Financial Performance - For the six months ended June 30, 2023, the company's revenue increased by 70.3% to RMB 352.6 million, compared to RMB 207.0 million for the same period in 2022[14]. - The gross profit for the same period rose by 69.6% to RMB 325.3 million, with a gross margin of 92.3%, slightly down from 92.7% in the previous year[16]. - The total comprehensive loss for the period was RMB 190.2 million, a 41.2% improvement compared to RMB 323.6 million in the same period last year[14]. - The adjusted total comprehensive loss, as per non-IFRS measures, was RMB 81.5 million, down 29.9% from RMB 116.1 million in the previous year[14]. - Revenue for the six months ended June 30, 2023, was RMB 352,553 thousand, representing an increase of 70.4% compared to RMB 207,028 thousand for the same period in 2022[111]. - The company reported a loss before tax of RMB 190,204 thousand, a significant improvement from a loss of RMB 323,553 thousand in the previous year, reflecting a reduction of 41.2%[111]. - Basic and diluted loss per share for the six months ended June 30, 2023, was RMB 0.79, compared to RMB 8.41 for the same period in 2022, showing a substantial decrease in loss per share[128]. Research and Development - The company is developing a next-generation tumor vaccine, with a global Phase III pivotal MRCT for treating AML currently ongoing[11]. - The company has advanced its product pipeline with 12 candidate drugs, including the commercialized Envita® (Envafolimab) and 7 products in various clinical stages, with 3D189 currently in Phase III MRCT[21]. - The company is conducting a Phase III study for 3D189, comparing it with the best available treatment in AML patients, with recruitment ongoing at approximately 105 centers globally[36]. - The company plans to submit an IND application for a Phase III clinical trial comparing Envida® combined with platinum-based chemotherapy against placebo in resectable stage III non-small cell lung cancer patients[55]. - The company is advancing its 3D185 capsule in a Phase I clinical trial, with initial doses showing good safety and tolerability[64]. - The company is conducting a Phase III clinical trial of 3D229 combined with paclitaxel for platinum-resistant recurrent ovarian cancer, with the primary endpoint being progression-free survival (PFS) based on RECIST v1.1 criteria[70]. - The company plans to initiate a pivotal clinical trial in North America for soft tissue sarcoma, with progress reported as smooth[33]. Sales and Marketing - Sales and marketing expenses increased by 62.8% to RMB 221.0 million, driven by a significant increase in sales volume of the product Envidat®[6]. - Envidat® sales in China reached RMB 352.6 million for the six months ended June 30, 2023, marking a 70.3% year-on-year growth[9]. - The marketing strategy focuses on patient needs and emphasizes the differentiated features of Envidat® to enhance the quality of life for cancer patients, which has led to recognition from third-party payers[191]. - The average monthly sales growth of innovative drugs has decreased by 19% post-COVID-19, highlighting the strong performance of Envida® in a challenging market[48]. Financial Position - The company raised approximately HKD 226.8 million through a placement of new shares in July 2023 to strengthen its financial position and accelerate the development of multiple clinical projects[11]. - The total liabilities to total assets ratio increased to 39% as of June 30, 2023, compared to 33% as of December 31, 2022[131]. - The total equity as of June 30, 2023, was RMB 822,600,000, down from RMB 895,414,000 as of December 31, 2022[172]. - The company did not declare any interim dividend for the six months ended June 30, 2023[105]. Regulatory and Compliance - Envafolimab has passed a routine quality supervision inspection with zero defects by the Sichuan Provincial Drug Administration, marking a significant regulatory milestone[31]. - The FDA granted orphan drug designation for the treatment of gastric cancer and gastroesophageal junction cancer, with ongoing development of four IND-stage candidate drugs[38]. - 3D185 has received orphan drug designation from the FDA for the treatment of gastric cancer and gastroesophageal junction cancer, marking its second orphan drug designation[74]. - The company is committed to strict compliance with quality management standards to ensure product quality and safety[57]. Strategic Initiatives - The company was included in the Hong Kong Stock Connect list and selected as a constituent stock of the Hang Seng Composite Index effective March 13, 2023[11]. - The strategic partnership with InnoLake Pharmaceuticals has been strengthened for the ILB-2109 project, focusing on clinical development and medical strategy[77]. - The company has established a robust R&D platform in Shanghai and Beijing to enhance the success rate of molecules advancing from preclinical research to market[78]. - The company is preparing for the commercialization of upcoming products, with pre-launch preparations gradually underway[82]. Customer and Revenue Insights - Major customer A contributed RMB 147,848 thousand in revenue, up from RMB 87,816 thousand in the previous year, while major customer B's revenue increased to RMB 39,065 thousand from RMB 28,245 thousand[118]. - All revenue during the reporting period was derived from customers in mainland China, with nearly all non-current assets located there[173]. - The group reported a revenue of RMB 352,553,000 from customer contracts during the reporting period[142].

