基石药业(02616) - 2025 - 中期业绩

Company Information and Report Overview Company Profile CStone Pharmaceuticals (Stock Code: 2616) announced its unaudited condensed consolidated interim results for the six months ended June 30, 2025 - CStone Pharmaceuticals (Stock Code: 2616) released its unaudited condensed consolidated interim results for the six months ended June 30, 2025[2] Financial Highlights For the six months ended June 30, 2025, revenue significantly decreased by 80.5% to RMB 49.4 million, leading to a RMB 270.2 million loss due to gross loss, increased R&D, and reduced administrative and marketing expenses Key Financial Indicators for H1 2025 (IFRS) | Indicator | H1 2025 (RMB million) | H1 2024 (RMB million) | Y-o-Y Change (%) | | :--- | :--- | :--- | :--- | | Revenue | 49.4 | 254.2 | -80.5% | | Cost of Revenue | 142.2 | 82.1 | +73.2% | | Gross Loss (Profit) | (92.8) | 172.0 | -153.9% | | R&D Expenses | 105.2 | 66.2 | +59.0% | | Administrative Expenses | 43.5 | 46.7 | -6.9% | | Selling and Marketing Expenses | 35.7 | 62.8 | -43.1% | | Loss (Profit) for the Period | (270.2) | 15.7 | -1827.4% | | Cash and Cash Equivalents and Time Deposits (Period-end) | 652.8 | 672.9 (Dec 31, 2024) | -3.0% | - Revenue significantly decreased by 80.5%, primarily due to Pralsetinib price adjustments and related one-time channel compensation, alongside reduced one-time milestone payments from Sugemalimab gastric cancer approval in H1 2024[3] - Cost of revenue increased, mainly due to inventory write-downs included in cost of revenue and related costs from early supply of Pralsetinib for patient assistance programs[3] - The company switched from profit to a loss of RMB 270.2 million for the period, primarily due to the gross profit turning into a gross loss[5] Business Overview Commercial Product Overview Commercial products are advancing globally with regulatory approvals and strategic partnerships, expanding international reach to over 60 countries, while localized production and national medical insurance inclusion are set to enhance profitability - Sugemalimab (Cejemly®) has submitted a new indication application for Phase III NSCLC to the EMA after receiving approval in the EU and UK for IV NSCLC[7] - Sugemalimab has expanded its international presence to over 60 countries through strategic collaborations with SteinCares and Gentili[8] - Pralsetinib (Gavreto®) received approval for localized production, with a gradual transition to domestic manufacturing expected from 2026 to improve cost-effectiveness and supply chain resilience[9] - Pralsetinib has passed the formal review for the 2025 National Medical Insurance Drug List negotiation[10] - Avapritinib (Ayvakit®) commenced domestic supply in February 2025, expected to drive gross margin growth[11] Clinical Stage Core Assets Overview Core clinical assets CS5001 and CS2009 show promising trial progress with good tolerability and anti-tumor activity, while Nofazinlimab demonstrates clinical benefit trends in OS, prompting registration pathway discussions - CS5001 global multi-center Phase Ib trial is actively recruiting patients in Australia, China, and the US, with no dose-limiting toxicity (DLT) observed to date[12] - CS2009 global multi-center Phase I/II clinical study is actively recruiting patients in Australia and China, with plans to expand to the US for Phase II enrollment[13] - CS2009 Phase Ia data demonstrated good tolerability, excellent PK characteristics, and anti-tumor activity, with Phase Ia data to be presented at the ESMO Congress in October 2025[14] - Final analysis of Nofazinlimab combined with Lenvatinib in a Phase III study showed a clear trend of clinical benefit in OS, and the company will engage with regulatory authorities to seek a registration pathway[15] Pre-clinical/IND Stage Projects and Proprietary ADC Platform Overview The pre-clinical pipeline includes over nine potential FIC/BIC candidates, leveraging an innovative proprietary ADC platform, with two autoimmune/inflammatory candidates expected to initiate IND preparation in H2 2025 - The pre-clinical pipeline includes over nine potential candidates, such as multi-specific antibodies and ADCs, covering oncology, autoimmune, and inflammatory diseases[16] - The innovative in-house ADC technology platform features optimized proprietary linkers, supporting multiple ADC products in Pipeline 2.0[16] - Two autoimmune/inflammatory candidates, CS2013 and CS2015, possess FIC/BIC potential and are expected to initiate IND preparation in H2 2025[17] Future Outlook and Vision The company is committed to delivering revolutionary therapies through scientific and technological innovation, focusing on advancing early-stage candidates, core clinical trials, maximizing commercial product value, and strengthening proprietary technology platforms in H2 2025 - The company's mission is to provide revolutionary therapies through scientific and technological innovation, benefiting patients worldwide[18] - Key drivers for H2 2025 include advancing early-stage candidates to clinical phases, progressing key CS5001 and CS2009 trials, maximizing the value of Ayvakit® and Gavreto®, accelerating Sugemalimab commercialization outside China, strengthening proprietary platforms, and publishing key clinical data[18][20] Management Discussion and Analysis Company Vision and Overview CStone Pharmaceuticals aims to be an innovation leader in improving global patient health, with four successfully launched innovative drugs, 16 NDA approvals, and a balanced pipeline of 16 potential FIC/BIC candidates - The company's vision is to be an innovation-driven leader in improving global patient