Financial Performance - Revenue for the six months ended June 30, 2022, was RMB 66.0 million, compared to zero for the same period in 2021, attributed to the commercialization of the CAR-T cell therapy product, Relma-cel, approved on September 1, 2021[14]. - Gross profit for the same period was RMB 23.1 million, resulting in a gross margin of 35.0%[16]. - Operating loss for the six months ended June 30, 2022, was RMB 431.9 million, compared to RMB 333.6 million in the same period of 2021[14]. - The net loss for the period was RMB 429.3 million, an increase of RMB 148.6 million from the previous year, influenced by higher unrealized foreign exchange losses and increased R&D and selling expenses[17]. - The adjusted net loss for the period, based on non-IFRS measures, was RMB 289.2 million, compared to RMB 272.6 million in the same period of 2021[14]. - The adjusted loss for the six months ended June 30, 2022, increased by RMB 16.6 million to RMB 289.2 million compared to RMB 272.6 million for the same period in 2021, primarily due to increased sales expenses from a growing workforce and business activities, as well as higher cash expenses allocated to R&D[21]. - Other income for the period was RMB 7.1 million, compared to RMB 3.9 million in the previous year[14]. Expenses - Research and development expenses increased to RMB 195.9 million from RMB 185.5 million in the previous year, primarily due to increased clinical trial activities and depreciation from upgraded facilities[16]. - General and administrative expenses decreased to RMB 90.9 million from RMB 105.1 million, mainly due to reduced share-based compensation expenses[16]. - Selling expenses rose significantly to RMB 84.4 million from RMB 46.2 million, driven by increased personnel costs and promotional activities for Relma-cel[17]. Market and Product Development - The company expects continued revenue growth from Relma-cel as commercialization progresses and more patients receive treatment[14]. - The company has made significant progress in clinical development, including the approval of key clinical trials for Relma-cel as a second-line treatment for LBCL[29]. - The company aims to expand the application potential of Relma-cel into broader disease areas, including systemic lupus erythematosus (SLE), with planned studies to evaluate its safety and pharmacokinetics[38]. - The company plans to expand into emerging solid tumor markets utilizing its comprehensive cell therapy platform[32]. - The company is developing JWCAR129, an autologous CAR-T therapy targeting BCMA for the treatment of multiple myeloma, with IND approval received in December 2021 and ongoing clinical evaluations in 2022[59]. Production and Capacity - The company achieved a 99% production success rate for the product Relma-cel since the initiation of LBCL registration clinical trials[30]. - The company is focusing on the development of JWATM214, a next-generation autologous cell therapy for HCC, with clinical studies expected to start in 2023[66]. - The company has established a commercial production base in Suzhou, covering approximately 10,000 square meters, designed to support all cell platforms and currently operating under GMP standards[70]. - The company is actively communicating with regulatory authorities to increase its production capacity, which is currently not at the designed capacity of supporting up to 2,500 patients annually for autologous CAR-T cell therapy[70]. Regulatory and Market Challenges - The clinical development process for biopharmaceutical products is lengthy and costly, with uncertain outcomes, and early research results may not predict future trial results[151]. - Regulatory approval processes for biopharmaceutical products are lengthy, time-consuming, and unpredictable, which could severely impact the company's business if candidates fail to obtain approval[153]. - The market opportunity for the company's candidate products may be limited to previously ineligible or treatment-failure patients, potentially resulting in a small market size[157]. Financial Position - Total current assets as of June 30, 2022, were RMB 1,636.7 million, down from RMB 1,895.0 million as of December 31, 2021[120]. - Total liabilities decreased from RMB 325.7 million as of December 31, 2021, to RMB 293.0 million as of June 30, 2022[120]. - The company reported a cash balance of RMB 1,519.7 million as of June 30, 2022[121]. - The company had unutilized bank loan facilities amounting to RMB 410.0 million as of the report date[122]. Employee and Management - As of June 30, 2022, the total employee count was 589, with a total salary cost of RMB 207.8 million, compared to RMB 200.2 million for the same period in 2021[137]. - The company appointed Dr. Shaun Paul Cordoba as Chief Scientific Officer in January 2022 to enhance internal R&D capabilities, with a focus on CAR technology innovations[85]. Shareholder Information - As of June 30, 2022, the total number of shares issued by the company is 410,606,944 shares[187]. - The total number of shares held by Dr. Li amounts to 27,829,975 shares, representing a significant ownership stake in the company[185]. - The company has a maximum of 36,031,500 shares available for incentive plans, which is approximately 8.78% of the total issued share capital as of June 30, 2022[188].

