[Table_Industry] 深耕自免+肿瘤 Biopharma 新星，海外管线推进与授权可预期 荣昌生物(9995.HK)/医药生 证券研究报告/公司深度报告 2024 年 04月 29日 物 [Table_Invest] [Table_Finance1] 评级：买入(首次) 公司盈利预测及估值 2022 2023 2024E 2025E 2026E 市场价格：27.85 指标 [Table_Authors] 营业收入（百万元） 772 1,083 1,611 2,174 2,892 分析师： 祝嘉琦 增长率yoy% -46% 40% 49% 35% 33% 执业证书编号：S0740519040001 净利润（百万元） -999 -1,511 -1,249 -969 -715 Email：zhujq@zts.com.cn 增长率yoy% -462% -51% 17% 22% 26% 每股收益（元） -1.83 -2.78 -2.30 -1.78 -1.31 [Table_Profit] 每股现金流量 -2.32 -2.76 -1.28 0.36 -2.83 基本状况 净资产收益率 -22% -45% - ...

浦银国际研究 公司研究 | 医药行业 荣昌生物（9995.HK）：1Q24 净亏损符合 阳景 浦 预期；公司维持 2024 年收入指引 首席医药分析师 银 Jing_yang@spdbi.com 国 (852) 2808 6434 际 1Q24净亏损符合预期。公司维持 2024年收入指引。我们维持“持有” 评级和目标价 33港元。在产品出海前景尚未有明确指引情况下，我们 胡泽宇 CFA 认为目前股价已处于合理估值区间。 医药分析师 ● 1Q24 净亏损符合预期：1Q24 实现收入人民币3.3 亿元（+96.41% YoY, ryan_hu@spdbi.com (852) 2808 6446 +6.6% QoQ），略微低于我们预期；净亏损为 3.49 亿元（+7.8% YoY, -27.4% QoQ），符合我们预期，主要由于毛利率略好于我们预期、运营费用（销 2024年4月29日 售费用、研发费用、行政费用）低于我们预期及其他非运营收入低于 我们预期。毛利率达到77.5%，较 4Q23 略微下降0.5 个百分点。经营 公 性现金流净流出4.3 亿元，基本符合我们预期。 司 评级 研 ● 维持2024年收入同比增 ...

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） 2024年第一季度報告 本公告乃根據香港聯合交易所有限公司證券上市規則第13.09(2)(a)條及第13.10B 條規則及《證券及期貨條例》（香港法例第571章）第XIVA部之內幕消息條例作出。 茲載列榮昌生物製藥（煙台）股份有限公司（「本公司」）在上海證券交易所網站刊發之 《榮昌生物製藥（煙台）股份有限公司2024年第一季度報告》，僅供參閱。以下為本公 司2024年第一季度報告，僅供參考。如有任何歧義，概以中文版本為準。 本公司董事會（「董事會」）提醒本公司股東及潛在投資者，本公告所載信息及財務 數據未經審計，已經本公司審核委員會審閱但未經獨立核數師審閱。 本公告所載2024年第一季度報告內的未經審計財務數據乃根據中華人民共和國會 計原則而非國際財務報告準則編製， ...

