Group 1 - The proposed sanctions by the Trump administration on innovative drugs have caused significant turmoil in the capital market, with the Hong Kong Hang Seng Biotechnology Index dropping by 7% at the opening, affecting leading companies like BeiGene and CSPC Pharmaceutical [1] - The National Medical Products Administration (NMPA) announced a reduction in the review and approval time for clinical trial applications to 30 working days, nearly halving the previous timeline, which has provided reassurance to the anxious market [1][8] - The U.S. aims to cut off the core profit path for Chinese innovative drugs through enhanced CFIUS reviews and increased FDA regulatory costs, while China is responding with accelerated approval processes and synchronized global research submissions [1][4] Group 2 - The Trump administration's draft executive order includes two main provisions targeting the key aspect of BD licensing for Chinese innovative drugs [2] - The first provision expands CFIUS reviews, requiring U.S. pharmaceutical companies to undergo mandatory safety reviews for acquiring rights to Chinese drugs in development, which could lead to longer transaction cycles and increased costs [3] - The second provision mandates more detailed FDA reviews of Chinese clinical data and higher regulatory fees for companies submitting trial data from China, raising the entry barriers for Chinese innovative drugs into the U.S. market [4] Group 3 - Data shows that the success rate for Chinese innovative drugs progressing from Phase I clinical trials to FDA approval is only 1.7%, highlighting the stringent nature of FDA approvals [4][6] - Currently, only two PD-1 inhibitors developed in China have received FDA approval, indicating the challenges faced by Chinese companies in the U.S. market [6] - The proposed U.S. measures may inadvertently strengthen the position of multinational corporations (MNCs) that are increasingly interested in Chinese innovative drugs due to their cost-effectiveness and high return on investment [7] Group 4 - The NMPA's recent policy to expedite clinical trial reviews is expected to significantly shorten the R&D cycle, enhancing China's attractiveness in the global R&D network and improving the bargaining power of local companies in international transactions [9][11] - The policy aims to create a more reliable domestic market as a "base" for innovative drug companies, especially when facing potential obstacles in international markets [9] - By 2025, the number of approved innovative drugs in China is projected to reach 43, with domestic drugs accounting for 93%, indicating a robust growth trajectory in the innovative drug sector [9][10] Group 5 - The Chinese government continues to support the development of innovative drugs through various policies, including the establishment of a comprehensive support system for R&D and payment mechanisms [10] - The introduction of a commercial health insurance directory for innovative drugs aims to provide new payment channels for high-value drugs, addressing the challenges of reimbursement under basic medical insurance [10] - The overall policy framework is designed to create a closed-loop system for the high-quality development of innovative drugs, enhancing clinical accessibility and stabilizing enterprise expectations [10][11]

Core Viewpoint - Heng Rui Medicine has made significant progress with two new drug approvals, including the first domestically developed EZH2 inhibitor for treating relapsed or refractory peripheral T-cell lymphoma and a new injection for long-term weight management [2][7][10]. Group 1: Drug Approvals - Heng Rui Medicine received conditional approval from the National Medical Products Administration for its innovative drug SHR2554 (Zemaitoside), which is the first domestically developed EZH2 inhibitor in China [2][7]. - SHR2554 is intended for adult patients with relapsed or refractory peripheral T-cell lymphoma (R/R PTCL) who have previously undergone at least one line of systemic therapy [7]. - The company’s subsidiary, Fujian Shengdi Pharmaceutical, has had its application for HRS9531 injection accepted, which is aimed at adult long-term weight management [4][7]. Group 2: Market Context and Financials - Peripheral T-cell lymphoma (PTCL) accounts for approximately 25% to 30% of non-Hodgkin lymphoma cases in China, with a median onset age of 52 years, indicating a younger patient demographic [7]. - The total R&D investment for SHR2554 has reached approximately 213 million yuan [7]. - HRS9531 is designed to regulate glucose and lipid metabolism, suppress appetite, and enhance insulin sensitivity, thereby improving blood sugar levels and aiding weight loss [4][8]. Group 3: Financial Performance - In the first half of 2025, Heng Rui Medicine reported revenue of 15.76 billion yuan, a year-on-year increase of 15.88%, with a net profit of 4.45 billion yuan, up 29.67% [10][11]. - The revenue from innovative drug sales and licensing reached 9.56 billion yuan, accounting for 60.66% of total revenue, with innovative drug sales alone amounting to 7.57 billion yuan [11]. - The company continues to invest heavily in R&D, with total R&D expenditures of 3.87 billion yuan in the reporting period [10].

