Company Overview - Sido Medical Co., Ltd. is an innovative pharmaceutical company focused on oncology and chronic disease treatment, with a vision to "help cancer patients live longer and better" [2] - The company has a product line of 12 innovative drugs with differentiated clinical value, 8 of which are in clinical development or commercialization stages [2] - The first subcutaneous PD-L1 monoclonal antibody, Envida, has been approved for sale by the National Medical Products Administration [2] - The company utilizes its proprietary mRNA research platform and tumor genomic big data AI analysis platform to develop a series of mRNA products [2] - Sido Medical has established capabilities across drug discovery, preclinical research, clinical development, regulatory submission, and commercialization [2] Financial Performance - As of December 31, 2024, Sido Medical reported total revenue of 446 million yuan, a year-on-year decrease of 29.81% [1] - The company recorded a net profit attributable to shareholders of -183 million yuan, an increase of 65.19% year-on-year [1] - The gross profit margin stands at 91.79%, with a debt-to-asset ratio of 42.14% [1] Market Position and Valuation - The average price-to-earnings (P/E) ratio for the pharmaceutical and biotechnology industry is 1.96 times, with a median of 6.18 times [1] - Sido Medical's P/E ratio is -5.69 times, ranking 132nd in the industry [1] - Comparatively, other companies in the industry have P/E ratios such as: Qingdao Haier Biomedical (0.86), Kingsray Biotechnology (1.43), Dongrui Pharmaceutical (3.06), and Jilin Changlong Pharmaceutical (6.00) [1]

Financial Performance - The company reported a revenue of $150 million for the fiscal year 2024, representing a 25% increase compared to the previous year[4]. - The company reported a revenue of HK$124.4 million for the year ended December 31, 2024, reflecting a year-on-year increase of 15%[10]. - In 2024, the company's revenue was RMB 445.6 million, a decrease of approximately 29.8% compared to 2023[42]. - The total comprehensive loss for the year was RMB 199.4 million, a significant improvement from a loss of RMB 562.5 million in 2023[143]. - The gross profit fell by 30.2% from RMB 585.8 million in 2023 to RMB 409.1 million in 2024, with a gross profit margin of 91.8% compared to 92.3% in the previous year[148]. - Other income and net gains increased to RMB 54.7 million in 2024 from RMB 41.0 million in 2023, driven by higher bank interest income, foreign exchange gains, and investment income[149]. User Growth and Market Expansion - User data showed a growth of 30% in active users, reaching 1.2 million by the end of the fiscal year[4]. - The user base expanded by 20% year-on-year, reaching a total of 1.2 million active users[10]. - The company is expanding its market presence in Southeast Asia, targeting a 10% market share within the next two years[4]. - The company plans to enter the North American market by Q3 2025, aiming to capture a 10% market share within the first year[10]. Research and Development - Research and development expenses increased by 30% to HK$37 million, focusing on innovative drug development[10]. - Research and development expenses were RMB 180.7 million, representing a 57.5% decrease from 2023[26]. - The company has made significant progress in its R&D pipeline, adding a new mRNA vaccine candidate and a radiopharmaceutical candidate in 2024[46]. - The company is actively developing early-stage pipeline candidates while strategically expanding its commercial portfolio to transform cancer into a manageable chronic disease[48][49]. - The company has established an ionizable cationic lipid R&D platform to enhance mRNA vaccine development efficiency and improve drug targeting precision[98]. Product Development and Innovation - New product launches contributed to 15% of total revenue, with the introduction of two innovative therapies in the oncology sector[4]. - The company has diversified its product pipeline to include 13 products, with the addition of the new radiopharmaceutical drug conjugate (RDC) 3D1015[25]. - The company is developing a proprietary AI-driven antigen prediction platform for tumor antigen screening and design for 3D124[94]. - The company has initiated the development of next-generation radioligand therapy products, leveraging PSMA as an entry point[112]. Cost Management and Operational Efficiency - The management highlighted a 5% reduction in operational costs due to improved efficiency measures implemented during the year[4]. - Administrative expenses decreased by RMB 138.8 million to RMB 78.3 million from RMB 217.1 million in 2023, primarily due to a reduction in share-based payment expenses[156]. - Selling and marketing expenses decreased by 37.7% from RMB 378.8 million in 2023 to RMB 235.9 million in 2024, reflecting a more effective sales promotion regime and cost reduction measures[157]. Strategic Partnerships and Acquisitions - A strategic acquisition of a biotech firm was completed, expected to enhance the company's R&D capabilities and product pipeline[4]. - The company has secured partnerships with three major pharmaceutical firms to enhance its distribution network[10]. - The company is exploring potential acquisitions to bolster its product pipeline and market presence[10]. Sustainability and Corporate Responsibility - The company is committed to sustainability, with a goal to reduce carbon emissions by 30% over the next five years[4]. - The company integrated Environmental, Social, and Governance (ESG) principles into its daily operations[25]. Clinical Development and Regulatory Progress - A new drug application (NDA) is expected to be submitted to the NMPA by the end of Q2 2025, targeting renal cell carcinoma[10]. - The execution team secured a Breakthrough Therapy designation from Chinese regulators, enhancing the company's strategic position[46]. - Envafolimab received Breakthrough Therapy Designation for treating unresectable or metastatic TMB-H solid tumors, addressing a critical unmet medical need in China[62]. Manufacturing and Infrastructure - The company has purchased land in Xuzhou, China, with an area of 65,637.97 square meters for building new manufacturing facilities, which have received construction permits and are currently under construction[118]. - Approximately 40% of the net proceeds from the 2023 Placing will be allocated to expedite the construction and procurement of new equipment for the manufacturing facilities in Xuzhou[120].