health[21] - Four innovative drugs have been successfully launched, with 16 New Drug Application (NDA) approvals covering nine indications[22] - The current R&D pipeline is balanced with 16 candidate drugs, including potential first-in-class or best-in-class ADCs, multi-specific antibodies, immunotherapies, and precision therapies[22] Product Pipeline Details The company provides updates on its commercial products, core clinical assets, and pre-clinical/IND candidates, highlighting regulatory approvals, commercial collaborations, clinical trial data, and technological platform innovations - The product pipeline chart illustrates the milestones and development status of selected assets as of the reporting date, covering regions including Mainland China, Taiwan, Hong Kong, the US, EU, and UK[23][24][26] Commercialized Products The company enhances commercialization efficiency through partnerships, expanding Sugemalimab's global market to over 60 countries, while Pralsetinib and Avapritinib advance through collaborations, localized production, and medical insurance inclusion - Collaborations with pharmaceutical and biotechnology companies are fundamental to the company's recent commercial plans and global vision, aiming to enhance commercialization efficiency and strategically focus on R&D[27] Cejemly® (Sugemalimab) Sugemalimab, a fully human anti-PD-L1 monoclonal antibody, has received multiple approvals in China, the EU, and the UK for various indications, with an EMA application for Phase III NSCLC, and its global market reach has expanded to over 60 countries through strategic partnerships - Sugemalimab has been approved in China, the EU, and the UK for five indications, including IV NSCLC, III NSCLC, NK/T-cell lymphoma, ESCC, and G/GEJ[28] - A new indication application for Phase III NSCLC has been submitted to the EMA, which, if approved, will solidify its position as a core immunotherapy for lung cancer[29] - Strategic agreements with SteinCares and Gentili have expanded Sugemalimab's global market coverage to over 60 countries and regions, with the Gentili agreement potentially reaching up to USD 192.5 million in total consideration[29] - Sugemalimab is recommended by ESMO guidelines as a Class [I, A] combination therapy for first-line treatment of non-driver gene positive metastatic squamous and non-squamous NSCLC[29] - Final analysis results of PFS and OS from the GEMSTONE-303 and GEMSTONE-302 studies were published in JAMA and The Lancet Oncology, respectively[29] Gavreto® (Pralsetinib) Pralsetinib, China's first-in-class RET inhibitor, has received NMPA approval for RET fusion-positive NSCLC and RET-mutant thyroid cancer, with localized production approved and formal review passed for the 2025 National Medical Insurance Drug List negotiation - Pralsetinib has been approved by China's NMPA for patients with RET fusion-positive NSCLC and RET-mutant thyroid cancer[32] - A commercial collaboration with Allist Pharmaceuticals allows Pralsetinib to benefit from Allist's mature commercial team and market coverage[32] - In July 2025, the localized marketing application for Pralsetinib capsules was approved by China's NMPA, with a gradual transition to domestic production expected from 2026[32] - In August 2025, Pralsetinib passed the formal review for the 2025 National Medical Insurance Drug List negotiation[32] - Pralsetinib has been included in 11 Chinese clinical practice guidelines and upgraded to a Class I recommendation in the CSCO NSCLC Treatment Guidelines (2024 edition)[32] Ayvakit® (Avapritinib) Avapritinib, a first-in-class KIT/PDGFRA inhibitor, has received NMPA approval for PDGFRA exon 18 mutant GIST, with domestic supply commencing in February 2025 through a collaboration with Hengrui Medicine, expected to significantly boost gross margins and included in China's 2023 National Medical Insurance Drug List - Avapritinib has been approved by China's NMPA for adult patients with unresectable or metastatic GIST carrying PDGFRA exon 18 mutations (including PDGFRA D842V mutation)[31] - A commercial collaboration with Hengrui Medicine, with its localized production application approved in August 2024, led to domestic supply starting in February 2025, expected to significantly boost gross margins[35] - Avapritinib has been included in China's 2023 National Medical Insurance Drug List and passed the formal review for renewal negotiation in the 2025 National Medical Insurance Drug List[35] - Avapritinib is recommended by the updated CSCO Guidelines for Gastrointestinal Stromal Tumors (2022 edition) and the Chinese Guidelines for Diagnosis and Treatment of Adult Systemic Mastocytosis (2022 edition)[35] Clinical Stage Core Products The core clinical pipeline, including CS5001 and CS2009, shows significant progress with promising efficacy and safety, while CS1002 advances through strategic collaboration, and Nofazinlimab demonstrates clinical benefit trends in OS, prompting registration pathway discussions - As of the reporting date, the company's product pipeline has achieved significant progress[33] CS5001 (ROR1 ADC) CS5001, a clinical-stage ROR1 ADC with a tumor-specific activated PBD dimer prodrug payload and linker, is advancing in global multi-center Ia/Ib trials in the US, Australia, and China, exploring monotherapy for advanced lymphoma and combination therapies for DLBCL and solid tumors - CS5001 is a clinical-stage ROR1-targeted ADC, utilizing a dual-control mechanism to reduce toxicity and offering precision treatment potential[34] - Global multi-center Phase Ia/Ib clinical trials are simultaneously progressing in the US, Australia, and China, exploring