Performance Summary [Business Summary](index=1&type=section&id=Business%20Summary) The company achieved significant progress in commercialization, product pipeline, and operations, with strong sales of core products Telitacicept and Disitamab Vedotin driving a **76.5% year-on-year revenue increase**, alongside key clinical trial advancements including FDA Fast Track Designation Revenue Performance for H1 2024 | Metric | H1 2024 (RMB) | H1 2023 (RMB) | YoY Growth | | :--- | :--- | :--- | :--- | | Revenue from Product Sales & R&D Services | 739.7 million | 419.1 million | 76.5% | - Core product Telitacicept (RC18) received FDA Fast Track Designation (FTD) for the treatment of primary Sjögren's Syndrome (pSS)[3](index=3&type=chunk) - Core product Disitamab Vedotin (RC48) achieved its primary endpoint in a Phase III clinical study for HER2-positive advanced breast cancer[3](index=3&type=chunk) - Investigational drug RC88 received FDA FTD for the treatment of platinum-resistant recurrent epithelial ovarian cancer and other indications[4](index=4&type=chunk) [Financial Summary](index=3&type=section&id=Financial%20Summary) For the six months ended June 30, 2024, the Group's revenue reached **RMB 739.7 million** with a gross profit of **RMB 570.4 million**, but a **49.2% increase in R&D expenses to RMB 806.2 million** led to a **11.0% expansion in pre-tax loss to RMB 780.5 million**, with cash and bank balances at **RMB 673.3 million** Key Financial Data for H1 2024 | Financial Metric | Amount (RMB) | YoY Change | | :--- | :--- | :--- | | Revenue | 739.7 million | N/A | | Gross Profit | 570.4 million | N/A | | R&D Expenses | 806.2 million | +49.2% | | Loss Before Tax | 780.5 million | +11.0% | | Loss for the Period | 780.5 million | +11.0% | | Adjusted Net Loss | 743.4 million | +12.7% | | Period-end Bank Balances & Cash | 673.3 million | N/A | Management Discussion and Analysis [Company Overview](index=4&type=section&id=Company%20Overview) The company is a fully integrated biopharmaceutical firm focused on innovative biologics discovery, development, and commercialization in autoimmune, oncology, and ophthalmology, having successfully commercialized two products, Telitacicept and Disitamab Vedotin, and built an integrated platform with over ten drug candidates - The company is positioned as a fully integrated biopharmaceutical company, focusing on three major therapeutic areas: autoimmune diseases, oncology, and ophthalmology[6](index=6&type=chunk) - The company has successfully commercialized two products: Telitacicept (Tai'ai®) and Disitamab Vedotin (Aidexi®), and possesses a product pipeline of over ten drug candidates, with seven in clinical development[6](index=6&type=chunk) [Extensive Product Pipeline](index=5&type=section&id=Extensive%20Product%20Pipeline) As of June 30, 2024, the company's extensive product pipeline spans autoimmune, oncology, and ophthalmology, with core products Telitacicept and Disitamab Vedotin undergoing clinical development for over twenty indications, alongside other candidates like RC88 and RC28 in various clinical stages, demonstrating continuous innovation - The company has over ten drug candidates, with seven in clinical development, targeting more than twenty indications[6](index=6&type=chunk) Key Pipeline Products and Progress | Candidate Drug | Target | Indications (Partial) | Development Stage | | :--- | :--- | :--- | :--- | | Telitacicept (RC18) | BLyS/APRIL | Neuromyelitis Optica, IgG4-Related Disease, etc. | Pivotal/Phase III, Commercialized | | Disitamab Vedotin (RC48) | HER2 | Urothelial Carcinoma, Breast Cancer, Gastric Cancer | Pivotal/Phase III, Commercialized | | RC88 | Mesothelin | Ovarian Cancer, Various Solid Tumors | Phase I/II | | RC28 | VEGF/FGF | Wet Age-related Macular Degeneration, Diabetic Macular Edema | Phase III | [Business Review](index=6&type=section&id=Business%20Review) During the reporting period, the company achieved significant business progress, with core products Telitacicept and Disitamab Vedotin showing positive clinical trial results and regulatory