Core Viewpoint - Heng Rui Medicine has achieved record high operating performance driven by its innovative drugs, with significant revenue and profit growth in the first half of 2025 [1][4]. Financial Performance - In the first half of 2025, Heng Rui Medicine reported revenue of 15.761 billion yuan, a year-on-year increase of 15.88%, and a net profit attributable to shareholders of 4.450 billion yuan, up 29.67% [1][4]. - The company has maintained a three-year trend of increasing both revenue and net profit since the mid-2023 [2]. - The revenue from innovative drug sales and licensing reached 9.561 billion yuan, accounting for 60.66% of total revenue [2][7]. - Quarterly performance showed revenue of 7.206 billion yuan and 8.556 billion yuan for Q1 and Q2 respectively, with year-on-year growth of 20.14% and 12.53% [5][6]. Innovation and R&D - Heng Rui Medicine has significantly increased its R&D investment, totaling 3.871 billion yuan in the first half of 2025, which is 24.56% of its revenue [2][10]. - The company ranks second globally in the number of self-developed drug pipelines [3][12]. - Heng Rui has submitted five new drug applications in the first half of 2025 and has over 100 self-innovated products in clinical development [10]. Licensing and International Expansion - The company has achieved notable success in international markets, receiving upfront payments of 200 million USD from Merck Sharp & Dohme and 75 million USD from IDEAYA, contributing to revenue growth [2][7]. - Innovative drug licensing has become a regular business for Heng Rui, significantly impacting its revenue structure [7]. Market Position and Future Outlook - Heng Rui Medicine aims to establish itself as a leading innovative pharmaceutical company rooted in China with a highly differentiated product matrix [10]. - The company is focused on addressing unmet medical needs across various therapeutic areas, including oncology, metabolic diseases, and immunology [12].

Core Viewpoint - Heng Rui Medicine has entered a period of significant growth driven by innovative drug sales, with strong financial performance in the first half of 2025 [2][3] Financial Performance - In the first half of 2025, the company achieved operating revenue of 15.761 billion yuan, a year-on-year increase of 15.88% - Net profit attributable to shareholders reached 4.450 billion yuan, up 29.67% year-on-year - Operating cash flow net amount was 4.300 billion yuan, reflecting a growth of 41.80% year-on-year [2] Innovation and R&D Investment - The company has maintained high R&D investment, totaling 3.871 billion yuan in the first half of 2025, with 3.228 billion yuan classified as expensed R&D [5] - Cumulative R&D investment has exceeded 48 billion yuan, supporting a surge in innovative results [5] - Six class 1 innovative drugs were approved for market launch during the reporting period, along with multiple new indications for existing drugs [5][6] Sales and Licensing of Innovative Drugs - Innovative drug sales and licensing revenue reached 9.561 billion yuan, accounting for 60.66% of total operating revenue, with innovative drug sales alone at 7.570 billion yuan [3] - The company received significant licensing fees, including 200 million USD from Merck and 75 million USD from IDEAYA, contributing to revenue growth [3] International Collaboration and Expansion - The company has strengthened international cooperation, granting exclusive rights for certain drugs to global partners, including a 200 million USD upfront payment from Merck for HRS-5346 [7] - A collaboration with GSK was established to co-develop up to 12 innovative drugs, with an upfront payment of 500 million USD and potential total payments of around 12 billion USD [8]

Core Insights - The company reported a revenue of approximately RMB 15.761 billion for the first half of 2025, representing a year-on-year growth of 15.9% [1] - Net profit attributable to shareholders was RMB 4.45 billion, reflecting a year-on-year increase of 29.7% [1] - Basic earnings per share were RMB 0.70 [1] Revenue Breakdown - The growth in revenue and profit was primarily driven by increased sales and licensing income from innovative drugs, which amounted to RMB 9.561 billion, a year-on-year increase of 26.8%, accounting for 60.7% of total revenue [1] - Sales revenue from innovative drugs reached RMB 7.57 billion [1] Innovative Drug Performance - Key innovative drugs such as Rivoceranib, Darsylin, and Henggrelizumab have effectively addressed unmet clinical needs, with strong clinical data gaining recognition from doctors and patients, leading to continued rapid revenue growth [1] - Earlier launched innovative drugs like Arixtra, Remimazolam, Pyrotinib, and Fluorouracil have expanded their application scope due to accumulating post-market research evidence and new indications, contributing to sales revenue [1] - Other innovative products like Apatinib, Sulfapyridine, and Hecuqipob have also seen growth during the reporting period [1] Licensing Income - The company recognized licensing income as a regular business activity, with significant payments received from Merck Sharp & Dohme (USD 200 million) and IDEAYA Biosciences (USD 75 million), further boosting operational performance [2] Generic Drug Performance - Although sales revenue from generic drugs included in centralized procurement experienced a slight decline, high-quality generic products such as Liposomal Bupivacaine and the first approved generic product of Albumin-bound Paclitaxel in the U.S. saw rapid revenue growth, leading to a slight overall increase in generic drug business revenue [2]

