Core Viewpoint - The company, Innocare Pharma, is holding an investor briefing on May 26, 2025, to discuss its Q1 2025 financial results and operational performance [1][2]. Group 1: Meeting Details - The investor briefing is scheduled for May 26, 2025, from 9:00 AM to 10:00 AM [2]. - The meeting will take place at the Shanghai Stock Exchange Roadshow Center, accessible via the website: http://roadshow.sseinfo.com/ [2]. - The format of the meeting will be an online interactive session [1][2]. Group 2: Participation Information - Investors can submit questions from May 19, 2025, to May 23, 2025, by visiting the Roadshow Center's website or emailing IR@innocarepharma.com [1][3]. - The company will address commonly asked questions during the briefing [1][3]. Group 3: Attendees - Key attendees include Dr. Jisong Cui (Chairman and CEO), Ms. Hulan (Independent Non-Executive Director), Mr. Fu Xin (CFO), and Ms. Yuan Bei (Domestic Information Disclosure Representative) [2].

| A | 股代码：688428 | A 股简称：诺诚健华 | 公告编号：2025-017 | | --- | --- | --- | --- | | 港股代码：09969 | | 港股简称：诺诚健华 | | 诺诚健华医药有限公司 关于召开 2025 年第一季度业绩说明会的公告 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。 重要内容提示： 会议召开时间：2025 年 5 月 26 日(星期一)上午 9:00-10:00 会 议 召 开 地 点 ： 上 海 证 券 交 易 所 上 证 路 演 中 心 （ 网 址 ： http://roadshow.sseinfo.com/） 会议召开方式：上证路演中心网络互动 独立非执行董事：胡兰女士 投资者可于 2025 年 5 月 19 日（星期一）至 5 月 23 日（星期五）16:00 前登录上证路演中心网站首页点击"提问预征集"栏目或通过公司邮箱 IR@innocarepharma.com 进行提问。公司将在说明会上对投资者普遍关注的问题 进行回答 诺诚健华医药有限公司（以下简称"公 ...

Group 1: Financial Performance - In Q1 2025, the company achieved revenue of 381 million yuan, representing a year-on-year increase of 129.92%, with a net profit attributable to shareholders of 17.97 million yuan and a non-GAAP net profit of 1.59 million yuan [1] - The revenue from Obinutuzumab reached 311 million yuan in Q1 2025, showing an increase of 89.22%, driven by the rapid growth in demand for the exclusive MZL indication [1] Group 2: Product Development and Pipeline - The company is advancing multiple innovative drug developments, with Tafasitamab expected to receive approval in the first half of 2025, enhancing the product pipeline in the hematological oncology field [2] - The global Phase III clinical study for Obinutuzumab in PPMS/SPMS is expected to complete the first patient enrollment within 2025, while the ITP indication is in Phase III and is anticipated to submit an NDA in the first half of 2026 [1][2] - The company has submitted an NDA for the pan-TRK inhibitor zurletrectinib (ICP-723), which has been granted priority review status [2] Group 3: Revenue Forecast and Valuation - The company has adjusted its revenue forecasts, expecting revenues of 1.442 billion yuan, 1.737 billion yuan, and 2.128 billion yuan for 2025 to 2027, with year-on-year growth rates of 42.8%, 20.5%, and 22.5% respectively [3] - The projected net profit attributable to shareholders for the same period is expected to be -259 million yuan, -214 million yuan, and -213 million yuan, leading to corresponding PE ratios of -140.7, -169.7, and -170.8 [3]