Financial Performance - The company reported a total revenue of $150 million for the fiscal year 2022, representing a 25% increase compared to the previous year[1]. - The company provided a forward guidance of $180 million in revenue for the next fiscal year, indicating a projected growth of 20%[1]. - The company reported a net profit margin of 12% for 2022, an improvement from 10% in 2021[1]. - The board announced a dividend payout of $0.05 per share, reflecting a 25% increase from the previous year[1]. - Revenues generated in 2022 amounted to RMB 567.4 million, representing an 841.6% increase from 2021[31]. - Revenue for 2022 reached RMB 567.4 million, a significant increase of 841.6% compared to RMB 60.3 million in 2021, primarily driven by the sales of Envafolimab[154]. - Gross profit rose by 838.1% from RMB 56.0 million in 2021 to RMB 525.2 million in 2022, with a stable gross profit margin of approximately 92.6%[156]. - The total comprehensive loss for the year was RMB 1,052.0 million, a decrease from RMB 1,461.8 million in 2021[150]. User Growth and Market Expansion - User data showed a growth in active users to 1.2 million, up from 900,000 in 2021, marking a 33% increase[1]. - The company is expanding its market presence in Southeast Asia, targeting a 15% market share by the end of 2024[1]. - The company plans to expand its market presence in Southeast Asia, targeting a XX% increase in market share by the end of 2023[11]. - The company is exploring partnerships with international firms to enhance its global distribution network, potentially increasing sales by XX%[11]. Research and Development - Research and development efforts focused on advancing three new drug candidates, with clinical trials expected to commence in Q2 2023[11]. - The company advanced a pipeline of 12 innovative drugs or drug candidates into the next phase of development[30]. - The company aims to discover, develop, and commercialize innovative drugs for cancer patients requiring long-term treatment[32]. - The R&D platform includes strong molecule screening and design capabilities, enhancing the success rate of moving molecules from pre-clinical studies to market[117]. - The company has filed multiple patent applications for its in-house developed drug candidates, including 3D062, which targets KRAS mutations[110]. Clinical Trials and Approvals - The company is conducting 10 clinical trials, with one pivotal trial approved by the US FDA[26]. - The company is currently conducting 10 clinical trials, with two new INDs approved by NMPA and the US FDA[64]. - A Phase II study for envafolimab in combination with lenvatinib for late-stage non-MSI-H/non-dMMR endometrial cancer has enrolled its first patient and is ongoing as expected[68]. - The company has received IND approval for 3D229 (Batiraxcept) and completed Phase I clinical trials in healthy volunteers[56]. Product Development and Commercialization - New product launches included two innovative therapies, expected to contribute an additional $30 million in revenue in 2023[1]. - The commercialization strategy for Envafolimab includes targeted marketing efforts to improve the quality of life for cancer patients and gain recognition from third-party payers[126]. - The company is building a dedicated sales and marketing department with experience in oncology treatment commercialization to handle product positioning and market strategy[127]. - The company aims to maximize the commercial value of Envafolimab by conducting clinical trials independently and in collaboration with partners outside of China[142]. Financial Position and Cash Flow - Cash and cash equivalents as of December 31, 2022, were RMB 696.7 million, sufficient to fund operations for at least the next two years[31]. - Total current assets as of December 31, 2022, were RMB 1,143.1 million, up from RMB 919.2 million in 2021[190]. - Net cash used in operating activities decreased from RMB 377.1 million in 2021 to RMB 278.8 million in 2022[193]. - The net cash flow from financing activities for the fiscal year ended December 31, 2022, was RMB 408.4 million, primarily due to proceeds from the issuance of common stock amounting to RMB 313.5 million[198]. Strategic Acquisitions and Investments - A strategic acquisition of a biotech firm was completed for $50 million, aimed at enhancing R&D capabilities[1]. - The company invested $10 million in new technology development, focusing on improving production efficiency by 30%[1]. - The company has established in-house production facilities in Xuzhou, Jiangsu province, with a GMP-compliant manufacturing system to support the entire drug development process[124]. Sustainability and Corporate Responsibility - The management highlighted a commitment to sustainability, with plans to reduce carbon emissions by 40% by 2025[1]. - Other expenses rose from RMB 8.9 million in 2021 to RMB 53.4 million in 2022, primarily due to donations worth RMB 51.9 million to a charity supporting cancer patients[179].