Group 1 - The biotechnology stocks in the Hong Kong market mostly declined, with notable drops in several companies [1] - Kangfang Biotech (09926.HK) experienced a decline of over 12% [1] - Yunkang Group (02325.HK) fell by more than 6% [1] - Other companies such as Sillod Medical (01244.HK) and Zai Lab (09688.HK) also saw declines exceeding 4% [1]

Financial Performance - For the fiscal year ending December 31, 2024, the company's revenue decreased by 29.8% to RMB 445.6 million from RMB 634.9 million in 2023, primarily due to intensified market competition [10]. - The company's gross profit fell by 30.2% to RMB 409.1 million, with a gross margin of 91.8% for 2024, slightly down from 92.3% in 2023, attributed to increased sales-related taxes and product quality costs [8]. - The total comprehensive loss for the year narrowed to RMB 199.4 million from RMB 562.5 million in 2023, indicating improved operational efficiency [13]. - The company reported a pre-tax loss of RMB 199.4 million in 2024, a significant improvement from a loss of RMB 562.5 million in 2023 [54]. - The company reported a net loss of RMB 199.4 million for the year ended December 31, 2024, compared to a net loss in the previous year [107]. - Basic and diluted loss per share for the year was RMB 0.75, compared to RMB 2.30 in 2023, showing a reduction in loss per share [102]. - Total liabilities decreased to RMB 512.5 million in 2024 from RMB 558.2 million in 2023, reflecting a decline of about 8.2% [104]. - The company's equity decreased to RMB 703.7 million in 2024 from RMB 870.7 million in 2023, a drop of approximately 19.2% [104]. Research and Development - Research and development expenses decreased by 57.5% to RMB 180.7 million from RMB 425.5 million in 2023, mainly due to reduced third-party contractor fees and employee benefit costs [11]. - The company has a diversified product pipeline with 13 products, including a new drug candidate 3D1015 aimed at treating metastatic castration-resistant prostate cancer [15]. - The company is leveraging an AI-driven antigen prediction platform for the development of personalized cancer vaccines [15]. - The establishment of an AI-driven 3D-PreciseAg antigen prediction platform has led to the identification of 24 antigens for a universal mRNA tumor vaccine [16]. - The company achieved significant progress in its R&D pipeline, adding a new mRNA vaccine candidate, 3D124, and replacing 3D011 with 3D1015, both showing positive signals in preclinical trials [22]. - The company has filed a PCT patent for key components of its self-developed lipid nanoparticles for nucleic acid drug delivery, indicating ongoing innovation in drug delivery technologies [22]. - The company is actively expanding its research and development efforts in innovative therapies, as evidenced by the promising results from multiple clinical trials [10][11][12][13][14][33][34][35]. Sales and Marketing - Sales and marketing expenses dropped by 37.7% to RMB 235.9 million from RMB 378.8 million in 2023, as new promotional strategies and cost-cutting measures were implemented [12]. - The sales revenue of Envida® (Envafolimab) in China reached RMB 4.456 billion in 2024, contributing to a total sales amount of approximately RMB 1.7 billion [21]. - The total revenue of the group decreased by approximately 29.8% compared to the same period in 2023, primarily due to a decline in Envida® sales [21]. - The company has initiated international commercialization efforts, with a licensing agreement for Envafolimab with Glenmark, allowing entry into the Macau market, which is expected to provide new revenue growth opportunities [22]. - The company plans to expand the development and commercialization of Envidat® into emerging markets through strategic partnerships [77]. Clinical Trials and Approvals - A total of 22 prospective research results related to Envida® were published in 2024, including 5 full papers in international high-level journals and over 17 reports at international conferences [18]. - Envafolimab has been recognized as a breakthrough therapy for patients with high tumor mutation burden (TMB-H) unresectable or metastatic solid tumors [20]. - The company received approval for a supplemental new drug application (sNDA) to change the production scale from 1000L to 2000L and to add new raw material suppliers [20]. - The clinical data for Envafolimab combined with Lenvatinib for treating advanced endometrial cancer showed improved efficacy and safety for patients who failed or could not tolerate prior platinum-based chemotherapy [26]. - The ENLIGHTEN study reported an Objective