Financial Performance - Revenue increased by 32.9% from RMB 66.0 million for the six months ended June 30, 2022, to RMB 87.7 million for the six months ended June 30, 2023, driven by the commercialization of the CAR-T cell therapy product, Relma-cel [54]. - Loss for the six months ended June 30, 2023, was RMB 380.4 million, a decrease from RMB 429.3 million for the same period in 2022, primarily due to increased revenue and improved operational efficiency [23]. - Gross profit increased by 93.9% from RMB 23.1 million for the six months ended June 30, 2022, to RMB 44.8 million for the six months ended June 30, 2023, with a gross margin rising from 35.0% to 51.1% [55]. - Operating loss decreased to RMB 389.92 million for the six months ended June 30, 2023, down from RMB 431.96 million in the same period of 2022, reflecting improved operational efficiency [84]. - The adjusted loss for the six months ended June 30, 2023, was RMB 267.07 million, a reduction from RMB 289.20 million in the same period of 2022, primarily due to increased sales revenue and gross profit from the product Benodara® [86]. - Total revenue for the six months ended June 30, 2023, was RMB 87.74 million, a 32.8% increase from RMB 66.01 million for the same period in 2022 [191]. Research and Development - The company’s R&D expenses details for the six months ended June 30, 2022, and 2023, are provided, indicating ongoing investment in product development [13]. - Research and development expenses rose by 10.5% from RMB 195.9 million for the six months ended June 30, 2022, to RMB 216.5 million for the six months ended June 30, 2023, mainly due to increased depreciation and clinical trial costs [41]. - The company has made significant progress in developing Beinuoda® for treating hematological malignancies and expanding its product portfolio for solid tumors [71]. - The company is developing two dual-targeted autologous CAR T-cell therapies aimed at enhancing efficacy and performance in treating autoimmune diseases and B-cell malignancies [67]. - The company has initiated clinical studies for relma-cel in treating moderate to severe active SLE patients, with IND approval received in April 2023 [93]. - The company is developing two new CAR products for solid tumors, expected to be delivered for clinical use in 2025 [181]. Cost Management - General and administrative expenses decreased from RMB 909 million for the six months ended June 30, 2022, to RMB 787 million for the six months ended June 30, 2023, primarily due to a reduction in employee benefits expenses of approximately RMB 96 million [12]. - Sales expenses decreased by 28.7% to RMB 60.17 million, down from RMB 84.45 million, due to optimized staffing for commercial operations [83]. - The company continues to implement cost reduction strategies, achieving an 18.1% decrease in sales costs per batch compared to the average sales cost in 2022, contributing to the increase in gross margin [74]. - The company continues to execute cost reduction plans, enhancing operational efficiency and reducing cash outflows [88]. - Employee benefits expenses for the six months ended June 30, 2023, were RMB 46,831 thousand, a decrease of 17.1% from RMB 56,462 thousand for the same period in 2022 [196]. Product Development and Commercialization - The company has established a dedicated commercial team for the commercialization of Relma-cel in China, having completed assessments and training for 118 hospitals by June 30, 2023 [124]. - The first product, Beinuoda® (relma-cel), is the first CAR-T cell therapy approved in China for treating adult patients with r/r LBCL and r/r FL after two lines of systemic therapy [97]. - Beinuoda® demonstrated an objective response rate (ORR) of 77.6% and a complete response rate (CRR) of 53.5% in a Phase II clinical trial for third-line LBCL treatment [107]. - The company plans to submit a supplemental new drug application to the National Medical Products Administration by the end of 2023 based on the promising data from ongoing studies [114]. - The company aims to solidify its leadership in hematology through the continued development of its product,倍諾達®, and further expansion into autoimmune disease clinical development [161]. Regulatory Compliance and Governance - The company has fully complied with the listing rules following the appointment of Dr. Debra Yu as a director on March 1, 2023 [18]. - The company has not reported any major shareholders or their associates receiving stock options exceeding the 1% individual limit as per the listing rules [7]. - The company did not engage in any significant acquisitions or disposals during the six months ended June 30, 2023 [16]. Market and Competitive Position - The company expects the superior product characteristics of Relma-cel to provide breakthrough value for patients [54]. - Relma-cel has been approved by the FDA in February 2021, based on the same CAR structure as Juno's product, indicating its competitive positioning in the market [129]. - The company is exploring innovative payment solutions to alleviate the financial burden on patients receiving Beinuoda® treatment [100]. - The company aims to expand its commercial insurance coverage and continue collaborating with leading payment platforms [100].

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責，對其準確 性或完整性亦不發表任何聲明，並明確表示，概不就因本公告全部或任何部分內容而產生或 因倚賴該等內容而引致的任何損失承擔任何責任。 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） 截至2023年6月30日止六個月之中期業績公告 藥明巨諾（開曼）有限公司（「本公司」）之董事（「董事」）會（「董事會」）欣然公佈 本公司及其附屬公司（統稱「本集團」或「我們」）截至2023年6月30日止六個月（「報 告期間」）之未經審核簡明綜合中期業績，連同2022年相應期間之比較數字。該 等中期業績已由本公司審核委員會（「審核委員會」）及核數師羅兵咸永道會計 師事務所審閱。 中期業績摘要 財務摘要 國際財務報告準則計量： ‧ 收入由截至2022年6月30日止六個月 的人民幣66.0百萬元增加32.9%至截 至2023年6月30日止六個月的人民幣87.7百萬元，該增長是由於我們的 ...

