交银国际研究 消息快报 荣昌生物 (9995 HK) 泰它西普 gMG III 期数据公布，差异化竞争优势明显，维持买入 此报告最后部分的分析师披露、商业关系披露和免责声明为报告的一部分，必须阅读。 下载本公司之研究报告，可从彭博信息：BOCM 或 https://research.bocomgroup.com Ethan.Ding@bocomgroup.com (852) 3766 1834 诸葛乐懿 Gloria.Zhuge@bocomgroup.com (852) 3766 1845 丁政宁 医药 2025 年 4 月 10 日 泰它西普 gMG III 期数据优于已上市竞品：公司在美国神经病学会年会 （AAN 2025）上公布了泰它西普治疗重症肌无力（gMG）的中国内地III 期 研究结果。研究招募 114 例基线 MG-ADL 评分≥6、QMG 评分≥8 的 gMG 患 者，其中泰它西普组（皮下给药 240mg QW）和安慰剂组各 57 例，中位 MG-ADL 评分和 QMG 评分分别为 10 分/18-19 分，高于 VYVGART® III 期 ADAPT 研究中的 9 分/16 分（即泰它西普 ...

交银国际研究 消息快报 荣昌生物 (9995 HK) 泰它西普 gMG III 期数据公布，差异化竞争优势明显，维持买入 此报告最后部分的分析师披露、商业关系披露和免责声明为报告的一部分，必须阅读。 下载本公司之研究报告，可从彭博信息：BOCM 或 https://research.bocomgroup.com 丁政宁 Ethan.Ding@bocomgroup.com (852) 3766 1834 诸葛乐懿 Gloria.Zhuge@bocomgroup.com (852) 3766 1845 医药 2025 年 4 月 10 日 泰它西普 gMG III 期数据优于已上市竞品：公司在美国神经病学会年会 （AAN 2025）上公布了泰它西普治疗重症肌无力（gMG）的中国内地III 期 研究结果。研究招募 114 例基线 MG-ADL 评分≥6、QMG 评分≥8 的 gMG 患 者，其中泰它西普组（皮下给药 240mg QW）和安慰剂组各 57 例，中位 MG-ADL 评分和 QMG 评分分别为 10 分/18-19 分，高于 VYVGART® III 期 ADAPT 研究中的 9 分/16 分（即泰它西普 ...

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，概不對因本公告全部或任何部份內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 RemeGen Co., Ltd.* 榮 昌 生 物 製 藥（ 煙 台 ）股 份 有 限 公 司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：9995） 截至2024年12月31日止年度 年度業績公告 董事會欣然宣佈本公司截至2024年12月31日止年度的綜合業績，連同截至2023年 12月31日止年度的比較數字。 業務摘要 過去一年，本公司於推進商業化、產品管線及業務運營方面取得重大進展： 商業化 － 本公司截至2024年12月31日止年度的產品銷售收益約為人民幣1,699.1百萬 元，較去年同期的人民幣1,049.2百萬元增長61.9%，主要得益於自身免疫 類商業化產品泰它西普（RC18，商品名：泰愛®）及抗腫瘤類商業化產品維 迪西妥單抗（RC48，商品名：愛地希®）的強勁銷售增長帶動。 1 產品管線 泰它西普（RC18，商品名：泰愛®） 2 － 2024年3月，FDA授予泰它西普快速通 ...