Core Viewpoint - InnoCare Pharma reported strong financial performance in Q1 2025, with significant revenue growth and a shift to profitability, driven by the sales ramp-up of its key product, orelabrutinib [1][5]. Financial Performance - Q1 2025 revenue reached Rmb381 million, representing a 130% year-over-year increase, while net profit was Rmb18 million, a turnaround from net losses of Rmb142 million in Q1 2024 [1]. - Sales of orelabrutinib amounted to Rmb311 million, reflecting an 89% year-over-year growth [1]. - R&D expenses were Rmb208 million, up 17% year-over-year, and selling expenses reached Rmb114 million, increasing by 27% year-over-year, with the selling expense ratio decreasing by 24.1 percentage points to 30% [1]. - Gross profit margin improved by 5.2 percentage points to 90.5% due to enhanced production efficiency and contributions from business development revenue [1]. - As of March 2025, the company had a cash balance of approximately Rmb7.8 billion [1]. Product Development and Sales Outlook - The sales target for orelabrutinib has been raised from over 30% year-over-year to over 35% year-over-year for 2025, supported by the addition of three indications into the National Reimbursement Drug List (NRDL) and recent NMPA approval for first-line CLL/SLL [1]. - Orelabrutinib is currently undergoing phase III trials for immune thrombocytopenic purpura (ITP) in China, with a new drug application (NDA) expected in the first half of 2026, and phase IIb trials for systemic lupus erythematosus (SLE) with data readouts anticipated in Q4 2025 [1]. Other Product Developments - The Biologics License Application (BLA) for tafasitamab for relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL) was accepted by the NMPA, with approval expected in 2025 [2]. - ICP-248 (BCL-2) is in phase III trials in combination with orelabrutinib for first-line CLL/SLL, and has received breakthrough therapy designation (BTD) from the CDE for r/r mantle cell lymphoma (MCL) [2]. - The company is actively developing pipelines for autoimmune diseases, including phase III trials for atopic dermatitis (AD) and psoriasis, and has pre-clinical assets targeting IL-17 [3]. ADC Product Development - The company filed an Investigational New Drug (IND) application for its first antibody-drug conjugate (ADC) product, ICP-B794 (B7-H3 ADC), which has shown promising therapeutic effects and safety in preclinical studies [4]. Investment Outlook - The EPS forecast has been adjusted from -Rmb0.21 to -Rmb0.19 for 2025, from -Rmb0.06 to -Rmb0.05 for 2026, and a forecast of Rmb0.16 for 2027 [5]. - The target price has been raised from HK$10.0 to HK$11.8, indicating a 25% upside potential, and the company maintains a BUY rating [5].

Group 1 - The core viewpoint of the news is that 诺诚健华 (Nocera) has shown significant financial improvement in Q1, with a total revenue of 381 million yuan, representing a year-on-year increase of 129.92%, and a net profit of 17.97 million yuan, recovering from a loss of 142 million yuan in the same period last year [1] - The sales revenue of the core product, 奥布替尼 (Obinutuzumab), reached 311 million yuan, marking a year-on-year growth of 89.22% [1] - Management has raised the annual revenue growth forecast for 奥布替尼 from 30% to 35% year-on-year, anticipating that the contribution from the MZL indication will increase from 30% in 2024 to 50% in 2025 [1] Group 2 - 奥布替尼 has received approval for the 1L CLL/SLL indication in April, and the company is actively preparing for national negotiations regarding this indication [2] - The international PPMS trial (N=700+) is expected to enroll its first patient by the end of Q2, while the SPMS trial (N=900+) is anticipated to enroll its first patient by the end of Q3 or early Q4 [2] - The company aims to submit a market application for the ITP indication in China in the first half of 2026, with patient enrollment and follow-up expected to be completed this year [2]

Core Viewpoint - Nocera Biopharma (688428.SH) has reported its first profitable quarter since its IPO, indicating a positive trend in its operations with significant revenue and profit growth in Q1 2025 [1][2] Financial Performance - The company achieved a revenue of 381 million yuan in Q1 2025, representing a year-on-year increase of 129.92% [1] - The net profit attributable to shareholders was 17.97 million yuan, up 112.62% year-on-year [1] - The net profit excluding non-recurring items was 1.59 million yuan, reflecting a growth of 101.19% year-on-year [1] - Operating cash flow turned positive for the first time, amounting to 56.52 million yuan [1] Product Performance - Sales revenue from the core product, Obinutuzumab (brand name: Yinuokai), reached 311 million yuan in Q1 2025, marking an increase of 89.22% year-on-year [2] - The growth in sales is attributed to the inclusion of three major indications for Obinutuzumab in medical insurance, particularly for marginal zone lymphoma [2] Strategic Partnerships - Nocera Biopharma and Connoa announced a licensing agreement with Prolium Bioscience for the development and commercialization of the CD20×CD3 bispecific antibody ICP-B02 (CM355) [2] - The agreement includes potential payments of up to 520 million USD, covering upfront and milestone payments, along with royalties on future product sales [2] Research and Development - The company has committed significant resources to R&D, with investments of 649 million yuan, 757 million yuan, and 815 million yuan planned for 2022, 2023, and 2024 respectively [3] - A strategic cooperation framework and research cooperation agreement was signed with Westlake University to support innovative drug development, with funding of up to 54 million yuan allocated for joint projects [3] Cash Position - As of March 31, 2025, Nocera Biopharma held approximately 7.78 billion yuan in cash and cash equivalents, providing a strong financial foundation for accelerating pipeline project development [2]

