微芯生物(688321) - 2024 Q2 - 季度财报

Definitions This section defines key pharmaceutical industry terms and specifies the reporting period from January 1 to June 30, 2024 - The reporting period refers to January 1, 2024, to June 30, 2024[10] - The report defines key pharmaceutical industry terms such as GMP, clinical trial phases (I, II, III), and First-in-Class/Best-in-Class innovative drugs[10] Company Profile and Key Financial Indicators This section provides an overview of the company's basic information, contact details, information disclosure, stock summary, and key financial performance metrics Company Basic Information Chipscreen Biosciences Co., Ltd. (Chipscreen Biosciences) is registered at Building B, 21F-24F, Zhigu Industrial Park, Shuguang Community, Xili Street, Nanshan District, Shenzhen, with XIANPING LU as its legal representative - The company's Chinese name is Shenzhen Chipscreen Biosciences Co., Ltd., abbreviated as Chipscreen Biosciences[12] - The company's legal representative is XIANPING LU[12] - The company's registered address is Building B, 21F-24F, Zhigu Industrial Park, Shuguang Community, Xili Street, Nanshan District, Shenzhen[12] Contact Persons and Information The contact address, telephone number, and email for the company's Board Secretary Hai Ou and Securities Affairs Representative Lu Zengling are disclosed, all located at Building B, 21F-24F, Zhigu Industrial Park, Shuguang Community, Xili Street, Nanshan District, Shenzhen - The Board Secretary is Hai Ou, and the Securities Affairs Representative is Lu Zengling[13] - The contact number is 0755-26952070, and the email address is ir@chipscreen.com[13] Information Disclosure and Document Custody Location Changes The company's designated information disclosure newspapers are "Shanghai Securities News" and "Securities Times," the website for the semi-annual report is www.sse.com.cn, and the report's custody location is the company's Board of Directors Office - The information disclosure newspapers are "Shanghai Securities News" and "Securities Times"[14] - The report is published on www.sse.com.cn[14](index=14&type=chunk) Company Stock/Depositary Receipt Summary The company's A-shares are listed on the STAR Market of the Shanghai Stock Exchange, with the stock abbreviation Chipscreen Biosciences and stock code 688321 - The company's stock type is A-shares, listed on the STAR Market of the Shanghai Stock Exchange[15] - The stock abbreviation is Chipscreen Biosciences, and the stock code is 688321[15] Company's Key Accounting Data and Financial Indicators During the reporting period, the company's operating revenue increased by 25.06% to 302 million yuan, driven by increased sales of Chidamide and Chiglitazar, while net profit attributable to shareholders decreased by 126.34% to -41 million yuan due to the non-consolidation of Chipscreen New Domain in the prior period, with non-recurring net profit increasing by 68.04% and net operating cash flow growing by 112.81% Key Accounting Data (January-June 2024) | Indicator | Current Period (Jan-Jun) (Yuan) | Prior Period (Yuan) | YoY Change (%) | | :--- | :--- | :--- | :--- | | Operating Revenue | 302,160,509.05 | 241,603,895.80 | 25.06 | | Net Profit Attributable to Shareholders | -41,006,398.91 | 155,689,740.46 | -126.34 | | Net Profit Attributable to Shareholders Excluding Non-Recurring Items | -47,178,228.95 | -147,625,906.11 | 68.04 | | Net Cash Flow from Operating Activities | 15,547,805.71 | -121,379,696.03 | 112.81 | | Net Assets Attributable to Shareholders (End of Period) | 1,654,261,404.95 | 1,709,895,871.95 | -3.25 | | Total Assets (End of Period) | 3,304,507,875.04 | 3,203,249,429.12 | 3.16 | Key Financial Indicators (January-June 2024) | Indicator | Current Period (Jan-Jun) (Yuan/share) | Prior Period (Yuan/share) | YoY Change (%) | | :--- | :--- | :--- | :--- | | Basic Earnings Per Share (Yuan/share) | -0.1005 | 0.3817 | -126.33 | | Diluted Earnings Per Share (Yuan/share) | -0.1005 | 0.3817 | -126.33 | | Basic EPS Excluding Non-Recurring Items (Yuan/share) | -0.1156 | -0.3620 | 68.07 | | Weighted Average Return on Net Assets (%) | -2.43 | 9.65 | Decrease 12.08 percentage points | | Weighted Average Return on Net Assets Excluding Non-Recurring Items (%) | -2.80 | -10.11 | Increase 7.31 percentage points | | R&D Investment as % of Operating Revenue (%) | 59.60 | 102.48 | Decrease 42.88 percentage points | - Operating revenue increased by 25.06%, primarily due to a 11.74% increase in Chidamide sales volume (revenue up 4.15%) and a 396.15% increase in Chiglitazar sales volume (revenue up 632.48%)[18] - Net profit decreased by 126.34%, mainly because Chipscreen New Domain was no longer consolidated in the prior period, leading to the recognition of investment income[18] - Net profit excluding non-recurring items increased by 68.04% year-on-year, primarily due to increased operating revenue and decreased expenses[18] Non-Recurring Gains and Losses Items and Amounts During the reporting period, the company's total non-recurring gains and losses amounted to 6.1718 million yuan, primarily comprising government grants, fair value changes in financial assets, and other non-operating income and expenses Non-Recurring Gains and Losses Items and Amounts | Non-Recurring Gains and Losses Item | Amount (Yuan) | | :--- | :--- | | Gains/Losses on Disposal of Non-Current Assets | -36,436.35 | | Government Grants Recognized in Current Profit/Loss | 5,188,279.82 | | Gains/Losses from Fair Value Changes and Disposal of Financial Assets and Liabilities Held by Non-Financial Enterprises | 1,172,142.48 | | Other Non-Operating Income and Expenses Apart from the Above | 338,261.98 | | Less: Income Tax Impact | 490,417.90 | | Total | 6,171,830.03 | Management Discussion and Analysis This section provides an in-depth analysis of the company's industry, core business, R&D