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科济药业(02171) - 2025 - 年度业绩
CARSGENCARSGEN(HK:02171)2025-08-14 14:30

Performance Highlights Financial Highlights For the six months ended June 30, 2025, the company significantly improved its financial position, with revenue of RMB 51 million, gross profit of RMB 29 million, and a narrowed net loss of RMB 75 million, supported by strong cash reserves Key Financial Indicators for the Six Months Ended June 30, 2025 | Metric | H1 2025 (Million RMB) | H1 2024 (Million RMB) | YoY Change | | :--- | :--- | :--- | :--- | | Revenue | Approx. 51 | Approx. 6.3 | +704% | | Gross Profit | Approx. 29 | Approx. 1.6 | +1712% | | Net Loss | Approx. 75 | Approx. 352 | Loss narrowed by 78.7% | | Adjusted Net Loss | Approx. 72 | Approx. 342 | Loss narrowed by 79.0% | | Cash and Bank Balances at Period-End | Approx. 1,261 | - | - | - The significant reduction in net loss was primarily due to: (i) increased net other income; (ii) a RMB 116 million decrease in R&D expenses; (iii) a RMB 47 million decrease in administrative expenses; and (iv) increased gross profit5 - As of June 30, 2025, cash and bank balances were approximately RMB 1.261 billion, with existing funds projected to support operations until 20287 Business Highlights The company achieved significant business progress, with successful commercialization of core product CT053, NDA acceptance for CT041, and active advancement of differentiated allogeneic CAR-T pipelines using proprietary platforms - Commercialization of CT053 (Zevor-cel) in mainland China, in collaboration with Huadong Medicine, progressed smoothly, securing 111 valid orders in H1 20259 - The New Drug Application (NDA) for CT041 (Sure-cel) for advanced gastric cancer was accepted by China's NMPA, granted priority review, and designated as a breakthrough therapy10 - The company is advancing multiple allogeneic CAR-T cell products, including CT0596, using its proprietary THANK-uCAR® and upgraded THANK-u Plus™ platforms to overcome limitations of existing therapies11 Business Review and Outlook Company Overview and Strategy Coherent Biopharma is a biopharmaceutical company focused on innovative CAR-T cell therapies with end-to-end capabilities, strategically optimizing its pipeline for differentiated clinical and commercial value while expanding into the US market - The company is positioned as a biopharmaceutical firm dedicated to developing innovative CAR-T cell therapies addressing unmet clinical needs in hematological malignancies, solid tumors, and autoimmune diseases12 - The company's strategy focuses on developing breakthrough CAR-T products, regularly evaluating its pipeline for differentiated projects, and actively integrating resources to advance its US market strategy13 Product Pipeline Review The company boasts a rich product pipeline, including commercialized CT053, NDA-accepted CT041, and multiple clinical and preclinical candidates targeting novel antigens and allogeneic CAR-T, demonstrating robust R&D innovation Key Product Pipeline Progress | Candidate Product | Target | Primary Indication | Latest Progress | | :--- | :--- | :--- | :--- | | Zevor-cel (CT053) | BCMA | Relapsed/Refractory Multiple Myeloma | Commercialized in China | | Sure-cel (CT041) | Claudin18.2 | Gastric Cancer/GEJ Adenocarcinoma | NDA accepted in China | | CT071 | GPRC5D | Relapsed/Refractory Multiple Myeloma | Phase I clinical, ORR data 100% | | CT011 | GPC3 | Hepatocellular Carcinoma | NMPA IND approved | | Allogeneic CAR-T | BCMA, CD19/20, etc. | Multiple Myeloma, B-cell Lymphoma, etc. | Multiple products in IIT stage, CT0596 showing positive preliminary efficacy | Zevor-cel (CT053) - BCMA CAR-T Zevor-cel (CT053), an NMPA-approved all-human BCMA CAR-T product, is commercializing well in China with 111 orders in H1 2025 and showed a 92.2% ORR in LUMMICAR-1, though its US/Canada LUMMICAR-2 study priority has been strategically reduced - In collaboration with Huadong Medicine for commercialization in mainland China, Coherent Biopharma is eligible for up to RMB 1.025 billion in regulatory and sales milestone payments, having secured 111 valid orders in H1 202517 - LUMMICAR-1 study data showed an Overall Response Rate (ORR) of 92.2% and a stringent Complete Response (sCR)/Complete Response (CR) rate of 71.6% in 102 patients20 - As part of a strategic adjustment, the company decided to de-prioritize the LUMMICAR-2 study for Zevor-cel in the US and Canada21 Sure-cel (CT041) - Claudin18.2 CAR-T Sure-cel (CT041), a potential global first-in-class Claudin18.2 CAR-T, received NMPA NDA acceptance, priority review, and breakthrough