香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其 準確性或完整性亦不發表任何聲明，並明確表示概不因本公告全部或任何部份內容而產 生或因依賴該等內容而引致的任何損失承擔任何責任。 上 海 復 旦 張 江 生 物 醫 藥 股 份 有 限 公 司 Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.* 二零二二年第一季度報告 上海復旦張江生物醫藥股份有限公司（「本公司」，聯同其附屬公司，「本集團」）之董 事會（「董事會」）欣然宣佈本公司及其附屬公司截至二零二二年三月三十一日止第一季 度（「本報告期」）期間按照中國企業會計準則編製的未經審計財務資料（「第一季度報 告」）。本公告乃根據香港法例第 571 章證券及期貨條例第 XIVA 部項下內幕消息條文及 香港聯合交易所有限公司證券上市規則第 13.09(2)和第 13.10B 條的要求作出。 1 / 9 主要財務數據 | --- | --- | --- | --- | |-----------------------------------------------|---------- ...

复旦我江 FUDAN-ZHANGJIANG 上 海 復 旦 張 江 生 物 醫 藥 股 份 有 限 公 司 Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. (於中華人民共和國註冊成立的股份有限公司) (股票號碼：1349) " 僅供歲別 年報 2021 目錄 頁碼 | --- | |--------------------| | | | 公司資料 | | 五年財務摘要 | | 主席報告 | | 管理層的討論及分析 | | 董事會報告 | | 監事會報告 | | 審核委員會報告 | | 薪酬委員會報告 | | 提名委員會報告 | | 戰略委員會報告 | | 獨立非執行董事報告 | | | 2 4 6 20 33 63 66 69 71 73 75 企業管治報告 77 | --- | --- | |-------|----------------------------| | | | | | 董事、監事及高級管理層簡介 | | | 環境、社會及管治報告 | | | 獨立核數師報告 | | | 合併財務報表 | | • | 合併資產負債表 | | • | ...

Financial Performance - The company's operating revenue for 2021 reached RMB 1,140,313,088, representing a year-on-year increase of 36.76%[28]. - Net profit attributable to shareholders for 2021 was RMB 213,295,758, up 29.53% compared to the previous year[28]. - The net profit attributable to shareholders after deducting non-recurring gains and losses increased by 35.96% to RMB 173,169,675 in 2021[28]. - The net cash flow from operating activities surged by 137.96% to RMB 268,899,775 in 2021[28]. - The company's total assets at the end of 2021 were RMB 2,781,172,268, reflecting an 11.22% increase from the end of 2020[28]. - The company's revenue for the reporting period reached RMB 1,140,313,088, representing a year-on-year increase of 36.76% compared to RMB 833,802,693 in the previous year[120]. - The operating costs increased to RMB 80,955,367, up 24.91% from RMB 64,811,766, primarily due to improved sales performance[120]. - The company reported a significant increase in sales expenses, which rose by 41.12% to RMB 599,696,956, attributed to improved sales conditions and the inclusion of share-based payment expenses[120]. Research and Development - Research and development expenses accounted for 21.76% of operating revenue in 2021, an increase of 3.17 percentage points from the previous year[28]. - The total R&D investment for the year reached ¥248,153,842, a significant increase of 60.13% compared to the previous year[84]. - The proportion of R&D investment to operating revenue increased to 21.76%, up from 18.59% in the previous year, reflecting a 3.18% rise[84]. - The company has developed PEGylated liposomal doxorubicin, which has shown improved efficacy and reduced cardiac toxicity compared to traditional formulations[63]. - The company is currently conducting Phase I clinical trials for multiple innovative drug candidates, including anti-CD30 antibody conjugate DM1 and anti-Trop2 antibody conjugate SN38, both of which are at the international leading level[95]. - The company has established a gene engineering technology platform, focusing on the development of cytokine, fusion protein, monoclonal antibody, and antibody-drug conjugate products, with plans to enhance clinical research and registration for gene drugs[71]. - The company has completed bioequivalence studies for obeticholic acid, targeting a significant market in China for liver and biliary diseases, and has received clinical approval for confirmatory studies[174]. Product Development and Innovation - The company reported a significant focus on the development of anthracycline drugs, including doxorubicin, epirubicin, and pirarubicin, which are widely used for treating various malignancies[20]. - The company is engaged in the research and development of liposomal formulations, which enhance drug targeting and reduce toxicity[20]. - The company emphasizes the importance of bioequivalence (BE) studies to ensure that generic drugs meet the quality and efficacy standards of original drugs[20]. - The main product, Aira® (Ammonium Pentanoate), is the world's first photodynamic drug for treating genital warts, significantly reducing recurrence rates compared to traditional therapies[41]. - The company launched Aira® in 2007, which has been included in clinical treatment guidelines and textbooks since 2013, highlighting its effectiveness in treating subclinical and latent infections[42]. - The company introduced Revmeda® (Heimofen) in 2017, the first photodynamic drug for treating port-wine stains, showing high cure rates and low recurrence compared to traditional methods[43]. - The company is focusing on innovative drug development in areas such as photodynamic therapy for skin diseases and tumors, and antibody-drug conjugates for cancer treatment[159]. Market and Sales Strategy - The company employs a distribution model for sales, with its own team marketing photodynamic drugs while using a CSO for its anti-tumor product[48]. - The company’s revenue model primarily relies on sales from its pharmaceutical products, with a focus on self-developed products[45]. - The company is focusing on academic promotion as a primary marketing strategy, utilizing a WeChat platform for clinical communication and case sharing[115]. - The company is actively pursuing the internationalization of its core products, particularly through the successful registration of Heimofen in the U.S. market[87]. - The company is exploring new sales models through its WeChat platform, which facilitates academic exchanges among dermatologists and addresses common issues faced by patients[100]. Corporate Governance and Compliance - The company has received a standard unqualified audit report from PwC Zhong Tian[8]. - The company has not reported any non-operating fund occupation by controlling shareholders or related parties[12]. - The company has not reported any violations of decision-making procedures for external guarantees[12]. - The company is committed to maintaining a transparent and accountable management structure to protect shareholder interests[49]. - The company has not ventured into new industries, new business models, or new formats during the reporting period[68]. Risks and Challenges - The company faces risks related to the lengthy and costly drug development process, which can take over ten years and involves significant uncertainty[105]. - The company is at risk of losing core technical personnel, which could impact its competitive advantage and stability in R&D and production services[106]. - The company faced risks related to potential declines in sales revenue and net profit due to competitive bidding outcomes for its drugs[155]. - The company is exposed to product concentration risk, as its main products are subject to competition and regulatory changes[108]. - The company faces risks related to a lack of actual controlling shareholder, which may affect governance and decision-making efficiency[107]. Investment and Financial Position - The investment cash flow net amount was negative at RMB -355,671,109, primarily due to capital contributions and equity transfer payments totaling RMB 266 million[123]. - The company has made a significant equity investment of RMB 325 million, reflecting a growth of 430.13%[199]. - The company acquired a 39.5663% stake in Shanghai Handu through an investment of RMB 266 million during the reporting period[200]. - Long-term equity investments surged by 430.13% to 325,816,669, representing 11.72% of total assets[143]. - The company has overseas assets totaling 15,038,439, which accounts for 0.54% of total assets[146].