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 | --- | --- | |-------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------- ...

Financial Performance - Total revenue for the six months ended June 30, 2021, was zero, consistent with the same period in 2020[10] - Operating loss for the six months ended June 30, 2021, was RMB 333.6 million, compared to RMB 158.3 million for the same period in 2020[10] - Net loss for the six months ended June 30, 2021, decreased to RMB 280.7 million from RMB 650.0 million in the same period of 2020, a reduction of RMB 369.3 million[12] - The company reported a basic and diluted loss per share of RMB 0.71 for the six months ended June 30, 2021, compared to RMB 9.96 for the same period in 2020[13] - The adjusted loss for the six months ended June 30, 2021, was RMB 268.2 million, an increase of RMB 167.2 million from RMB 101.0 million for the same period in 2020[18] - The company reported a comprehensive loss of RMB 317,257 million for the six months ended June 30, 2021, compared to RMB 668,367 million for the same period in 2020[190] Expenses - General and administrative expenses increased by RMB 24.1 million to RMB 105.1 million for the six months ended June 30, 2021, compared to RMB 81.0 million for the same period in 2020[12] - Research and development expenses rose significantly from RMB 82.3 million in the six months ended June 30, 2020, to RMB 185.5 million in the same period of 2021, an increase of RMB 103.2 million[10] - Sales expenses of RMB 46.2 million were incurred in the six months ended June 30, 2021, compared to zero in the same period of 2020, due to the establishment of a sales and marketing team[12] - The total employee compensation cost for the six months ended June 30, 2021, was RMB 200.2 million, compared to RMB 103.0 million for the same period in 2020, representing an increase of approximately 94.5%[106] Assets and Liabilities - Total assets as of June 30, 2021, were RMB 3,484.7 million, down from RMB 3,779.5 million as of December 31, 2020[16] - Total liabilities decreased to RMB 306.8 million as of June 30, 2021, from RMB 349.8 million as of December 31, 2020[16] - Total current assets as of June 30, 2021, were RMB 2,268.1 million, down from RMB 2,647.4 million as of December 31, 2020[94] - The total equity attributable to equity holders as of June 30, 2021, was RMB 3,177,841 million, down from RMB 3,429,735 million as of December 31, 2020[195] Clinical Development and Product Pipeline - The company is focused on advancing clinical research activities related to its therapies for liver cancer and acute lymphoblastic leukemia, which are expected to drive future growth[10] - The company has established a comprehensive and differentiated pipeline of cell immunotherapy products, with a focus on both validated targets and novel tumor antigens[26] - The company is developing relma-cel as a third-line treatment for LBCL and exploring its potential for other types of non-Hodgkin lymphoma (NHL)[28] - The company is conducting a Phase II trial for relma-cel in MCL patients who have received prior chemotherapy and targeted therapies, with patient enrollment starting in January 2021[35] - Plans are in place to initiate a Phase I/II trial for relma-cel in pediatric and adolescent patients with r/r ALL, with an IND application expected to be submitted in 2022[37] Regulatory Approvals and Market Potential - The company received approval from the National Medical Products Administration for its CAR-T product, relma-cel, on September 3, 2021, making it the first CAR-T product approved in China under Class 1 biological products[21] - The CAR-T therapy market in China is expected to reach RMB 5.4 billion by 2024 and RMB 24.3 billion by 2030, indicating significant growth potential[22] - A breakthrough therapy designation was granted for relma-cel to treat FL in September 2020, with plans to submit a supplemental new drug application in the following year[34] Production and Commercialization - The company has a fully integrated platform for the development, manufacturing, and commercialization of breakthrough cell immunotherapies[21] - The company has enhanced its production capacity and sales and marketing capabilities in anticipation of the full commercialization of relma-cel following regulatory approval[30] - The new commercial production facility in Suzhou spans approximately 10,000 square meters and is capable of producing up to 2,500 autologous CAR-T cell therapies annually[51] Strategic