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，並明確表示概不就因本公告全部或任何部分內容所產生或因依賴 該等內容而引致的任何損失承擔任何責任。 Jiangsu Hengrui Pharmaceuticals Co., Ltd. 江蘇恒瑞醫藥股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：1276） 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第13.10B條刊發。 根據中華人民共和國的有關法例規定，江蘇恒瑞醫藥股份有限公司（「本公司」）在 上海證券交易所網站( www.sse.com.cn )刊發了以下公告。茲載列如下，僅供參閱。 承董事會命 江蘇恒瑞醫藥股份有限公司 董事長 孫飄揚先生 中國上海 2025年8月20日 於本公告日期，董事會成員包括(i)執行董事孫飄揚先生、戴洪斌先生、馮佶女 士、張連山先生、江寧軍先生及孫杰平先生；(ii)非執行董事郭叢照女士；及(iii) 獨立非執行董事董家鴻先生、曾慶生先生、孫金雲先生及周紀恩先生。 江苏恒瑞医药股份有限公司 2025 年半年度报告 公司代码：600276 ...

Core Viewpoint - Heng Rui Pharmaceutical's recent IPO in Hong Kong marks a significant step towards internationalization, raising approximately 9.89 billion HKD, making it the largest domestic pharmaceutical IPO of the year [3][4]. Group 1: Company Overview - Heng Rui Pharmaceutical has been a leader in China's innovative drug sector, with a strong focus on international operations through licensing agreements, contributing significantly to its revenue [3][4]. - The company has completed 14 licensing agreements for innovative drugs, with 9 of these occurring in the last three years, indicating a rapid acceleration in its international expansion efforts [3][10]. Group 2: Market Challenges - The implementation of national drug procurement policies since 2016 has significantly impacted Heng Rui's revenue, particularly affecting its generics business, which accounted for 82% of its revenue in 2019 [8][9]. - The average price drop for drugs that entered procurement has exceeded 50%, leading to substantial revenue declines for Heng Rui, which saw its revenue peak at 27.735 billion CNY in 2020 before experiencing consecutive declines [9][16]. Group 3: Strategic Transformation - In response to market pressures, Heng Rui has shifted its focus towards innovative drugs, with the proportion of innovative drug revenue rising to 46.6% in 2023, surpassing 10 billion CNY for the first time [10][24]. - The company has significantly reduced its generics R&D projects, focusing instead on innovative drugs, with 57 clinical approvals for innovative drugs compared to only 1 for generics in 2024 [24][25]. Group 4: Financial Performance - Heng Rui's revenue dropped by 6.59% in 2021, marking its first decline post-IPO, largely due to the impact of procurement policies [16][18]. - The company's net profit increased by 32.98% in 2024, attributed to recognizing a 1.6 billion EUR upfront payment from Merck for licensing agreements [59]. Group 5: Internationalization Strategy - Heng Rui's internationalization strategy includes various approaches such as direct licensing and joint development with foreign companies, aiming to enhance its global market presence [57][58]. - The company has engaged in several business development (BD) transactions, including a notable partnership with Merck, which could yield significant future revenues [59][60]. Group 6: Competitive Landscape - The competitive landscape for innovative drugs is intensifying, with rivals like BeiGene achieving significant sales milestones, highlighting the need for Heng Rui to innovate and differentiate its product offerings [28][31]. - Heng Rui's leading product, the PD-1 inhibitor, has faced pricing pressures due to increased competition, necessitating ongoing investment in marketing and physician education to maintain market share [35][36].