Financial Performance - The company's operating revenue for Q3 2021 was ¥299,076,861, representing a year-on-year increase of 14.77%[6] - The net profit attributable to shareholders for the same period was ¥53,128,822, a decrease of 4.73% compared to the previous year[6] - The net profit attributable to shareholders after deducting non-recurring gains and losses was ¥47,320,806, showing a slight decrease of 0.56% year-on-year[6] - Total operating revenue for Q3 2021 reached 698,113,963, a 40.7% increase from 496,213,149 in the same period of 2020[40] - Net profit for Q3 2021 was 117,926,892, compared to 84,859,395 in Q3 2020, representing a 38.9% growth[42] - Earnings per share for Q3 2021 were 0.11, an increase from 0.09 in Q3 2020[45] - The company reported a total comprehensive income of 116,165,685 for Q3 2021, compared to 84,776,793 in Q3 2020, reflecting a 37.0% increase[45] Research and Development - The total R&D investment for Q3 2021 was ¥70,765,888, an increase of 41.05% compared to the same period last year[8] - R&D investment accounted for 23.66% of operating revenue in Q3 2021, an increase of 4.41 percentage points year-on-year[8] - Research and development expenses for Q3 2021 totaled 159,207,486, up from 102,365,503 in Q3 2020, indicating a 55.4% increase[40] - The company plans to invest a total of RMB 60,000,000 in the construction of a second-phase pharmaceutical production base to support future R&D projects[26] Cash Flow and Liquidity - The net cash flow from operating activities for the year-to-date period was ¥147,058,878, reflecting a significant increase of 662.49%[8] - Operating cash inflow for the first three quarters of 2021 reached RMB 775,540,672, a 40% increase from RMB 553,608,496 in the same period of 2020[48] - Cash and cash equivalents at the end of the period stood at RMB 919,497,196, down from RMB 1,416,742,573 at the end of the previous year[51] - The company reported a decrease in cash paid to employees to RMB 112,130,627 from RMB 119,862,895, reflecting a 6% reduction[48] - The net cash flow from financing activities was -RMB 88,889,372, a significant decrease from RMB 855,952,866 in the previous year[51] Assets and Liabilities - The total assets at the end of the reporting period were ¥2,543,080,453, a 1.69% increase from the end of the previous year[8] - The equity attributable to shareholders at the end of the reporting period was ¥2,067,806,206, up 2.83% from the previous year[8] - The company's long-term equity investments increased significantly to RMB 321,918,991 from RMB 61,459,426, marking a growth of approximately 423.5%[30] - The total current assets decreased to RMB 1,739,117,480 from RMB 2,026,574,174, reflecting a reduction of about 14.2%[30] - Total liabilities decreased slightly to RMB 411,221,966 from RMB 427,925,821, a reduction of about 3.5%[34] Inventory and Shareholder Information - The company reported an increase in inventory to RMB 40,154,851 from RMB 36,009,341, which is an increase of approximately 11.9%[30] - The number of shareholders as of the reporting period was 21,993, with 21,842 holding A shares and 151 holding H shares[22] - The company granted 32.77 million restricted shares to 258 incentive recipients at a price of RMB 8.90 per share as part of its employee stock incentive plan[25]

[Company's Key Financial Indicators](index=2&type=section&id=%E5%85%AC%E5%8F%B8%E4%B8%BB%E8%A6%81%E8%B2%A1%E5%8B%99%E6%8C%87%E6%A8%99) H1 2021 performance significantly recovered, with revenue up **69.36%** and net profit attributable to parent up **125.20%**, driven by post-pandemic market recovery [Key Accounting Data and Financial Indicators](index=2&type=section&id=%E4%B8%80%E3%80%81%E5%85%AC%E5%8F%B8%E4%B8%BB%E8%A6%81%E6%9C%83%E8%A8%88%E6%95%B8%E6%93%9A%E5%92%8C%E8%B2%A1%E5%8B%99%E6%8C%87%E6%A8%99) H1 2021 performance significantly recovered, with revenue up **69.36%** and net profit attributable to parent up **125.20%**, driven by post-pandemic market recovery - During the reporting period, with the domestic epidemic under control, drug circulation and hospital patient visits significantly recovered, leading to improved drug sales and a **69.36%** year-on-year increase in operating revenue, with net profit attributable to shareholders of listed companies increasing by **125.20%**[6](index=6&type=chunk) 2021 H1 Key Accounting Data (RMB Yuan) | Key Accounting Data | This Reporting Period (Jan-Jun 2021) | Prior Year Period | YoY Change (%) | | :--- | :--- | :--- | :--- | | Operating Revenue | 399,037,102 | 235,614,896 | 69.36 | | Net Profit Attributable to Shareholders of Listed Companies | 65,485,448 | 29,078,874 | 125.20 | | Net Profit Attributable to Shareholders of Listed Companies (Excluding Non-recurring Items) | 54,543,664 | 10,530,619 | 417.95 | | Net Cash Flow from Operating Activities | 56,033,635 | 60,819,045 | -7.87 | 2021 H1 Key Financial Indicators | Key Financial Indicators | This Reporting Period (Jan-Jun 2021) | Prior Year Period | Change | | :--- | :--- | :--- | :--- | | Basic Earnings Per Share (RMB/share) | 0.06 | 0.03 | 100.00% | | Weighted Average Return on Net Assets (%) | 3.20 | 3.19 | Increased by 0.01 percentage points | | R&D Investment as % of Operating Revenue (%) | 26.94 | 24.15 | Increased by 2.79 percentage points | - Total non-recurring gains and losses during the reporting period amounted to **RMB 10,941,784**, primarily from interest income of **RMB 11,894,781** from structured deposits[7](index=7&type=chunk) [Management Discussion and Analysis](index=5&type=section&id=%E7%AE%A1%E7%90%86%E5%B1%A4%E8%A8%8E%E8%AB%96%E8%88%87%E5%88%86%E6%9E%90) This section reviews the company's industry, core business, R&D progress, competitive strengths, and operational