progress, core competitiveness, operational performance, and risk factors Description of the Company's Industry and Main Business During the Reporting Period Chipscreen Biosciences, an innovative drug company, specializes in pharmaceutical manufacturing, leveraging AI-assisted design and chemical genomics platforms to develop several global first-in-class or best-in-class drugs and a rich R&D pipeline across five major therapeutic areas including oncology and metabolic diseases - The company's industry is pharmaceutical manufacturing (C27), specifically chemical raw material drug manufacturing (C2710) and chemical drug preparation manufacturing (C2720)[22] - The company adheres to the philosophy of "Original, Safe, Efficacious, China," committed to providing innovative mechanism drugs that address urgent clinical needs[22] - The company utilizes an integrated AI-assisted design and chemical genomics drug discovery platform, establishing a complete industry chain from early exploration to commercialization[22] (1) Chidamide Chidamide, the world's first subtype-selective histone deacetylase (HDAC) inhibitor, has received approval for multiple indications in China, Japan, and Taiwan, with ongoing clinical explorations in immuno-oncology for DLBCL, colorectal cancer, and non-small cell lung cancer - Chidamide is the world's first subtype-selective histone deacetylase (HDAC) inhibitor and the first oral drug approved globally for peripheral T-cell lymphoma and advanced hormone receptor-positive breast cancer[25] - In April 2024, it was approved in China for combination with R-CHOP to treat newly diagnosed diffuse large B-cell lymphoma (DLBCL) patients with MYC and BCL2 expression[27] - In June 2024, Chidamide in combination with Sintilimab and Bevacizumab for advanced MSS/pMMR colorectal cancer was designated as a "Breakthrough Therapy Product"[28] (2) Chiglitazar Chiglitazar, the world's first PPAR pan-agonist approved for type 2 diabetes, has been approved in China and included in national medical insurance, with a new indication for combination therapy with metformin approved during the reporting period, and positive efficacy results from its Phase II clinical trial for non-alcoholic steatohepatitis (NASH) - Chiglitazar is the world's first PPAR pan-agonist approved for the treatment of type 2 diabetes[29] - In July 2024, a new indication for Chiglitazar in combination with metformin for type 2 diabetes was approved[31] - The Phase II clinical trial of Chiglitazar monotherapy for non-alcoholic steatohepatitis (NASH) met its primary efficacy endpoint, demonstrating good efficacy[32] (3) Chiauranib Chiauranib is a multi-pathway targeted kinase inhibitor with unique Aurora B inhibitory activity, advancing clinical trials in various oncology indications including small cell lung cancer, ovarian cancer, triple-negative breast cancer, and pancreatic cancer, with its Phase III clinical trial for small cell lung cancer having completed database lock and preparing for NDA submission - Chiauranib is a selective Aurora B inhibitor that also inhibits VEGFR, CSF1R, and DDR1 pathways, possessing a multi-pathway anti-tumor mechanism[32] - In April 2024, the Phase III clinical trial of Chiauranib monotherapy for small cell lung cancer completed database lock and is preparing to submit Pre-NDA communication materials[32] - Enrollment for the Phase III clinical trial of Chiauranib combined with chemotherapy for ovarian cancer has exceeded two-thirds[32] (4) CS23546 CS23546 is a highly effective small molecule PD-L1 inhibitor independently developed by the company, with its Phase I dose escalation trial progressing as planned, expected to demonstrate differentiated advantages in treating various malignant tumors - CS23546 is a highly effective small molecule PD-L1 inhibitor that binds to PD-L1 and induces its internalization to relieve immunosuppression[33] - As of the end of the reporting period, the Phase I dose escalation of CS23546 is progressing as planned[34] (5) CS32582 CS32582 is a highly selective TYK2 small molecule allosteric inhibitor that specifically blocks cytokine signaling pathways by inhibiting TYK2, intended for autoimmune diseases like psoriasis, with its Phase I dose escalation progressing as planned - CS32582 is a highly selective tyrosine kinase 2 (TYK2) small molecule allosteric inhibitor for autoimmune diseases such as psoriasis[35] - As of the end of the reporting period, the Phase I dose escalation of CS32582 is progressing as planned[35] (6) CS12192 CS12192 is a highly selective JAK3 kinase inhibitor, also partially inhibiting JAK1 and TBK1, primarily for autoimmune diseases, having completed its Phase I clinical trial for rheumatoid arthritis in China - CS12192 is a highly selective JAK3 kinase inhibitor for autoimmune diseases[36] - The company has completed the Phase I clinical trial of CS12192 for rheumatoid arthritis in China[36] (7) Other Pipeline Products The company has a pipeline of several Best-in-Class potential drug candidates across five major therapeutic areas: malignant tumors, metabolic diseases, autoimmune diseases, central nervous system diseases, and antiviral therapies, with some projects already in preclinical research - The company has strategically developed multiple R&D projects with differentiated advantages and global competitiveness across five major therapeutic areas[37] - The company has reserved Best-in-Class potential drug candidates such as CS231295, CS12088, CS08399, and CS25141[37] Core Technologies and R&D Progress The company's core technology platform integrates AI-assisted design with chemical genomics, covering all stages of new drug development, with continued R&D investment, expansion of clinical pipelines, and multiple invention patent grants during the reporting period - The company's core technology platform is based on an integrated