its potential as a monotherapy for advanced lymphoma and in combination therapies for DLBCL and solid tumors[37] - CS5001 is the first ROR1 ADC to demonstrate clinical anti-tumor activity in both solid tumors and lymphoma[34] CS2009 (PD-1/VEGF/CTLA-4 Tri-specific Antibody) CS2009, a potential FIC/BIC PD-1/VEGF/CTLA-4 tri-specific antibody, is advancing in global multi-center Phase I/II studies, with Ia data showing good tolerability, excellent PK characteristics, and anti-tumor activity, slated for presentation at the ESMO Congress in October 2025 - CS2009 is a potential first-in-class/best-in-class PD-1/VEGF/CTLA-4 tri-specific antibody, featuring balanced monovalent PD-1 and CTLA-4 binding arms, and a bivalent anti-VEGFA binding arm[37] - Global multi-center Phase I/II studies are actively recruiting patients in Australia and China, with plans to expand to the US for Phase II enrollment[37] - The Phase Ia dose-escalation study has completed five dose levels, with no DLT observed, demonstrating good tolerability, excellent PK characteristics, and anti-tumor activity[14][37][40] - Phase Ia data (including safety, PK, PD, and anti-tumor activity) are expected to be presented at the ESMO Congress in October 2025[40] CS1002 (Anti-CTLA-4 Antibody) CS1002 (SHR-8068) is advancing through a strategic collaboration with Hengrui Medicine, which holds exclusive rights in Greater China for its development, registration, manufacturing, and commercialization, actively progressing two major late-stage clinical trials for advanced NSCLC and HCC, with plans for additional combination therapies in various solid tumors - An exclusive license agreement with Hengrui grants them exclusive rights for the development, registration, manufacturing, and commercialization of CS1002/SHR-8068 in Greater China[40] - Hengrui is actively advancing two major late-stage clinical trials: a Phase II/III trial for first-line treatment of advanced or metastatic non-squamous NSCLC, and a Phase III trial for first-line treatment of advanced HCC[40] - Hengrui plans several other clinical trials to evaluate CS1002/SHR-8068 combination therapies in various solid tumors, including an IND for a Phase II CRC study that has been accepted[40] Nofazinlimab (Anti-PD-1 Antibody) The CS1003-305 study, an international multi-center Phase III registration trial evaluating nofazinlimab combined with lenvatinib for first-line unresectable or metastatic HCC, showed a clear trend of clinical benefit in OS, PFS, and ORR, with no new safety signals, prompting discussions with regulatory authorities for a registration pathway - The CS1003-305 study is an international multi-center Phase III registration study evaluating nofazinlimab combined with lenvatinib for first-line treatment of unresectable or metastatic HCC patients[39] - Final analysis results showed a clear trend of clinical benefit in OS, with clinically meaningful improvements in PFS and ORR, and no new safety signals observed[15][41] - The company will engage with regulatory authorities to seek a registration pathway for this combination therapy[15][41] Pre-clinical/IND Candidate Drugs The company is dedicated to pioneering next-generation cancer therapies, including multi-specific antibodies and ADCs, expanding early-stage research into autoimmune and inflammatory diseases, leveraging its proprietary ADC technology platform, and developing FIC/BIC potential autoimmune/inflammatory multi-specific antibodies CS2013 and CS2015 - The company is committed to pioneering next-generation cancer therapies, including multi-specific antibodies and ADCs, and has expanded early-stage research projects into autoimmune and inflammatory diseases[42] Proprietary ADC Technology Platform CStone Pharmaceuticals is advancing next-generation linker technology to enhance ADC systemic stability and tumor selectivity, featuring a unique tandem cleavable β-glucuronide linker that improves hydrophilicity, enables tumor-selective payload release via tandem cleavage, and supports multiple ADC candidates - The proprietary ADC technology platform has optimized ADC safety/efficacy profiles, broadened target compatibility, and supports multiple ADC candidates[43] - The unique tandem cleavable β-glucuronide linker features enhanced hydrophilicity, tumor-selective payload release via tandem cleavage, and manufacturability[44] Core ADC Pipeline The company's core ADC pipeline includes CS5007 (EGFR/HER3 bi-specific ADC) for tumor heterogeneity, CS5005 (SSTR2 ADC) and CS5008 (SSTR2/DLL3 bi-specific ADC) for SSTR2-positive solid tumors, and CS5006 (ITGB4 ADC), a first-in-class pan-cancer ADC targeting ITGB4 for broad indications - CS5007 (EGFR/HER3 bi-specific ADC) aims to address tumor heterogeneity by simultaneously targeting EGFR and HER3, with the potential to be a best-in-class candidate for various solid tumors[45] - CS5005 (SSTR2 ADC) and CS5008 (SSTR2/DLL3 bi-specific ADC) target SSTR2-positive solid tumors like NEN and SCLC, with CS5008 overcoming tumor heterogeneity through dual targeting[46] - CS5006 (ITGB4 ADC) is a first-in-class ADC targeting the novel pan-cancer target ITGB4, addressing a wide range of indications[46] Autoimmune and Inflammatory Multi-specific Antibodies The company is developing multi-specific antibodies for autoimmune and inflammatory diseases, including CS2013 (BAFF/APRIL bi-specific antibody) for B-cell mediated autoimmune diseases and CS2015 (OX40L/TSLP bi-specific antibody) as a potential first-in-class treatment for Th2-mediated inflammatory diseases - CS2013 (BAFF/APRIL bi-specific antibody) aims to treat various B-cell mediated autoimmune diseases