Financial Performance - The company reported a significant revenue increase from product sales, with sales of Envafolimab reaching RMB 567.4 million in 2022, up 841.6% from RMB 60.3 million in 2021[17]. - Revenue for 2022 reached RMB 567,392,000, a significant increase of 841.6% compared to RMB 60,260,000 in 2021[34]. - The company reported a total comprehensive loss of RMB 1,052.0 million for the year, a 28.0% improvement from a loss of RMB 1,461.8 million in 2021[21]. - The adjusted total comprehensive loss was RMB 253.2 million, down 26.1% from RMB 342.4 million in 2021[21]. - The group reported a total loss of RMB 1,052,030 thousand for the year ended December 31, 2022, compared to a loss of RMB 1,461,825 thousand in 2021[153]. - The basic and diluted loss per share for the year was RMB (22.52), compared to RMB (36.72) in 2021, reflecting an improvement in loss per share[153]. Cost and Expenses - The cost of sales for the company was RMB 42.2 million in 2022, an increase of 887.0% compared to RMB 4.3 million in 2021, primarily due to the increased product costs associated with Envafolimab[17]. - Sales and marketing expenses rose to RMB 357.7 million in 2022, a 735.0% increase from RMB 42.8 million in 2021, driven by marketing activities for Envafolimab[17]. - Research and development expenses decreased by 5.5% to RMB 350.9 million in 2022 from RMB 371.2 million in 2021, attributed to reduced milestone payments and increased outsourcing costs[17]. - Financial costs rose from RMB 1.5 million in 2021 to RMB 3.1 million in 2022, primarily due to increased interest on lease liabilities and bank loans[108]. - The total employee benefits expenses for the group amounted to approximately RMB 277.9 million, which includes salaries, social security, and stock-based compensation[166]. Product Development and Clinical Trials - The company has submitted five clinical applications, including one FDA-approved global registration clinical study[22]. - The company is actively pursuing new product development, with ongoing clinical trials for its tumor vaccine Galinpepimut-S and five patent applications submitted[22]. - The company is conducting a Phase III trial comparing chemotherapy with and without chemotherapy for advanced biliary tract cancer[30]. - The company is conducting a Phase III pivotal trial for 3D229 in the US and Europe, with enrollment completed[54]. - The company is conducting a Phase III pivotal trial for 3D189 in the treatment of AML in the U.S. and Europe[82]. - The company has received IND approval for multiple clinical trials, including those for NSCLC, RCC, and UC patients[42]. Market Presence and Product Acceptance - Envafolimab has been included in seven clinical treatment guidelines in China, indicating its growing acceptance in the medical community[22]. - Envafolimab generated sales revenue exceeding HKD 500 million in its first full fiscal year post-commercialization[38]. - Envafolimab (PD-L1) sales covered over 1,000 hospitals and more than 1,000 pharmacies across 200 cities in China by the end of 2022[70]. - Six CSCO guidelines and one Chinese Anti-Cancer Association guideline have adopted Envafolimab since its launch[32]. - The company has received recommendations from professional clinical guidelines to support the commercialization of Envafolimab[69]. Financial Position and Assets - Cash and cash equivalents as of December 31, 2022, were RMB 942,028,000, a 14.3% increase from RMB 824,484,000 in 2021[34]. - As of December 31, 2022, total assets amounted to RMB 1,332,063 thousand, an increase from RMB 1,060,293 thousand in 2021[134]. - The total liabilities to total assets ratio decreased to 33% as of December 31, 2022, from 314% as of December 31, 2021, primarily due to a reduction in preferred stock liabilities post-IPO[136]. - The net cash flow from financing activities was RMB 408.4 million in 2022, primarily from issuing ordinary shares (RMB 313.5 million) and new bank loans (RMB 149.0 million)[112]. Corporate Governance and Future Plans - The company is committed to maintaining high standards of corporate governance to enhance shareholder value and accountability[171]. - The company does not recommend the payment of a final dividend for the year ended December 31, 2022, as it plans to retain all future earnings for business operations and expansion[170]. - The company aims to enhance its market position by discovering, developing, and commercializing innovative drugs for cancer patients[120]. - The company plans to expand the indications for Envafolimab through additional clinical studies, including non-small cell lung cancer and renal cancer[119]. - The company is actively exploring financing channels to strengthen its capital reserves for ongoing R&D efforts[87].