chemical genomics drug discovery and early evaluation system, supported by AI technology assistance and comprehensive clinical development strategies[52] - During the reporting period, the PD-L1 oral small molecule inhibitor and Tyk2 inhibitor successively received clinical trial approval, with Phase I dose escalation progressing smoothly; anti-tumor candidate molecule CS231295 and antiviral candidate molecule CS12088 also completed most of their preclinical research[38] 1. Core Technologies, Their Advanced Nature, and Changes During the Reporting Period The company's core technology platform integrates AI-assisted design with chemical genomics to enhance new drug R&D success rates through early risk prediction, with continuous R&D investment, clinical pipeline expansion, and active exploration of synergistic development with macromolecule drugs during the reporting period - The core technology system utilizes chemical genomics and AI-assisted design for comprehensive evaluation of new drug candidates' efficacy, differentiation, and potential toxicity, reducing late-stage development risks[52] - During the reporting period, the PD-L1 oral small molecule inhibitor and Tyk2 inhibitor received clinical trial approval, and CS231295 and CS12088 completed most of their preclinical research[38] 2. R&D Achievements During the Reporting Period During the reporting period, the company's Chidamide received market approval for a new DLBCL indication, multiple clinical trial applications were approved or designated as breakthrough therapies, and a total of 24 domestic and international invention patents were granted - The marketing application for Chidamide in combination with RCHOP for the new DLBCL indication has obtained a drug registration certificate[39] - The breakthrough therapy application for Chidamide in combination with Sintilimab and Bevacizumab for advanced MSS/pMMR colorectal cancer was included in the breakthrough therapy product list[39] Intellectual Property List During the Reporting Period | | New Applications This Period (units) | Grants (units) | Cumulative Applications (units) | Cumulative Grants (units) | | :--- | :--- | :--- | :--- | :--- | | Invention Patents | 24 | 24 | 687 | 204 | | Software Copyrights | 0 | 0 | 3 | 3 | | Others | 3 | 0 | 125 | 115 | | Total | 27 | 24 | 815 | 322 | 3. R&D Investment Table During the reporting period, the company's total R&D investment was 180 million yuan, a 27.26% year-on-year decrease, primarily due to the non-consolidation of Chipscreen New Domain, with R&D investment as a percentage of operating revenue at 59.60%, a 42.88 percentage point decrease year-on-year R&D Investment Status | Indicator | Current Period Amount (Yuan) | Prior Period Amount (Yuan) | Change (%) | | :--- | :--- | :--- | :--- | | Expensed R&D Investment | 102,214,756.98 | 162,172,756.59 | -36.97 | | Capitalized R&D Investment | 77,886,063.24 | 85,421,889.54 | -8.82 | | Total R&D Investment | 180,100,820.22 | 247,594,646.13 | -27.26 | | Total R&D Investment as % of Operating Revenue (%) | 59.60 | 102.48 | Decrease 42.88 percentage points | | Proportion of Capitalized R&D Investment (%) | 43.25 | 34.50 | Increase 8.75 percentage points | - Total R&D investment decreased by 27.26%, mainly because Chipscreen New Domain's R&D expenses were included in the consolidated financial statements in the prior period but are no longer included in the current period[45] 4. R&D Project Status The company achieved significant progress in multiple R&D projects, including Chidamide DLBCL Phase III market approval, Chiauranib SCLC Phase III database lock completion, positive efficacy in Chiglitazar NASH Phase II, and CS23546 and CS32582 entering Phase I clinical trials - The Phase III clinical trial of Chidamide for DLBCL received conditional market approval on April 24, 2024[47] - The Phase III clinical trial of Chiauranib monotherapy for small cell lung cancer completed database lock on April 12, 2024, and is preparing to submit its NDA marketing application[47] - The Phase II clinical trial of Chiglitazar monotherapy for non-alcoholic steatohepatitis (NASH) showed good efficacy, with the Phase III protocol currently being finalized[47][48] - Phase I dose escalation trials for CS23546 and CS32582 are progressing as planned[48][49] 5. R&D Personnel Status As of the end of the reporting period, the company had 295 R&D personnel, accounting for 28.64% of the total workforce, including 31 PhDs, 98 Masters, and 152 Bachelors, with an average R&D personnel compensation of 193,800 yuan Basic Information of R&D Personnel | Indicator | Current Period | Prior Period | | :--- | :--- | :--- | | Number of Company R&D Personnel (persons) | 295 | 340 | | R&D Personnel as % of Total Company Staff (%) | 28.64% | 32.38% | | Total R&D Personnel Compensation (10,000 yuan) | 5,765 | 7,203 | | Average R&D Personnel Compensation (10,000 yuan) | 19.38 | 21.25 | Educational Background of R&D Personnel | Educational Background | Number (persons) | Proportion (%) | | :--- | :--- | :--- | | PhD | 31 | 10.5% | | Master | 98 | 33.2% | | Bachelor | 152 | 51.5% | | Junior College | 14 | 4.7% | | Total | 295 | 100% | Analysis of Core Competitiveness During the Reporting Period The company's core competitiveness lies in its proprietary core technology platform based on chemical genomics and AI assistance, strong innovative drug R&D capabilities, rich product pipeline, sustained R&D investment, comprehensive intellectual property protection, international vision, and GMP-compliant industrialization capabilities - Possesses a proprietary core technology platform, integrating chemical genomics and AI-assisted design, covering all stages of new drug R&D[52] - Focuses on original small molecule drug R&D, successfully developing Chidamide, the world's first subtype-selective HDAC inhibitor, and Chiglitazar, the world's