like SLE, RA, and IgAN by simultaneously blocking BAFF and APRIL[46] - CS2015 (OX40L/TSLP bi-specific antibody), a potential first-in-class, potently blocks OX40L and TSLP, with the potential to treat Th2-mediated inflammatory diseases such as AD, asthma, and COPD[46] Business Development and Strategic Partnerships The business development team drives strategic growth by expanding commercialization of launched drugs, strengthening the clinical pipeline, and acquiring innovative technologies through strategic collaborations with leading companies, particularly for Sugemalimab's global commercialization - The business development team plays a crucial role in expanding commercialization of launched drugs, strengthening the clinical pipeline, and acquiring innovative technologies[48] - Strategic collaborations have been established with leading companies including Pfizer, Sanofi, Hengrui, 3SBio, Allist, Ewopharma, Pharmalink, SteinCares, and Gentili[48] - An exclusive commercialization agreement for Gavreto® was signed with Allist, and a strategic commercialization partnership for Ayvakit® was established with Hengrui[48] - Sugemalimab's global commercialization continues to expand through collaborations with Ewopharma, Pharmalink, SteinCares, and Gentili, covering regions such as Switzerland, Central and Eastern Europe, the Middle East, North Africa, South Africa, Latin America, Western Europe, and the UK[49] Financial Performance Analysis For the six months ended June 30, 2025, revenue significantly decreased by 80.5% to RMB 49.4 million, leading to a RMB 270.2 million loss due to gross loss, increased R&D expenses, and decreased administrative, selling, and marketing expenses, with adjusted loss for the period also increasing significantly Revenue For the six months ended June 30, 2025, revenue decreased by 80.5% to RMB 49.4 million, primarily due to Pralsetinib price adjustments and reduced one-time Sugemalimab milestone payments, with authorization fee income expected in H2 2025 from the Gentili agreement Revenue Comparison | Indicator | H1 2025 (RMB million) | H1 2024 (RMB million) | Change (RMB million) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Revenue | 49.4 | 254.2 | -204.8 | -80.5% | - Pralsetinib sales revenue significantly decreased year-over-year, primarily due to price adjustments and related one-time channel compensation in preparation for National Medical Insurance Drug List negotiations[76] - License fee income significantly decreased year-over-year, mainly due to the substantial contribution from a one-time milestone payment for Sugemalimab gastric cancer approval in H1 2024[76] - A significant external licensing agreement was entered with Gentili in July 2025, with license fee income expected in H2 2025[76] Cost of Revenue For the six months ended June 30, 2025, cost of revenue increased by RMB 60.1 million to RMB 142.2 million, primarily due to inventory write-downs and related costs from early supply of Pralsetinib for patient assistance programs to mitigate trade uncertainties Cost of Revenue Comparison | Indicator | H1 2025 (RMB million) | H1 2024 (RMB million) | Change (RMB million) | | :--- | :--- | :--- | :--- | | Cost of Revenue | 142.2 | 82.1 | +60.1 | - The increase in cost of revenue was mainly due to inventory write-downs included in cost of revenue and related costs from early supply of Pralsetinib for patient assistance programs[77] Other Income For the six months ended June 30, 2025, other income decreased by RMB 5.5 million to RMB 9.3 million, primarily due to reduced bank and other interest income Other Income Comparison | Indicator | H1 2025 (RMB million) | H1 2024 (RMB million) | Change (RMB million) | | :--- | :--- | :--- | :--- | | Other Income | 9.3 | 14.8 | -5.5 | - The decrease in other income was mainly due to reduced bank and other interest income[77] Other Gains and Losses For the six months ended June 30, 2025, other gains and losses decreased by RMB 8.3 million to RMB 4.6 million, primarily due to a net loss from fair value changes of financial assets measured at fair value through profit or loss Other Gains and Losses Comparison | Indicator | H1 2025 (RMB million) | H1 2024 (RMB million) | Change (RMB million) | | :--- | :--- | :--- | :--- | | Other Gains and Losses | 4.6 | 12.9 | -8.3 | - The decrease was mainly due to a net loss from fair value changes of financial assets measured at fair value[77] Research and Development Expenses For the six months ended June 30, 2025, R&D expenses increased by RMB 39.0 million to RMB 105.2 million, primarily due to increased milestone fees and third-party contract costs at different stages of clinical trials R&D Expenses Comparison | Indicator | H1 2025 (RMB million) | H1 2024 (RMB million) | Change (RMB million) | | :--- | :--- | :--- | :--- | | R&D Expenses | 105.2 | 66.2 | +39.0 | - The increase was mainly attributable to increased milestone fees and third-party contract costs at different stages of clinical trials[78] Administrative Expenses For the six months ended June 30, 2025, administrative expenses decreased by RMB 3.2 million to RMB 43.5 million, primarily due to reduced depreciation and amortization Administrative Expenses Comparison | Indicator | H1 2025 (RMB million) | H1 2024 (RMB million) | Change (RMB million) | | :--- | :--- | :--- | :--- | | Administrative Expenses | 43.5 | 46.7 | -3.2 | - The decrease was mainly due to reduced depreciation and amortization[79] Selling and Marketing Expenses For the six months ended June 30, 2025, selling and marketing expenses decreased by RMB 27.1 million to RMB 35.7 million, primarily due to reduced channel