Group 1 - The company, Rongchang Biopharma (09995.HK), has entered into a placement agreement with Morgan Stanley and Huatai International to issue 19 million new H-shares at a placement price of HKD 42.44, which represents a discount of approximately 9.51% compared to the closing price of HKD 46.90 on May 21 [1] - The placement shares will account for about 10.02% of the existing issued H-shares and approximately 3.49% of the total issued shares as of the announcement date [1] - Assuming no other changes in the issued share capital, the placement shares will represent about 9.11% of the enlarged issued H-shares and approximately 3.37% of the total issued shares after the placement [1] Group 2 - The total estimated proceeds from the placement are approximately HKD 806 million, with net proceeds expected to be around HKD 796 million after deducting commissions and estimated expenses [2] - The company plans to use the net proceeds for the expansion of its core product, RC18, into key indications such as myasthenia gravis, membranous nephropathy, and for general corporate purposes [2]

| 证券代码：688331 | 证券简称：荣昌生物 | 公告编号：2025-025 | | --- | --- | --- | | 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 关于根据一般授权发行 H 股的公告 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。 释义 | 除非文义另有所指外，下列词汇具有以下涵义： | | --- | | A股 | 指 | 本公司股本中每股面值人民币1.00元之人民币普 | | --- | --- | --- | | | | 通股，于上海证券交易所科创板上市 | | 年度股东大会 | 指 | 本公司于2024年6月28日举行的年度股东大会 | | 联系人 | 指 | 具有《上市规则》所赋予的涵义 | | 董事会 | 指 | 本公司董事会 | | | | 持牌银行于香港一般开放营业及联交所于香港一 | | 营业日 | 指 | 般开放买卖证券的任何日子（周六、周日及香港公 | | | | 众假期除外） | | | | 中华人民共和国（仅就本公告而言，不包括香 ...

Group 1 - The Hong Kong Innovation Drug Index (987018) has seen a strong increase of 4.01% as of May 20, 2025, with notable gains from companies such as 3SBio (01530) up 30.90%, Zai Lab (09688) up 6.59%, and Rongchang Bio (09995) up 5.69% [1] - The Hong Kong Innovation Drug ETF (159567) opened high and rose by 3.66%, marking its third consecutive increase, with the latest price reported at 1.27 yuan [1] - Over the past week, the Hong Kong Innovation Drug ETF has accumulated a rise of 5.31%, with a turnover rate of 7.38% and a transaction volume of 1.09 billion yuan [1] Group 2 - Donghai Securities reported that Trump's executive order requiring pharmaceutical companies to sell drugs in the U.S. at "most favored nation" prices may face judicial challenges and execution details, leading to short-term uncertainty [2] - Long-term implications suggest that breaking the current international drug pricing gradient could prompt global pharmaceutical companies to adjust pricing strategies, with China's innovative drugs benefiting from low R&D costs and high efficiency [2] - The report highlights potential investment opportunities in segments such as innovative drug chains, medical devices, traditional Chinese medicine, medical services, and chain pharmacies [2]

Core Viewpoint - The company's Q1 2025 performance met expectations, maintaining a "Hold" rating and target prices of HKD 29 for Hong Kong shares and RMB 40 for A-shares [1][3]. Revenue Performance - Q1 2025 revenue reached RMB 526 million, representing a 59.2% year-over-year increase and a 4.9% quarter-over-quarter increase, primarily driven by revenues from products RC18 and RC48 [1]. - The Q1 2025 revenue accounted for approximately 24% of the company's full-year revenue guidance of 30% year-over-year growth, aligning with expectations [1]. Cost Management and Net Loss - R&D expenses for Q1 2025 were RMB 329 million, a decrease of 0.7% year-over-year and 14.9% quarter-over-quarter, representing 25% of the annual guidance of under RMB 1.3 billion [2]. - Sales expenses were RMB 251 million, up 33.7% year-over-year but down 23.1% quarter-over-quarter, with a sales expense ratio of 47.7%, consistent with the guidance of keeping it below 50% [2]. - Management expenses were RMB 90 million, increasing by 21.4% year-over-year but decreasing