first PPAR pan-agonist[53] - Has a rich product pipeline, including marketed products and multiple new drugs at various clinical stages, covering multiple disease areas[54] - Continuously increases R&D investment, with a high proportion of R&D investment to operating revenue[54] - Established a systematic intellectual property management system, with 687 invention patent applications globally and 204 granted patents[54] - Possesses an international perspective, actively participating in international pharmaceutical regulatory market competition and cooperation[54] - Possesses GMP-compliant industrialization capabilities, including Chiglitazar API and tablet workshops, and Chiauranib API and capsule workshops[54] Discussion and Analysis of Operations In the first half of 2024, amidst a complex market environment, the company achieved operating revenue growth by strengthening early R&D, clinical trials, commercialization, capacity enhancement, and management efficiency, though net profit declined due to non-recurring gains and losses; the company actively promoted product hospital access and international cooperation, while also enhancing talent development - In the first half of 2024, the biopharmaceutical industry continued to face a complex market environment and challenges, with strong demand for refinancing among innovative drug companies and increasing performance pressure[55] - The company made progress in early R&D, clinical trial execution, commercialization, capacity enhancement, and management efficiency improvement[55] (一) Key Performance Highlights During the reporting period, the company's operating revenue reached 302 million yuan, a 25.06% year-on-year increase, primarily driven by increased sales of Chidamide and Chiglitazar; net cash flow from operating activities was 15.55 million yuan, up 112.81% year-on-year; R&D investment was 180 million yuan, down 27.26% year-on-year, mainly due to the non-consolidation of Chipscreen New Domain - Operating revenue was 302.16 million yuan, a 25.06% increase compared to the prior period[56] - Chidamide sales volume increased by 11.74%, with revenue up 4.15%; Chiglitazar sales volume increased by 396.15%, with revenue up 632.48%[56] - Net cash flow from operating activities was 15.55 million yuan, a 112.81% year-on-year increase, primarily due to increased sales collections[56] - The company's R&D investment was 180.10 million yuan, a 27.26% decrease compared to the prior period, mainly because Chipscreen New Domain's R&D expenses were included in the consolidated financial statements in the prior period but are not included in the current consolidated financial statements[56] (二) Significant R&D Progress The company's early R&D projects CS231295 and CS12088 completed most preclinical research; domestically, Chidamide's new DLBCL indication was approved for market, Chiauranib SCLC Phase III completed database lock, Chiglitazar combined with metformin received new indication approval with good NASH Phase II efficacy, CS12192 completed Phase I, and CS23546 and CS32582 Phase I dose escalation progressed smoothly; in US clinical trials, Chiauranib CAR107 Phase Ib progressed well with no significant safety issues reported - CS231295 (multi-target kinase inhibitor) and CS12088 (HBV capsid protein inhibitor) completed most of their preclinical research[58] - The pivotal Phase III clinical trial of Chidamide combined with R-CHOP as first-line standard treatment for double-expression diffuse large B-cell lymphoma received conditional market approval from CDE on April 24, 2024[59] - The pivotal randomized, double-blind, controlled, multi-center Phase III clinical trial of Chiauranib monotherapy for small cell lung cancer completed database lock on April 12, 2024, and is currently preparing to submit NDA marketing application materials[60] - The marketing application for Chiglitazar combined with metformin for type 2 diabetes received CDE approval for a new indication on July 16, 2024[60] - The dose escalation Phase Ib trial of Chiauranib monotherapy for advanced solid malignant tumors and relapsed/refractory small cell lung cancer (CAR107) progressed smoothly, with no significant safety issues reported[62] (二) Product Sales and Commercial Status As of the end of the reporting period, Chidamide achieved national coverage through 62 primary distributors, 168 secondary distributors, and 848 dual-channel pharmacies, while Chiglitazar achieved national coverage through 107 primary distributors, 298 secondary distributors, and 2,886 pharmacies, with access to 1,654 graded hospitals and sales of 963,680 boxes - Chidamide sales achieved national coverage through 62 primary distributors, 168 secondary distributors, and 848 dual-channel pharmacies[63] - Chiglitazar achieved national coverage through 107 primary distributors, 298 secondary distributors, and 2,886 pharmacies, with access to a total of 1,654 graded hospitals nationwide, selling 963,680 boxes[63] (三) Industrialization Status Chengdu Chipscreen completed the pharmaceutical submission for Chiauranib NDA, and Workshop 5 of Phase III construction finished installation, debugging, and process validation; Shenzhen Chipscreen completed installation, debugging, and equipment validation for Chidamide API crude product Line 2, with a capacity three times that of the original Line 1; the company established Pengzhou Chipscreen Pharmaceutical Co., Ltd. to plan for Chiglitazar capacity expansion - Chengdu Chipscreen completed the pharmaceutical submission for Chiauranib NDA in the first half of the year; Workshop 5 of Phase III construction has completed installation and debugging, and is undergoing process validation production[64] - Shenzhen Chipscreen completed the installation, debugging, and equipment validation for Chidamide API crude product Line 2 in the first half of the year, with Line 2's