Partnerships and Collaborations - A partnership with Thermo Fisher was established to ensure non-exclusive commercialization rights for Gibco CTS Dynabeads CD3/CD28, supporting clinical development and commercialization of relma-cel in China[55] - The company aims to leverage strategic partnerships to expand into new and undeveloped cell-targeting and therapeutic areas[64] Risks and Challenges - The clinical development process for biopharmaceutical products is lengthy and costly, with uncertain outcomes, which may lead to additional costs or delays in product development and commercialization[125] - The company may encounter difficulties in the complex production processes of its cell therapy candidates, potentially delaying clinical trials or product supply[126] - Regulatory approval processes for biopharmaceutical products are lengthy and unpredictable, and delays could severely impact the company's business[125] - The company faces significant risks related to international trade policies and ongoing tensions between the US and China, which may adversely affect its business and expansion plans[122] Shareholder Information - The company has a significant shareholder, Juno, holding 70,231,140 shares, representing approximately 17.52% of the company[149] - As of June 30, 2021, the total issued shares were 400,924,836[145] - The pre-IPO incentive plan allows for a maximum of 36,031,500 shares to be granted, representing approximately 8.99% of the total issued share capital as of June 30, 2021[167]

Financial Performance - The company incurred a net loss of RMB 1,663.8 million in 2020, an increase of RMB 1,030.5 million from a net loss of RMB 633.3 million in 2019, primarily due to losses from the fair value changes of preferred shares and increased operating losses[22]. - The adjusted net loss (non-IFRS) for 2020 was RMB 303.9 million, up from RMB 188.8 million in 2019, mainly due to listing expenses and increased cash expenditures for R&D and clinical trials[28]. - General and administrative expenses rose from RMB 72.9 million in 2019 to RMB 231.3 million in 2020, mainly due to an increase in share-based compensation of RMB 103.9 million and listing expenses of RMB 35.6 million related to the company's listing on the Hong Kong Stock Exchange[18]. - R&D expenses increased from RMB 136.1 million in 2019 to RMB 225.2 million in 2020, primarily due to higher employee costs and clinical trial activities related to ongoing studies for DLBCL and other indications[17]. - The company reported a significant increase in net loss from RMB 633.3 million in 2019 to RMB 1,663.8 million in 2020, primarily due to an increase in preferred share fair value losses of RMB 1,062 million and operating losses of RMB 236.2 million[89]. - The company reported a net financial income of RMB 2.7 million in 2020, an increase from RMB 469,000 in 2019, reflecting improved financial management[87]. - Adjusted net loss increased from RMB 188.8 million for the year ended December 31, 2019, to RMB 303.9 million for the year ended December 31, 2020, primarily due to increased listing expenses, R&D personnel cash expenditures, and clinical trial costs[90]. Capital Raising and IPO - JW (Cayman) Therapeutics reported a successful IPO on November 3, 2020, raising HKD 2.5 billion after the underwriters exercised their over-allotment option[10]. - The company completed a Series B financing round totaling USD 100 million in May 2020 and successfully listed on the Hong Kong Stock Exchange in November 2020, raising HKD 2.5 billion[31]. - The total assets increased significantly from RMB 668.6 million in 2019 to RMB 3,779.5 million in 2020, reflecting the company's growth and capital raising efforts[24]. - The total cash and cash equivalents increased to RMB 2,630.6 million as of December 31, 2020, up from RMB 254.9 million at the end of 2019, due to capital raised from the issuance of preferred shares[114]. Product Development and Clinical Trials - The National Medical Products Administration of China accepted the new drug application for relmacabtagene autoleucel (relma-cel) for diffuse large B-cell lymphoma (DLBCL) in June 2020[10]. - In September 2020, the company received priority review status for relma-cel and breakthrough therapy designation for follicular lymphoma (FL) from the National Medical Products Administration[10]. - The company has initiated a Phase II registration clinical trial in China to evaluate the efficacy of relma-cel in patients with MCL who have