approvals across multiple indications, while ophthalmology drug RC28-E's Phase III study advanced steadily, and other early-stage pipeline products like RC88 demonstrated promising potential [Telitacicept (RC18, Tai'ai®)](index=6&type=section&id=Telitacicept%20(RC18,%20Tai%27ai%C2%AE)) Telitacicept (RC18) demonstrated rapid clinical development progress across multiple autoimmune diseases, with its rheumatoid arthritis (RA) indication approved in China post-period, and key advancements in Phase III trials for primary Sjögren's Syndrome (pSS) and generalized Myasthenia Gravis (gMG), securing FDA Fast Track or Orphan Drug Designations, highlighting its global market potential - In July 2024, Telitacicept was approved for the treatment of rheumatoid arthritis (RA) in China[11](index=11&type=chunk) - For primary Sjögren's Syndrome (pSS), patient enrollment for the Phase III clinical trial in China has been completed, and it received FDA Fast Track Designation (FTD) in March 2024[13](index=13&type=chunk) - For generalized Myasthenia Gravis (gMG), the Phase III clinical trial in China met its primary endpoint, and the first patient was enrolled in the global multi-center Phase III clinical study in the US[14](index=14&type=chunk) [Disitamab Vedotin (RC48, Aidexi®)](index=8&type=section&id=Disitamab%20Vedotin%20(RC48,%20Aidexi%C2%AE)) Disitamab Vedotin (RC48), China's first approved domestic ADC, continues to achieve breakthroughs in treating various HER2-expressing solid tumors, with its Phase III trial for HER2-positive advanced breast cancer with liver metastasis meeting its primary endpoint, and combination studies with PD-1 antibodies for urothelial and gastric cancers showing encouraging efficacy, while global collaboration with Seagen/Pfizer progresses with ongoing international clinical trials - The Phase III clinical trial for HER2-positive advanced breast cancer with liver metastasis achieved positive results, meeting its primary endpoint[20](index=20&type=chunk) - Patient enrollment for the Phase III clinical trial of Disitamab Vedotin combined with a PD-1 antibody as first-line treatment for advanced urothelial carcinoma has been completed[18](index=18&type=chunk) - Global collaboration with Seagen/Pfizer is progressing well, with Seagen conducting a pivotal Phase II clinical trial in the US evaluating Disitamab Vedotin for urothelial carcinoma[21](index=21&type=chunk)[22](index=22&type=chunk) [RC28-E](index=12&type=section&id=RC28-E) RC28-E, a novel VEGF and FGF-targeting fusion protein for ophthalmic diseases, has published positive Ib clinical data for wet Age-related Macular Degeneration (wAMD) in an international journal, demonstrating good safety and efficacy, with its Phase III study initiated in China, and patient recruitment completed for the Phase III trial in Diabetic Macular Edema (DME) - Ib clinical study results for wet Age-related Macular Degeneration (wAMD) were published in an international journal, showing good safety and efficacy, with its Phase III clinical study initiated in China[24](index=24&type=chunk) - Patient recruitment for the Phase III clinical trial of RC28-E for Diabetic Macular Edema (DME) has been completed[25](index=25&type=chunk) [Other Clinical Stage Drug Candidates](index=13&type=section&id=Other%20Clinical%20Stage%20Drug%20Candidates) The company actively advances clinical development for other innovative drugs, with RC88 (mesothelin-targeting ADC) progressing well in Phase II trials for ovarian cancer and other solid tumors, and first patient enrollments achieved for multiple Phase I candidates including RC148 (PD-1/VEGF bispecific antibody), RC198 (IL-15/IL-15Rα fusion protein), and RC248 (DR5-targeting ADC), showcasing a rich early-stage R&D pipeline - RC88 (mesothelin-targeting ADC) is progressing well in its Phase II clinical trial for platinum-resistant recurrent ovarian cancer and other indications[26](index=26&type=chunk) - First patient enrollments have been achieved for Phase I clinical programs including RC148 (PD-1/VEGF bispecific antibody), RC198 (IL-15 fusion