capacity being three times that of the original Line 1[64] - In May 2024, the company established its wholly-owned subsidiary, Pengzhou Chipscreen Pharmaceutical Co., Ltd., planning to expand Chiglitazar production by building a new innovative drug manufacturing base[64] (四) Business Cooperation The company continues to advance external collaborations for existing products, explore combination therapy partnerships for key indications, actively participates in domestic and international industry conferences, and has reached cooperation intentions with several foreign companies for overseas markets - The company continues to advance various external cooperation initiatives for existing products, exploring external combination therapy partnerships for key indications[65] - The company actively participated in major domestic and international industry conferences, engaging in discussions with hundreds of domestic and international companies regarding external collaborations for pipeline products; currently, cooperation intentions have been reached with some foreign companies for certain overseas regional markets[65][66] (五) Talent Development and Management Efficiency The company actively engages in talent team building, implementing management assessments and probationary mechanisms, enhancing management levels through organizational observation, and continuously offering specialized training courses to build a digital learning and operations system, fostering employee growth - The company actively carries out talent team building, implementing management assessments and probationary mechanisms for new managers to ensure objectivity and scientific rigor in talent selection[67] - By organizational observation, identifying, analyzing, and solving management problems, the company enhances overall organizational management; it continuously offers specialized training courses and builds a digital learning and operations system to support employee growth[67] Risk Factors The company faces risks including significant performance decline or losses, impairment of core competitiveness, rising raw material prices, intensified product commercialization competition, industry policy changes, and adjustments and negotiations related to the national medical insurance catalog - There is a risk of significant performance decline or losses if R&D project progress or post-launch commercialization falls short of expectations[67] - Faces core competitiveness risks, including intense competition from large domestic and international pharmaceutical companies and small biotech firms, as well as pressure from technological upgrades[67] - Operational risks include significant increases in raw material prices and intensified product commercialization competition[67] - Financial risk primarily stems from potential working capital pressure due to a sustained significant increase in accounts receivable[67] - Industry risks include changes in industry policies and medical insurance catalog adjustments and negotiation policies, which may affect sales growth for new indications or lead to a decrease in sales revenue[68] Key Operating Performance During the Reporting Period During the reporting period, the company's operating revenue increased by 25.06% year-on-year, primarily driven by the increased sales volume of Chiglitazar; operating costs, selling expenses, financial expenses, and net cash flow from operating activities all increased, while administrative and R&D expenses decreased; the asset and liability structure underwent several changes, with intangible assets and development expenditures adjusted due to new indication market approval (一) Analysis of Main Business During the reporting period, the company's operating revenue increased by 25.06% year-on-year, primarily driven by a 632.48% increase in Chiglitazar sales revenue; operating costs rose by 59.16% with sales volume; selling expenses increased by 4.61% due to higher marketing costs; administrative expenses decreased by 19.02% due to the absence of equity incentive expenses; financial expenses increased by 17.15% due to higher bank loan interest; R&D expenses decreased by 36.97% as Chipscreen New Domain was no longer consolidated; and net cash flow from operating activities significantly increased by 112.81% due to higher sales collections Analysis Table of Financial Statement Items Changes | Item | Current Period Amount (Yuan) | Prior Period Amount (Yuan) | Change (%) | | :--- | :--- | :--- | :--- | | Operating Revenue | 302,160,509.05 | 241,603,895.80 | 25.06 | | Operating Cost | 36,516,344.47 | 22,942,791.07 | 59.16 | | Selling Expenses | 149,709,739.04 | 143,106,572.09 | 4.61 | | Administrative Expenses | 36,692,834.36 | 45,310,604.94 | -19.02 | | Financial Expenses | 7,722,364.97 | 6,591,650.76 | 17.15 | | R&D Expenses | 102,214,756.98 | 162,172,756.59 | -36.97 | | Net Cash Flow from Operating Activities | 15,547,805.71 | -121,379,696.03 | 112.81 | | Net Cash Flow from Investing Activities | -147,692,368.57 | -216,231,795.82 | 31.70 | | Net Cash Flow from Financing Activities | 67,020,162.42 | 311,811,902.67 | -78.51 | - The change in operating revenue was primarily due to the growth in Chiglitazar sales revenue, which increased by 632.48% year-on-year[69] - The change in R&D expenses was mainly because Chipscreen New Domain's R&D expenses were included in the consolidated financial statements in the prior period, but after losing control of Chipscreen New Domain at the end of June 2023, it is no longer included in the consolidated financial statements[69] (三) Analysis of Assets and Liabilities As of the end of the reporting period, the company's accounts receivable decreased by 22.02% due to better collections, intangible assets significantly increased by 112.68% as R&D expenditures were transferred out due to DLBCL new indication market approval, and