Investment Rating - The report maintains a "Buy" rating for Rongchang Biologics with a target price adjusted to HKD 19.00 from HKD 21.80 [4][5][14]. Core Insights - The company is expected to see a significant increase in revenue, with a forecasted sales revenue of approximately RMB 1.715 billion for 2024, representing a year-on-year growth of nearly 60% [1]. - Shareholder net losses are projected to decrease by about RMB 410 million to approximately RMB 1.47 billion compared to the previous year [1]. - The main product, Taitasip, is anticipated to drive high revenue growth in 2024, particularly in indications such as lupus [1][2]. Revenue and Loss Forecast - Revenue forecasts for 2024-2026 have been raised by 6.1%, 2.6%, and 1.1% respectively, reflecting the company's strong sales performance [3]. - Despite an increase in sales expense forecasts, shareholder net losses are still expected to narrow year-on-year [3]. Product Development and Approvals - The company is making progress in the approval and development of new indications for its main products, Taitasip and Vidisizumab, with potential approvals expected in 2025 for several new indications [2]. - New product applications are anticipated to be submitted within the year, aligning with the company's development timeline [2]. Financial Data Summary - The financial data indicates a significant recovery trajectory, with total revenue expected to grow from RMB 768 million in 2022 to RMB 3.084 billion by 2026 [12]. - Shareholder net losses are projected to decrease from RMB 999 million in 2022 to RMB 438 million by 2026, indicating a substantial improvement in financial health [12].

Investment Rating - The report maintains a "Buy" rating for the company with a target price of HKD 23.95, indicating a potential upside of 40.7% from the current price [4]. Core Insights - The company has demonstrated significant revenue growth, achieving Q3 revenue of CNY 467 million, a year-on-year increase of 34.6% and a quarter-on-quarter increase of 13.6%. Cumulatively, revenue for the first three quarters grew by 57.1% [1]. - Cost control measures have led to a notable reduction in losses, with Q3 net loss narrowing by 32.6% to CNY 291 million. The gross margin for Q3 improved to 82.1%, up 4.1 percentage points from the previous quarter [1]. - The company is focusing resources on key pipelines, with several clinical trials progressing well, including the completion of patient enrollment for various Phase III trials [3]. Financial Performance - The company reported a cash and cash equivalents balance of CNY 1.12 billion as of September 30, with a loan credit line of CNY 2.8 billion [1]. - The sales revenue for the product 泰它西普 reached approximately CNY 270 million in Q3, reflecting a year-on-year growth of about 43% [2]. - The projected revenues for the company for the years 2024, 2025, and 2026 are CNY 1.624 billion, CNY 2.411 billion, and CNY 3.243 billion, respectively [4].

Investment Rating - The report initiates coverage with a "Buy" rating and sets a target price of HKD 21.80 [81][85]. Core Insights - Rongchang Biopharmaceutical (9995 HK) is a leading domestic manufacturer in the ADC and fusion protein sectors, with a strong R&D pipeline [6][15]. - The company's core products, including the first domestic ADC, Vadisizumab (爱地希), and the dual-target biological drug, Taisip (泰爱), are expected to see rapid revenue growth [7][21]. - The revenue forecast for Vadisizumab is projected to increase from RMB 530 million in 2023 to RMB 1.31 billion by 2026, with a CAGR of 35.3% [29][30]. - Taisip is anticipated to benefit from the strong demand for systemic lupus erythematosus treatments, with revenue expected to grow from RMB 520 million in 2023 to RMB 1.71 billion by 2026, reflecting a CAGR of 48.8% [41][53]. Summary by Sections Company Overview - Rongchang Biopharmaceutical was established in 2008 and went public in Hong Kong in 2020, focusing on R&D and production in oncology, autoimmune diseases, and ophthalmology [15][19]. - The company has established three major technology platforms: ADCs, fusion proteins, and bispecific antibodies, with six additional products in the pipeline [15][19]. Product Pipeline - The company has a robust pipeline with six investigational drugs in oncology and ophthalmology, including RC28 and RC88, which are expected to have significant market potential [2][67]. - RC28 is in Phase III clinical trials targeting age-related macular degeneration and diabetic macular edema, while RC88 is in Phase II trials for MSLN-positive solid tumors [2][67][71]. Financial Performance - Revenue is projected to grow from RMB 1.08 billion in 2023 to RMB 3.05 billion by 2026, with a CAGR of 41.5% [75]. - The company is expected to reduce shareholder net losses gradually, with a forecasted loss of RMB 432 million by 2026 [76]. Market Position and Competitive Advantage - Vadisizumab is the only approved domestic ADC in China, benefiting from increasing market demand for ADCs [29][30]. - Taisip's clinical data shows superior efficacy compared to its main competitor, Benlysta, which positions it favorably in the market for systemic lupus erythematosus [41][47]. Valuation and Investment Thesis - The report uses a DCF model to price the stock, indicating a target price of HKD 21.80, suggesting significant upside potential based on current valuations [86]. - The company’s current stock price reflects a lower valuation compared to peers, indicating room for growth as the market recognizes its product pipeline and revenue potential [81][85].