therapy designation in June 2025 for advanced gastric/GEJ adenocarcinoma, demonstrating significant PFS/OS improvement and manageable safety in a confirmatory Phase II trial - In June 2025, the NDA for Sure-cel was accepted by China's NMPA for Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma patients who failed at least two prior lines of therapy23 - Confirmatory Phase II clinical trial (CT041-ST-01) data showed a median Overall Survival (mOS) of 9.17 months for Sure-cel-treated patients, compared to only 3.98 months for the control group24 - The company is actively exploring the product's application in earlier cancer treatment and perioperative settings, including adjuvant therapy for pancreatic cancer and post-gastrectomy consolidation therapy for gastric cancer25 CT011 - GPC3 CAR-T CT011, an autologous GPC3-targeted CAR-T product for hepatocellular carcinoma (HCC), received NMPA IND approval in January 2024 for adjuvant therapy in GPC3-positive Stage IIIa HCC patients at risk of recurrence post-surgery, building on the founder's pioneering work - CT011 is an autologous GPC3-targeted CAR-T product for the treatment of hepatocellular carcinoma (HCC)30 - In January 2024, CT011 received NMPA IND approval for adjuvant therapy in GPC3-positive Stage IIIa HCC patients at risk of recurrence after surgical resection30 CT071 - GPRC5D CAR-T CT071, an autologous GPRC5D-targeted CAR-T developed with the CARcelerate® platform to reduce manufacturing time to 30 hours, demonstrated a 100% ORR and 70% sCR in a Phase I investigator-initiated trial for newly diagnosed multiple myeloma, highlighting its significant therapeutic potential - CT071, developed using the proprietary CARcelerate® platform, reduces manufacturing time to approximately 30 hours, yielding younger and more potent CAR-T cells32 - In a Phase I study for high-risk newly diagnosed multiple myeloma, CT071 achieved a 100% Overall Response Rate (ORR), with 70% of patients achieving stringent Complete Response (sCR)32 Allogeneic CAR-T Cell Products Leveraging its proprietary THANK-uCAR® and upgraded THANK-u Plus™ platforms, the company is aggressively advancing its allogeneic CAR-T pipeline, with BCMA-targeted CT0596 showing encouraging efficacy and safety in R/R MM, and a dedicated subsidiary, Youkai-cel, established for R&D and commercialization of multiple allogeneic products - The company developed the THANK-u Plus™ platform as an upgrade to THANK-uCAR® technology, aiming to overcome the potential impact of NKG2A expression levels on allogeneic CAR-T efficacy34 - In a preliminary clinical study of allogeneic product CT0596 for R/R MM, 3 out of 5 (60%) patients who completed initial efficacy assessment achieved sCR/CR, 4 (80%) achieved MRD negativity, with good safety36 - The company established Youkai-cel, a subsidiary, and secured RMB 80 million in external investment, focusing on the R&D, manufacturing, and commercialization of allogeneic CAR-T cell therapies in China38 Technology Platforms and Innovation The company addresses CAR-T challenges through innovative platforms: THANK-uCAR®/THANK-u Plus™ for effective allogeneic CAR-T, CARcelerate® for 30-hour manufacturing, and CycloCAR®/LADAR™ for enhanced solid tumor efficacy and improved target availability/safety, holding over 300 patents Core Technology Platforms | Technology Platform | Goals and Advantages | | :--- | :--- | | THANK-uCAR® / THANK-u Plus™ | Develop allogeneic CAR-T, improve patient accessibility, enhance cell expansion and persistence | | CARcelerate® | Reduce CAR-T cell manufacturing time to approximately 30 hours, improving production efficiency and cell potency | | CycloCAR® | Co-express IL-7 and CCL21, enhance efficacy against solid tumors, reduce lymphodepletion requirements | | LADAR™ | Precisely control CAR-T cell activation through dual-antigen recognition, enhance safety, and address target availability challenges | - As of June 30, 2025, the company holds over 300 patents, including 140 globally authorized patents, demonstrating a robust intellectual property portfolio44 Manufacturing Capabilities The company has established vertically integrated GMP manufacturing capabilities for plasmids, lentiviral vectors, and CAR-T cell products, supporting clinical trials and commercialization, with its Shanghai Jinshan plant serving China and the US RTP facility cleared by FDA for overseas clinical trials - The company has established vertically integrated CAR-T manufacturing capabilities, encompassing plasmids, lentiviral vectors, and CAR-T cell products, enhancing efficiency, control, and cost reduction46 - The Shanghai Jinshan