by 7.1% quarter-over-quarter, with a management expense ratio reduced to 17.1% [2]. - The net loss attributable to the parent company for Q1 2025 was RMB 254 million, a reduction of 27.2% year-over-year and 0.9% quarter-over-quarter, in line with expectations [2]. Cash Flow and Financial Strategy - As of March 31, the company had cash and cash equivalents of RMB 722 million, a slight decrease from RMB 762 million at the end of 2024, indicating that most cash outflows are covered by commercial revenues [3]. - The company plans to apply for a total credit facility of up to RMB 5.5 billion from banks and other financial institutions in 2025, suggesting a reliance on bank credit for cash flow supplementation [3]. Valuation and Future Outlook - The company maintains a "Hold" rating and target prices of HKD 29 for Hong Kong shares and RMB 40 for A-shares, with slight adjustments to net loss forecasts for 2025E/2026E/2027E due to minor revenue and gross margin adjustments [3]. - The current valuation is considered reasonable, with potential for stock price upgrades if the product Tai Tasi Pu successfully expands internationally [3].

Financial Performance - The company's revenue for Q1 2025 reached ¥525,968,624.06, representing a year-on-year increase of 59.17% compared to ¥330,434,802.62 in the same period last year[8] - The net profit attributable to shareholders was a loss of ¥254,144,470.06, an improvement from a loss of ¥348,921,696.49 in the previous year[8] - The net cash flow from operating activities was a negative ¥188,315,133.08, showing an improvement from a negative ¥426,289,929.83 in the same period last year[8] - Total operating costs for Q1 2025 were ¥783,824,467.59, up from ¥682,453,542.19 in Q1 2024, reflecting a 15% increase[20] - Net loss for Q1 2025 was ¥254,144,470.06, an improvement from a net loss of ¥348,921,696.49 in Q1 2024[20] - Cash flow from operating activities for Q1 2025 was negative at ¥-188,315,133.08, compared to ¥-426,289,929.83 in Q1 2024, indicating a reduction in cash burn[22] - The company reported a gross profit margin decline, with gross profit for Q1 2025 at ¥-257,855,843.53, compared to a gross profit of ¥-352,018,739.57 in Q1 2024[20] Research and Development - Research and development expenses totaled ¥328,884,698.70, accounting for 62.53% of revenue, down from 100.23% in the previous year, a decrease of 37.70 percentage points[9] - Research and development expenses for Q1 2025 were ¥328,884,698.70, slightly down from ¥331,178,800.01 in Q1 2024[20] Assets and Liabilities - Total assets at the end of the reporting period were ¥5,307,345,048.02, a decrease of 3.48% from ¥5,498,518,168.82 at the end of the previous year[9] - Total liabilities as of the end of the reporting period were ¥3,535,919,952.95, compared to ¥3,512,317,547.88 in the previous year[18] - The equity attributable to shareholders decreased by 10.81% to ¥1,771,425,095.07 from ¥1,986,200,620.94 at the end of the previous year[9] - The company's cash and cash equivalents as of March 31, 2025, amount to ¥721,718,278.96, a decrease from ¥762,492,395.54 at the end of 2024[17] - Accounts receivable decreased to ¥331,962,831.52 from ¥383,388,743.02, indicating improved collection efficiency[17] - Inventory levels are reported at ¥638,250,683.99, down from ¥659,368,730.71, suggesting better inventory management[17] - Total current assets decreased to ¥2,160,787,697.47 from ¥2,289,796,373.31, reflecting a tighter liquidity position[17] - The total non-current assets include fixed assets valued at ¥2,415,481,681.93, slightly down from ¥2,457,180,322.07[17] - The company has a long-term equity investment of ¥8,724,070.05, indicating strategic investments in other entities[17] Shareholder Information - Total number of common shareholders at the end of the reporting period is 6,766[14] - The largest shareholder, HKSCC NOMINEES LIMITED, holds 189,566,728 shares, representing a significant portion of the equity[15] - The total number of A-share common shareholders is 6,742, while H-share common shareholders total 24[15] Future Outlook - The company plans to continue focusing on market expansion and new product development to drive future growth[23] - The increase in revenue was primarily driven by higher sales volumes of the products TaiTasi and VidiXimab[12] - The company emphasizes the importance of careful consideration by shareholders and potential investors when trading its securities[4]