Core Viewpoint - Heng Rui Medicine has successfully listed on the Hong Kong Stock Exchange, raising approximately HKD 98.9 billion, marking the largest pharmaceutical IPO in China this year. This move is seen as a significant step towards internationalization for the company [2]. Group 1: Company Overview - Heng Rui Medicine is recognized as a leading company in China's innovative drug sector, with a strong pipeline of products. The company has primarily relied on licensing agreements for international expansion, with 14 licensing deals completed, 9 of which occurred in the last three years [2][3]. - The company has not engaged in any financing activities since its A-share IPO in 2000, making this recent listing a notable event in its history [3]. Group 2: Impact of Policy Changes - The implementation of national drug procurement policies since 2016 has significantly impacted Heng Rui's operations, particularly affecting its revenue from generic drugs, which constituted 82% of its income in 2019 [7][8]. - The average price drop for drugs that have undergone procurement has exceeded 50%, creating substantial pressure on the company's profitability [7][21]. Group 3: Financial Performance - Following a peak revenue of CNY 27.735 billion in 2020, Heng Rui's income has declined for two consecutive years due to procurement policies, but it began to stabilize in 2023 [8]. - The company's revenue from innovative drugs has increased to 46.6% of total revenue in 2023, surpassing CNY 10 billion for the first time [8][27]. Group 4: Strategic Transformation - Heng Rui has shifted its focus from generic drugs to innovative drug development, significantly reducing its generic drug projects and increasing its innovative drug pipeline [27][29]. - The company has established research centers globally to monitor trends and gather patent information, although it lacks a standout blockbuster product [36]. Group 5: International Expansion Strategies - Heng Rui's international strategy includes three main approaches: self-expansion, direct licensing, and joint ventures. The company has increasingly opted for direct licensing to reduce costs and risks [57][65]. - Recent licensing agreements have generated significant upfront payments, such as a EUR 160 million deal with Merck, contributing to a 32.98% increase in net profit in 2024 [66]. Group 6: Challenges and Future Outlook - The company faces challenges in the competitive landscape of innovative drugs, particularly in the PD-1 market, where it must navigate pricing pressures and market acceptance [40][43]. - Heng Rui's recent foray into NewCo transactions, which involve complex asset and equity financing, indicates a strategic pivot towards leveraging external capital for growth [68][69].

Investment Rating - The report maintains a "Buy" rating for the company [5] Core Views - The company is expected to achieve an EPS of 1.06/1.17 CNY for 2025-26, with a new forecast of 1.42 CNY for 2027. The target price is set at 56.18 CNY based on a PE ratio of 53 for 2025 [2] - The company reported a significant revenue increase of 22.63% year-on-year for 2024, reaching 27.985 billion CNY, and a net profit increase of 47.28%, totaling 6.337 billion CNY [9] - The company is actively advancing its internationalization efforts, with several products receiving FDA approval and significant licensing agreements contributing to revenue growth [9] Financial Information Summary - Revenue (in million CNY): - 2023A: 22,820 - 2024A: 27,985 (22.6% YoY growth) - 2025E: 31,684 (13.2% YoY growth) - 2026E: 35,553 (12.2% YoY growth) - 2027E: 40,900 (15.0% YoY growth) [4] - Net Profit (in million CNY): - 2023A: 4,302 - 2024A: 6,337 (47.3% YoY growth) - 2025E: 6,759 (6.7% YoY growth) - 2026E: 7,477 (10.6% YoY growth) - 2027E: 9,060 (21.2% YoY growth) [4] - EPS (in CNY): - 2023A: 0.67 - 2024A: 0.99 - 2025E: 1.06 - 2026E: 1.17 - 2027E: 1.42 [4] - Gross Margin: - 2023A: 84.6% - 2024A: 86.2% - 2025E: 84.5% - 2026E: 84.9% - 2027E: 85.4% [4] - Net Margin: - 2023A: 18.9% - 2024A: 22.6% - 2025E: 21.3% - 2026E: 21.0% - 2027E: 22.2% [4]

Investment Rating - The report maintains a "Buy" rating for the company [5] Core Views - The company is expected to achieve an EPS of 1.06/1.17 CNY for 2025-26, with a new forecast of 1.42 CNY for 2027. The target price is set at 56.18 CNY based on a PE ratio of 53 for 2025 [2] - The company reported a significant revenue increase of 22.63% year-on-year for 2024, reaching 27.985 billion CNY, and a net profit increase of 47.28%, totaling 6.337 billion CNY [9] - The company is actively advancing its internationalization efforts, with several products receiving FDA approval and significant licensing agreements contributing to revenue growth [9] Financial Information Summary - Revenue (in million CNY): - 2023A: 22,820 - 2024A: 27,985 (22.6% YoY growth) - 2025E: 31,684 (13.2% YoY growth) - 2026E: 35,553 (12.2% YoY growth) - 2027E: 40,900 (15.0% YoY growth) [4] - Net Profit (in million CNY): - 2023A: 4,302 - 2024A: 6,337 (47.3% YoY growth) - 2025E: 6,759 (6.7% YoY growth) - 2026E: 7,477 (10.6% YoY growth) - 2027E: 9,060 (21.2% YoY growth) [4] - EPS (in CNY): - 2023A: 0.67 - 2024A: 0.99 - 2025E: 1.06 - 2026E: 1.17 - 2027E: 1.42 [4] - Gross Margin: - 2023A: 84.6% - 2024A: 86.2% - 2025E: 84.5% - 2026E: 84.9% - 2027E: 85.4% [4] - Net Margin: - 2023A: 18.9% - 2024A: 22.6% - 2025E: 21.3% - 2026E: 21.0% - 2027E: 22.2% [4]