facility supports the commercial production of Zevor-cel and prepares for the commercialization of Sure-cel46 - The RTP manufacturing facility in North Carolina, USA, passed an FDA re-inspection with zero deficiencies in September 2024, leading to the lifting of clinical hold on three trials by the FDA in October of the same year47 Market Outlook and Future Prospects The global CAR-T market shows strong growth, with significant unmet needs in solid tumors; the company aims to advance core products into earlier treatment, develop innovative technologies, expand manufacturing, and seek collaborations to maximize value - The global CAR-T market is experiencing strong growth, yet significant unmet needs persist in solid tumor treatment, presenting development opportunities for the company48 - The company's future focus includes: 1) advancing core products into earlier treatment; 2) developing other clinical and preclinical products; 3) continuously innovating CAR-T technologies; 4) expanding US and China manufacturing capabilities; and 5) establishing more external collaborations49 Financial Review Operating Performance Analysis During the reporting period, the company's operating loss significantly narrowed from RMB 362 million to RMB 77 million, with net loss decreasing by RMB 277 million to RMB 75 million, primarily due to controlled expenses, increased foreign exchange gains, and higher gross profit Operating Loss and Net Loss | Metric | H1 2025 (Million RMB) | H1 2024 (Million RMB) | | :--- | :--- | :--- | | Operating Loss | 77 | 362 | | Net Loss | 75 | 352 | - The reduction in loss was primarily attributed to decreased R&D expenses, reduced administrative expenses, increased net foreign exchange gains, and higher gross profit51 Non-IFRS Measures To better assess core business performance, the company reported Non-IFRS measures, with adjusted net loss for the six months ended June 30, 2025, significantly narrowing to RMB 71.8 million from RMB 342 million after excluding non-cash items like share-based compensation Reconciliation of Net Loss to Adjusted Net Loss (RMB Thousand) | Item | H1 2025 (Unaudited) | H1 2024 (Unaudited) | | :--- | :--- | :--- | | Loss for the period | (75,483) | (351,558) | | Add: Share-based payment expenses | 3,684 | 9,190 | | Adjusted Net Loss | (71,799) | (342,368) | Analysis of Key Financial Items During the period, the company effectively controlled expenses, with revenue growing over 7-fold to RMB 50.96 million, R&D expenses decreasing by 47% to RMB 130 million, and administrative expenses by 54% to RMB 39 million, primarily due to lower staff costs, professional fees, and depreciation - R&D expenses decreased by 47% from RMB 246 million to RMB 130 million, primarily due to reduced employee benefit expenses, testing and clinical expenses, and depreciation of property, plant, and equipment58 - Administrative expenses decreased by 54% from RMB 86 million to RMB 39 million, mainly due to reduced employee benefit expenses, professional service fees, and depreciation of property, plant, and equipment5960 - Total employee benefit expenses decreased from RMB 154 million to RMB 89.79 million, primarily due to a reduction in headcount and lower remuneration60 Liquidity and Capital Resources As of June 30, 2025, the company held RMB 1.261 billion in cash and bank balances, with improved net cash outflow from operating activities of RMB 196 million and a net outflow of RMB 30 million from financing activities, resulting in zero total borrowings and a reduced liability ratio of 7.2%, indicating a more robust financial structure Condensed Cash Flow Statement (RMB Thousand) | Item | H1 2025 (Unaudited) | H1 2024 (Unaudited) | | :--- | :--- | :--- | | Net cash used in operating activities | (196,308) | (255,947) | | Net cash generated from investing activities | 1,715 | 6,584 | | Net cash (used in)/generated from financing activities | (29,635) | 24,688 | | Cash and cash equivalents at period-end | 1,260,793 | 1,652,569 | - As of June 30, 2025, the Group's total borrowings decreased to zero, and the liability ratio (sum of borrowings and lease liabilities/total equity) decreased from 15.75% at the end of 2024 to 7.2%69 - As of June 30, 2025, the company's total headcount was 371, a reduction from 468 at the end of 202478 Supplemental Announcement Regarding 2024 Annual Report Impairment Background and Reasons This supplemental announcement clarifies asset impairments in the 2024 annual report, stemming from a strategic shift to allogeneic CAR-T pipelines due to strong data and competitive changes, reallocating resources from certain