Response Rate (ORR) of 45% and a Disease Control Rate (DCR) of 80% in advanced biliary tract cancer patients [26]. - Envafolimab demonstrated a pathological complete response (pCR) rate of 30.7% and a major pathological response (MPR) rate of 53.8% in a study involving resectable stage II-IIIB NSCLC patients [28]. - The combination therapy of TACE, Envafolimab, and Lenvatinib for unresectable hepatocellular carcinoma (uHCC) demonstrated an ORR of 50% and a DCR of 83.3%, with a surgical conversion rate of 47.2% and a 100% R0 resection rate [11]. Corporate Governance and Strategy - The company adheres to high standards of corporate governance and has complied with all applicable code provisions during the reporting period [86]. - The board believes that the current structure of having the same individual as both Chairman and CEO does not impair the balance of power and authority [87]. - The company plans to retain all future earnings for business operations and expansion, with no immediate plans for a dividend policy [88]. - The company has established a comprehensive quality management system based on GLP, GCP, and GMP standards to ensure compliance from early development to final product launch [46]. - The company is focused on expanding its research and development capabilities in cell gene therapy and oncology [129]. Future Outlook - The company anticipates continued progress in advancing late-stage clinical drugs to NDA stage, which is expected to bring incremental cash flow in the foreseeable future [69]. - The company plans to submit multiple IND applications in various countries this year, indicating a strong pipeline for future product development [25]. - The company projects a revenue growth of 20% for the next fiscal year, driven by new product launches and market expansion [132]. - The company aims to reduce operational costs by 15% over the next two years through process optimization [132].

Financial Performance - 3D Medicines reported a significant increase in revenue, reaching approximately HK$ 150 million for the first half of 2024, representing a 25% growth compared to the same period last year[1]. - The company reported a total revenue of RMB 1,200,000,000 for the first half of 2024, reflecting a year-over-year growth of 15%[11]. - For the six months ended June 30, 2024, the company's revenue decreased by 41.4% to RMB 206.4 million from RMB 352.6 million for the same period in 2023, primarily due to a highly competitive market for PD-1/L1 products[16]. - The total comprehensive loss for the period was RMB 114.1 million, a 40.0% improvement from RMB 190.2 million in the same period of 2023[16]. - The company reported a net loss of RMB 150,000,000 for the first half of 2024, compared to a net loss of RMB 120,000,000 in the same period last year[11]. - The total comprehensive loss for the period ended June 30, 2024, was RMB (114,074) thousand, a 40.0% improvement compared to RMB (190,204) thousand for the same period in 2023[22]. - The company reported a basic and diluted loss per share of RMB 0.42 for the period, compared to RMB 0.79 in the same period last year[150]. Research and Development - 3D Medicines is investing heavily in R&D, allocating approximately HK$ 50 million for the development of new therapies, including a focus on PD-L1 inhibitors[1]. - Research and development expenses for the first half of 2024 were RMB 300,000,000, representing an increase of 25% compared to the same period last year[11]. - Research and development expenses decreased by 43.7% to RMB 85.3 million from RMB 151.6 million, mainly due to a reduction in employee benefit expenses related to research and development personnel[17]. - The company has a pipeline of 12 drug candidates, with seven in various stages of clinical development[23]. - The company is focusing on cutting-edge research in TIL and CAR-T therapies to promote diversification and specialization of its research and development[29]. Market Expansion and Strategy - The company is actively expanding its market presence, with plans to enter two new international markets by the end of 2024[1]. - The company plans to expand its market presence in Asia, targeting a 30% increase in market share by the end of 2025[11]. - Future guidance indicates an anticipated revenue growth of 20% for the full year 2024, driven by new product introductions and market expansion efforts[11]. - The company aims to enhance its digital marketing strategies, targeting a 40% increase in online engagement with healthcare professionals by mid-2025[1]. Product Development and Clinical Trials - The company is on track