Investment Rating - The investment rating for Rongchang Biologics is "Accumulate" (maintained) [1] Core Views - The company's revenue for the third quarter reached 4.7 billion yuan, representing a year-on-year growth of 34.6% [1] - The total revenue for the first nine months of 2024 was 12.1 billion yuan, with a year-on-year increase of 57.1% [1] - The net loss for the third quarter was 2.9 billion yuan, which is a decrease in loss by 32.6% compared to the previous quarter [1] - The company continues to see robust growth in revenue, aligning with expectations, and maintains strong profitability [1] Financial Summary - **Revenue Forecasts**: - 2022A: 772 million yuan - 2023A: 1,083 million yuan - 2024E: 1,608 million yuan - 2025E: 2,167 million yuan - 2026E: 2,880 million yuan - Year-on-year growth rates: 2023A: 40%, 2024E: 48%, 2025E: 35%, 2026E: 33% [1][2] - **Net Profit Forecasts**: - 2022A: -999 million yuan - 2023A: -1,511 million yuan - 2024E: -1,025 million yuan - 2025E: -776 million yuan - 2026E: -587 million yuan - Year-on-year growth rates: 2023A: -51%, 2024E: 32%, 2025E: 24%, 2026E: 24% [1][2] - **Earnings Per Share (EPS)**: - 2022A: -1.83 yuan - 2023A: -2.78 yuan - 2024E: -1.88 yuan - 2025E: -1.43 yuan - 2026E: -1.08 yuan [1][2] - **Cash Flow**: - Operating cash flow for 2023A: -1,502 million yuan - Net profit for 2023A: -1,511 million yuan [3] Research and Development - The company is advancing its international research and development efforts, with significant clinical trials ongoing for key products such as Taitasip and Vidisizumab [1] - The early pipeline aligns with industry development trends and demonstrates differentiation [1]

Investment Rating - The report maintains a rating of "Buy" for Rongchang Biopharmaceuticals [2][4]. Core Views - The company achieved a revenue of 470 million RMB in Q3 2024, representing a year-on-year growth of 34.6%, with a net loss of 290 million RMB, which is a reduction of 40 million RMB compared to the previous year [3][4]. - The gross margin improved to 82.1%, an increase of 5.8 percentage points, due to enhanced product processes and increased sales scale [4]. - The company is focusing on late-stage pipelines and controlling R&D expenses, with an R&D expense ratio of 74.3%, down by 17.2 percentage points [4]. - Revenue forecasts for 2024-2026 are maintained at 1.647 billion, 2.504 billion, and 3.319 billion RMB respectively [4]. Financial Summary - Revenue for 2022A was not provided, but for 2023A it is projected at 1,083 million RMB, with a significant increase to 1,647 million RMB in 2024E, and further growth to 2,504 million RMB in 2025E and 3,319 million RMB in 2026E [1]. - The net profit figures indicate a loss of 999 million RMB in 2024E, with losses decreasing to 856 million RMB in 2025E and 299 million RMB in 2026E [1]. - The PE ratio is projected to improve from -28.33 in 2024E to -6.68 in 2026E, while the PB ratio is expected to rise from 5.82 in 2024E to 11.81 in 2026E [1].