protein), and RC248 (DR5-targeting ADC)[27](index=27&type=chunk) [Commercialization Progress](index=15&type=section&id=Commercialization%20Progress) The company established two independent sales teams for autoimmune and oncology products, significantly enhancing market access as core products Telitacicept and Disitamab Vedotin were included in the National Medical Insurance Drug List, with Telitacicept gaining access to over **900 hospitals** and Disitamab Vedotin to over **700 hospitals** by June 30, 2024, demonstrating effective commercialization - The company has established two independent sales teams for autoimmune and oncology fields, responsible for product commercialization[28](index=28&type=chunk) Core Product Hospital Access (As of June 30, 2024) | Product | Number of Hospitals Accessed | | :--- | :--- | | Telitacicept | Over 900 | | Disitamab Vedotin | Over 700 | - Both core products have been included in the National Medical Insurance Drug List, significantly improving product accessibility[28](index=28&type=chunk) [Significant Events After Reporting Period](index=16&type=section&id=Significant%20Events%20After%20Reporting%20Period) Post-reporting period, the company achieved several key milestones, including Telitacicept's rheumatoid arthritis (RA) indication approval in China, its generalized Myasthenia Gravis (gMG) China Phase III trial meeting its primary endpoint, and the first patient enrolled in its global Phase III trial in the US, alongside Disitamab Vedotin's Phase III trial with PD-1 for advanced urothelial carcinoma completing patient enrollment, further solidifying the late-stage pipeline value - In July 2024, Telitacicept was approved for the treatment of rheumatoid arthritis (RA) in China[29](index=29&type=chunk) - In August 2024, Telitacicept's China Phase III clinical trial for generalized Myasthenia Gravis (gMG) met its primary endpoint, and the first patient was enrolled in its global Phase III clinical trial in the US[29](index=29&type=chunk) - In August 2024, patient enrollment for Disitamab Vedotin combined with PD-1 as first-line treatment for advanced urothelial carcinoma Phase III clinical trial was completed[29](index=29&type=chunk) [Future Development](index=16&type=section&id=Future%20Development) The company aims to become a world-class biopharmaceutical leader, continuing to advance the commercialization of Telitacicept and Disitamab Vedotin in China and accelerating other pipeline clinical trials in H2 2024, while internationally focusing on global clinical studies for core products, including multiple Telitacicept Phase III trials in the US, and collaborating with Pfizer/Seagen on Disitamab Vedotin's global development - Domestic Strategy: Continuously advance the commercialization of Telitacicept and Disitamab Vedotin, and accelerate clinical trials for other investigational products[30](index=30&type=chunk) - International Strategy: Accelerate international clinical research for core products, especially Telitacicept's Phase III clinical trials in the US, and collaborate with Pfizer/Seagen to advance the global development of Disitamab Vedotin[30](index=30&type=chunk) Financial Review [Operating Performance Analysis](index=17&type=section&id=Operating%20Performance%20Analysis) In H1 2024, the company's revenue grew **76.5% year-on-year to RMB 739.7 million** due to strong core product sales, but total expenses significantly increased, with R&D expenses rising **49.2% to RMB 806.2 million** and sales and distribution expenses increasing **11.3% to RMB 389.7 million**, alongside higher finance costs, resulting in a **loss for the period expanding from RMB 703.4 million to RMB 780.5 million** Key Income Statement Item Changes for H1 2024 | Item | H1 2024 (RMB) | H1 2023 (RMB) | Reason for Change | | :--- | :--- | :--- | :--- | | Revenue | 739.7 million | 419.1 million | Strong growth in core product sales | | Sales and Distribution Expenses | 389.7 million | 350.2 million | Increased team building and promotional investment | | Administrative Expenses | 155.2 million | 168.6 million | Slight decrease | | R&D Expenses | 806.2 million | 540.5 million | Increased clinical trial expenses (especially overseas) | | Finance Costs | 31.9 million | 6.0 million | Increased interest on bank borrowings and bill discounts | | Loss for the Period | 780.5 million | 703.4 million | R&D and other expenses grew faster than revenue | - The increase in R&D expenses was primarily driven by clinical trial expenses (an increase of **RMB 120.2 million**), raw material expenses (an increase of **RMB 62.2 million**), and employee benefit expenses (an increase of **RMB 33.5 million**)[34](index=34&type=chunk)[35](index=35&type=chunk) [Liquidity and Capital Resources](index=20&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2024, the company's cash and cash equivalents decreased to **RMB 673.3 million** from **RMB 726.6 million** at year-end 2023, primarily used for daily operations, while total interest-bearing bank and other borrowings reached **RMB 2.2745 billion**, and the debt-to-asset ratio rose from **37.8% to 53.7%**, reflecting increased debt financing to support R&D and operations Key Financial Position Indicators | Indicator | June 30, 2024 (RMB) | December 31, 2023 (RMB) | | :--- | :--- | :--- | | Cash and Cash Equivalents | 673.3 million | 726.6 million | | Interest-bearing Bank and Other Borrowings | 2.2745 billion | N/A | | Debt-to-Asset Ratio | 53.7% | 37.8% | - Net cash used in operating activities during the reporting period was **RMB 826.3 million**, primarily funding R&D expenses[40](index=40&type=chunk) Financial Statements [Interim Condensed Consolidated Statement of Profit or Loss](index=23&type=section&id=Interim%20Condensed%20Consolidated%20Statement%20of%20Profit%20or%20Loss) For the six months ended June 30, 2024, the company reported revenue of **RMB 739.7 million**, a **76.5% increase** from **RMB 419.1 million** in the prior year, with gross profit at **RMB 570.4 million**, but high R&D costs (**RMB 806.2 million**) and sales and distribution expenses (**RMB 389.7 million**) led to a pre-tax loss of **RMB 780.5 million**, expanding from **RMB 703.4 million** in the previous period H1 2024 Statement of Profit or Loss Summary | Item (Thousand RMB) | H1 2024 (Unaudited) | H1 2023 (Unaudited) | | :--- | :--- | :--- | | Revenue | 739,656 | 419,073 | | Gross Profit | 570,385 | 316,418 | | R&D Costs | (806,233) | (540,453) | | Loss Before Tax | (780,460) | (703,362) | | Loss for the Period | (780,460) | (703,362) | [Interim Condensed Consolidated Statement of Financial Position](index=25&type=section&id=Interim%20Condensed%20Consolidated%20Statement%20of%20Financial%20Position) As of June 30, 2024, the company's total assets were **RMB 5.7545 billion**, total liabilities **RMB 3.0899 billion**, and net assets **RMB 2.6646 billion**, with total assets slightly decreasing and total liabilities significantly increasing from year-end 2023, primarily due to interest-bearing bank and other borrowings rising from **RMB 1.127 billion to RMB 2.2745 billion**, and net current assets decreasing from **RMB 1.0914 billion to RMB 845.5 million** Statement of Financial Position Summary (As of June 30, 2024) | Item (Thousand RMB) | June 30, 2024 (Unaudited) | December 31, 2023 (Audited) | | :--- | :--- | :--- | | Total Non-current Assets | 3,260,658 | 3,299,310 | | Total Current Assets | 2,493,879 | 2,228,933 | | **Total Assets** | **5,754,537** | **5,528,243** | | Total Current Liabilities | 1,648,428 | 1,137,541 | | Total Non-current Liabilities | 1,441,499 | 953,433 | | **Total Liabilities** | **3,089,927** | **2,090,974** | | **Net Assets** | **2,664,610** | **3,437,269** | Other Information [Corporate Governance and Compliance](index=22&type=section&id=Corporate%20Governance%20and%20Compliance) During the reporting period, the company adopted and complied with all applicable provisions of the Corporate Governance Code, with directors and supervisors confirming adherence to the standard code for securities transactions, and interim financial results reviewed by independent auditor Ernst & Young and confirmed