service fees and other expenses Selling and Marketing Expenses Comparison | Indicator | H1 2025 (RMB million) | H1 2024 (RMB million) | Change (RMB million) | | :--- | :--- | :--- | :--- | | Selling and Marketing Expenses | 35.7 | 62.8 | -27.1 | - The decrease was mainly due to reduced channel service fees and other expenses[80] Finance Costs For the six months ended June 30, 2025, finance costs decreased by RMB 1.4 million to RMB 6.9 million, primarily due to reduced interest on bank borrowings Finance Costs Comparison | Indicator | H1 2025 (RMB million) | H1 2024 (RMB million) | Change (RMB million) | | :--- | :--- | :--- | :--- | | Finance Costs | 6.9 | 8.3 | -1.4 | - The decrease was mainly due to reduced interest on bank borrowings[81] Loss (Profit) for the Period and Adjusted Loss (Profit) for the Period For the six months ended June 30, 2025, the company switched from profit to a loss of RMB 270.2 million, with the adjusted loss (excluding share-based payment expenses) for the period significantly increasing to RMB 265.1 million from a profit of RMB 10.8 million in the prior year Loss (Profit) for the Period and Adjusted Loss (Profit) for the Period Comparison | Indicator | H1 2025 (RMB thousand) | H1 2024 (RMB thousand) | | :--- | :--- | :--- | | Loss (Profit) for the Period | (270,183) | 15,699 | | Add: Share-based payment expenses | 5,084 | (4,889) | | Adjusted Loss (Profit) for the Period | (265,099) | 10,810 | - The loss for the period was RMB 270.2 million, an increase in loss of RMB 285.9 million compared to a profit of RMB 15.7 million in H1 2024, primarily due to gross profit turning into gross loss[5] - After adjustment (excluding share-based payment expenses), the adjusted loss for the period was RMB 265.1 million, an increase in loss of RMB 275.9 million compared to a profit of RMB 10.8 million in H1 2024[5] Employees and Remuneration Policy As of June 30, 2025, the company had 131 employees, with R&D personnel accounting for 63.36% and sales, general, and administrative personnel for 36.64%, with remuneration including salaries, bonuses, provident funds, social insurance contributions, and other benefits in compliance with applicable Chinese laws Employee Functional Distribution (As of June 30, 2025) | Function | Number of Employees | % of Total Employees | | :--- | :--- | :--- | | R&D | 83 | 63.36 | | Sales, General and Administrative | 48 | 36.64 | | Total | 131 | 100.0 | - Employee remuneration includes salaries, bonuses, employee provident funds, social insurance contributions, and other benefit payments[87] Liquidity and Financial Resources The company maintains prudent capital management, funding operations through various sources, with cash and cash equivalents and time deposits at RMB 652.8 million as of June 30, 2025, a slight decrease due to R&D expenses, salaries, and inventory purchases, and a gearing ratio of 73.6% with no assets pledged - The company adopts a prudent capital management policy, funding operations and meeting capital needs for development through multiple sources[88] Cash and Cash Equivalents and Time Deposits | Indicator | As of June 30, 2025 (RMB million) | As of December 31, 2024 (RMB million) | Change (RMB million) | | :--- | :--- | :--- | :--- | | Cash and Cash Equivalents and Time Deposits | 652.8 | 672.9 | -20.1 | - The decrease in cash was mainly due to payments for R&D expenses, salaries, and inventory purchases[90] - As of June 30, 2025, the gearing ratio was 73.6% (December 31, 2024: 73.9%)[91] - As of June 30, 2025, the Group had no assets pledged[92] Material Investments, Acquisitions and Disposals As of June 30, 2025, the company held no material investments, nor were there any material acquisitions or disposals, and no specific future plans for material investments or capital assets, or significant acquisitions or disposals of subsidiaries, associates, and joint ventures - As of June 30, 2025, the company held no material investments, nor were there any material acquisitions or disposals[93] Foreign Exchange Risk The company's financial statements are presented in RMB, but some assets and liabilities are denominated in foreign currencies, exposing it to foreign exchange risk; while currently without a hedging policy, management monitors this risk and considers hedging significant exposures when necessary - The company's financial statements are presented in RMB, but some assets and liabilities are denominated in foreign currencies, exposing it to foreign exchange risk[94] - The company currently has no foreign exchange hedging policy, but management monitors foreign exchange risk and considers hedging significant exposures when necessary[94] Bank Loans and Other Borrowings As of June 30, 2025, the company's bank borrowings totaled RMB 363.2 million, all denominated in RMB - As of June 30, 2025, the company's bank borrowings amounted to RMB 363.2 million, all denominated in RMB[95] Contingent Liabilities As of June 30, 2025, the company had no material contingent liabilities - As of June 30, 2025, the company had no material contingent liabilities[96] Financial Statements Condensed Consolidated Statement of Profit or Loss and Other Comprehensive Income For the six months ended June 30, 2025, revenue significantly decreased to RMB 49,451 thousand, with cost of revenue increasing, resulting in a gross loss of RMB 92,790 thousand and a loss for the period of RMB 270,183 thousand, leading to a basic and diluted loss per share of RMB 0.21 Condensed Consolidated Statement of Profit or Loss and Other Comprehensive Income (For the six months ended June 30) | Indicator | 2025 (RMB thousand) | 2024 (RMB