to submit a biologic license application (BLA) for Envafolimab by Q4 2024, which is expected to accelerate its market entry[1]. - Envafolimab achieved sales revenue of RMB 206.4 million in China for the six months ended June 30, 2024, a decrease of 41.4% compared to the same period last year[23]. - Envafolimab's phase III trial in NSCLC perioperative regimens is progressing smoothly[23]. - The confirmed overall response rate (ORR) for Envafolimab combined with Lenvatinib in advanced endometrial cancer was 40.0%[24]. - The ongoing Phase III trial (KN035-CN-017) is assessing the efficacy and safety of Envafolimab in combination with neoadjuvant platinum-based chemotherapy, with a focus on patients with resectable NSCLC[30]. Cost Management and Operational Efficiency - 3D Medicines reported a 15% reduction in operational costs due to improved manufacturing efficiencies[1]. - The company aims to reduce operational costs by 10% over the next year through efficiency improvements and strategic partnerships[11]. - Selling and marketing expenses decreased by 50.2% to RMB 110.1 million from RMB 221.0 million, primarily due to a sales drop of Envafolimab, with the decrease rate of marketing expenses exceeding the sales decline rate[18]. Financial Position and Cash Flow - As of June 30, 2024, cash and bank balances amounted to RMB 898,578,000, a decrease of 19.8% compared to RMB 1,120,849,000 as of December 31, 2023[14]. - Current assets as of June 30, 2024, were RMB 1,037.0 million, a decrease from RMB 1,095.2 million as of December 31, 2023[67]. - Cash and cash equivalents decreased by RMB 177.8 million to RMB 488.7 million as of June 30, 2024, from RMB 666.5 million as of December 31, 2023[68]. - Net cash used in operating activities for the six months ended June 30, 2024, was RMB 223.6 million, up from RMB 168.1 million in 2023[70]. Corporate Governance - The company has complied with all applicable code provisions of the CG Code during the reporting period, with some deviations noted[87]. - The roles of chairman and chief executive are held by the same individual, Dr. Gong Zhaolong, which deviates from the CG Code[87]. - The board structure includes three independent non-executive directors out of seven, ensuring sufficient checks and balances[88]. Shareholder Information - Dr. Gong holds a total of 35,992,364 shares, representing approximately 13.94% of the company's shareholding interest[92]. - The shareholding structure indicates a significant concentration of ownership among key directors and their affiliates[93]. - The company has established a share option scheme to incentivize key employees, approved on June 26, 2023[7].

Financial Performance - Revenue for the six months ended June 30, 2024, was RMB 206.4 million, a decrease of 41.4% from RMB 352.6 million in the same period of 2023[2]. - Gross profit for the same period was RMB 188.9 million, down 41.9% from RMB 325.3 million, with a gross margin of 91.5% compared to 92.3% in the previous year[3]. - The adjusted total comprehensive loss for the period was RMB 97.7 million, an increase of 19.9% compared to RMB 81.5 million in the same period of 2023[5]. - The company reported a pre-tax loss of RMB 114.1 million, a reduction of 42.6% from RMB 190.2 million in the previous year[2]. - Total comprehensive loss for the six months ended June 30, 2024, was RMB 114.1 million, a decrease of RMB 76.1 million from RMB 190.2 million in the same period of 2023[38]. - Basic and diluted loss per share improved to RMB (0.42) from RMB (0.79) year-on-year[73]. Expenses - Research and development expenses decreased by 43.7% to RMB 85.3 million from RMB 151.6 million, primarily due to reduced employee benefits costs[4]. - Sales and marketing expenses fell by 50.2% to RMB 110.1 million from RMB 221.0 million, attributed to decreased sales of the product Envidat®[4]. - The company’s sales cost decreased by 36.0% to RMB 17.5 million from RMB 27.3 million, reflecting reduced sales volume[3]. - Administrative expenses reduced by RMB 34.9 million to RMB 43.5 million for the six months ended June 30, 2024, compared to RMB 78.4 million in the same period of 2023[35]. - Licensing fees decreased by RMB 19.5 million to RMB 15.6 million for the six months ended June 30, 2024, compared to RMB 35.1 million in the same period of 2023[37]. Cash and Assets - Cash and bank balances decreased by 19.8% to RMB 898.6 million from RMB 1,120.8 million as of December 31, 2023[2]. - Total assets as of June 30, 2024, were RMB 1,263,535 thousand, down from RMB 1,428,882 thousand as of December 31, 2023[58]. - Cash and cash equivalents