Financial Performance - The company reported a basic earnings per share of -0.4600 yuan for Q1 2025, an improvement of 29.23% compared to -0.6500 yuan in Q1 2024 [1] - The total revenue for Q1 2025 was 5.26 billion yuan, representing a significant increase of 59.39% from 3.3 billion yuan in Q1 2024 [1] - The net profit for Q1 2025 was -2.54 billion yuan, which is a 27.22% improvement from -3.49 billion yuan in Q1 2024 [1] - The company's net asset return rate was -13.61% in Q1 2025, a decline from -10.72% in Q1 2024 [1] Shareholder Information - The top ten unrestricted shareholders collectively hold 23,806.06 million shares, accounting for 67.72% of the circulating shares, with a decrease of 2.28 million shares compared to the previous period [2] - HKSCC NOMINEES LIMITED remains the largest shareholder with 18,956.67 million shares, representing 53.93% of the total share capital, unchanged from the previous period [3] - The company has seen a new entry in the top ten shareholders with Shanghai Liyi Investment Management Partnership holding 3,062.2 thousand shares [3] Dividend Policy - The company has announced that it will not distribute dividends or transfer shares this time [4]

Sales and Market Expansion - RemeGen's sales of Taitasip for systemic lupus erythematosus (SLE) saw significant growth in 2024, benefiting from its inclusion in the national medical insurance catalog and being approved in over 1,000 hospitals in China[10]. - The commercialization team for Taitasip has over 800 professionals, and the company plans to expand market coverage in 2025[10]. - The sales of VidiSita for treating locally advanced or metastatic gastric cancer (GC) also increased significantly in 2024, with approval in over 1,000 hospitals in China[11]. - RemeGen's oncology commercialization team consists of approximately 600 professionals, aiming to improve market penetration in 2025[11]. - The company has established independent sales teams for autoimmune and oncology products, with over 1,000 hospitals approved for the sale of Taizhisip and Vidisicimab as of December 31, 2024[42]. Clinical Development and Trials - The company is conducting Phase III clinical trials for VidiSita in combination with PD-1 therapy for HER2-expressing patients, with positive results reported[13]. - Taitasip received full approval from NMPA in July 2024 for treating rheumatoid arthritis (RA) and has ongoing clinical trials for other indications[10]. - The company is actively conducting Phase III clinical trials for RC18 in multiple indications, including IgA nephropathy and myasthenia gravis, with patient recruitment completed for both studies by mid-2024[24]. - The company is exploring additional indications for RC18, including membranous nephropathy and autoimmune diseases, with ongoing investigator-initiated studies[26]. - The company is actively pursuing clinical trials for RC48 in various cancers, addressing significant unmet medical needs in the oncology space[27]. - The company has initiated a Phase III clinical trial for Vidisicimab combined with PD-1 therapy in first-line UC, currently enrolling patients[34]. - The company has initiated a Phase III clinical trial for RC28-E in DME and a Phase II trial in DR, with patient recruitment completed by December 31, 2024[39]. Financial Performance - Revenue increased from RMB 1,076.1 million in 2023 to RMB 1,710.2 million in 2024, driven