thousand) | | :--- | :--- | :--- | | Revenue | 49,451 | 254,165 | | Cost of Revenue | (142,241) | (82,136) | | Gross Loss (Profit) | (92,790) | 172,029 | | Other Income | 9,315 | 14,824 | | Other Gains and Losses | 4,566 | 12,884 | | R&D Expenses | (105,166) | (66,248) | | Selling and Marketing Expenses | (35,654) | (62,769) | | Administrative Expenses | (43,546) | (46,672) | | Finance Costs | (6,908) | (8,349) | | Loss (Profit) for the Period | (270,183) | 15,699 | | Total Comprehensive Expense (Income) for the Period | (269,914) | 15,688 | | Basic Loss (Earnings) Per Share (RMB) | (0.21) | 0.01 | Condensed Consolidated Statement of Financial Position As of June 30, 2025, total assets less current liabilities decreased to RMB 566,109 thousand, with net assets falling to RMB 315,044 thousand, and net current assets also decreasing from RMB 407,902 thousand to RMB 275,693 thousand Condensed Consolidated Statement of Financial Position (As of June 30, 2025) | Indicator | As of June 30, 2025 (RMB thousand) | As of December 31, 2024 (RMB thousand) | | :--- | :--- | :--- | | Non-current Assets | 290,416 | 303,558 | | Current Assets | 901,489 | 1,089,908 | | Current Liabilities | 625,796 | 682,006 | | Net Current Assets | 275,693 | 407,902 | | Total Assets Less Current Liabilities | 566,109 | 711,460 | | Non-current Liabilities | 251,065 | 347,589 | | Net Assets | 315,044 | 363,871 | | Total Equity | 315,044 | 363,871 | Notes to the Financial Statements General Information and Basis of Preparation The company, incorporated in the Cayman Islands, focuses on R&D and sales of complex biopharmaceutical products, with condensed consolidated financial statements prepared under IAS 34 and HKEX Listing Rules, using a going concern basis - The company is a listed company incorporated in the Cayman Islands, primarily engaged in the R&D and sales of highly complex biopharmaceutical products[54] - The condensed consolidated financial statements are prepared in accordance with International Accounting Standard 34 and the HKEX Listing Rules, adopting a going concern basis[54] Accounting Policies The condensed consolidated financial statements are prepared on a historical cost basis, with certain financial instruments measured at fair value, and the first-time application of revised IFRS accounting standards in this interim period had no significant impact on financial position or performance - The condensed consolidated financial statements are prepared on a historical cost basis, except for certain financial instruments measured at fair value where appropriate[55] - The revised IFRS accounting standards were first applied in this interim period, but had no significant impact on the financial position or performance[56] Revenue Disaggregation and Segment Information For the six months ended June 30, 2025, revenue primarily comprised drug sales (RMB 20,216 thousand), license fees (RMB 17,934 thousand), and royalty income (RMB 11,301 thousand), all recognized at a point in time, with the company operating in a single reportable segment of biopharmaceutical R&D, sales, and IP licensing, and revenue mainly derived from Mainland China and outside Mainland China Disaggregation of Revenue from Contracts with Customers (For the six months ended June 30) | Type of Goods or Services | 2025 (RMB thousand) | 2024 (RMB thousand) | | :--- | :--- | :--- | | Sales of pharmaceutical products | 20,216 | 118,279 | | License fee income | 17,934 | 122,567 | | Royalty income | 11,301 | 13,319 | | Total Revenue | 49,451 | 254,165 | - The company operates in a single reportable segment, which is the R&D, sales, and intellectual property licensing of highly complex biopharmaceutical products[59] Geographical Information of Revenue (For the six months ended June 30) | Region | 2025 (RMB thousand) | 2024 (RMB thousand) | | :--- | :--- | :--- | | Mainland China | 26,942 | 232,106 | | Outside Mainland China | 22,509 | 22,059 | | Total Revenue | 49,451 | 254,165 | Other Income and Other Gains and Losses For the six months ended June 30, 2025, other income was RMB 9,315 thousand, mainly from amortization of exclusive promotion rights and government grants, while other gains and losses were RMB 4,566 thousand, primarily from net foreign exchange gains and a net loss from fair value changes of financial assets Other Income (For the six months ended June 30) | Item | 2025 (RMB thousand) | 2024 (RMB thousand) | | :--- | :--- | :--- | | Bank and other interest income | 1,087 | 7,439 | | Government grants income | 2,712 | 525 | | Amortisation of amounts received for exclusive promotion rights granted | 5,193 | 3,443 | | Scrap sales income | – | 2,723 | | Others | 323 | 694 | | Total | 9,315 | 14,824 | Other Gains and Losses (For the six months ended June 30) | Item | 2025 (RMB thousand) | 2024 (RMB thousand) | | :--- | :--- | :--- | | Net foreign exchange gains | 7,021 | 3,235 | | Net fair value gains on money market funds | 136 | 196 | | Net fair value (losses) gains on financial assets measured at fair value | (2,617) | 9,132 | | Gain on disposal of property, plant and equipment | – | 340 | | Others | 26 | (19) | | Total | 4,566 | 12,884 | Income Tax Expense For the six months ended June 30, 2025 and 2024, no income tax expense was recognized as the company did not generate any taxable profit in its operating entities - As the Group did not generate any taxable profit in its operating entities, no income tax expense was recognized for the six months ended June 30, 2025 and 2024[63] Details of Loss (Profit) for the Period For the six months ended June 30, 2025, the loss for the period was RMB 270,183 thousand, after deducting