Summary of the Conference Call for 诺诚健华 Company Overview - **Company**: 诺诚健华 (Nuo Cheng Jian Hua) - **Industry**: Biotechnology and Pharmaceuticals Key Financial Performance - **Q1 2025 Financials**: - Achieved a net profit of 0.14 billion RMB, a significant turnaround from a loss of 1.45 billion RMB in the same period last year [2][4] - Total revenue reached 3.81 billion RMB, a year-on-year increase of 129.92% [4] - Cash reserves stood at 77.78 billion RMB, providing a solid foundation for future R&D and market expansion [2][4] Product Development and Approvals - **Obinutuzumab (奥布替尼)**: - Approved for first-line treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), with expected growth over 35% for the year [2][8] - Revenue from Obinutuzumab reached 3.11 billion RMB, up 89.2% year-on-year [4] - **Mino-Kai (坦西妥单抗)**: - Received priority review for market approval, expected to fill unmet needs in diffuse large B-cell lymphoma treatment, with peak sales estimated at 0.5 to 1 billion RMB [2][21] - **ICP723 (NTRK Inhibitor)**: - Application for market approval accepted and prioritized, showing a total response rate of 85.5%, expected to be approved within a year [3][28] - **Self-immune Disease Pipeline**: - Advancements in clinical trials for PPMS and SPMS, with patient enrollment expected to start mid-2025 [6][12] - ITP phase III clinical trial expected to submit NDA in H1 2026 [6] Strategic Collaborations - **Partnership with Prologue**: - Global strategic cooperation worth 5.2 billion USD, with 8.75 million USD confirmed revenue in Q1 [7] R&D and Financial Metrics - **R&D Expenses**: - Q1 R&D expenses were approximately 208 million RMB, a 16.8% increase year-on-year, with an annual growth forecast of 15%-20% [2][9] - Gross margin improved to 90.5%, up from 85.4% year-on-year, attributed to increased sales of Obinutuzumab and reduced costs [9] Market Dynamics and Future Outlook - **Market Expansion**: - The company is focusing on expanding its market presence in the treatment of marginal zone lymphoma, with expectations of significant growth [24][38] - Plans to explore new indications and expand its pipeline, particularly in autoimmune diseases and ADC platforms [25][41] - **Impact of US Drug Pricing Reforms**: - Potential adjustments in US drug pricing could enhance the importance of the Chinese market for innovative drugs, with a diversified strategy for international expansion [18][19] Conclusion - **Future Growth**: - The company anticipates strong growth in 2025 and 2026, driven by new product launches and ongoing clinical trials [40][41] - Continued collaboration with research institutions to enhance R&D capabilities and expedite product development [41]