decreased from RMB 666.5 million as of December 31, 2023, to RMB 488.7 million as of June 30, 2024, a reduction of RMB 177.8 million[41]. - Total equity as of June 30, 2024, was RMB 772,866 thousand, down from RMB 870,685 thousand at the end of 2023[59]. Market and Competition - The decline in revenue was primarily due to increased competition in the PD-1/L1 market[3]. - The total revenue for the group decreased by approximately 41.4% compared to the same period in 2023, primarily due to the decline in Envafolimab sales[8]. - Major customer A contributed RMB 86,014 thousand to revenue, accounting for 41.6% of total revenue, compared to RMB 147,848 thousand in the previous year[65]. Product Development and Pipeline - The company has a pipeline of 12 candidate drugs, with two-thirds currently in clinical development, indicating a high maturity level of the pipeline[9]. - The company is focusing on external collaborations, particularly in TIL and CAR-T therapies, to diversify and specialize its research and development efforts[9]. - The company anticipates the continuous launch of new products over the next three to five years, leveraging its mature product pipeline[9]. - Envafolimab (恩維達®) generated sales revenue of RMB 206.4 million in China for the six months ended June 30, 2024, a decrease of 41.4% compared to the same period last year[6]. - The company is developing a new mRNA cancer vaccine, 3D124, which targets multiple tumor-specific antigens and has shown strong anti-tumor effects in preclinical studies[18]. Regulatory and Compliance - Envafolimab (KN035) received regulatory approval in Macau for treating adult patients with unresectable or metastatic MSI-H or dMMR solid tumors[12]. - The company has received orphan drug designation from the FDA for candidate drugs 3D185 and 3D189, targeting specific cancers[47]. - The company has complied with all applicable corporate governance codes, except for the separation of the roles of Chairman and CEO, which are held by the same individual[52]. Strategic Initiatives - The company aims to enhance its product pipeline through global drug development initiatives[47]. - The company plans to implement improved sales strategies to drive growth, especially after expanding Envafolimab's indications[8]. - The company is focused on expanding its market presence in the oncology sector, particularly in non-small cell lung cancer (NSCLC) and renal cell carcinoma (RCC)[79]. - The company is actively monitoring market trends to inform future product development and expansion strategies[79].

Financial Overview - The total expected amount for product and drug candidates development is RMB 232,927.9 thousand, with core product envafolimab accounting for RMB 128,110.3 thousand[4]. - The total budget for the development and commercialization of products and drug candidates is set to reach RMB 232,927.9 thousand by December 2025[4]. - The company generated revenues of RMB634.9 million in 2023, a significant increase from RMB567.4 million in 2022, reflecting a year-on-year growth of approximately 11.5%[91]. - Total comprehensive loss for 2023 was RMB562.5 million, a reduction from RMB1,052.0 million in 2022, indicating improved financial performance[91]. - Total assets as of December 31, 2023, were RMB1,428.9 million, compared to RMB1,332.1 million in 2022, showing a growth of approximately 7.2%[89]. - Total liabilities stood at RMB1,000.0 million as of December 31, 2023, reflecting an increase from RMB900.0 million in 2022[89]. - The company reported stable profit margins alongside sales growth of 11.9%[100]. - The increase in other income and gains was recorded at RMB41.0 million for the year ended December 31, 2023, compared to RMB48.9 million for the same period in 2022[192]. - Total comprehensive loss decreased by 46.5% from RMB 1,052.0 million in 2022 to RMB 562.5 million in 2023[196]. - Adjusted total comprehensive loss for the year was RMB 263.6 million in 2023, compared to RMB 253.2 million in 2022[198]. Research and Development - The overall strategy includes a focus on research and development to drive future growth and market expansion[4]. - Research and development expenses amounted to RMB425.5 million, representing a 21.3% increase from RMB350.9 million in 2022[91]. - The company is focused on augmenting its internal discovery capabilities and conducting pivotal clinical trials to optimize treatment options for cancer patients[93]. - The company is developing next-generation cancer vaccines, including peptide and mRNA cancer vaccines, which aim to activate CD8+ T cells for improved patient outcomes[122]. - The