performance [Industry and Main Business Overview](index=5&type=section&id=%E4%B8%80%E3%80%81%E5%91%8A%E6%9C%9F%E5%85%A7%E5%85%AC%E5%8F%B8%E6%89%80%E5%B1%AC%E8%A1%8C%E6%A5%AD%E5%8F%8A%E4%B8%BB%E7%87%9F%E6%A5%AD%E5%8B%99%E6%83%85%E6%B3%81%E8%AA%AA%E6%98%8E) The company specializes in biopharmaceutical R&D, production, and sales, with core revenue from three key products marketed via distribution - The Group is primarily engaged in the innovative research and development, manufacturing, and marketing of biopharmaceuticals, with main business revenue primarily derived from the sales of pharmaceutical products[9](index=9&type=chunk)[19](index=19&type=chunk) - The Group's main products currently on sale include dermatological products Aila® (aminolevulinic acid hydrochloride for external use) and Fumeida® (haematoporphyrin for injection), and the anti-tumor product Libaoduo® (pegylated liposomal doxorubicin hydrochloride for injection)[16](index=16&type=chunk)[17](index=17&type=chunk)[18](index=18&type=chunk) - The Group adopts a distribution sales model, with photodynamic drugs Aila® and Fumeida® marketed by its own team, while the anti-tumor drug Libaoduo® is marketed through a CSO (Contract Sales Organization)[22](index=22&type=chunk) [Core Technologies and R&D Progress](index=8&type=section&id=%E4%BA%8C%E3%80%81%E6%A0%B8%E5%BF%83%E6%8A%80%E8%A1%93%E8%88%87%E7%A0%94%E7%99%BC%E9%80%B2%E5%B1%95) The company leverages four core technology platforms, investing **RMB 107.50 million** in R&D, with significant progress in ADC and new photodynamic drug indications - The company has formed four core technology platforms: gene engineering, photodynamic, nanotechnology, and oral solid preparation technology platforms, all developed independently[23](index=23&type=chunk) 2021 H1 R&D Investment (RMB Yuan) | Item | Current Period | Prior Period | Change (%) | | :--- | :--- | :--- | :--- | | Total R&D Investment | 107,503,707 | 56,903,236 | 88.92 | | R&D Investment as % of Operating Revenue (%) | 26.94 | 24.15 | Increased by 2.79 percentage points | | Capitalized R&D Investment as % | 8.59 | 4.45 | Increased by 4.14 percentage points | - Significant R&D achievements during the reporting period include: - Parecoxib Sodium for Injection obtained a Drug Registration Certificate[29](index=29&type=chunk) - Obeticholic Acid project received a Drug Clinical Trial Approval Notice[29](index=29&type=chunk) - Anti-Trop2 Antibody-Drug Conjugate (FDA018 for injection) received a Drug Clinical Trial Approval Notice[29](index=29&type=chunk) - The number of R&D personnel increased from **99** people to **127** people, raising their proportion of total company staff from **16.02%** to **18.22%**[35](index=35&type=chunk) [Core Competitiveness Analysis](index=14&type=section&id=%E4%B8%89%E3%80%81%E5%91%8A%E6%9C%9F%E5%85%A7%E6%A0%B8%E5%BF%83%E7%AB%B6%E7%88%AD%E5%8A%9B%E5%88%86%E6%9E%90) The company's strengths lie in R&D innovation, diverse technology platforms, market promotion, quality control, and a robust management team - The company's core competitiveness is based on an R&D orientation that addresses unmet clinical needs, with listed and pipeline projects less affected by policy changes[36](index=36&type=chunk) Core Technology Platforms and Pipeline Project Progress | Technology Platform | Project Name | Proposed Indication | Progress Achieved | | :--- | :--- | :--- | :--- | | Gene Engineering Technology | Anti-CD30 Antibody-Drug Conjugate | Oncology | Phase I Clinical Study | | | Anti-Trop2 Antibody-Drug Conjugate | Oncology | Phase I Clinical Study | | Photodynamic Technology | Haemoporfin | Port-wine Stains | Phase IV Clinical Study/US Registration in progress | | | Aminolevulinic Acid Hydrochloride | HPV-infected Cervical Diseases | Phase II Clinical Study | | | Aminolevulinic Acid Hydrochloride | Acne | Phase II Clinical Study | | Nanotechnology | Doxorubicin Hydrochloride Liposome | Oncology | Domestic Consistency Evaluation and US Registration in progress | | Oral Solid Preparation | JAK1 Inhibitor | Rheumatoid Arthritis | Phase I Clinical Study | | | Obeticholic Acid | Hepatobiliary Diseases | Confirmatory Clinical Study | - The company adheres to academic promotion as its primary marketing strategy and has established an online service system for doctor academic exchange and doctor-patient interaction using new media platforms like WeChat official accounts[39](index=39&type=chunk) [Discussion and Analysis of Operating Performance](index=17&type=section&id=%E5%9B%9B%E3%80%81%E7%B6%93%E7%91%86%E6%83%85%E6%B3%81%E7%9A%84%E8%A8%8E%E8%AB%96%E8%88%87%E5%88%86%E6%9E%90) Operating revenue rebounded to **RMB 399 million**, up **69.36%** YoY, with core products contributing **99.6%** of sales - During the reporting period, the company achieved operating revenue of **RMB 399 million**, a year-on-year increase of **69.36%**[42](index=42&type=chunk) - The three core products, Aila® (for condyloma acuminata), Libaoduo® (for oncology), and Fumeida® (for port-wine stains), contributed **99.6%** to pharmaceutical product sales revenue[42](index=42&type=chunk) [Risk Factors](index=17&type=section&id=%E4%BA%94%E3%80%81%E9%A2%A8%E9%9A%AA%E5%9B%A0%E7%B4%A0) Key risks include long R&D cycles, product concentration, competition, policy changes, and potential loss of core technical personnel - New drug R&D involves long cycles, high costs, and significant uncertainty, and failure to successfully develop or obtain approval for pipeline products would result in losses on prior investments[43](index=43&type=chunk) - The company's product portfolio is relatively concentrated, with Aila®, Libaoduo®, and Fumeida® accounting for a large proportion of total revenue, exposing it to competitive