Investment Rating - The report maintains a "Buy" rating for the Hong Kong stock and a "Hold" rating for the A-share, with target prices set at HKD 11.7 and CNY 19.6 respectively [7][9][10]. Core Insights - The company's 1Q25 performance slightly exceeded expectations, with total revenue reaching CNY 381 million, representing a year-on-year increase of 129.9% and a quarter-on-quarter increase of 22.3% [7][10]. - The revenue from the drug Oubatinib was CNY 311 million, up 89.2% year-on-year and 1.2% quarter-on-quarter, leading to an upward revision of the annual revenue growth guidance for Oubatinib from 30% to 35% [7][10]. - The report highlights the strong sales growth of Oubatinib, driven by the increasing market share in the r/r CLL/SLL segment and the expansion of indications [7][10]. Financial Performance Summary - 1Q25 net profit attributable to shareholders was CNY 17.97 million, which is an improvement compared to previous losses, attributed to better-than-expected revenue and lower sales and administrative expenses [7][10]. - The gross margin for product sales improved to 88.4%, up from 85.3% in 1Q24 and 87% in 4Q24, indicating enhanced operational efficiency [7][10]. - The report projects significant revenue growth for the coming years, with expected revenues of CNY 1.45 billion in 2025, reflecting a 43.9% year-on-year increase [9][10]. Research and Development Progress - The company is advancing two TYK2 inhibitors, with ongoing clinical trials for ICP-332 and ICP-448, expected to yield important data in the coming years [7][10]. - Key upcoming catalysts include new indication approvals and significant data readouts for Oubatinib and other products [7][10]. Market Position and Valuation - The current market capitalization is approximately HKD 20.066 billion, with a recent average trading volume of HKD 121 million over the past three months [2][4]. - The stock has a 52-week price range of HKD 4.2 to HKD 11.0, indicating potential for growth based on the target price [2][4].

Core Insights - Nuo Cheng Jian Hua reported a significant revenue growth of 129.9% year-on-year for Q1 2025, reaching 380 million yuan, driven by the strong performance of its core product, Oubutini, and a licensing agreement with Prolium [1] - The revenue from Oubutini increased by 89.2% year-on-year to 310 million yuan, primarily due to the inclusion of three major indications in medical insurance and enhanced execution by the commercialization team [1] - The gross profit margin improved by 5.1 percentage points year-on-year to 90.5%, with a net profit of 14 million yuan for Q1 2025, marking a profitable quarter [1] - As of March 31, 2025, the company held approximately 7.78 billion yuan in cash and cash equivalents, which will support the acceleration of multiple Phase III clinical trials and investments in differentiated ADCs and other pipelines [1] Company Developments - The CEO, Dr. Cui Jisong, highlighted that 2025 marks the 10th anniversary of the company's development, celebrating a strong start in Q1 with breakthroughs in internationalization and sustained commercialization growth [2] - The company aims to enhance its innovation, commercialization, and internationalization efforts, accelerating multiple Phase III clinical studies in China and globally to benefit more patients [2]

Core Viewpoint - The company, Nuo Cheng Jian Hua, reported significant growth in Q1 2025, with a revenue increase of 129.92% year-on-year, driven primarily by the sales of its core product, Acalabrutinib (brand name: Ibrutinib) [1][4][5]. Financial Performance - Q1 2025 revenue reached 381 million yuan, up from 165.82 million yuan in the same period last year, marking a 129.92% increase [3]. - The net profit attributable to shareholders was 17.97 million yuan, a turnaround from a loss of 142.4 million yuan in the previous year [3]. - Gross margin improved to 90.5%, an increase of 5.1 percentage points year-on-year [1][3]. Product Performance - Acalabrutinib sales reached 311.67 million yuan in Q1 2025, reflecting a year-on-year growth of 89.22% [5]. - The product has received approval for its first-line treatment indication for chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) in adults, expected to enter medical insurance this year, which is anticipated to be a new growth driver for the company [4][6][7]. Research and Development - The company invested approximately 207.6 million yuan in R&D, which accounted for 54.45% of its revenue, a decrease of 52.73 percentage points compared to the previous year [3]. - Nuo Cheng Jian Hua aims to develop five to six innovative drugs over the next three to five years, with ongoing clinical trials for various indications [8][9]. Strategic Partnerships - The company signed a strategic cooperation framework agreement with Westlake University to enhance drug development and talent cultivation, with funding support not exceeding 54 million yuan [9]. - Nuo Cheng Jian Hua is actively exploring international collaborations and licensing agreements to expand its business beyond the Chinese market [9]. Financial Position - As of March 31, 2025, the company had cash and cash equivalents totaling approximately 4.84 billion yuan, with total liquid assets around 7.78 billion yuan [10].