phase I clinical trial for the FIC cancer peptide vaccine targeting WT1 (3D189) has completed patient enrollment[122]. - The mRNA cancer vaccine 3D124 is currently in the pre-clinical development stage, utilizing a unique AI algorithm to enhance its efficacy[122]. - The company is developing four drug candidates in the IND-enabling stage, enhancing its R&D capabilities[176]. - The R&D platform has strong molecule screening and design capabilities to enhance success rates in drug development[154]. Product Development and Commercialization - The company plans to conduct more clinical studies to advance the commercialization of its products, including Envafolimab[189]. - The company aims to maximize the commercial value of Envafolimab through independent clinical trials and collaborations with partners outside of China[189]. - The company is strategically collaborating with partners to expand into emerging markets for the development and commercialization of 恩維達®[161]. - The commercialization network includes 30 provinces, 312 cities, 1,300 hospitals, and 1,100 pharmacies[100]. - The company has proven its internal research and development capabilities in innovative products, further solidifying its market position[161]. - The company is working with qualified CMOs to manufacture and test drug candidates for pre-clinical and clinical supply[182]. - The company has established R&D centers in Shanghai and Beijing, focusing on chronic cancer treatment[182]. Employee Incentives and Share Options - The Share Option Scheme was adopted on June 26, 2023, to attract and retain high-quality employees and enhance performance[24]. - The Company aims to motivate eligible participants through the Share Option Scheme to optimize their performance for the benefit of the Group[24]. - The RSU Scheme is valid for ten years, with approximately 7.47 years remaining as of December 31, 2023[37]. - The vesting schedule allows for 25% of the awards to vest after 12 months, 50% after 24 months, 75% after 36 months, and 100% after 48 months from the grant date[43]. - The Company emphasizes maintaining flexibility in the range and nature of rewards offered to eligible participants[24]. - The ESOP Department has the discretion to grant RSUs based on performance conditions and other criteria[40]. Sales Performance - Sales revenue from Envafolimab reached RMB 634.9 million, representing a year-on-year growth of 11.9%[61]. - Envafolimab received market approval in Macau and was included in three NCCN guidelines[61]. - The company anticipates stable sales growth for Envafolimab due to ongoing efforts in research and development and commercialization[61]. - Continuous efforts in research, development, and commercialization are anticipated to lead to stable growth in 恩維達® sales[84]. - Envafolimab achieved remarkable sales revenue of RMB 634.9 million in China for the year ended December 31, 2023, representing a growth rate of 11.9% compared to the same period last year[100]. Regulatory and Market Approvals - Envafolimab received approval from the FDA for a Phase III study in endometrial cancer on October 28, 2023[100]. - On November 24, 2023, Envafolimab was granted breakthrough therapy designation by the NMPA for advanced endometrial cancer[101]. - The company has received NDA approval for the treatment of previously treated MSI-H/dMMR advanced solid tumors on November 24, 2021, and is actively selling Envafolimab through pharmacy operating companies and distributors[157]. - The FDA granted orphan drug designation for 3D185 for the treatment of gastric cancer and gastroesophageal junction cancer on January 13, 2023[142]. Strategic Partnerships and Collaborations - The company is strengthening its strategic partnership with Innolake Biopharm (Hangzhou) Co. Ltd.[149]. - On January 26, 2024, a strategic cooperation agreement was signed with Qingdao Sino-Cell Biomedicine Co., Ltd. to enhance oncology immunotherapy research[153]. - A strategic cooperation signing ceremony with Novatim was held on February 21, 2024, focusing on the combination of Envafolimab and KY-0118[153]. Awards and Recognition - The company received the "Outstanding Healthcare Enterprise of the Year" Award on December 21, 2023[186]. - In November 2023, 3D Medicines was listed in the "Top 100 Chinese Pharmaceutical Innovation Enterprises" and the "Top 20 ESG Competitiveness of Chinese Listed Pharmaceutical Companies"[158]. - This is the second consecutive year that 3D Medicines received the "Top 100 Chinese Pharmaceutical Innovation Enterprises" title and the first ESG-related award since its listing[158].