pressures and drug price reduction risks[44](index=44&type=chunk)[45](index=45&type=chunk) - The stability of core technical personnel is crucial for the company, and their loss could adversely affect its core competitiveness and sustained profitability[46](index=46&type=chunk) [Key Operating Performance](index=19&type=section&id=%E5%85%AD%E3%80%81%E5%91%8A%E6%9C%9F%E5%85%A7%E4%B8%BB%E8%A6%81%E7%B6%93%E7%91%86%E6%83%85%E6%B3%81) H1 2021 saw full operational recovery, **69.36%** revenue growth, increased expenses, and significant investment in Shanghai Handu - Looking ahead, the company will continue to focus R&D resources on ADC drugs, photodynamic drugs, small molecule targeted drugs (such as JAK1 inhibitors), and nanomedicines, and plans to venture into neurological slow-release drugs and explore gene therapy[50](index=50&type=chunk)[51](index=51&type=chunk)[52](index=52&type=chunk) Financial Statement Item Variation Analysis (RMB Yuan) | Item | Current Period | Prior Year Period | Change (%) | Main Reason | | :--- | :--- | :--- | :--- | :--- | | Operating Revenue | 399,037,102 | 235,614,896 | 69.36 | Sales rebound after pandemic control | | Selling Expenses | 184,117,626 | 117,516,961 | 56.67 | Increased with sales growth | | R&D Expenses | 98,267,565 | 54,373,006 | 80.73 | Increased R&D project investment | | Net Cash Flow from Investing Activities | -295,770,820 | -32,205,077 | 818.40 | Payment for capital injection and equity acquisition in Shanghai Handu | | Net Cash Flow from Financing Activities | -38,726,106 | 923,837,507 | -104.19 | Prior period included bank loans and A-share issuance proceeds | - During the reporting period, the company invested **RMB 266 million** to increase capital and acquire a total of **39.5663%** equity in Shanghai Handu, leading to a **428.13%** increase in long-term equity investments[62](index=62&type=chunk)[63](index=63&type=chunk) [Corporate Governance](index=29&type=section&id=%E5%85%AC%E5%8F%B8%E6%B2%BB%E7%90%86) This section details the company's shareholder meetings, equity incentive plans, and overall governance structure [Shareholder Meeting Information](index=29&type=section&id=%E4%B8%80%E3%80%81%E8%82%A1%E6%9D%B1%E5%A4%A7%E6%9C%83%E6%83%85%E6%B3%81%E7%B0%A1%E4%BB%8B) The company held its 2020 AGM and A/H Share Class Meetings, approving the annual report, profit distribution, and H-share repurchase - The company held a general meeting of shareholders on May 27, 2021, approving various proposals including the "Company's 2021 Restricted Share Incentive Plan (Draft)" and a general mandate to the Board of Directors to repurchase H shares[70](index=70&type=chunk)[72](index=72&type=chunk) [Equity Incentive Plan](index=31&type=section&id=%E5%9B%9B%E3%80%81%E5%85%AC%E5%8F%B8%E8%82%A1%E6%AC%8A%E6%BF%80%E5%8B%B5%E8%A8%88%E5%8A%83) The company adopted a 2021 restricted share incentive plan, granting **32.77 million** shares to **258** grantees at **RMB 8.90** per share - The company adopted the 2021 Restricted Share Incentive Plan, proposing to grant **38 million** shares, accounting for approximately **3.64%** of the total share capital[75](index=75&type=chunk) - On July 22, 2021, the company initially granted **32.77 million** restricted shares to **258** grantees at a grant price of **RMB 8.90** per share[75](index=75&type=chunk)[76](index=76&type=chunk) [Environmental and Social Responsibility](index=34&type=section&id=%E7%92%B0%E5%A2%83%E8%88%87%E7%A4%BE%E6%9C%83%E8%B2%AC%E4%BB%BB) The company prioritizes environmental protection through strict waste treatment, energy-saving measures, and social contributions [Environmental Information](index=34&type=section&id=%E4%B8%80%E3%80%81%E7%92%B0%E5%A2%83%E4%BF%A1%E6%81%AF%E6%83%85%E6%B3%81) The company maintains strict environmental management, ensuring compliant waste treatment and promoting energy efficiency, with no reported violations - The company strictly processes wastewater, exhaust gas, and waste generated during production in accordance with national and local standards, and engages qualified entities for regular monitoring, with no related violations reported during the period[79](index=79&type=chunk) - The company formulated the "Energy and Resource Management Procedure" and implemented energy-saving and emission reduction measures through energy performance management and the renovation of water production equipment for waste heat utilization[82](index=82&type=chunk) - During the reporting period, the company donated **RMB 100,000** to the Gongshan Education Foundation in Nanjiang County, Bazhong City, Sichuan Province, to establish scholarships and grants supporting rural education revitalization[83](index=83&type=chunk) [Significant Matters](index=37&type=section&id=%E9%87%8D%E8%A6%81%E4%BA%8B%E9%A0%85) This section covers the fulfillment of commitments made during the A-share IPO and the progress of raised funds utilization [Fulfillment of Commitments](index=37&type=section&id=%E4%B8%80%E3%80%81%E6%89%BF%E8%AB%BE%E4%BA%8B%E9%A0%85%E5%B1%A5%E8%A1%8C%E6%83%85%E6%B3%81) The company and major shareholders strictly fulfilled all A-share IPO commitments, including share lock-up and avoiding competition - Major shareholders including Shanghai Pharma, Xinqi Phase II, Yang Zongmeng, and Chairman Wang Haibo all committed to a **36 months** lock-up period from the date of A-share listing[84](index=84&type=chunk)[85](index=85&type=chunk) - Major shareholders such as Shanghai Pharma committed to avoiding horizontal competition, regulating related-party transactions, and made prudent arrangements for share reductions after the lock-up period expires[89](index=89&type=chunk)[90](index=90&type=chunk)[93](index=93&type=chunk) [Progress of Raised Funds