autologous pipelines lacking clear commercialization plans - For the year ended December 31, 2024, the company recorded an impairment of RMB 162.3 million for property, plant, and equipment, RMB 26.5 million for right-of-use assets, and RMB 0.3 million for intangible assets81 - The primary reason for impairment was a strategic shift: due to excellent allogeneic CAR-T data, the company decided to reallocate resources from certain autologous CAR-T pipelines to allogeneic pipelines8283 Key Assumptions and Impairment Testing The company conducted impairment tests on long-term assets based on strategic adjustments, using the Value in Use (VIU) method for autologous pipeline assets without clear commercialization plans, and fully impairing assets solely dedicated to these pipelines due to zero expected future cash inflows - Key impairment testing assumptions included reduced resource allocation to autologous pipelines without clear commercialization plans, and no definite commercialization plans for other autologous pipelines beyond those already marketed or in NDA stage83 - The company used the Value in Use (VIU) method for impairment testing, with assets solely dedicated to de-prioritized autologous pipelines assigned a zero VIU, leading to a full impairment provision8485 Condensed Consolidated Financial Statements Consolidated Statement of Profit or Loss and Other Comprehensive Income For the six months ended June 30, 2025, the company reported a gross profit of RMB 29.37 million, a significantly narrowed operating loss of RMB 76.70 million from RMB 362 million, and a net loss of RMB 75.48 million, representing a 78.5% year-over-year reduction, with basic loss per share at RMB 0.14 Condensed Interim Consolidated Statement of Profit or Loss Summary (RMB Thousand) | Item | H1 2025 (Unaudited) | H1 2024 (Unaudited) | | :--- | :--- | :--- | | Revenue | 50,961 | 6,340 | | Gross Profit | 29,369 | 1,617 | | Operating Loss | (76,704) | (361,540) | | Loss before income tax | (75,483) | (351,558) | | Loss for the period attributable to owners of the parent | (75,483) | (351,558) | | Basic and diluted loss per share (RMB) | (0.14) | (0.63) | Consolidated Statement of Financial Position As of June 30, 2025, the company reported total assets of RMB 1.513 billion, total liabilities of RMB 551 million, and net assets of RMB 962 million, with strong liquidity from RMB 1.380 billion in current assets, including RMB 1.261 billion in cash and bank balances, and an optimized balance sheet with zero interest-bearing bank borrowings Condensed Interim Consolidated Statement of Financial Position Summary (RMB Thousand) | Item | As of June 30, 2025 (Unaudited) | As of December 31, 2024 (Audited) | | :--- | :--- | :--- | | Total non-current assets | 133,498 | 142,759 | | Total current assets | 1,379,893 | 1,530,275 | | Total Assets | 1,513,391 | 1,673,034 | | Total current liabilities | 213,799 | 254,007 | | Total non-current liabilities | 337,459 | 362,320 | | Total Liabilities | 551,258 | 616,327 | | Net Assets | 962,133 | 1,056,707 | | Total Equity | 962,133 | 1,056,707 | Corporate Governance and Other Information Dividends and Securities Transactions The Board recommends no interim dividend for the six months ended June 30, 2025, with no purchases, sales, or redemptions of listed securities by the company or its subsidiaries during the period, and all directors confirmed compliance with the adopted standard code - The Board recommends no interim dividend for the reporting period116 - During the reporting period, neither the company nor its subsidiaries acquired, disposed of, or redeemed any of the company's listed securities117 Use of Proceeds from Global Offering The company, listed in June 2021, utilized approximately RMB 2.497 billion of its HKD 3.008 billion net global offering proceeds by June 30, 2025, primarily for CT053 development, pipeline R&D, and manufacturing, with the remaining balance expected to be fully used by 2026 Use of Proceeds from Global Offering (As of June 30, 2025) | Use of Proceeds | Planned Allocation (Million RMB) | Amount Utilized (Million RMB) | Balance (Million RMB) | | :--- | :--- | :--- | :--- | | Development of core product BCMA CAR-T (CT053) | 851.7 | 851.7 | 0 | | R&D for other pipelines | 849.9 | 759.6 | 90.3 | | Manufacturing and commercialization capabilities | 548.3 | 415.2 | 133.1 | | Technology upgrades and early-stage R&D | 274.1 | 214.7 | 59.4 | | Working capital and others | 255.5 | 255.5 | 0 | | Total | 2,779.5 | 2,496.7 | 282.8 | - The unutilized portion of the net proceeds is expected to be fully used for its intended purposes by 2026124