by the audit committee to comply with accounting standards and regulations - The company complied with all applicable provisions of the Corporate Governance Code during the reporting period[46](index=46&type=chunk) - The interim financial information has been reviewed by independent auditor Ernst & Young in accordance with Hong Kong Standard on Review Engagements 2410[47](index=47&type=chunk) [Interim Dividend](index=22&type=section&id=Interim%20Dividend) The Board of Directors does not recommend the payment of an interim dividend for the six months ended June 30, 2024 - The Board of Directors does not recommend the payment of an interim dividend for 2024[48](index=48&type=chunk)

一、"聚焦经营主业，提升核心竞争力"相关措施的实施情况 报告期内，公司持续专注于主营业务的发展，不断提高自身竞争 力，并取得了一定的成效。 1、临床研发方面：公司积极推动泰它西普、维迪西妥单抗、RC88 等分子的临床研究，取得了一系列成果： （1）2024 年 7 月，泰它西普(商品名：泰爱®)新适应症上市申请 获得中国国家药品监督管理局（NMPA）批准，具体为：泰它西普与甲 氨蝶呤联合，用于对甲氨蝶呤疗效不佳的中、重度活动性类风湿关节 炎（RA）成人患者。这是泰它西普在中国获批的第 2 项适应症，其系 统性红斑狼疮适应症（SLE）已于 2021 年 3 月获批国内上市。 （2）2024 年 6 月，维迪西妥单抗(商品名：爱地希®)治疗 HER2 阳性存在肝转移的晚期乳腺癌患者的Ⅲ期临床取得阳性结果，达到主 要研究终点。 （3）2024 年 6 月，2024 年 ASCO 大会公布了 RC88 在铂耐药卵巢 癌中的临床数据，其客观缓解率取得了明显高出标准疗法的惊艳结果。 （4）2024 年 5 月，泰它西普治疗原发性干燥综合征（pSS）的国 内Ⅲ期临床试验已完成全部患者入组。 荣昌生物制药（烟台）股份有限公司 ...

R&D Investment and Product Development - The company is committed to maintaining a significant scale of R&D investment for ongoing product clinical research and global trials, which may lead to increased short-term losses[4]. - The company is actively developing a pipeline of innovative therapies across multiple disease treatment areas[4]. - The company is focused on developing innovative biopharmaceuticals, particularly in the field of antibody drugs, to meet unmet clinical needs[25]. - The company reported a total R&D investment of ¥806,232,656.31, representing a 49.18% increase compared to the previous year[50]. - The company has established three core technology platforms with independent intellectual property rights, enhancing its drug discovery and development capabilities[42]. - The company is actively preparing for clinical trials for several dual/multi-specific antibodies targeting various diseases, including tumors and autoimmune conditions[43]. - The company is focused on increasing research and development investment to enhance its competitive edge in the market[123]. Financial Performance - The company's operating revenue for the first half of the year reached ¥741,756,779.89, a 75.59% increase compared to ¥422,427,546.05 in the same period last year[17]. - The net profit attributable to shareholders was -¥780,459,767.69, compared to -¥703,360,797.19 in the previous year, indicating a continued loss[17]. - The total assets increased by 4.09% to ¥5,754,539,046.77 from ¥5,528,240,704.59 at the end of the previous year[18]. - The basic earnings per share for the first half of the year was -¥1.45, a decrease from -¥1.30 in the same period last year[19]. - The company's R&D investment accounted for 108.69% of operating revenue, down from 127.94% year-on-year, reflecting a 19.25% decrease[19]. - The company reported a weighted average return on equity of -25.62%, a decrease of 10.52 percentage points from -15.10% in the previous year[19]. - The company achieved a revenue of 742 million yuan in the reporting period, representing a 75.59% increase compared to 422 million yuan in the same period last year[61]. Market Position and Strategy - The company is actively pursuing market expansion strategies and new product development to enhance its competitive position in the biopharmaceutical sector[12]. - The company is exploring Taitasib for additional autoimmune diseases, including antiphospholipid syndrome and thrombocytopenia[31]. - The company plans to expand its market presence in Southeast Asia, targeting a 30% increase in market share by the end of 2025[119]. - The company is committed to maintaining a stable dividend policy, with a proposed dividend payout ratio of 40% for the fiscal year[119]. - The company is focused on expanding its commercialization efforts for multiple indications and products, aiming to improve its