Utilization](index=61&type=section&id=%E5%8D%81%E4%BA%8C%E3%80%81%E5%8B%9F%E9%9B%86%E8%B3%87%E9%87%91%E4%BD%BF%E7%94%A8%E9%80%B2%E5%B1%95%E8%AA%AA%E6%98%8E) As of June 30, 2021, **RMB 393 million** of A-share raised funds were used for key projects, with **RMB 96 million** over-raised funds for working capital Utilization of Raised Funds (As of June 30, 2021, RMB 10,000) | Planned Project | Budgeted Amount | Amount Used | Remaining Amount | | :--- | :--- | :--- | :--- | | Haemoporfin US Registration Project | 23,000.00 | 2,032.02 | 20,967.98 | | Biopharmaceutical Innovation R&D and Sustainable Development Project | 24,000.00 | 9,827.46 | 14,172.54 | | Acquisition of Minority Equity in Taizhou Fudan-Zhangjiang Project | 18,000.00 | 17,839.30 | 160.70 | | Over-raised Funds | – | 9,600.00 | 22,832.39 | | **Total** | **65,000.00** | **39,298.78** | **60,155.90** | [Share Changes and Shareholder Information](index=63&type=section&id=%E8%82%A1%E4%BB%BD%E8%AE%8A%E5%8B%95%E5%8F%8A%E8%82%A1%E6%9D%B1%E6%83%85%E6%B3%81) This section details changes in share capital and provides an overview of the company's shareholder structure [Share Capital Changes](index=63&type=section&id=%E4%B8%80%E3%80%81%E8%82%A1%E6%9C%AC%E8%AE%8A%E5%8B%95%E6%83%85%E6%B3%81) Total share capital remained stable, but **167,577,060** restricted shares became tradable, altering the proportion of restricted vs. unrestricted shares - On June 21, 2021, a portion of the company's initially issued restricted shares, totaling **167,577,060** shares, became tradable after a **12 months** lock-up period[130](index=130&type=chunk) - After the reporting period, the company implemented an H-share repurchase, cumulatively repurchasing **1,469,000** shares, which, if cancelled, would slightly reduce total share capital and positively impact EPS and net assets per share[130](index=130&type=chunk) [Shareholder Information](index=66&type=section&id=%E4%BA%8C%E3%80%81%E8%82%A1%E6%9D%B1%E6%83%85%E6%B3%81) As of the reporting period end, the company had **21,885** shareholders, with HKSCC NOMINEES LIMITED, Shanghai Pharma, and Xinqi Phase II as top holders - As of the end of the reporting period, the company had a total of **21,885** ordinary shareholders, comprising **21,736** A-share holders and **149** H-share holders[132](index=132&type=chunk) Top Five Shareholders' Holdings (As of June 30, 2021) | Shareholder Name | Number of Shares Held at Period End | Proportion (%) | | :--- | :--- | :--- | | HKSCC NOMINEES LIMITED | 241,867,900 | 23.19 | | Shanghai Pharma Group Co., Ltd. | 210,142,560 | 20.15 | | Xinqi Phase II Venture Capital Enterprise | 156,892,912 | 15.04 | | Yang Zongmeng | 80,000,000 | 7.67 | | Wang Haibo | 57,886,430 | 5.55 | [Financial Statements](index=78&type=section&id=%E8%B2%A1%E5%8B%99%E5%A0%B1%E8%A1%A8) This section presents the company's consolidated balance sheet, income statement, and cash flow statement [Consolidated Balance Sheet](index=78&type=section&id=%E5%90%88%E4%BD%B5%E8%B3%87%E7%94%A2%E8%B2%A0%E5%82%B5%E8%A1%A8) As of June 30, 2021, total assets were **RMB 2.479 billion**, with a slight decrease from year-end, while equity attributable to parent company shareholders increased Consolidated Balance Sheet Key Items (RMB Yuan) | Item | June 30, 2021 | December 31, 2020 | | :--- | :--- | :--- | | Total Assets | 2,479,272,106 | 2,500,701,037 | | Total Liabilities | 453,915,407 | 492,211,194 | | Total Equity Attributable to Parent Company Shareholders | 2,028,213,577 | 2,010,930,752 | [Consolidated Income Statement](index=82&type=section&id=%E5%90%88%E4%BD%B5%E5%88%A9%E6%BD%A4%E8%A1%A8) H1 2021 saw **RMB 399 million** in operating revenue, up **69.36%** YoY, leading to a **125.20%** increase in net profit attributable to parent company shareholders Consolidated Income Statement Key Items (RMB Yuan) | Item | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :--- | :--- | :--- | | Operating Revenue | 399,037,102 | 235,614,896 | | Operating Profit | 68,518,791 | 27,703,448 | | Total Profit | 66,786,868 | 27,996,722 | | Net Profit | 65,069,479 | 29,364,848 | | Net Profit Attributable to Parent Company Shareholders | 65,485,448 | 29,078,874 | [Consolidated Cash Flow Statement](index=85&type=section&id=%E5%90%88%E4%BD%B5%E7%8F%BE%E9%87%91%E6%B5%81%E9%87%8F%E8%A1%A8) H1 2021 operating cash flow was **RMB 56.03 million**, with significant investing cash outflow due to equity investments Consolidated Cash Flow Statement Key Items (RMB Yuan) | Item | Six Months Ended June 30, 2021 | Six Months Ended June 30, 2020 | | :--- | :--- | :--- | | Net Cash Flow from Operating Activities | 56,033,635 | 60,819,045 | | Net Cash Flow Used in Investing Activities | (295,770,820) | (32,205,077) | | Net Cash Flow (Used in)/Generated from Financing Activities | (38,726,106) | 923,837,507 | | Net (Decrease)/Increase in Cash | (278,495,510) | 952,502,846 | | Cash Balance at Period End | 1,118,394,682 | 1,529,302,256 |

