team to develop innovative products with global commercialization rights and improved performance characteristics[30] - The company has initiated clinical studies for "倍諾達®" in treating moderate to severe active SLE patients, with the first patient infusion completed in March 2023[9] - The company aims to expand the application of "倍諾達®" into broader disease areas, including autoimmune diseases, through ongoing research[10] - The company is exploring new technologies and process platforms to improve production efficiency and reduce costs in the long term[33] Product Development and Clinical Trials - The product "倍諾達®" has achieved a best overall response rate (ORR) of 77.6% and a complete response rate (CRR) of 53.5% in a Phase II registration clinical trial for LBCL, with a two-year overall survival (OS) rate of 69.3%[12] - The company has completed a single-arm Phase I trial in China for "倍諾達®" in high-risk LBCL patients, showing a best ORR of 75.0% and a best CRR of 33.3%[13] - The company is conducting a Phase II open-label, multi-center study in China to evaluate the efficacy and safety of Beiduo Da® for treating MCL patients who have previously undergone chemotherapy and targeted therapy, with 59 patients enrolled as of now[16] - A Phase I/II registration trial has begun in China to assess the efficacy of Beiduo Da® in children and adolescents with r/r ALL after at least two lines of treatment, with IND approval received in April 2022[17] - The company has initiated clinical trials for new indications, including a new IND application for the product as a second-line treatment for r/r LBCL patients and a trial for pediatric patients with r/r acute lymphoblastic leukemia[29] Market Position and Strategy - The CAR-T therapy market in China is expected to experience strong growth until 2030, positioning the company favorably due to its differentiated product pipeline and integrated development platform[6] - The company has established a differentiated pipeline for cell immunotherapy, showing significant advantages in the field of hematological cancer cell therapy, with opportunities to expand into solid tumors and autoimmune diseases[9] - The company aims to expand into the solid tumor market using its comprehensive cell therapy platform and is focusing on high-growth or breakthrough technology potential in cell therapy[53][56] - The company is focusing on developing autologous products and designing new pipeline products to address unmet needs in Asian blood and solid cancers, utilizing advanced manufacturing methods[25] - The company has established a dedicated commercial team of approximately 88 employees to support the product's commercialization in China, optimizing team structure for operational efficiency[7] Financial Position and Cash Flow - Total cash and cash equivalents as of December 31, 2022, were RMB 1,383.3 million, a decrease of RMB 451.1 million from RMB 1,834.4 million as of December 31, 2021[86] - The current ratio as of December 31, 2022, was 4.8, down from 9.5 in 2021, indicating a significant reduction in liquidity[126] - The total liabilities amounted to RMB 437,063,000, an increase from RMB 325,749,000 in 2021, reflecting a growth of approximately 34.1%[137] - The total equity decreased to RMB 2,354,284,000 from RMB 2,790,857,000, indicating a decline of about 15.6% year-over-year[137] - The company maintained unutilized bank loan facilities amounting to RMB 367.7 million as of the announcement date[102] Regulatory and Compliance - The National Medical Products Administration (NMPA) approved the supplemental new drug application for "倍諾達®" as a third-line treatment for r/r FL in October 2022, making it the first CAR-T product approved for this indication in China[15] - The company has received breakthrough therapy designation for "倍諾達®" as a third-line treatment for r/r FL from the NMPA in September 2020[15] - The company has received breakthrough therapy designation for its product for MCL patients who have received several prior lines of therapy[29] - The company has adopted the corporate governance code as per the listing rules to enhance shareholder value and accountability[188] - The company has not entered into any foreign exchange hedging transactions during the reporting period, indicating a strategy focused on monitoring and minimizing foreign currency exposure[129]

ai1663661172104_JW Therapeutics IR2022 Cover 9mm op.pdf 1 20/9/2022 下午4:06 JW (Cayman) Therapeutics Co. Ltd * JW (Cayman) Therapeutics Co. Lt *d Stock Code: 2126 (Incorporated in the Cayman Islands with limited liability) 2022 INTERIM REPORT 2022 中期報告 Interim Report JW (Cayman) Therapeutics Co. Ltd * 股份代號: 2126 (於開曼群島註冊成立的有限公司) 2022 中期報告 * * 目錄 公司資料2 財務摘要4 業務摘要7 管理層討論與分析 10 企業管治及其他資料 31 簡明綜合損益表 45 簡明綜合全面虧損表 46 簡明綜合資產負債表 47 簡明綜合權益變動表 49 簡明綜合現金流量表 50 簡明中期財務資料附註 51 釋義及技術詞彙 73 公司資料 | --- | --- | |-------------- ...

JW (Cayman) Therapeutics Co. Ltd * 股份代號: 2126 (於開曼群島註冊成立的有限公司) 年度報告 * 目錄 2 公司資料 4 主席報告 7 財務摘要 11 業務摘要 14 管理層討論及分析 41 董事及高級管理人員 49 董事會報告 92 企業管治報告 111 獨立核數師報告 116 綜合損益表 117 綜合全面虧損表 118 綜合資產負債表 120 綜合權益變動表 121 綜合現金流量表 122 綜合財務報表附註 189 釋義及技術詞彙 公司資料 | --- | --- | |-------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------- ...

% 药明巨话 JW Therapeutics JW (Cayman) Therapeutics Co. Ltd 藥 明 巨 諾 ( 開 曼 ) 有 限 公 司 * (於開曼群島註冊成立的有限公司) 股份代號: 2126 中 期 報 告 Therapeutics 药明巨诺五周年 ・僅供識別 目錄 財務摘要4 管理層討論與分析7 企業管治及其他資料 26 簡明綜合損益表 40 簡明綜合全面虧損表 41 簡明綜合資產負債表 42 簡明綜合權益變動表 44 簡明綜合現金流量表 45 簡明中期財務資料附註 46 公司資料2 釋義及技術詞彙 71 公司資料 | --- | --- | |----------------------------------------------------------|-----------------------------------------------------------------------------------------------------| | 董事會 | 香港法律顧問 | | 執行董事 | 方達律師事務所 | | Yiping James Li （李怡平） ...

年度報告 2020 JW (Cayman) Therapeutics Co. Ltd * 股份代號: 2126 (於開曼群島註冊成立的有限公司 曼群島註冊成立的有限公司) 公司資料 目錄 公司資料2 主席報告4 1 藥明巨諾（開曼）有限公司 2020年年度報告 | --- | --- | |----------------------|-------| | | | | 財務摘要 | | | 業務摘要 | | | 管理層討論及分析 | | | 董事及高級管理人員 | | | 董事會報告 | | | 企業管治報告 | | | 環境、社會及管治報告 | | | 獨立核數師報告 | | | 綜合損益表 | | | 綜合全面虧損表 | | | 綜合資產負債表 | | | 綜合權益變動表 | | | 綜合現金流量表 | | | 綜合財務報表附註 | | | 釋義及技術詞彙 | | | | | | | | | --- | --- | |------------------------------------------------------|---------------------------------------- ...