financial performance and achieve profitability[68]. Clinical Trials and Approvals - The product "Taitasip" (RC18) received full approval in China for the treatment of systemic lupus erythematosus, following conditional approval in November 2023[26]. - The company is involved in clinical trial management through Site Management Organizations (SMOs) to enhance trial quality and compliance with regulations[11]. - The company’s ADC drug, RC48, has received dual breakthrough therapy designation from both the FDA and China's regulatory authority, highlighting its clinical significance[31]. - Taitasib's clinical trial for treating severe myasthenia gravis in China completed patient enrollment in 2023, with results published in a top international journal[27]. - The company plans to submit new drug applications for Taitasib in various indications, reflecting its commitment to expanding its product pipeline[31]. Financial Management and Governance - The board of directors has confirmed the authenticity, accuracy, and completeness of the semi-annual report[5]. - The company maintains transparency in its financial disclosures, with reports available on multiple financial news platforms and its official website[15]. - The company has established a dedicated EHS department to manage pollutant emissions and ensure compliance with environmental regulations[101]. - The company has committed to improving its governance structure to enhance operational efficiency and risk management[125]. - The company will utilize funds from its stock issuance to bolster its main business and capitalize on growth opportunities in the seed industry[123]. Risks and Challenges - The company has outlined various risk factors that may impact its operations and financial status in the report[4]. - The company faces risks related to market competition and potential delays in drug approval processes, which could impact future revenues[70]. - The company reported a net cash flow from operating activities of -820 million yuan, indicating reliance on external financing for working capital[72]. - The company’s financial expenses increased significantly due to higher bank loans and interest costs, with a total of 32 million yuan in financial expenses reported[75]. Shareholder and Equity Information - The company has commitments related to share lock-up periods and restrictions on share transfers, effective from March 31, 2022, until March 31, 2026[110]. - The company will automatically extend the lock-up period by six months if the closing price of A-shares falls below the issue price for a continuous period of twenty trading days[111]. - The company has established a policy to ensure that any share reductions post-lock-up will not be below the IPO price[117]. - The company reported a total of RMB 32,344,000 in related party transactions during the reporting period, with RMB 12,292,070 being the amount incurred[143]. - The company’s registered capital is CNY 544,263,003.00, with a total of 54,426,301 shares issued at a price of CNY 48.00 per share during the IPO[188].

| 证券代码：688331 | 证券简称：荣昌生物 公告编号：2024-040 | | --- | --- | | 港股代码：09995 | 港股简称：榮昌生物 | 荣昌生物制药（烟台）股份有限公司 关于 2024 年度向特定对象发行 A 股股票预案（修订稿） 披露的提示性公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 荣昌生物制药（烟台）股份有限公司（以下简称"公司"）于 2024 年 7 月 24 日召开第二届董事会第十四次会议和第二届监事会第十一次会议，审议通过了《关 于调整公司向特定对象发行股票方案的议案》《关于公司向特定对象发行股票预 案（修订稿）的议案》等相关议案，对公司 2024 年度向特定对象发行 A 股股票预 案进行了修订，相关文件于 2024 年 7 月 25 日在上海证券交易所网站 （www.sse.com.cn）披露，敬请广大投资者注意查阅。 本次向特定对象发行股票预案（修订稿）披露事项不代表审批机关对本次向 特定对象发行股票相关事项的实质性判断、确认或批准，预案所述本次向特定对 象发行 A 股股 ...

证券代码：688331 证券简称：荣昌生物 公告编号：2024-042 港股代码：09995 港股简称：榮昌生物 荣昌生物制药（烟台）股份有限公司 关于 2024 年度向特定对象发行 A 股股票 摊薄即期回报及填补措施与相关主体承诺 （修订稿）的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担法律责任。 荣昌生物制药（烟台）股份有限公司（以下简称"公司""上市公司"或"荣 昌生物"）拟向特定对象发行 A 股股票（以下简称"本次向特定对象发行股票" 或"本次发行"）。根据《国务院办公厅关于进一步加强资本市场中小投资者合法 权益保护工作的意见》（国办发[2013]110 号）《国务院关于进一步促进资本市场 健康发展的若干意见》（国发[2014]17 号）和《关于首发及再融资、重大资产重 组摊薄即期回报有关事项的指导意见》（证监会公告[2015]31 号）等法律、法规、 规章及其他规范性文件的要求，为保障中小投资者利益，公司就本次向特定对象 发行股票事项对即期回报摊薄的影响进行了分析，结合实际情况提出了具体的填 补回报措施，且相关主体对填 ...