Financial Performance - The company reported a total revenue of RMB 1.2 billion for the first half of 2021, representing a year-on-year increase of 15%[2]. - The net profit for the period was RMB 300 million, which is a 20% increase compared to the same period last year[2]. - The company's operating revenue for the first half of 2021 was 399,037,102 RMB, representing a year-on-year increase of 69.36% compared to 235,614,896 RMB in the same period last year[25]. - The net profit attributable to shareholders of the listed company reached 65,485,448 RMB, a significant increase of 125.20% from 29,078,874 RMB in the previous year[25]. - The net profit attributable to shareholders after deducting non-recurring gains and losses was 54,543,664 RMB, showing a remarkable growth of 417.95% compared to 10,530,619 RMB in the same period last year[25]. - The company's cash flow from operating activities was 56,033,635 RMB, a decrease of 7.87% from 60,819,045 RMB in the previous year[25]. - The total comprehensive income for the period was RMB 69,016,856, up from RMB 29,416,219 in the previous year, indicating a growth of 134%[193]. - Basic and diluted earnings per share increased to RMB 0.06, compared to RMB 0.03 in the same period last year[193]. Research and Development - Research and development expenses increased by 18%, totaling RMB 150 million, reflecting the company's commitment to innovation[2]. - The R&D investment accounted for 26.94% of the operating revenue, an increase of 2.79 percentage points from 24.15% in the previous year[25]. - The company reported a significant increase in R&D expenditures, with total R&D investment reaching approximately ¥107.5 million, an 88.92% increase compared to the previous period[61]. - The company has received 13 new patents during the reporting period, bringing the total number of patents obtained to 103[61]. - The company’s research and development strategy focuses on addressing clinical gaps and achieving differentiated competition through innovative drug development[47]. - The company is focusing on drug development based on gene engineering, photodynamic technology, nanotechnology, and oral solid preparation technology platforms[78]. Market Expansion and Product Development - The company has outlined a future outlook projecting a revenue growth of 10-15% for the second half of 2021[2]. - New product development includes the launch of a novel photodynamic therapy product, expected to enter the market by Q4 2021[2]. - The company is expanding its market presence in Southeast Asia, targeting a 30% increase in market share by the end of 2022[2]. - The company aims to expand its market presence through the development of new drugs and technologies, focusing on unmet medical needs in dermatology and oncology[36]. - The company’s flagship product, Ai La®, is the first photodynamic drug for treating genital warts, significantly reducing recurrence rates compared to traditional therapies[38]. - The company has introduced Huimeida® for the treatment of port-wine stains, which is recognized for its high cure rate and low recurrence compared to traditional laser treatments[39]. Financial Position and Investments - The total assets amounted to 2,479,272,106 RMB, which is a decrease of 0.86% compared to 2,500,701,037 RMB at the end of the previous year[25]. - The net assets attributable to shareholders at the end of the reporting period were 2,028,213,577 RMB, reflecting a slight increase of 0.86% from 2,010,930,752 RMB at the end of the previous year[25]. - The company has made a significant investment of RMB 266 million in Shanghai Handu, resulting in a 428.13% increase in its equity investment to RMB 325 million[99]. - The company has completed the construction of two production lines for the production of raw materials and injections, enhancing its industrialization capabilities[92]. - The company plans to register multiple generic drugs to utilize the production capacity of its newly built lines before obtaining production licenses for its innovative drugs[92]. Risks and Challenges - The company has identified key risks including regulatory changes and market competition, which are detailed in the risk factors section of the report[2]. - The company is facing risks related to new drug development, including high costs and long timelines, which can take over ten years[78]. - The product portfolio is relatively concentrated, with the three main products being vulnerable to competition and regulatory changes[80]. - The company is at risk of losing core technical personnel, which is crucial for maintaining its competitive edge in the industry[79]. Corporate Governance and Compliance - The company is committed to maintaining a robust management structure to ensure transparency and accountability, with no significant changes to its operational model during the reporting period[46]. - The company will continue to strictly adhere to legal requirements regarding related party transactions and ensure fair pricing and timely information disclosure[132]. - The company has established a framework for monitoring and enforcing compliance with share transfer commitments among its executives[138]. - The company emphasizes compliance with relevant laws and regulations regarding share transfers and disclosures, ensuring transparency in their operations[137]. Environmental Responsibility - The company has implemented measures to improve resource utilization and reduce pollution during production, including the use of clean energy and advanced technology[119]. - The company strictly adheres to national and local environmental standards for wastewater and emissions, with no violations reported during the reporting period[122]. - The company has established an environmental emergency response mechanism and conducts regular monitoring of wastewater and emissions by qualified testing units[119]. - The company has developed a supplier management policy to ensure compliance with environmental and social responsibilities[123].

2021 年第一季度报告 公司代码：688505 公司简称：复旦张江 上海复旦张江生物医药股份有限公司 2021 年第一季度报告 1 / 22 2021 年第一季度报告 í 二、 11Í 四、 目录 | --- | |--------------| | | | 重要提示 | | 公司基本情况 | | 重要事项 | | 附录 | 2 / 22 2021 年第一季度报告 单位：元 币种：人民币 一、 重要提示 1.1 公司董事会、监事会及董事、监事、高级管理人员保证季度报告内容的真实、准确、完整， 不存在虚假记载、误导性陈述或者重大遗漏，并承担个别和连带的法律责任。 1.2 公司全体董事出席董事会审议季度报告。 1.3 公司负责人王海波、主管会计工作负责人薛燕及会计机构负责人（会计主管人员）章雯保证 季度报告中财务报表的真实、准确、完整。 1.4 本公司第一季度报告未经审计。 二、 公司基本情况 2.1 主要财务数据 | --- | --- | --- | --- | |-----------------------------------------------|----------------|------- ...