total depreciation and amortization of RMB 22,095 thousand, directors' emoluments of RMB 10,909 thousand, other staff costs of RMB 51,722 thousand, and including inventory write-downs of RMB 64,901 thousand Items Deducted from (Included in) Loss (Profit) for the Period (For the six months ended June 30) | Item | 2025 (RMB thousand) | 2024 (RMB thousand) | | :--- | :--- | :--- | | Total depreciation and amortisation | 22,095 | 24,007 | | Directors' emoluments | 10,909 | 15,423 | | Other staff costs | 51,722 | 51,930 | | Impairment loss recognised on construction in progress | 4,303 | 4,161 | | Inventory write-down (reversal) | 64,901 | (2,710) | | Cost of inventories recognised as cost of revenue | 53,181 | 43,529 | Dividends During the interim period, no dividends were paid, declared, or proposed to the company's ordinary shareholders, nor have any been proposed since the end of the reporting period - No dividends were paid, declared, or proposed to the company's ordinary shareholders during the interim period, nor have any been proposed since the end of the reporting period[66] Loss (Earnings) Per Share For the six months ended June 30, 2025, the loss attributable to owners of the company was RMB 270,183 thousand, resulting in a basic and diluted loss per share of RMB 0.21, with diluted loss per share not assuming the exercise of share options and vesting of restricted share units due to their anti-dilutive effect Calculation of Loss (Earnings) Per Share (For the six months ended June 30) | Indicator | 2025 (RMB thousand) | 2024 (RMB thousand) | | :--- | :--- | :--- | | Loss (Profit) for the period attributable to owners of the company | (270,183) | 15,699 | | Weighted average number of ordinary shares (thousand shares) | 1,314,139 | 1,275,512 | | Basic and diluted loss (earnings) per share (RMB) | (0.21) | 0.01 | - Diluted loss (earnings) per share did not assume the exercise of share options and vesting of restricted share units, as their inclusion would have an anti-dilutive effect[69] Trade Receivables The company generally grants an average credit period of 60 days to its customers, with total trade receivables amounting to RMB 62,536 thousand as of June 30, 2025, of which RMB 35,786 thousand were overdue by more than 90 days - The Group generally grants an average credit period of 60 days to its customers[70] Ageing Analysis of Trade Receivables (As of the end of the reporting period) | Ageing | As of June 30, 2025 (RMB thousand) | As of December 31, 2024 (RMB thousand) | | :--- | :--- | :--- | | 0 to 60 days | 24,923 | 48,688 | | 61 to 90 days | 1,827 | – | | Over 90 days | 35,786 | 35,241 | | Total | 62,536 | 83,929 | Trade and Other Payables and Accrued Expenses As of June 30, 2025, total trade and other payables and accrued expenses amounted to RMB 387,690 thousand, with trade payables of RMB 212,085 thousand, having a credit period of 0 to 90 days, and RMB 141,887 thousand overdue by more than 90 days Trade and Other Payables and Accrued Expenses (As of the end of the reporting period) | Item | As of June 30, 2025 (RMB thousand) | As of December 31, 2024 (RMB thousand) | | :--- | :--- | :--- | | Trade payables | 212,085 | 338,029 | | Other payables and accrued expenses | 175,605 | 238,152 | | Total | 387,690 | 576,181 | - The credit period for trade payables is 0 to 90 days[73] Ageing Analysis of Trade Payables (As of the end of the reporting period) | Ageing | As of June 30, 2025 (RMB thousand) | As of December 31, 2024 (RMB thousand) | | :--- | :--- | :--- | | 0 to 30 days | 47,336 | 74,545 | | 31 to 60 days | 16,635 | 142,635 | | 61 to 90 days | 6,227 | 24,848 | | Over 90 days | 141,887 | 96,001 | | Total | 212,085 | 338,029 | Events After the Reporting Period On July 16, 2025, the company completed the placing of 100,000,000 placing shares at HKD 4.72 per share, raising net proceeds of approximately HKD 467.28 million (equivalent to RMB 425.79 million) - On July 16, 2025, the company completed the placing of 100,000,000 placing shares at a placing price of HKD 4.72 per share[75] - The net proceeds from the placing amounted to approximately HKD 467.28 million (equivalent to RMB 425.79 million)[75] Corporate Governance and Other Information Company Registration and Listing Information CStone Pharmaceuticals was incorporated in the Cayman Islands on December 2, 2015, and its shares were listed on the Stock Exchange on February 26, 2019 - The company was incorporated in the Cayman Islands on December 2, 2015, and its shares were listed on the Stock Exchange on February 26, 2019[97] Compliance with Corporate Governance Code The company's Board of Directors is committed to achieving high standards of corporate governance and complied with all code provisions of the Corporate Governance Code in Appendix C1 of the HKEX Listing Rules during the reporting period - The company's Board of Directors is committed to achieving high standards of corporate governance and complied with all code provisions of the Corporate Governance Code in Appendix C1 of the HKEX Listing Rules during the reporting period[98] Model Code for Securities Transactions by Directors of Listed Issuers The company adopted a policy for directors' securities transactions, no less exacting than the Model Code in Appendix C3 of the Listing Rules, and all directors confirmed compliance during the reporting period, with no instances of non-compliance by employees noted - The company adopted a policy for directors' securities transactions, with terms no less exacting than the Model Code in Appendix C3 of the Listing Rules[99] - All directors confirmed compliance with the securities transaction