Sales Performance - The sales of Taitasip for the treatment of systemic lupus erythematosus (SLE) saw significant growth in 2023, attributed to its inclusion in the national medical insurance drug list and a commercial team of over 700 professionals covering more than 2,300 hospitals in China[5]. - The sales of Vidiqi monoclonal antibody for the treatment of locally advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma) also experienced notable growth, supported by its inclusion in the national medical insurance drug list and a commercial team of over 600 professionals covering more than 2,000 hospitals in China[5]. - The company reported a significant increase in sales volume for both of its marketed products in 2023, reflecting strong market demand[5]. - The company's revenue increased from RMB 767.8 million in 2022 to RMB 1,076.1 million in 2023, driven by strong sales of its autoimmune product TaiTasi and oncology product VidiCim[30]. Clinical Development - The company initiated three Phase III clinical studies in 2023 for Taitasip, targeting IgA nephropathy, Sjögren's syndrome, and myasthenia gravis, with significant progress reported[5]. - The Phase III clinical trial for systemic lupus erythematosus (SLE) in China was completed in Q3 2022 with positive results, leading to NMPA approval in November 2023[11]. - The Phase III clinical trial for IgA nephropathy has been initiated in China in H1 2023, following positive results from a Phase II trial[13]. - The FDA approved the global Phase III IND for the treatment of adult primary Sjögren's syndrome (pSS) in December 2023[14]. - The company is currently conducting a Phase III clinical trial for HER2-expressing urothelial carcinoma patients and a Phase II trial for HER2-expressing invasive bladder cancer patients in China[6]. Research and Development - The company has established a comprehensive end-to-end drug development capability since its founding in 2008, focusing on unmet medical needs in China and globally[5]. - The company is focused on expanding its market presence both domestically and internationally, maintaining strong momentum in 2024[6]. - The company is developing multiple candidates, including RC88 (Mesothelin ADC), which has the potential to be the next first-in-class product[6]. - The company has a robust pipeline with over ten candidate drugs in various stages of clinical development targeting a wide range of indications[7]. - The company aims to develop more first-in-class and best-in-class products to meet unmet medical needs and provide substantial returns to shareholders[6]. Financial Performance - The company reported a net loss of RMB 1,511,229,000 for the year 2023, compared to a loss of RMB 998,830,000 in 2022[191]. - The net loss for the year was RMB 1,511,229 thousand, an increase from RMB 998,830 thousand in the previous year, indicating a worsening financial position[186]. - Basic loss per share for the year was RMB 2.80, compared to RMB 1.88 in 2022, showing a decline in shareholder value[186]. - Total revenue for 2023 reached RMB 1,076,130 thousand, a 40.1% increase from RMB 767,775 thousand in 2022[186]. - The company’s cash and cash equivalents decreased to RMB 726,552,000 in 2023 from RMB 2,069,180,000 in 2022, a decline of 64.9%[188]. Corporate Governance - The board consists of four executive directors, two non-executive directors, and three independent non-executive directors, ensuring compliance with listing rules regarding independence[59]. - The company has maintained compliance with corporate governance codes throughout the fiscal year ending December 31, 2023[58]. - The board is committed to high standards of corporate governance to protect shareholder interests[58]. - The company has implemented a robust internal control and risk management system, overseen by the board of directors[61]. - The company has purchased liability insurance for directors and senior management to cover potential legal responsibilities[61]. Risk Management - The company faces risks related to delays in clinical development and regulatory approvals, which could severely impact its business[102]. - The company has implemented a risk management framework to identify, assess, and monitor key risks related to its strategic objectives[87]. - The audit committee has conducted an annual review and is confident in the implementation and effectiveness of the group's risk management and internal control procedures[88]. - The company has established a mechanism for the board to obtain independent opinions and advice, ensuring effective governance practices[72]. - The company warns that it cannot ensure the successful development and commercialization of its drug candidates, urging shareholders and potential investors to act cautiously[20][24][27]. Shareholder Engagement - The company emphasizes the importance of maintaining effective communication with investors to enhance transparency and mutual understanding[96]. - The company encourages shareholder participation in meetings to express concerns and provide feedback to the board[95]. - The company has made amendments to its articles of association to improve governance in accordance with regulatory requirements[97]. - The company has not disclosed any significant interests held by the controlling shareholder in contracts important to the group's business during the reporting period[115]. - The company has established employee incentive platforms holding a total of 102,381,891 A-shares as of December 31, 2023[145]. Future Outlook - The company aims to commercialize TaiTasi and VidiCim in China and expand their market presence in 2024[30]. - The company plans to enhance market penetration for Vidiqi monoclonal antibody in 2024 through continued efforts in the oncology sector[5]. - The company plans to utilize all remaining unutilized A-share issuance funds by December 31, 2024, based on current market conditions[44]. - The company aims to enhance its long-term incentive mechanism to attract and retain talent, aligning the interests of shareholders, the company, and core team members[136]. - The company plans to expand its market presence with new product launches and technology developments in the upcoming quarters[124].

Investment Rating - The report downgrades the investment rating of Rongchang Biopharmaceutical (9995.HK) to "Hold" from a previous rating, maintaining a target price of HKD 33.0, indicating a potential upside of 12% from the current price of HKD 30.0 [1][2]. Core Views - The company is expected to achieve a revenue growth of over 50% year-on-year in 2024, driven by its innovative drugs RC18 and RC48. However, the lack of clear guidance on the international launch timeline for its product Tai Tasi Pu has led to the downgrade in rating [1][2]. - The company reported a revenue of RMB 1.08 billion in 2023, reflecting a year-on-year increase of 40.2%, with product sales contributing RMB 1.05 billion, up 42.1% year-on-year. The net loss attributable to shareholders was RMB 1.51 billion, a 51.3% increase year-on-year [1][2]. - The report highlights that the company has sufficient cash flow to sustain operations for approximately three years, with a cash balance of RMB 727 million at the end of 2023 and a net cash burn of RMB 1.5 billion for the year [1][2]. Financial Performance - The report provides a financial forecast indicating that revenue is expected to grow to RMB 1.61 billion in 2024, representing a 49.9% year-on-year increase, and further to RMB 2.52 billion in 2025 [6][7]. - The gross profit margin for product sales improved to 75.9% in 2023, an increase of 12.4 percentage points year-on-year, primarily driven by the sales growth of innovative drugs [1][2]. - The report anticipates that research and development expenses will rise to RMB 1.5 billion in 2024, reflecting the ongoing clinical trials for core products [1][2]. Key Catalysts - Major catalysts for 2024 include potential international licensing for RC18, approval for RA indications in China, and data readouts for RC48 and RC88 in clinical trials [1][2]. - The management expressed confidence in achieving the revenue guidance for 2024, citing strong sales performance in the first quarter [1][2].