Sales Performance - 3D Medicines Inc.'s first commercial product, Envida®, has accumulated sales exceeding RMB 1 billion[5] - The sales growth rate for Envida® in 2023 was 11.9%, surpassing the growth rate of sales and marketing expenses[5] Expenses - Sales and marketing expenses increased by 5.9% from RMB 357.7 million for the year ended December 31, 2022, to RMB 378.8 million for the year ended December 31, 2023[5]

Financial Performance - The net cash used in operating activities for the year ended December 31, 2023, was RMB 144.4 million, compared to RMB 278.8 million for 2022[1]. - The company reported a basic and diluted loss per share of RMB (2.30) for 2023, compared to RMB (22.52) for 2022[28]. - The total comprehensive loss for the year decreased by 46.5% to RMB 562.5 million in 2023 from RMB 1,052.0 million in 2022, indicating improved financial performance[87]. - Adjusted total comprehensive loss for the year was RMB 263.6 million, a 4.1% increase compared to RMB 253.2 million in 2022[92]. - The total comprehensive loss for the year decreased by 46.5% from RMB 1,052.0 million in 2022 to RMB 562.5 million in 2023[92]. Revenue Growth - Revenue from the mainland China market for the year 2023 was RMB 634.9 million, an increase from RMB 567.4 million in 2022, representing a growth of approximately 11.3%[20]. - The company's revenue for the year ended December 31, 2023, increased by 11.9% to RMB 634.9 million from RMB 567.4 million in 2022, reflecting strong sales growth of the product Envidat (Envafolimab) since its launch in 2021[88]. - Envidat® achieved sales revenue of RMB 634.9 million in China for the year ended December 31, 2023, representing an 11.9% increase year-over-year[93]. - The main drivers for revenue and gross profit growth for the year ended December 31, 2023, were the significant increase in sales volume and gross margin of Envida®[76]. Research and Development - Research and development expenses increased by 21.3% to RMB 425.5 million, up from RMB 350.9 million in the same period of 2022[70]. - The company is focusing on developing next-generation tumor immune checkpoint inhibitors and researching mRNA candidates based on its extensive clinical development experience[76]. - The company is committed to enhancing its internal discovery capabilities and conducting critical clinical trials to address unmet clinical needs in cancer patients[76]. - The company is advancing its pipeline with next-generation tumor immunotherapy candidates, including peptide and mRNA tumor vaccines[79]. - The ongoing Phase I clinical study of 3D189, a peptide cancer vaccine targeting WT1 protein, has shown satisfactory progress in safety and immunogenicity among Chinese hematological cancer patients[124]. Clinical Trials and Approvals - The company received IND approval for a Phase III clinical trial of Envidat in combination with platinum-based chemotherapy for resectable stage III non-small cell lung cancer (NSCLC) patients[84]. - The FDA approved a Phase III clinical study for Envidat® in combination with Lenvatinib for the treatment of advanced or recurrent endometrial cancer on October 28, 2023[105]. - The recruitment for the Phase II clinical study of ENVOVIL monoclonal antibody combined with BD0801 for the treatment of advanced solid tumors was completed on March 9, 2023[107]. - The clinical study for the treatment of advanced solid tumors with Envidat® in combination with BD0801 has completed patient recruitment[133]. Strategic Initiatives - The company plans to utilize approximately 50% of the net proceeds from the 2023 placement for clinical trials of the Envorili monoclonal therapy, amounting to RMB 103.7 million[9]. - The construction of the production facility in Xuzhou, China, is expected to utilize 40% of the net proceeds, which is approximately RMB 82.9 million[9]. - 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[94]. - The company has established a sales and marketing department focused on the commercialization of pipeline products, covering 1,300 hospitals and 1,100 pharmacies across 30 provinces[163]. Employee and Operational Expenses - The total employee benefits expenses for the year ended December 31, 2023, amounted to approximately RMB 403.7 million[3]. - Administrative expenses increased significantly by RMB 74.3 million to RMB 217.1 million, primarily due to an increase in share-based payment expenses of RMB 85.4 million[200]. - Sales and marketing expenses increased by 5.9% from RMB 357.7 million in 2022 to RMB 378.8 million in 2023, driven by a sales growth rate of 11.9% for Envidat®[91]. Market Position and Product Development - The company has established a pipeline consisting of 12 drugs or candidates, with Envida® being commercialized in mainland China in November 2021 and in Macau in January 2024[76]. - Envidat® has been included in three NCCN clinical practice guidelines and nine Chinese clinical treatment guidelines as of the performance announcement date[94]. - Envidat® has accumulated sales exceeding RMB 1 billion, marking its first commercialized product[152]. - The company holds a broad patent portfolio, including 13 granted patents in China and 18 in other jurisdictions, along with 21 pending patent applications[165].