Financial Performance - Total revenue for the year ended December 31, 2020, was RMB 833.8 million, a decrease of 19% from RMB 1,029.3 million in 2019[4] - Profit before tax for 2020 was RMB 176.7 million, down 28.2% from RMB 246.3 million in 2019[4] - The net profit attributable to shareholders for 2020 was RMB 164.7 million, a decrease of 27.6% compared to RMB 227.4 million in 2019[4] - The company reported a basic and diluted earnings per share of RMB 0.1663 for 2020, down from RMB 0.2463 in 2019[4] - The company's main business revenue for 2020 was approximately RMB 832,467,000, a decrease of 19% compared to RMB 1,028,955,000 in 2019[60] - Sales revenue from medical and diagnostic products was RMB 820,810,000, down 17.68% from RMB 997,065,000 in 2019, with major products contributing 36%, 53%, and 9% to total revenue[61] - The company confirmed technology transfer income of approximately RMB 11,500,000 in 2020, down from RMB 29,900,000 in 2019[62] - The company’s net profit margin for 2020 was 20%, down from 21% in 2019, primarily due to decreased sales revenue and increased R&D expenses[77] - The company achieved a revenue of approximately 834 million RMB in 2020, representing a year-on-year decline of 19%[103] Assets and Liabilities - The company's total assets increased to RMB 2,500.7 million in 2020, up 60% from RMB 1,564.8 million in 2019[6] - The total liabilities for 2020 were RMB 492.2 million, a decrease from RMB 631.7 million in 2019[6] Research and Development - The company emphasizes a long-term value-oriented R&D strategy, focusing on projects that meet clinical needs and demonstrate unique therapeutic effects[9] - The R&D strategy is concentrated on antibody-drug conjugates (ADCs) for tumors, photodynamic drugs for skin diseases and cervical precancerous lesions, and small molecule targeted drugs for autoimmune diseases and tumors[12] - Research and development expenses for the year 2020 amounted to RMB 139,268,000, a 9% increase from RMB 127,822,000 in 2019[68] - Total research and development investment for 2020 was RMB 154,973,000, representing a 19% increase compared to the previous year[71] - The proportion of research and development investment to operating revenue was 18.59% in 2020[71] Product Development and Innovation - The company aims to become an innovator and leader in the biopharmaceutical industry, focusing on addressing clinical treatment gaps[9] - The company is focusing on drug development in oncology, dermatology, and autoimmune diseases, while exploring new research directions in molecular targeting and immunotherapy[102] - The company has developed PEGylated doxorubicin liposome, which shows lower cardiac toxicity and improved tumor targeting compared to traditional formulations[125] - The company is actively involved in the research and development of liposomal formulations, which have shown promising results in reducing side effects associated with traditional chemotherapy[121] - The company has established a nanotechnology platform to develop lipid-based formulations, with its drug 裡葆多® launched in 2009, aiming to enhance industrialization capabilities[142] Market and Sales Strategy - The ongoing COVID-19 pandemic significantly impacted hospital operations and sales strategies, yet the company maintained normal operations[9] - The company is developing a new sales model for Fumida®, integrating direct distribution with hospitals and pharmaceutical companies[45] - The company is exploring new sales models utilizing its WeChat platform for academic promotion and interaction between doctors and patients[46] - The recovery of drug distribution and hospital patient visits has begun as the domestic pandemic is under control, but patient numbers remain significantly below normal levels[103] Corporate Governance and Shareholder Information - The board proposed a final dividend of RMB 0.05 per share for the year ending December 31, 2020, totaling approximately RMB 52,150,000[163] - The company has implemented a stable and proactive profit distribution policy since 2015, ensuring a cash dividend distribution of no less than 10% of the distributable profit each year[160] - The company maintains a diverse shareholder base, including both domestic and foreign investors[196] - The company has purchased liability insurance for directors and senior management to cover their responsibilities and risks associated with daily operations[189] Future Outlook and Strategic Initiatives - The company is positioned for long-term growth driven by factors such as aging population and increasing health awareness, despite short-term challenges from the pandemic[57] - The company plans to enhance gross profit levels while maintaining strict cost control under the current industry structure[65] - The company aims to leverage the advantages of combining vascular inhibitors with PD-1 in ADC drug development for lung and liver cancer treatments[22] - The company plans to utilize the remaining fundraising by December 31, 2023, in accordance with its development strategy[100]

Financial Performance - The company's operating revenue for 2020 was ¥833,802,693, a decrease of 18.99% compared to ¥1,029,294,769 in 2019[28]. - The net profit attributable to shareholders for 2020 was ¥164,662,782, down 27.58% from ¥227,357,983 in 2019[28]. - The net profit after deducting non-recurring gains and losses was ¥127,366,610, a decrease of 35.96% compared to ¥198,897,143 in 2019[28]. - The net cash flow from operating activities was ¥113,003,294, down 58.03% from ¥269,232,612 in 2019[28]. - The company's revenue for 2020 was RMB 833,802,693, a decrease of 18.99% compared to RMB 1,029,294,769 in the previous year[118]. - The sales revenue for the reporting period decreased by 19% compared to the previous year, with the three main products contributing 99% of total medical product sales revenue[109]. - Sales revenue from the product Aila® decreased by 35% in 2020 due to the impact of the COVID-19 pandemic[110]. - The revenue from medical products was RMB 820,810,438, accounting for 98.60% of the main business income, a decrease of 17.68% from the previous year[124]. Dividend and Capital Management - The company plans to distribute a cash dividend of RMB 0.5 per 10 shares, totaling RMB 52.15 million, which accounts for 31.67% of the net profit attributable to shareholders for 2020[7]. - The company does not plan to increase capital reserves or issue bonus shares for the year[7]. - The company's capital reserve increased by 404.68% to RMB 1.20 billion, reflecting the successful fundraising efforts[142]. R&D and Innovation - The R&D investment as a percentage of operating revenue increased to 18.59% in 2020, up 5.91 percentage points from 12.68% in 2019[28]. - The company has invested a total of CNY 154,973,280 in R&D for the year, representing an 18.75% increase compared to the previous year, with R&D expenses accounting for 18.59% of total revenue[80]. - The company is focusing on the development of Antibody-Drug Conjugates (ADC) as a key direction within its gene engineering technology platform, which has become a hotspot in targeted cancer therapy[70]. - The company has established a photodynamic technology platform that is at the forefront of the world, with ongoing projects aimed at expanding indications for existing photodynamic drugs[71]. - The company is developing a second ADC drug targeting triple-negative breast cancer, bladder cancer, and gastric cancer, with clinical research registration classified as Class 1 therapeutic biological products[160]. - The company is exploring the development of Her3-Dxd