证券代码：688331 证券简称：荣昌生物 荣昌生物制药（烟台）股份有限公司 RemeGen Co., Ltd. （中国（山东）自由贸易试验区烟台片区烟台开发区北京中路 58 号） 2024 年度向特定对象发行 A 股股票 募集资金使用的可行性分析报告 （修订稿） 二〇二四年七月 荣昌生物制药（烟台）股份有限公司 2024年度向特定对象发行A股股票 募集资金使用的可行性分析报告（修订稿） 一、本次募集资金使用计划 荣昌生物制药（烟台）股份有限公司（以下简称"荣昌生物"或"公司") 为 进一步增强公司综合竞争力，根据公司业务发展需要，拟向特定对象发行股票募 集资金总额不超过195,292.12万元（含本数），募集资金总额扣除相关发行费用后 的净额将用于投资以下项目： 单位：万元 1、项目基本情况 公司是一家具有全球化视野的创新型生物制药企业，为满足市场不断增长的 需求，推动公司创新药物的研发进程，巩固并进一步提高公司的核心竞争力，公 司及其全资子公司上海荣昌生物科技有限公司作为该项目的实施主体，拟使用募 集资金195,292.12万元用于创新药物的研究与开发，包括RC18、RC48、RC28、 RC88、RC1 ...

Investment Rating - The report maintains a "Buy" rating for the company with a target price of HKD 56.00, representing a potential upside of 86.7% from the current price of HKD 30.00 [9][10]. Core Insights - The company reported strong product sales in Q1 2024, with revenue reaching RMB 330 million, a year-on-year increase of 96.4% and a quarter-on-quarter growth of 5.4%. The net loss narrowed to RMB 350 million, down from RMB 480 million in Q4 2023, aided by a reduction in sales and R&D expenses [1][2]. - The management has guided for over 50% revenue growth for the full year 2024, with expectations of further declines in R&D and sales expense ratios. The company anticipates a funding requirement of approximately RMB 1.5 to 2 billion for the year [1][2]. - The upcoming ASCO conference will showcase 16 clinical study results, including the first human data for the mesothelin ADC RC88, which is being compared with other treatments [2]. - The company is progressing with its international expansion, with significant milestones expected in 2024, including the initiation of Phase III trials for its products [2][3]. Financial Summary - Revenue projections for the company are as follows: RMB 1.663 billion in 2024, RMB 2.503 billion in 2025, and RMB 3.728 billion in 2026, with net losses expected to gradually narrow [3][10]. - The company reported a cash balance of RMB 620 million as of Q1 2024, with an additional bank credit line of RMB 4 billion, ensuring operational sustainability until breakeven [1][2]. - The financial outlook includes a projected EBIT of RMB 821 million by 2027, indicating a path towards profitability [6][10].

Investment Rating - The report maintains a "Buy" rating for the company with a target price of HKD 37.02, indicating a potential upside of 24.2% from the current price of HKD 29.80 [2][3]. Core Insights - The company is expected to achieve a revenue of CNY 1.08 billion in 2023, representing a year-on-year growth of 40.2%. However, it is projected to incur a net loss of CNY 1.51 billion, which is an increase of 51.3% compared to the previous year [1]. - The company has seen a recovery in Q1 2024, with revenues reaching CNY 330 million, a quarter-on-quarter increase of over 13%, and a reduction in net loss by 27.4% to CNY 349 million [1]. - The company plans to initiate an A-share private placement to raise CNY 2.55 billion, aimed at supporting innovative drug research and development [1]. Summary by Sections Financial Performance - The company reported a total revenue of CNY 1.08 billion for 2023, with a year-on-year growth of 40.2%. The net loss for the year is projected at CNY 1.51 billion, which is a 51.3% increase from the previous year [1]. - In Q1 2024, the company achieved revenues of CNY 330 million, with a quarter-on-quarter growth of over 13% and a net loss reduction of 27.4% to CNY 349 million [1]. Funding and Financial Strategy - As of the end of Q1 2024, the company had CNY 620 million in cash and equivalents. It is actively seeking various financing tools to increase cash reserves, in addition to a CNY 4.4 billion loan obtained in Q1 [1]. - The company announced plans for a private placement to raise CNY 2.55 billion, which will be fully allocated to support innovative drug development [1]. Product Pipeline and Market Potential - The company is advancing its product pipeline, with multiple candidates entering Phase III clinical trials, including indications for SLE, MG, pSS, and IgAN [2]. - The company is facing a strategic decision regarding the timing of data release for its product, which could impact potential overseas licensing agreements and FDA approval [2]. - The oncology pipeline is set to present up to 16 research data points at the upcoming ASCO conference, which could provide significant insights into the company's future growth [2].

