Macro Commentary - The US economy shows signs of slowing down, with significant declines in retail and manufacturing output due to tariff impacts, particularly affecting durable goods like automobiles and electronics [2] - Despite the slowdown, unemployment claims remain stable, indicating that the service sector is less affected, and employment in this sector remains robust [2] - Inflation is expected to rebound temporarily from May to August, with the Federal Reserve likely to maintain interest rates until September, when a potential rate cut may occur [2] Industry Commentary - The Chinese pharmaceutical sector is experiencing a strong trend in innovative drug exports, with several significant business development transactions occurring despite recent tariff tensions [5][6] - The MSCI China Healthcare Index has risen by 14.9% since early 2025, although it has underperformed compared to the broader MSCI China Index [5] - The US innovative drug prices are unlikely to decrease in the short term due to recent executive orders, but long-term pressures on healthcare spending are anticipated [7] Company Initiation - The report covers Angelalign Technology (6699 HK), a leading provider of invisible orthodontic solutions in China, which has maintained a market share of 42% in the domestic market [9][10] - The company is expected to achieve a revenue compound annual growth rate (CAGR) of 23.8% from 2019 to 2024, with a projected CAGR of 18.0% from 2024 to 2027 [9] - Angelalign is expanding internationally, with a goal to cover over 50 countries and achieve significant revenue growth from overseas markets, which is expected to account for 30% of total revenue by 2024 [11][12]

InnoCare Pharma (9969.HK) Earnings Review Summary Company Overview - **Company**: InnoCare Pharma (9969.HK) - **Industry**: Biotechnology Key Financial Highlights - **1Q Sales Performance**: - Orelabrutinib sales reached Rmb312 million, representing an increase of 89% year-over-year and a slight increase of 1.5% quarter-over-quarter, outperforming expectations [1] - Sales growth driven by volume expansion in Marginal Zone Lymphoma (MZL) due to National Reimbursement Drug List (NRDL) coverage and market share gains in relapsed/refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) and Mantle Cell Lymphoma (MCL) [1] - **Profitability**: - The company turned profitable in 1Q with earnings of Rmb18 million compared to a net loss of Rmb165 million in 4Q24 [1] - **Gross Margin**: - Improved to 88.4% from 85.3% in 1Q24 and 86.8% in 4Q24, attributed to product scale-up [1] - **Expenses**: - Selling expenses increased by 27% year-over-year, but selling expenses as a percentage of total sales decreased to 37% from 47% in 4Q24 [1] - R&D expenses rose by 17% year-over-year as more assets progressed to pivotal stages [1] - **Cash Position**: - As of 1Q25, the company holds a cash balance of Rmb7.8 billion, providing flexibility for global development and in-licensing opportunities [1] Sales Guidance and Forecasts - **Revised Sales Guidance**: - Management raised sales guidance for Orelabrutinib to over 35% year-over-year growth in 2025, up from the previous estimate of 30% [1] - **Future Sales Growth**: - Sales growth in 2026 may depend on the magnitude of price cuts for Orelabrutinib in the 2025 NRDL revision [1] Clinical Development Updates - **Global Trial Acceleration**: - The company is accelerating global clinical trials for selected assets, including: - ICP-332 (TYK2-JH1) for prurigo nodularis, with phase 2 studies starting in 1H25 [2] - Orelabrutinib's phase 3 global trials for Primary Progressive Multiple Sclerosis (PPMS) and Secondary Progressive Multiple Sclerosis (SPMS) set to begin in mid-2025 [2] - NDA filing for MCL in regions outside the US, such as Singapore [2] - Focus on Acute Myeloid Leukemia (AML) for mesuloclax (BCL2) global development [2] Potential Catalysts - **Upcoming Data Releases**: - Expected phase 2b data for Orelabrutinib in Systemic Lupus Erythematosus (SLE) by the end of 2025 [3] - Phase 2 data for ICP-332 in vitiligo anticipated by mid-2026 [3] - Preliminary clinical data for the company's first Antibody-Drug Conjugate (ADC), ICP-B794 (B7-H3), expected by the end of 2025 or early 2026 [6] Price Target and Risks - **Price Target**: - 12-month target price set at HK$12.72 for H shares and Rmb23.10 for A shares, reflecting a potential upside of 33.9% and 13.5% respectively [7][9] - **Key Risks**: - R&D risks for key clinical assets, lack of proven commercialization track record, pricing uncertainties, and potential entry of generic ibrutinib in 2027 in China [8] Conclusion InnoCare Pharma shows strong sales growth and improved profitability in 1Q, with a solid cash position to support ongoing clinical development. The revised sales guidance and upcoming clinical data releases present potential catalysts for future growth, although risks remain in R&D and market competition.

Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Insights - The company's core product, Acalabrutinib, has shown strong sales growth, leading to an upward revision of the annual sales guidance to 3.5 billion yuan [6] - In 2024, the company achieved revenue of 1.009 billion yuan, a year-on-year increase of 36.68%, while the net profit attributable to the parent company was -440 million yuan [6] - For Q1 2025, the company reported revenue of 381 million yuan, a year-on-year increase of 129.92% and a quarter-on-quarter increase of 22.32%, marking a return to profitability [6] - The company has adjusted its revenue forecasts for 2025-2027, expecting revenues of 1.47 billion, 1.79 billion, and 2.21 billion yuan respectively, with year-on-year growth rates of 45.7%, 21.7%, and 23.3% [6] Sales Performance - The core product Acalabrutinib achieved sales revenue of approximately 1 billion yuan in 2024, representing a year-on-year growth of 49.14% [6] - In Q1 2025, Acalabrutinib's sales revenue reached 311 million yuan, a year-on-year increase of 89.22% [6] Product Pipeline and Internationalization - The company is focusing on building a product matrix in the hematology field centered around Acalabrutinib, with multiple new indications approved and in clinical trials [7][8] - Acalabrutinib received approval for new indications in April 2025 and is expected to rapidly expand in the market due to its inclusion in medical insurance [7] - The company is actively exploring international collaborations and licensing agreements for its important pipelines, including a dual antibody product developed in collaboration with Connoa [8] Financial Summary and Valuation Metrics - The company’s projected revenues for 2025, 2026, and 2027 are 1.47 billion, 1.79 billion, and 2.21 billion yuan respectively, with corresponding P/S ratios of 25.1, 20.6, and 16.7 [10] - The gross margin is expected to remain high, with projections of 87.3% in 2025 and 87.1% in 2027 [10] - The net profit margin is projected to improve from -23.2% in 2025 to -17.5% in 2027 [10]

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]