drugs and Dxd class ADCs targeting small cell lung cancer, as well as Trop2-Dxd projects for treating solid tumors like gastric and triple-negative breast cancer[162]. Market and Industry Trends - The Chinese pharmaceutical industry is experiencing continuous growth, with an increasing importance in the national economy[48]. - The demand for pharmaceuticals in China is increasing due to population growth and aging, with the population aged 65 and above rising from 144 million in 2015 to 176 million in 2019, accounting for 12.6% of the total population[61]. - The global pharmaceutical market is expected to exceed $1.5 trillion in spending by 2023, with China's annual drug expenditure growth projected to remain between 3%-6%[198]. - The pharmaceutical industry in China is undergoing significant transformation, with accelerated drug approval processes and a focus on innovation[199]. Corporate Governance and Risk Management - The company has identified significant risks in its operations, which are detailed in the report[5]. - The audit report issued by PwC confirms that the financial statements are free from material misstatements[6]. - There are no non-operating fund occupations by controlling shareholders or related parties[9]. - The company has not faced any violations in decision-making procedures regarding external guarantees[9]. - The company operates without a controlling shareholder, which may lead to governance instability and decision-making inefficiencies[104]. - The company is exposed to drug price reduction risks due to increasing competition and regulatory changes in the pharmaceutical industry[106]. Product Development and Sales Strategy - The company’s main products include innovative drugs such as Aira® and Reumida®, which address unmet medical needs in dermatology and oncology[38][41]. - The company primarily employs a distribution model for product sales, with its photodynamic therapy drugs, Aira® and Fumida®, marketed by its own team, while the anti-tumor drug Liboduo® is marketed through a contracted CSO[45]. - The company is committed to establishing a standardized and robust corporate management structure to enhance transparency and accountability, thereby protecting shareholder interests[46]. - The company is exploring new sales models leveraging its academic promotion platform to address common issues in the current marketing environment[94]. - The company is exploring new sales models utilizing its WeChat platform for academic promotion and doctor-patient interactions[114]. Impact of COVID-19 - The COVID-19 pandemic impacted the company's main business, leading to a decrease in revenue due to disruptions in drug distribution and patient visits to hospitals[30]. - The impact of COVID-19 has led to delays in resuming production and a decrease in non-epidemic related prescriptions, affecting the industry negatively in the short term[199]. Financial Health and Assets - The total assets at the end of 2020 were ¥2,500,701,037, an increase of 59.81% from ¥1,564,824,553 at the end of 2019[28]. - The net assets attributable to shareholders at the end of 2020 were ¥2,010,930,752, up 115.88% from ¥931,525,379 at the end of 2019[28]. - Cash and cash equivalents increased by 142.18% to RMB 1.40 billion, primarily due to funds raised from the initial public offering[142]. - The company’s total liabilities decreased significantly, with short-term borrowings reduced to zero from RMB 148.94 million[142]. Clinical Trials and Regulatory Approvals - The company has received clinical approval for its small molecule targeted drug JAK1 selective inhibitor and has commenced Phase I clinical trials[77]. - The company has completed Phase I clinical research for Aira in treating moderate to severe acne and is moving into Phase II trials, while also exploring painless treatment options[166]. - The company is preparing to submit clinical applications for Aira in treating photodamaged skin conditions and gliomas, with preclinical studies already completed[166]. - The company is conducting a consistency evaluation study for Liposomal Doxorubicin and is in the process of registration in the U.S.[178].

Financial Performance - Operating income decreased by 20.59% to CNY 496,213,149 for the period from January to September compared to the same period last year[18]. - Net profit attributable to shareholders decreased by 30.15% to CNY 84,847,892 for the period from January to September compared to the same period last year[18]. - Basic and diluted earnings per share decreased by 30.77% to CNY 0.09[18]. - The company reported a net profit of ¥650,545,247, compared to ¥632,910,658 in the previous period, showing a slight increase[56]. - Net profit for Q3 2020 reached ¥55,494,547, compared to ¥30,917,760 in Q3 2019, marking an increase of 79.5%[60]. - The total profit for Q3 2020 was ¥60,582,841, significantly higher than ¥31,707,875 in Q3 2019, indicating a growth of 91.1%[60]. - The total comprehensive income for Q3 2020 was ¥55,360,574, compared to ¥31,016,300 in Q3 2019, reflecting a growth of 78.6%[62]. - The total profit for the third quarter was CNY 62,546,035, compared to CNY 30,437,223 in the previous quarter, representing an increase of approximately 105.5%[66]. Assets and Liabilities - Total assets increased by 54.41% to CNY 2,416,168,482 compared to the end of the previous year[18]. - Current liabilities decreased to ¥413,364,109 from ¥551,266,597, a reduction of about 25%[53]. - Total liabilities decreased to ¥467,678,820 from ¥600,234,806, a decline of about 22%[53]. - Non-current liabilities totaled ¥54,314,711, up from ¥48,968,209, indicating an increase of about 7%[53]. - Long-term equity investments increased by 116.34% to ¥60,745,118, attributed to additional investments in a health care investment center[31]. Cash Flow - The net cash flow from operating activities decreased by 85.93% to CNY 19,286,594 for the period from January to September compared to the same period last year[18]. - The company reported a net cash flow from operating activities of ¥19,286,594, down 85.93% compared to the previous year due to reduced sales revenue[34]. - Cash inflow from investment activities totaled CNY 1,889,963,114, an increase from CNY 1,378,304,833 year-over-year[78]. - Net cash flow from investment activities was negative CNY 25,885,812, improving from negative CNY 182,196,622 in the previous year[78]. - Cash inflow from financing activities reached CNY 1,047,247,427, compared to CNY 100,000,000 in the same period last year[78]. - Net cash flow from financing activities was CNY 859,824,372, a turnaround from negative CNY 82,138,103 in the previous year[78]. Shareholder Information - The total number of shareholders reached 25,461, with 25,310 holding A shares and 151 holding H shares[28]. - Shareholders' equity increased to ¥2,079,305,632 from ¥1,087,347,148, reflecting a growth of approximately 91%[56]. Research and Development - R&D investment as a percentage of operating income increased by 5.98 percentage points to 21.58%[18]. - Research and development expenses rose by 7.41% to ¥102,365,503, reflecting increased investment in ongoing projects[34]. - Research and development expenses in Q3 2020 amounted to ¥47,992,497, representing a 8.6% increase from ¥44,109,468 in Q3 2019[57]. - Research and development expenses amounted to CNY 45,888,924, slightly up from CNY 44,222,357 in the previous quarter, reflecting a year-over-year increase of about 3.8%[66]. Market Strategy - The company plans to continue expanding its market presence and investing in new product development to drive future growth[59].