Investment Rating - The report assigns an "Buy" rating for Rongchang Biopharma (9995.HK) [3][6] Core Insights - Rongchang Biopharma is positioned as a pioneer in the domestic autoimmune and oncology sectors, with a comprehensive capability from R&D to commercialization, and is advancing multiple clinical studies overseas [7][14] - The company has successfully launched two products: VidiXimab, the first domestic ADC, and Taitasip, the first domestic biological agent for systemic lupus erythematosus (SLE) [14][24] - The report anticipates significant revenue growth, projecting revenues of 16.1 billion, 21.7 billion, and 28.9 billion CNY for 2024, 2025, and 2026 respectively [6][8] Summary by Sections Company Overview - Rongchang Biopharma was established in 2008 and focuses on discovering, developing, and commercializing innovative biopharmaceuticals targeting major diseases such as autoimmune disorders and cancer [14][18] - The company has a strong executive team with extensive experience in the pharmaceutical industry, enhancing its strategic planning and operational capabilities [18][20] Product Pipeline - The company has eight products in clinical trials, with VidiXimab and Taitasip already approved for commercialization [14][15] - Taitasip is positioned as a potential global best-in-class (BIC) and first-in-class (FIC) product for SLE, with multiple ongoing clinical studies [35][40] - VidiXimab has been recognized as the first domestic ADC and has established a partnership with Seagen for global development [24][30] Financial Projections - The report estimates revenues for VidiXimab to be 7.6 billion, 8.5 billion, and 11.7 billion CNY for 2024, 2025, and 2026 respectively [8][6] - Taitasip is projected to generate revenues of 7.6 billion, 12.4 billion, and 15.9 billion CNY over the same period [8][6] Market Potential - The report highlights the significant market potential for VidiXimab in gastric cancer and urothelial carcinoma, with a large patient base and promising early clinical data [25][30] - The global market for ADCs is expected to grow, with VidiXimab leading the way in the domestic market [24][30] Conclusion - The report concludes with a total valuation of Rongchang Biopharma at 241 billion CNY, equivalent to 265 billion HKD, supporting the "Buy" rating [6][8]

Investment Rating - The report maintains a "Hold" rating for Rongchang Biologics (9995.HK) with a target price of HKD 33 [2][4]. Core Views - The net loss for Q1 2024 was in line with expectations, with revenue reaching RMB 330 million, representing a year-on-year increase of 96.41% and a quarter-on-quarter increase of 6.6%. The net loss was RMB 349 million, up 7.8% year-on-year but down 27.4% quarter-on-quarter, primarily due to better-than-expected gross margin and lower operating expenses [2]. - The company maintains its revenue guidance for 2024, projecting a 50% year-on-year increase, driven by sales from two listed products, RC18 and RC48, both expected to grow by over 50% [2]. - The A-share private placement of RMB 2.55 billion is still pending regulatory approval, with no clear timeline for issuance. The funds will support innovative drug development [2]. - Key catalysts for 2024 include potential overseas licensing for RC18, approval for RA indications in China, and data readouts for RC48 and RC88 at the 2024 ASCO conference [2]. Financial Summary - Q1 2024 revenue was RMB 330 million, with a gross margin of 77.5%, slightly down from 4Q23 [2]. - The company expects total revenue of RMB 1.6 billion in 2024, with a projected net loss of RMB 1.39 billion [6][8]. - The financial outlook includes a significant increase in revenue from RMB 1.08 billion in 2023 to RMB 1.61 billion in 2024, with continued losses expected to decrease over the following years [6][8].