M N 2 Apr 2024 CMB International Global Markets | Equity Research | Company Update RemeGen (9995 HK) Awaiting the fruition of overseas BD collaborations RemeGen recorded RMB1.08bn of revenue in FY23, including RMB1.05bn from Target Price HK$41.72 product sales (+42% YoY), contributed equally by RC18 and RC48. In FY23, (Previous TP HK$57.65) GP margin (vs product sales) increased to 76.9% (vs 63.4% in FY22). Selling Up/Downside 53.7% expense ratio (vs product sales) increased from 60% in FY22 to 74% in FY23, ...

海 外 研 证券研究报告 究 ＃industryId＃ 医疗保健业 ＃investSuggestion＃ ＃ ＃09995 .HK ＃荣dy昌Com生pa物ny＃ 港股通（沪/深） 增持 ( i维 nve持 stS ） dyStockco uggesti d e＃ ＃title＃ onChan 管线全球进展顺利，销售表现稳健 ge＃ ＃市场ma数rk据et Data＃ ＃createTime1＃ 2024年 04月 03日 日期 2024-04-02 公 收盘价（港元） 27.65 投资要点 司 ＃summary＃ 总股本（百万股） 544.33 ⚫ 事件：公司公告2023年年报，2023年实现营业收入10.76亿元，同比增 点 流通股本（百万股） 189.58 长40.16%，实现归母净利润-15.11亿元（2022年同期为-9.99亿元）。 评 净资产（百万元） 3437.27 报 总资产（百万元） 5528.24 ⚫ 点评：公司泰它西普和维迪西妥单抗2023年销售保持稳健增长，两个产 告 每股净资产（元） 6.31 品医院药品准入进展顺利，泰它西普多个适应症全球持续进展，有望逐 数据来源：Wind，兴业 ...

交银国际研究 公司更新 医药 收盘价 目标价 潜在涨幅 2024年3月28日 港元27.15 港元56.00↓ +106.3% 荣昌生物 (9995 HK) FY23 产品收入强劲，FY24 重点关注泰它西普海外进展，维持买入评级  FY23 产品收入强劲，1H24 高增长可期：2023 年收入 10.76 亿元（同比 个股评级 +40.2%），其中产品收入10.49亿元（+42.1%），维迪西妥和泰它西普分 买入 别录得 5.3 亿/5.2 亿元（+56%/+32%）。净亏损 15.11 亿元（同比扩大 +51.3%）。截至2023年末，公司银行结余及现金7.27亿元，银行授信约 40亿元。销售费用7.75亿元（+75.9%），费用率72%（+15百分点）；研 1年股价表现 发费用13.06亿元（+33.0%）。进入2024年，公司预计全年产品销售增长 9995 HK 恒生指数 50%以上（即15.7亿元以上），四个季度的爬坡曲线将相对平缓。考虑到 20% 10% 1H23在销售策略调整等因素的影响下，收入基数较低，而商业化团队扩 0% -10% 张和培训优化已基本完成，我们看好公司在1H24的收入环比和 ...

股 票 研 究 [Table_industryInfo] 医药 [ Table_Main[荣I Tnaf 昌bol]e 生_Ti物tle]（ 9995） [评Tab级le_：Inv est] 增持 当前价格（港元）： 25.65 业绩符合预期，商业化有望加速兑现 2024.03.29 海 ——荣昌生物2023 年报点评 [ 交Ta易bl数e_M据a rket] 外 丁丹(分析师) 甘坛焕(分析师) 52周内股价区间（港元） 15.22-52.00 当前股本（百万股） 544 公 0755-23976735 021-38675855 当前市值（百万港元） 13,962 司 dingdan@gtjas.com gantanhuan028803@gtjas.com 证书编号 S0880514030001 S0880523080007 （ [ Table_PicQuote] 中 本报告导读： 52周内股价走势图 国 2023年两款药物销售额均超 5亿元，泰它西普MG适应症预计年底提交NDA，RC48 荣昌生物 恒生指数 香 国内外提线临床进展顺利，预计2024年产品收入增速超50%。维持“增持”评级。 10% 摘要： ...

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2023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2023年12月31日止年度的綜合業績，連同截至2022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2023年12月31日止年度的產品銷售收益約為人民幣1,049.2百萬 元，較去年同期的人民幣738.2百萬元增長42.1%，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 ...