development expenditures decreased by 34.81% accordingly; short-term borrowings decreased by 61.59% due to repayment of matured loans, and non-current liabilities due within one year increased by 81.21% due to new long-term borrowings Changes in Assets and Liabilities | Item Name | Current Period End Amount (Yuan) | % of Total Assets at Period End (%) | Prior Year End Amount (Yuan) | % of Total Assets at Prior Year End (%) | YoY Change in Amount at Period End (%) | Explanation | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Accounts Receivable | 152,752,842.72 | 4.62 | 195,879,741.71 | 6.12 | -22.02 | Primarily due to better collections during the reporting period | | Contract Assets | 1,796,468.86 | 0.05 | 941,920.80 | 0.03 | 90.72 | Primarily due to new technical services from Chipscreen New Domain during the reporting period | | Construction in Progress | 398,367,209.62 | 12.06 | 360,807,184.45 | 11.26 | 10.41 | Primarily due to progress in Phase III construction of Chengdu Innovative Drug Production Base during the reporting period | | Intangible Assets | 391,309,005.75 | 11.84 | 183,986,711.92 | 5.74 | 112.68 | Primarily due to the market approval of the new DLBCL indication during the reporting period, with related R&D expenditures transferred to intangible assets | | Development Expenditures | 259,829,718.95 | 7.86 | 398,561,645.92 | 12.44 | -34.81 | Primarily due to the market approval of the new DLBCL indication during the reporting period, with related R&D expenditures transferred to intangible assets | | Short-term Borrowings | 49,975,877.64 | 1.51 | 130,112,786.24 | 4.06 | -61.59 | Primarily due to repayment of matured loans during the reporting period | | Non-current Liabilities Due Within One Year | 73,591,108.58 | 2.23 | 40,610,886.29 | 1.27 | 81.21 | Primarily due to new long-term borrowings due within one year during the reporting period | - Overseas assets amounted to 57,315,705.43 yuan, accounting for 1.73% of total assets[73] - Assets pledged include office buildings in Shenzhen Nanshan Zhigu Industrial Park and No. 18 Xintongnan 1st Road, Chengdu High-tech Zone[74] (四) Analysis of Investment Status The company's financial assets measured at fair value had a period-end balance of 243 million yuan, with purchases of 481 million yuan, sales/redemptions of 455 million yuan, and fair value change gains/losses of 931,500 yuan during the current period Financial Assets Measured at Fair Value | Asset Category | Beginning Balance (Yuan) | Fair Value Change Gains/Losses This Period (Yuan) | Purchases This Period (Yuan) | Sales/Redemptions This Period (Yuan) | Ending Balance (Yuan) | | :--- | :--- | :--- | :--- | :--- | :--- | | Others | 216,717,350.00 | 931,522.65 | 481,000,000.00 | 454,900,000.00 | 242,931,522.65 | | Total | 216,717,350.00 | 931,522.65 | 481,000,000.00 | 454,900,000.00 | 242,931,522.65 | (六) Analysis of Major Holding and Associate Companies The company's major holding subsidiaries include Chengdu Chipscreen Pharmaceutical Co., Ltd., Shenzhen Chipscreen Pharmaceutical Co., Ltd., Chipscreen Biosciences (USA) Co., Ltd., and Pengzhou Chipscreen Pharmaceutical Co., Ltd., with businesses covering drug production, development, and technical services; Chengdu Chipscreen New Domain Biotechnology Co., Ltd. is an associate company - Chengdu Chipscreen Pharmaceutical Co., Ltd. has a registered capital of 860 million yuan, a 100% ownership stake, and its business nature is drug development and technical services78 - Shenzhen Chipscreen Pharmaceutical Co., Ltd. has a registered capital of 10 million yuan, a 100% ownership stake, and its business nature is the production of active pharmaceutical ingredients (Chidamide), tablets, and hard capsules (all anti-tumor drugs)78 - Pengzhou Chipscreen Pharmaceutical Co., Ltd. has a registered capital of 10 million yuan, a 100% ownership stake, and its business nature is drug R&D, production, and sales79 - Chengdu Chipscreen New Domain Biotechnology Co., Ltd. is an associate company, with Chengdu Chipscreen holding a 38.86% stake, and its business nature is research and experimental development78 Corporate Governance This section details the company's shareholder meetings, changes in directors, supervisors, senior management, and core technical personnel, as well as profit distribution plans and equity incentive schemes Overview of Shareholder Meetings During the reporting period, the company held two shareholder meetings, including the First Extraordinary General Meeting of Shareholders in 2024 and the 2023 Annual General Meeting of Shareholders, where all proposals were effectively passed, and the convening and conduct procedures were legal and valid - During the reporting period, the company held two shareholder meetings: the First Extraordinary General Meeting of Shareholders in 2024 (February 22) and the 2023 Annual General Meeting of Shareholders (April 19)[81] - The convening and conduct procedures of the company's shareholder meetings complied with laws, regulations, and the company's articles of association, with legal voting procedures and valid voting results, and no proposals were rejected[82] Changes in Directors, Supervisors, Senior Management, and Core Technical Personnel The company underwent a re-election on March 28, 2024, resulting in changes to some independent directors and supervisors, including the departure of Song Ruilin, Zhu Xun, and Li Xiangyan upon term expiration, and the election of Huang Min, Wang Yanmei, and Luo Yonggen as independent directors - The company conducted a re-election on March 28, 2024, leading to changes in the aforementioned personnel[84] - Independent directors Song Ruilin, Zhu Xun, and Li Xiangyan departed upon term expiration, and Huang Min, Wang Yanmei, and Luo Yonggen were elected as independent directors[83] - Supervisors Xie Zhengsheng and Zhu Jingzhong departed