by strong sales of the immunotherapy product Taitasip and the oncology product Vidisicimab[45]. - Research and development expenses rose from RMB 1,306.3 million in 2023 to RMB 1,539.8 million in 2024, with clinical trial expenses increasing by RMB 234.42 million due to ongoing drug development, particularly overseas[50][52]. - Selling and distribution expenses increased from RMB 775.2 million in 2023 to RMB 948.8 million in 2024, primarily due to higher marketing investments[48]. - The net loss for the company decreased from RMB 1,511.2 million in 2023 to RMB 1,468.4 million in 2024[57]. - The company reported a distributable reserve of approximately RMB 2,110 million as of December 31, 2024[171]. Governance and Management - The company has adhered to all applicable corporate governance code provisions as of December 31, 2024, ensuring high standards of corporate governance to protect shareholder interests[95]. - The board composition maintains a balance between executive and independent non-executive directors to ensure strong independence and effective judgment[95]. - The company emphasizes the importance of effective internal controls and accountability within its management structure[95]. - The management team has extensive experience in the pharmaceutical industry, with Lin Jian having over 35 years and Wang Liqiang over 26 years[75][76]. - The company has established mechanisms for obtaining independent advice for the board, ensuring effective governance[116]. Risks and Challenges - The company faces various risks and uncertainties related to its financial condition and additional funding needs, which are outlined in the risk management section[156]. - The company has incurred significant net losses since its inception and expects to continue doing so in the foreseeable future, raising concerns for potential investors about the risk of losing most of their investment[159]. - The success of the company's business and financial outlook largely depends on the success of its clinical and preclinical candidates; failure to complete clinical development or obtain regulatory approval could severely impact operations[160]. - The regulatory approval process from agencies like the Chinese FDA and EMA is lengthy and unpredictable; failure to obtain timely approvals could significantly harm the business[160]. - The company faces intense competition, and competitors may successfully develop or commercialize competing drugs before the company can[162]. Employee and Compensation - The total employee count as of December 31, 2024, is 3,497, with total compensation costs for 2024 amounting to RMB 1,175.2 million, up from RMB 1,152.3 million in 2023[65]. - The company has provided competitive salaries and benefits to employees, particularly key personnel, to maintain talent quality[65]. - The company has granted 850,000 shares to executive director Wang Weidong, with a vesting period until December 31, 2026[187]. - The company has granted 1,200,000 shares to executive director He Ruyi, with a vesting period until December 31, 2025[187]. - The company has a total of 20,000 shares granted to employees, with an exercise price of HKD 50.50, reflecting a closing price of HKD 51.70[187]. Shareholder Relations - The company emphasizes the importance of timely and accurate information disclosure to enhance transparency and investor relations[149]. - Shareholders holding 10% or more of the shares can request a special general meeting, with the board required to respond within 10 days[142]. - The company has established effective communication channels with investors, including a dedicated investor mailbox for inquiries[147]. - The company is committed to maintaining and developing investor relations through timely public disclosures and effective communication strategies[146]. - The company does not recommend the payment of a final dividend for the year ending December 31, 2024[167].