Investment Rating - The report maintains a "Buy" rating for Rongchang Biopharma (9995 HK) with a target price of HKD 24.00, indicating a potential upside of 45.6% from the current price of HKD 16.48 [1][3][5]. Core Insights - The company's 3Q24 core product sales continue to grow, with significant progress in overseas clinical registrations. The financial forecast for 2024 has been adjusted upwards based on better-than-expected performance in 3Q24 [1][3]. - The report highlights that the sales of the core products, Taitasip and Vidisizumab, are expected to expand further in the domestic market and continue steady progress in overseas clinical trials [1][3]. - The company has sufficient cash reserves of approximately RMB 1.12 billion and a credit line of RMB 2.8 billion to support its operations without needing to secure business development (BD) transactions in the near term [1][2]. Financial Performance Summary - In 3Q24, Rongchang Biopharma reported a revenue of RMB 470 million, a year-on-year increase of 34.6%. The sales of Taitasip reached RMB 270 million, up 43% year-on-year, while Vidisizumab sales were around RMB 200 million, up 25% year-on-year [2][3]. - The net loss for 3Q24 was RMB 290 million, a significant reduction from RMB 430 million in 2Q24. The gross margin improved to 82.1%, an increase of 5.8 percentage points year-on-year [2][3]. - The report projects a 6% increase in the 2024 revenue forecast to RMB 1.74 billion, with Taitasip and Vidisizumab expected to generate sales of RMB 960 million and RMB 760 million, respectively [3][4]. Future Outlook - Key upcoming milestones include the initiation of the second phase of the overseas SLE III trial for Taitasip in 4Q24, with data readout expected in 1H25. The report also notes ongoing registration and critical clinical trials for various indications in China [3][4]. - The report emphasizes the importance of monitoring the registration progress of Vidisizumab for breast cancer and the timeline for overseas submissions based on the progress of the first-line UC III trial [3][4].

Investment Rating - The report maintains a "BUY" rating for RemeGen, indicating a potential return of over 15% over the next 12 months [12]. Core Insights - RemeGen achieved record product sales in Q3 2024, with revenue of RMB467 million, reflecting a 14% quarter-over-quarter and 35% year-over-year increase, driven by strong sales of RC18 and RC48 [1]. - The company narrowed its net loss to RMB291 million in Q3 2024 from RMB432 million in Q2 2024, indicating improved financial performance [1]. - The gross profit margin improved to 82.1% in Q3 2024, up from 78.3% in the first half of 2024, while the SG&A expense ratio decreased to 68.5% [1]. - RemeGen's total revenue for the first nine months of 2024 reached RMB1,209 million, representing a 57% year-over-year growth and aligning with expectations [1]. - The report anticipates continued strong sales momentum into Q4 2024 and beyond, supporting the company's FY24 sales target of over 50% year-over-year growth [1]. Financial Summary - Revenue projections for FY24 are estimated at RMB1,740 million, with a year-over-year growth of 61.7% [2]. - The net profit for FY24 is projected to be a loss of RMB1,268 million, improving to a loss of RMB967 million in FY25 and further narrowing to RMB275 million in FY26 [2]. - R&D expenses are expected to be RMB1,450 million for FY24, remaining stable in FY25, and slightly increasing to RMB1,502 million in FY26 [2]. - The gross profit margin is projected to be 80.31% for FY24, improving to 81.15% in FY25 and 80.81% in FY26 [7]. Valuation - The report revises the DCF-based target price from HK$19.59 to HK$21.09, reflecting a 28% upside from the current price of HK$16.48 [3][4]. - The DCF per share is calculated at HK$21.09, based on a WACC of 12.93% and a terminal growth rate of 2.0% [4][5]. - The market capitalization of RemeGen is approximately HK$8,970.6 million, with an average three-month turnover of HK$42.5 million [3].