upon term expiration[83] Profit Distribution or Capital Reserve Conversion Plan During the reporting period, the company had no profit distribution plan or capital reserve to share capital conversion plan - During the reporting period, the company had no profit distribution plan or capital reserve to share capital conversion plan[84] Status and Impact of Company Equity Incentive Plans, Employee Stock Ownership Plans, or Other Employee Incentive Measures During the reporting period, the company's 2021 Restricted Stock Incentive Plan's second vesting period met vesting conditions, resulting in the cancellation of some restricted shares and the write-off of 2.7426 million repurchased shares - The second vesting period of the 2021 Restricted Stock Incentive Plan met vesting conditions, and those restricted shares were cancelled[85] - The second exercise period of the 2021 Stock Appreciation Rights Incentive Plan met exercise conditions, and those stock appreciation rights were cancelled[85] - As of May 31, 2024, the company has cancelled 2.7426 million repurchased shares from 2021 that were designated for the 2021 Restricted Stock Incentive Plan[85] Environment and Social Responsibility This section outlines the company's environmental protection mechanisms, pollution discharge information, facility operations, environmental impact assessments, emergency plans, and self-monitoring programs Environmental Information The company has established environmental protection mechanisms, investing 271,300 yuan in environmental protection during the reporting period; Chengdu Chipscreen Pharmaceutical and Shenzhen Chipscreen Pharmaceutical, as key polluting entities, both hold valid pollutant discharge permits, operate pollution control facilities normally, and have completed emergency response plans for environmental incidents and environmental self-monitoring programs - The company has established environmental protection mechanisms, investing 271,300 yuan in environmental protection during the reporting period[86] - Chengdu Chipscreen Pharmaceutical Co., Ltd. and Shenzhen Chipscreen Pharmaceutical Co., Ltd. are both designated as key polluting entities by environmental protection authorities[87][88] 1. Pollutant Discharge Information Chengdu Chipscreen Pharmaceutical's main pollutants are wastewater and exhaust gas, with discharge volumes complying with permitted limits; Shenzhen Chipscreen Pharmaceutical's main pollutant is exhaust gas, with both organized and unorganized emissions having clear permitted concentration limits - Chengdu Chipscreen Pharmaceutical Co., Ltd. updated its pollutant discharge permit on March 31, 2022, valid until March 30, 2027, with main pollutants being wastewater and exhaust gas[87] - Shenzhen Chipscreen Pharmaceutical Co., Ltd. obtained its pollutant discharge permit on April 3, 2023, valid until April 2, 2028, with main pollutants being exhaust gas[88] 2. Construction and Operation of Pollution Control Facilities The pollution control facilities of Chengdu Chipscreen Pharmaceutical Co., Ltd. and Shenzhen Chipscreen Pharmaceutical Co., Ltd. are operating normally, with no instances of faulty operation or exceeding discharge limits - The pollution control facilities of Chengdu Chipscreen Pharmaceutical Co., Ltd. and Shenzhen Chipscreen Pharmaceutical Co., Ltd. are operating normally, with no faulty operation or exceeding discharge limits[91] 3. Environmental Impact Assessment and Other Environmental Protection Administrative Permits for Construction Projects Shenzhen Chipscreen Pharmaceutical Co., Ltd.'s expansion project obtained environmental impact assessment approval on January 29, 2023, and re-obtained its pollutant discharge permit on April 3, 2023 - Shenzhen Chipscreen Pharmaceutical Co., Ltd.'s expansion project obtained the "Approval for the Environmental Impact Report of Shenzhen Chipscreen Pharmaceutical Co., Ltd.'s Production Scale Expansion Project" from the Pingshan Administration of Shenzhen Ecological Environment Bureau on January 29, 2023[92] - Re-obtained pollutant discharge permit on April 3, 2023, with certificate number: 91440300MA5EE1LH0B001Z[92] 4. Emergency Response Plans for Environmental Incidents Chengdu Chipscreen Pharmaceutical Co., Ltd. and Shenzhen Chipscreen Pharmaceutical Co., Ltd. have both completed the filing of their emergency response plans for environmental incidents - Chengdu Chipscreen Pharmaceutical Co., Ltd. completed the filing of its environmental emergency response plan on December 18, 2023, with filing number: 510109-2023-154-M[92] - Shenzhen Chipscreen Pharmaceutical Co., Ltd. completed the filing of its environmental emergency response plan on April 22, 2024, with filing number: 440310-2024-0019-L[92] 5. Environmental Self-Monitoring Program Chengdu Chipscreen Pharmaceutical and Shenzhen Chipscreen Pharmaceutical have both developed detailed environmental self-monitoring programs, covering online monitoring, monthly, quarterly, and annual monitoring indicators, as well as organized and unorganized exhaust gas emission monitoring - Chengdu Chipscreen Pharmaceutical's environmental self-monitoring program includes online monitoring of wastewater treatment plant outfalls (COD, ammonia nitrogen, total phosphorus, pH), as well as monthly, quarterly, and annual monitoring indicators[92] - Shenzhen Chipscreen Pharmaceutical's environmental self-monitoring program includes monitoring of quality inspection exhaust gas outlets, API exhaust gas outlets, and unorganized exhaust gas at the factory boundary, with monitoring frequencies ranging from monthly to semi-annually[93] Significant Matters This section covers the fulfillment of commitments, integrity status of the company and its controlling shareholders, major related party transactions, significant contracts, and the use of raised funds Fulfillment of Commitments The