code during the reporting period, and no instances of non-compliance by employees with the Model Code were noted[99] Purchase, Sale or Redemption of Listed Securities During the reporting period, neither the company nor its subsidiaries purchased, sold, or redeemed any of the company's listed securities, and as of June 30, 2025, the company held no treasury shares - During the reporting period, neither the company nor its subsidiaries purchased, sold, or redeemed any of the company's listed securities[100] - As of June 30, 2025, the company held no treasury shares[100] Material Litigation During the reporting period, the company was not involved in any material litigation or arbitration, and the directors were unaware of any pending or threatened material litigation or claims against the Group - During the reporting period, the company was not involved in any material litigation or arbitration[101] - The directors were also unaware of any pending or threatened material litigation or claims against the Group[101] Material Events After the Reporting Period On July 16, 2025, the company completed the placing of 100,000,000 placing shares at HKD 4.72 per share, raising net proceeds of approximately HKD 467.28 million - On July 16, 2025, the company completed the placing of 100,000,000 placing shares at a placing price of HKD 4.72 per share[102] - The net proceeds from the placing amounted to approximately HKD 467.28 million[102] Use of Net Proceeds The company detailed the planned and actual use of net proceeds from the Pfizer share subscription and the April 2025 placing, with Pfizer proceeds primarily for development activities under the collaboration agreement, and April 2025 placing proceeds mainly for R&D Pipeline 2.0, specifically CS5001 and CS2009 - The total proceeds from the Pfizer share subscription were approximately USD 200.0 million (approximately RMB 1,355.9 million), used to fund development activities under the collaboration agreement[103] Use of Pfizer Subscription Proceeds (As of June 30, 2025) | Purpose | Percentage of Use | Proceeds from Subscription (RMB million) | Unutilized as of Dec 31, 2024 (RMB million) | Actual Use During Reporting Period (RMB million) | Unutilized as of June 30, 2025 (RMB million) | | :--- | :--- | :--- | :--- | :--- | :--- | | Funding development activities under the collaboration agreement | 100% | 1,355.9 | 409.3 | 40.6 | 368.7 | - The net proceeds from the April 2025 placing were approximately HKD 232.29 million (approximately RMB 215.82 million), primarily used for R&D Pipeline "2.0"[106] Use of April 2025 Placing Proceeds (As of June 30, 2025) | Purpose | Percentage of Use | Proceeds from Placing (RMB million) | Actual Use During Reporting Period (RMB million) | Unutilized Net Proceeds (RMB million) | | :--- | :--- | :--- | :--- | :--- | | R&D Pipeline "2.0" (CS5001, CS2009, etc.) | 90% | 194.24 | 25.97 | 168.27 | | General corporate purposes | 10% | 21.58 | 4.28 | 17.30 | | Total | 100% | 215.82 | 30.25 | 185.57 | Audit Committee Review The Audit Committee reviewed the Group's accounting principles and practices, discussed internal controls and financial reporting with management, and confirmed that the interim financial results for the six months ended June 30, 2025, complied with relevant accounting standards, rules, and regulations, with appropriate disclosures - The Audit Committee reviewed and confirmed that the interim financial results for the six months ended June 30, 2025, complied with relevant accounting standards, rules, and regulations, with appropriate disclosures[108] Review of Interim Results Deloitte Touche Tohmatsu, the company's independent auditor, reviewed the interim financial information in accordance with International Standard on Review Engagements 2410, and the Audit Committee, with management, reviewed accounting principles, policies, internal controls, and financial reporting - Deloitte Touche Tohmatsu, the company's independent auditor, reviewed the interim financial information in accordance with International Standard on Review Engagements 2410[109] Interim Dividend The Board of Directors does not recommend the payment of an interim dividend for the six months ended June 30, 2025 - The Board of Directors does not recommend the payment of an interim dividend for the six months ended June 30, 2025 (2024: nil)[110] Publication of Interim Results Announcement and Interim Report This announcement will be published on the HKEX and company websites, and the interim report for the six months ended June 30, 2025, will be published on the HKEX and company websites in due course - This announcement will be published on the HKEX website (www.hkexnews.hk) and the **company website (www.cstonepharma.com)**[111](index=111&type=chunk) - The interim report for the six months ended June 30, 2025, will be published on the HKEX and company websites in due course[111] Acknowledgements and Board of Directors The Board of Directors extends sincere gratitude to shareholders, management, employees, business partners, and customers for their support and contributions, and lists the Board members as of the announcement date - The Board of Directors extends its sincere gratitude to the Group's shareholders, management team, employees, business partners, and customers for their support and contributions[112] - As of the announcement date, the Board of Directors includes Dr. Li Wei (Chairman and Non-executive Director), Dr. Yang Jianxin (Executive Director), Mr. Kenneth Walton Hitchner III and Mr. Hu Zhengguo (Non-executive Directors), and Mr. Hu Dingxu and Ms. He Ye (Independent Non-executive Directors)[113]