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]

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].

Financial Performance - JW Therapeutics reported revenue of RMB 30.8 million from the commercialization of its leading product, Relma-cel, in the last four months of 2021[8]. - For the fiscal year ended December 31, 2021, the company's revenue was RMB 30.8 million, a significant increase from zero in the previous year, attributed to the commercialization of the CAR-T product Relma-cel approved on September 3, 2021[18]. - The company reported a total revenue of RMB 30,797,000, with a gross profit of RMB 9,045,000[27]. - The net loss for the fiscal year ended December 31, 2021, was RMB 702.3 million, a reduction of RMB 961.5 million compared to the previous year's loss of RMB 1,663.8 million, primarily due to revenue generated from Relma-cel[24]. - The adjusted net loss for 2021, excluding non-cash items, was RMB 664,109,000, an increase from RMB 303,917,000 in 2020[31]. - The company incurred a net loss of RMB 702,328,000 in 2021, a significant improvement from the net loss of RMB 1,663,803,000 in 2020[31]. - The company reported a significant increase in revenue, achieving a total of $500 million for the fiscal year, representing a 25% year-over-year growth[164]. Research and Development - Research and development expenses increased from RMB 225.2 million in the previous year to RMB 414.4 million, driven by higher employee costs and increased clinical trial expenses[22]. - The company is focused on expanding its pipeline products and enhancing its production capabilities while implementing cost reduction strategies[34]. - The company is developing multiple candidates targeting various indications, including JWATM204 for HCC, which is currently in Phase I trials in China[50]. - The company is advancing the development of next-generation CAR-T products with a focus on reducing manufacturing costs and improving product characteristics[69]. - The company is committed to innovation in cancer immunotherapy, as evidenced by its ongoing research and development efforts[178]. - The company is actively pursuing new product development and technological advancements in the biopharmaceutical field[198]. Product Development and Commercialization - The company received approval from the National Medical Products Administration (NMPA) for Relma-cel as a new drug for the treatment of relapsed or refractory large B-cell lymphoma (LBCL) in September 2021[8]. - Relma-cel has been approved for clinical trials as a third-line treatment for pediatric and adolescent patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) and for relapsed or refractory LBCL[9]. - The company aims to create a new ecosystem for cell therapy products in China, enhancing the quality and safety of patient experiences[12]. - The company plans to continue the full commercialization of Relma-cel and expand its product pipeline in the blood cancer sector while leveraging its integrated cell therapy platform to enter emerging solid tumor markets[18]. - The company aims to explore the clinical potential of Relma-cel as a second-line treatment for LBCL and other hematological cancers[53]. - The company has established partnerships for commercialization rights in mainland China, Hong Kong, and Macau for several of its products[47]. Market Strategy and Expansion - The company aims to solidify its leadership in hematological cancers through the continued development of Benauda® for early treatment and other indications, with new supplemental new drug application approvals expected in 2022 and 2023[94]. - The company is focused on expanding its solid tumor market with products JWATM203 and JWATM204, having obtained development and commercialization rights from partners[95]. - The company is exploring strategic acquisitions to enhance its product portfolio, with a budget of $200 million allocated for potential deals[171]. - The company is expanding its market presence in Asia, targeting a 30% increase in market share within the next two years[169]. - The company plans to utilize its strategic partnerships to further expand into new and undeveloped cell-targeting and therapeutic areas[100]. Operational Efficiency and Cost Management - The management team is focused on enhancing production capacity and reducing costs through innovation and economies of scale, alongside pursuing licensing opportunities and selective acquisitions[18]. - The company has laid the foundation for reducing raw material costs and implemented related processes in its GMP operations for cost reduction in the second half of 2022[40]. - The company plans to enhance its operational efficiency, targeting a 15% reduction in operational costs over the next fiscal year[174]. - The company anticipates that gross margins will continue to rise starting in the second half of 2022 due to cost reduction initiatives and increased patient uptake[114]. Leadership and Governance - The new Chief Scientific Officer has joined the company, significantly enhancing early research capabilities and the potential for new pipeline products[12]. - The company has a strong leadership team with extensive experience in finance and compliance, including Mr. Fu, who has approximately 20 years of financial management experience in the healthcare industry[191]. - The board includes independent directors with significant experience in the pharmaceutical and healthcare sectors, enhancing corporate governance[182][186]. - The company has established a robust investor relations management strategy to enhance communication with stakeholders[191]. Clinical Trials and Efficacy - The best complete response rate (CRR) for the first 27 evaluable commercial patients treated with Relma-cel was 55.6%, consistent with clinical trial results[35]. - The median follow-up period for the clinical trial of Relma-cel was 17.9 months, with a one-year overall survival (OS) rate of 76.9%[55]. - The company achieved a 99% high production success rate for Relma-cel since the start of the LBCL registration clinical trial[40]. - In a clinical trial involving 28 patients treated with Beinuoda®, the overall response rate (ORR) was 100% and the complete response rate (CRR) was 92.6%[59]. Regulatory and Compliance - The company is committed to monitoring the impact of COVID-19 on its operations, including clinical trial patient recruitment and regulatory approvals, while implementing safety measures for employees and suppliers[91]. - The board of directors emphasized the importance of data security compliance, aligning with the new data protection regulations[173].

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].