company's actual controller, shareholders, related parties, and the company itself have timely and strictly fulfilled multiple commitments during or continuing into the reporting period, including share lock-ups, stabilizing stock prices, repurchase of shares issued fraudulently, compensating for diluted immediate returns, not seeking control of the company, and resolving horizontal competition and related party transactions - The commitments regarding share lock-up arrangements and voluntary lock-ups by the company's actual controller XIANPING LU and his concerted parties, as well as company shareholders such as Bio-O Technology, were all timely and strictly fulfilled[96][98][100] - The commitments regarding stabilizing stock prices by the company, XIANPING LU, all directors (excluding independent directors and foreign directors), and senior management were all timely and strictly fulfilled[96][101][103] - The commitments regarding the repurchase of shares issued fraudulently by the company and XIANPING LU were all timely and strictly fulfilled[96][103] - The commitments by shareholders such as Bio-O Technology, LAV ONE, and VERTEX not to seek control of the company were all timely and strictly fulfilled[96][108] - The commitments by the company's controlling shareholder, actual controller XIANPING LU, and his concerted parties to avoid horizontal competition with the company were all timely and strictly fulfilled[97][108][112] - The commitments by the company's controlling shareholder, actual controller XIANPING LU and his concerted parties, other major shareholders, and all directors, supervisors, and senior management regarding standardizing and reducing related party transactions were all timely and strictly fulfilled[97][109] Explanation of the Integrity Status of the Company, its Controlling Shareholder, and Actual Controller During the Reporting Period During the reporting period, the company, its controlling shareholder, and actual controller maintained good integrity, with no adverse integrity issues such as unfulfilled effective court judgments or significant overdue debts - During the reporting period, the company, its controlling shareholder, and actual controller maintained good integrity[114] - There were no adverse integrity issues such as unfulfilled effective court judgments or significant overdue debts[114] Major Related Party Transactions During the reporting period, the company's estimated daily related party transaction limits were disclosed in interim announcements, with no other undisclosed major related party transactions - The estimated daily related party transaction limits for 2024 were disclosed on the Shanghai Stock Exchange website on February 7, 2024[115] - There were no major related party transactions not disclosed in interim announcements during the reporting period[117] Major Contracts and Their Fulfillment During the reporting period, the company had multiple property lease contracts, with total leased asset value amounting to 3.9016 million yuan; the company provided several joint and several liability guarantees for its subsidiary Chengdu Chipscreen Pharmaceutical Co., Ltd., with a total guarantee amount of 300 million yuan, representing 18.13% of the company's net assets Lease Status | Lessor Name | Leased Asset Description | Amount Involved in Leased Assets (Yuan) | | :--- | :--- | :--- | | Beijing Shibo Shiyi Enterprise Management Consulting Co., Ltd. | Property Lease | 2,209,098.39 | | Lin Pingguo | Property Lease | 332,400.00 | | Nanjing Golden Eagle International Industrial Co., Ltd. | Property Lease | 247,350.00 | | Nanjing Ailong Commercial Management Co., Ltd. | Property Lease | 159,600.00 | | Ma Jikuan | Property Lease | 104,123.40 | | Xiuzheng Pharmaceutical Group Co., Ltd. | Property Lease | 38,871.95 | | 265 DAVIDSON AVE LLC | Property Lease | 379,430.83 | | Su Yan | Property Lease | 90,000.00 | | Total | / | 3,960,874.57 | - The company and its subsidiaries provided guarantees for the wholly-owned subsidiary Chengdu Chipscreen Pharmaceutical Co., Ltd., with a total guarantee balance for the subsidiary of 300,000,000.00 yuan at the end of the reporting period[121][122] - The total guarantee amount accounted for 18.13% of the company's net assets[122] Explanation of Progress in Use of Raised Funds The company's initial public offering raised a total of 1.022 billion yuan, with a net amount of 945 million yuan after deducting issuance expenses; the committed investment totaled 804 million yuan, with cumulative investment reaching 924 million yuan by the end of the reporting period, representing a 97.77% investment progress. The convertible bond issuance raised a total of 500 million yuan, with a net amount of 485 million yuan; the committed investment totaled 485 million yuan, with cumulative investment reaching 305 million yuan, representing a 62.89% investment progress. During the reporting period, the company adjusted its convertible bond investment projects, reallocating some production facilities for Chiglitazar capacity expansion Overall Use of Raised Funds | Source of Raised Funds | Total Raised Funds (Yuan) | Net Raised Funds After Issuance Expenses (1) (Yuan) | Total Committed Investment of Raised Funds in Prospectus or Offering Document (2) (Yuan) | Cumulative Raised Funds Invested as of Period End (4) (Yuan) | Cumulative Investment Progress of Raised Funds as of Period End (%) (6)=(4)/(1) | Amount Invested This Year (8) (Yuan) | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Initial Public Offering | 1,021,500,000.00 | 945,188,250.00 | 803,500,000.00 | 924,114,082.12 | 97.77 | 55,550,728.45 | | Issuance of Convertible Bonds | 500,000,000.00 | 484,537,300.00 | 484,537,300.00 | 304,721,803.99 | 62.89 | 42,473,845.60 | | Total | 1,521,500,000.00 | 1,429,725,550.00 | 1,288,037,300.00 | 1,228,835,886.11 | / | 98,024,574.