previously received chemotherapy and BTK inhibitors[41]. - The company aims to develop relma-cel not only as a third-line treatment for DLBCL but also for other types of NHL, including FL, MCL, CLL, and ALL[41]. - The company has initiated a single-arm Phase II registration trial in China to evaluate the efficacy of relma-cel for patients with refractory FL, with expected completion in 2021[48]. - A single-arm Phase II registration trial for relma-cel in MCL patients began in January 2021, targeting those who have undergone chemotherapy and other treatments[49]. - The company announced safety and efficacy data for relma-cel as a third-line therapy for DLBCL at the 62nd American Society of Hematology Annual Meeting in December 2020[32]. - The company has reported a low incidence of severe cytokine release syndrome (5.1%) and severe neurotoxicity (3.4%) in the clinical trial for relma-cel, indicating a favorable safety profile[44]. Market Position and Strategy - The company is positioned favorably in the rapidly growing cell immunotherapy market in China, with a comprehensive and differentiated pipeline of CAR-T products[14]. - The CAR-T therapy market in China is projected to grow from RMB 600 million in 2021 to RMB 5.4 billion by 2024, and further to RMB 24.3 billion by 2030, indicating a significant market opportunity[36]. - The management believes that the company is well-positioned in the rapidly growing CAR-T therapy market due to its integrated development platform and experienced management team[36]. - The company aims to enhance its production and supply chain through innovation and economies of scale[13]. - The company is focused on commercializing relma-cel and enhancing its marketing and academic education efforts[13]. - The company plans to establish a sales team of approximately 60 to 70 people to promote relma-cel in 50 top hospitals in China, with sales and marketing expenses amounting to RMB 13.3 million for the year ended December 31, 2020[66]. Regulatory Environment - The National Development and Reform Commission and the Ministry of Commerce released the "Encouragement Directory for Foreign Investment Industries (2020 Edition)," which includes cell therapy products for the first time, indicating a supportive regulatory environment[146]. - The company is expected to comply with the new regulations regarding the management of anti-tumor drug clinical applications to enhance medical quality and safety[144]. - The company is responsible for post-marketing change management according to the "Post-Marketing Change Management Measures (Trial)" issued by the National Medical Products Administration[137]. - The "Biological Safety Law of the People's Republic of China" was enacted to address biological safety risks and ensure public health, effective from April 15, 2021[139]. Leadership and Management - Dr. Yiping James Li has been the CEO since February 2016 and was appointed as an executive director in August 2020, focusing on corporate management and product development[150]. - The company has expanded its leadership team with experienced professionals from the biotech industry, including Mr. Hans Edgar Bishop and Dr. Krishnan Viswanadhan, enhancing strategic guidance in cell therapy[152][155]. - The board includes members with extensive experience in biopharmaceuticals, such as Dr. Ann Li Lee, who has over 30 years in vaccine and cell therapy development[158]. - The leadership team has a strong academic background, with members holding advanced degrees from prestigious institutions, contributing to the company's innovative capabilities[159]. Challenges and Risks - The clinical development process for biopharmaceutical products is lengthy, costly, and fraught with uncertainty, with early research results not necessarily predicting future trial outcomes[198]. - If the company's candidate products fail to demonstrate satisfactory safety and efficacy in clinical trials, it may incur additional costs and delays in development and commercialization[199]. - Regulatory approval processes for candidate products are lengthy, time-consuming, and unpredictable, which could severely impact the company's business if approvals are delayed or denied[200]. - The company has incurred substantial losses since its inception and may never achieve or maintain profitability[197]. - The company faces significant challenges and barriers in the emerging cancer treatment methods represented by its proprietary CAR-T technology and candidate products[198].