Financial Performance - Revenue for the six months ended June 30, 2023, increased by 70.3% to RMB 352,553,000 compared to RMB 207,028,000 in the same period of 2022[3]. - Gross profit for the same period rose by 69.6% to RMB 325,252,000, up from RMB 191,824,000 in 2022[3]. - Total comprehensive loss for the period improved by 41.2% to RMB 190,204,000 from RMB 323,553,000 in 2022[3]. - Adjusted total comprehensive loss decreased by 29.9% to RMB 81,454,000 from RMB 116,131,000 year-over-year[3]. - The company reported a significant increase in revenue, achieving $150 million for the first half of 2023, representing a 25% year-over-year growth[10]. - The company provided an optimistic outlook, projecting a revenue growth of 20% for the full year 2023, targeting $300 million[10]. - Total comprehensive loss for the period decreased to RMB (190,204) thousand in 2023 from RMB (323,553) thousand in 2022, representing a reduction of approximately 41%[148]. - Adjusted total comprehensive loss for the period improved to RMB (81,454) thousand in 2023 compared to RMB (116,131) thousand in 2022, indicating a 30% decrease[148]. Research and Development - Research and development expenses decreased by 12.4% to RMB 151,606,000 from RMB 173,135,000 year-over-year[3]. - Future outlook includes continued investment in R&D to drive innovation and potential new product launches[3]. - The company is committed to strict compliance with drug production quality management regulations to ensure product quality and control risks[103]. - The company has a total of 12 drug candidates in its pipeline, with seven in various stages of clinical development[67]. - The company is developing a new generation of tumor vaccines aimed at treating various types of blood and solid tumors, with a global Phase III pivotal MRCT for AML currently ongoing[110]. - The company has developed four drug candidates in the IND-enabling stage, including 3D062, a KRAS mutation inhibitor, with PCT applications submitted on January 17 and March 8, 2023[156][157]. - The company is enhancing rights related to the ILB-2109 project in Mainland China through collaboration with Innolake Biopharm[159]. - The R&D platform includes large and small molecule platforms, cell line screening, and compound screening, aimed at increasing the success rate of drug development[159]. Market Expansion and Strategy - The company is focusing on expanding its market presence and enhancing its product pipeline through ongoing research and development efforts[3]. - The company is exploring strategic partnerships and potential acquisitions to bolster its market position[3]. - The company is expanding its market presence in Southeast Asia, with plans to enter three new countries by the end of 2023[10]. - A strategic acquisition of a local biotech firm was announced, valued at $20 million, aimed at enhancing R&D capabilities[10]. - The company plans to increase its workforce by 10% to support growth initiatives and enhance customer service[10]. - The company continues to focus on expanding its product availability in pharmacies and hospitals to enhance sales growth[57]. - The company is gradually carrying out pre-market preparations for products that are close to commercialization[162]. Sales and Marketing - Selling and marketing expenses increased by 62.8% to RMB 220,969,000 compared to RMB 135,751,000 in the previous year[3]. - The increase in revenue was attributed to the differentiation advantages of 恩維達 ®, broader coverage of pharmacies and hospitals, and strong recognition from doctors and patients[166]. - Sales of 恩維達 ® have covered more than 1,150 hospitals and pharmacies in over 200 cities across 30 provinces in China[162]. - The company has established a dedicated sales and marketing department for the commercialization of its pipeline products[162]. - The strong sales performance of Envafolimab in the first half of 2023 is attributed to its differentiated advantages recognized by doctors, good patient compliance, and strategic collaborations[90]. Clinical Trials and Product Development - The phase Ib/II trial for Envafolimab in combination with Lenvatinib has completed patient enrollment, with preliminary results accepted for presentation at the ESMO Annual Meeting in October 2023[67]. - A phase II clinical trial for Envafolimab monotherapy in subjects with dMMR advanced solid tumors has been approved by the FDA, with preparations underway for patient enrollment in multiple regions[67]. - The ongoing ENVASARC study is currently enrolling patients for a 600mg every three weeks monotherapy with Envolimab, with plans for an interim analysis in Q3 2023[102]. - The objective response rate (ORR) in the clinical trial for 3D229 combined with SOX treatment was 50%, with a disease control rate (DCR) of 87.5%[151]. - The company is awaiting final results from a Phase III trial of 3D229 in combination with paclitaxel for platinum-resistant recurrent ovarian cancer, with ongoing studies in RCC and pancreatic cancer[128]. Financial Position and Cash Flow - Cash and bank balances decreased by 8.3% to RMB 864,236,000 from RMB 942,028,000[6]. - Current liabilities totaled RMB 424.1 million as of June 30, 2023, which includes trade payables of RMB 43.2 million and interest-bearing bank loans of RMB 151.6 million[150]. - As of June 30, 2023, total assets amounted to RMB 1,346.3 million, with total liabilities at RMB 523.7 million[195]. - The Group did not have any material contingent liabilities as of June 30, 2023, indicating a stable financial position[175]. - The net cash used in operating activities was RMB 168.1 million, compared to RMB 85.6 million for the same period in 2022, indicating a significant increase in cash outflow[173]. - The net cash flows from financing activities for the six months ended June 30, 2023, were RMB 76.3 million, primarily from new interest-bearing bank borrowings of RMB 127.6 million, partially offset by repayments of RMB 52.5 million[173].