Financial Performance - The company's revenue for Q1 2025 reached ¥525,968,624.06, representing a 59.17% increase compared to ¥330,434,802.62 in the same period last year[4] - The net profit attributable to shareholders was -¥254,144,470.06, an improvement from -¥348,921,696.49 year-over-year[4] - The basic and diluted earnings per share were both -¥0.46, an improvement from -¥0.65 in the same period last year[4] - Net loss for Q1 2025 was ¥254,144,470.06, an improvement from a net loss of ¥348,921,696.49 in Q1 2024[16] - The company recorded a comprehensive loss of ¥242,151,500.49 in Q1 2025, compared to a comprehensive loss of ¥372,204,285.59 in Q1 2024[16] - The total comprehensive income attributable to the parent company for Q1 2025 was -242.15 million RMB, compared to -372.20 million RMB in Q1 2024, showing an improvement of approximately 35%[17] Research and Development - Research and development (R&D) expenses totaled ¥328,884,698.70, accounting for 62.53% of revenue, a decrease of 37.70 percentage points from the previous year[5] - Research and development expenses for Q1 2025 were ¥328,884,698.70, nearly unchanged from ¥331,178,800.01 in Q1 2024[16] Cash Flow - The net cash flow from operating activities was -¥188,315,133.08, showing a significant improvement from -¥426,289,929.83 in the prior year[4] - Cash inflow from operating activities for Q1 2025 was 479.99 million RMB, up 66.2% from 289.13 million RMB in Q1 2024[17] - Net cash flow from operating activities for Q1 2025 was -188.32 million RMB, an improvement from -426.29 million RMB in Q1 2024[17] - Cash inflow from investing activities for Q1 2025 was 159.85 million RMB, significantly higher than 14.02 million RMB in Q1 2024[17] - Net cash flow from investing activities for Q1 2025 was -26.79 million RMB, compared to -81.36 million RMB in Q1 2024, reflecting a reduced outflow[17] - Cash inflow from financing activities for Q1 2025 was 530.70 million RMB, compared to 442.00 million RMB in Q1 2024, marking an increase of 20.1%[19] - The net cash flow from financing activities for Q1 2025 was 176.72 million RMB, down from 401.99 million RMB in Q1 2024[19] - The ending cash and cash equivalents balance for Q1 2025 was 718.78 million RMB, compared to 619.73 million RMB in Q1 2024, indicating a year-over-year increase of 16%[19] Assets and Liabilities - Total assets decreased by 3.48% to ¥5,307,345,048.02 from ¥5,498,518,168.82 at the end of the previous year[5] - Total assets as of March 31, 2025, amounted to ¥5,307,345,048.02, a decrease from ¥5,498,518,168.82 at the end of 2024[13] - Total liabilities increased slightly to ¥3,535,919,952.95 from ¥3,512,317,547.88 at the end of 2024[13] - Shareholders' equity attributable to the company decreased by 10.81% to ¥1,771,425,095.07 from ¥1,986,200,620.94[5] - The company’s total equity attributable to shareholders decreased to ¥1,771,425,095.07 from ¥1,986,200,620.94 at the end of 2024[13] Shareholder Information - The total number of common shareholders at the end of the reporting period was 6,766[9] - The company reported a total of 6,766 shareholders as of the end of the reporting period[11] Revenue Drivers - The increase in revenue was driven by higher sales of monoclonal antibodies, specifically TaiTasiPu and WeiDiXiTuo[8] Accounting Standards - The company did not apply new accounting standards for the first time in 2025[19]

Group 1 - The core point of the article is that Rongchang Bio reported a revenue of 526 million yuan in the first quarter of 2025, representing a year-on-year increase of 59.17% [1] - The company incurred a net loss of 254 million yuan, which is an improvement compared to a net loss of 349 million yuan in the same period last year [1]

Financial Performance - For the fiscal year ending December 31, 2024, the company's product sales revenue was approximately RMB 1,699.1 million, representing a 61.9% increase from RMB 1,049.2 million in the same period last year[4]. - The total revenue for the fiscal year was RMB 1,710.2 million, with a gross profit of RMB 1,367.4 million[9]. - Revenue increased from RMB 1,076.1 million in 2023 to RMB 1,710.2 million in 2024, driven by strong sales of the autoimmune product TaiTasi and the oncology product VidiSita[38]. - For the year ended December 31, 2024, the company's revenue increased to RMB 1,710,152 thousand, up from RMB 1,076,130 thousand in 2023, representing a growth of approximately 58.8%[63]. - The company reported a net loss of RMB 1,468,362,000 for the year ended December 31, 2024, compared to a net loss of RMB 1,511,229,000 in 2023, indicating a reduction in losses of approximately 2.8%[64]. - Total comprehensive loss for the year was RMB 1,499,240,000, down from RMB 1,570,147,000 in the previous year, reflecting a decrease of about 4.5%[64]. - The net loss for the year decreased to RMB 1,468.36 million in 2024 from RMB 1,511.23 million in 2023, showing a slight improvement in financial performance[48]. Research and Development - Research and development expenses increased by RMB 233.5 million or 17.9% to RMB 1,539.8 million for the fiscal year[9]. - The company has a comprehensive pipeline with over ten candidate drugs, seven of which are in clinical development targeting more than twenty indications[10]. - The company is actively exploring Taisai for other autoimmune diseases, including plans for a Phase III clinical study for membranous nephropathy[20]. - The company is conducting a Phase II clinical trial for RC148 in advanced lung cancer, progressing smoothly as of December 31, 2024[34]. - The company is focused on drug development and has received approval for the comprehensive marketing application of its drug, TaiTasiPu, in November 2023[69]. - The company is committed to adhering to corporate governance codes as outlined in the listing rules[106]. Clinical Trials and Approvals - The company received FDA Fast Track Designation for its product RC18 (Taitai) for the treatment of primary Sjögren's syndrome in March 2024[5]. - RC48 (Widi) showed positive results in a Phase III clinical trial for HER2-positive metastatic breast cancer, achieving the primary endpoint[6]. - Taisai (RC18) received full NMPA approval in China in November 2023 and was successfully included in the national medical insurance drug catalog by the end of 2023[14]. - The company initiated a Phase III clinical trial for Taisai in China for the treatment of IgA nephropathy in the first half of 2023, with patient recruitment completed by May 2024[16]. - The company submitted a Biologics License Application (BLA) for Taisai for rheumatoid arthritis in August 2023, with approval from NMPA expected in July 2024[15]. - The company has completed a Phase II clinical trial for Vidisicimab in HER2-overexpressing urinary tract cancer patients, leading to a multi-center Phase II registration trial[21]. - A Phase III clinical trial comparing Vidisicimab combined with chemotherapy for HER2-expressing locally advanced or metastatic urothelial carcinoma (la/mUC) is ongoing in China, with patient enrollment completed in August 2024[23]. Financial Position and Liabilities - The company's total liabilities to assets ratio increased to 63.9% as of December 31, 2024, compared to 37.8% in 2023, indicating a higher leverage position[51]. - The company's total liabilities increased significantly to RMB 3,512,318,000 in 2024 from RMB 2,091,074,000 in 2023, marking an increase of approximately 68%[66]. - The net asset value decreased to RMB 1,986,201,000 in 2024 from RMB 3,437,269,000 in 2023, a decline of about 42.3%[66]. - The company has cumulative losses of RMB 4,321,871,000 as of December 31, 2024, indicating ongoing financial challenges[69]. - The company maintains that its available funds and unused bank credit are sufficient to support its normal operations, research, and production activities for at least the next 12 months[69]. Market and Strategic Focus - The company aims to become a leading player in the global biopharmaceutical industry, focusing on unmet medical needs in autoimmune, oncology, and ophthalmology diseases[10]. - The company is one of the few Chinese biotech firms that have commercialized two products, RC18 and RC48[10]. - The company is actively pursuing new drug applications and clinical trials to expand its product pipeline[108]. - The core products include RC18 (brand name: 泰愛®), RC48 (brand name: 愛地希®), and RC28-E[107]. - The company is focused on developing antibody-drug conjugates (ADCs) for targeted cancer therapies[106]. Governance and Compliance - The company is subject to regulatory oversight by the National Medical Products Administration (NMPA) in China[108]. - The board of directors includes both executive and non-executive members, ensuring a diverse governance structure[109]. - The group has adopted revised international financial reporting standards, including IFRS 16 and IAS 1, with no impact on its financial position or performance[73]. - The company emphasizes the uncertainty in successfully developing and selling its core products, advising shareholders to act cautiously[105].