Core Viewpoint - The company, Lai Kai Pharmaceutical-B, reported a significant increase in other income and a reduction in losses for the first half of 2025, driven by government subsidies and ongoing clinical trials for its drug candidates targeting metabolic diseases and cancer [1]. Financial Performance - Other income for the first half of 2025 reached RMB 19.9 million, representing a year-on-year increase of 41.1% due to increased government subsidies [1]. - As of June 30, 2025, the company's cash and bank balance amounted to RMB 743.8 million [1]. Clinical Development - The company is focused on developing new therapies for metabolic diseases, cancer, and liver fibrosis, with seven clinical trials initiated for drug candidates LAE102, LAE002 (afuresertib), LAE001, and LAE005 [1]. - In the cancer sector, the company has established a comprehensive portfolio of drug candidates, including LAE002 (afuresertib), which is a potent AKT inhibitor targeting breast and prostate cancers [3]. Research and Development Team - The company has a skilled management team with extensive experience across the entire drug discovery and development cycle, supported by a research team of 60 employees, including 11 PhD holders and 33 master's degree holders [1]. Drug Candidates and Mechanism - LAE102 is positioned as a candidate drug for weight control by promoting muscle regeneration and fat reduction through the inhibition of the Activin-ActRII pathway [2]. - The company is also developing additional candidates, including LAE103 and LAE123, which are selective antibodies targeting ActRII receptors for muscle and other disease indications [2]. Strategic Partnerships - The company plans to seek strategic partnerships to accelerate the development and commercialization of its drug candidates, addressing significant unmet medical needs [3].

[Business Summary](index=1&type=section&id=%E6%A5%AD%E5%8B%99%E6%91%98%E8%A6%81) The company achieved significant clinical progress with its core products and anticipates key milestones in the latter half of 2025 [Clinical Trial Progress](index=1&type=section&id=%E8%87%A8%E5%BA%8A%E8%A9%A6%E9%A9%97%E9%80%B2%E5%B1%95) The company achieved significant clinical progress during the reporting period, advancing core products LAE102 (obesity) and LAE002 (afuresertib) in various clinical trials, alongside preclinical candidates - The self-developed obesity drug LAE102 (an ActRIIA-targeting monoclonal antibody) successfully completed its Phase I SAD study in China, demonstrating **good tolerability**, **no serious adverse events**, and **sustained pathway blockade**, laying the foundation for further development[4](index=4&type=chunk)[5](index=5&type=chunk) - The company entered a clinical collaboration with **Eli Lilly** to accelerate LAE102's global development, with Lilly responsible for and bearing the costs of the US Phase I clinical trial, where the **first subject was dosed in May 2025**[7](index=7&type=chunk) - The Phase III clinical trial AFFIRM–205 of LAE002 (afuresertib) combined with fulvestrant for HR+/HER2- breast cancer is ongoing in China, with patient enrollment planned for completion by **Q4 2025** and an NDA submission targeted for **H1 2026**[11](index=11&type=chunk) - The company has established a comprehensive ActRII product portfolio, including LAE103 (ActRIIB selective antibody) and LAE123 (ActRIIA/IIB dual antagonist antibody) in addition to LAE102, actively advancing their clinical research for muscle and other diseases[8](index=8&type=chunk)[10](index=10&type=chunk) [LAE102 for Obesity, Phase I](index=1&type=section&id=LAE102%E6%B2%BB%E7%99%82%E8%82%A5%E8%83%96%E7%97%87%EF%BC%8CI%E6%9C%9F) - In the China Phase I SAD study, LAE102 demonstrated **good tolerability** after intravenous (IV) and subcutaneous (SC) administration, with no serious adverse events or treatment-discontinuing adverse events reported[5](index=5&type=chunk) - The Phase I multiple ascending dose (MAD) study was initiated in China in **March 2025**, and the first subject was dosed in the US Phase I clinical trial in collaboration with Eli Lilly in **May 2025**[6](index=6&type=chunk)[7](index=7&type=chunk) [LAE002 (afuresertib) + Fulvestrant for HR+/HER2– Breast Cancer, Phase III](index=3&type=section&id=LAE002%20%28afuresertib%29%20%2B%E6%B0%9F%E7%B6%AD%E5%8F%B8%E7%BE%A4%E6%B2%BB%E7%99%82HR%2B%2FHER2%E2%80%93%20%E4%B9%B3%E8%85%BA%E7%99%8C%EF%BC%8CIII%E6%9C%9F) - The AFFIRM–205 Phase III clinical trial was initiated in China in **May 2024**, with ongoing recruitment targeting completion by **Q4 2025**[11](index=11&type=chunk) [LAE002 (afuresertib) + LAE001/Prednisone for mCRPC, Phase II](index=4&type=section&id=LAE002%20%28afuresertib%29%20%2B%20LAE001%E2%88%95%E6%BD%91%E5%B0%BC%E6%9D%BE%E6%B2%BB%E7%99%82mCRPC%2C%20II%E6%9C%9F) - The international multi-center Phase II clinical trial completed in **2024** showed a median radiographic progression-free survival (rPFS) of **8.1 months**, a significant improvement over the 2-4 months for standard therapy, with the combination therapy being well-tolerated[12](index=12&type=chunk) - The company has received **US FDA approval** for the Phase III clinical trial protocol for this indication and plans to seek strategic partners to accelerate development and commercialization[13](index=13&type=chunk) [Preclinical Candidate Drugs (PCC)](index=4&type=section&id=%E8%87%A8%E5%BA%8A%E5%89%8D%E5%80%99%E9%81%B8%E8%97%A5%E7%89%A9%28PCC%29) - The IND application for LAE103 was submitted to the US FDA in **June 2025**, with a Phase I clinical study planned for initiation in **H2 2025**; LAE123 is projected to advance to Phase I clinical trials in **2026**[14](index=14&type=chunk) - In oncology, the USP1 inhibitor LAE120 received **FDA approval** for clinical trials in **February 2025**, and the WRN inhibitor LAE122 completed PCC confirmation in **March 2025**[14](index=14&type=chunk) [Expected Milestones in H2 2025](index=4&type=section&id=2025%E5%B9%B4%E4%B8%8B%E5%8D%8A%E5%B9%B4%E7%9A%84%E9%A0%90%E6%9C%9F%E9%87%8C%E7%A8%8B%E7%A2%91) The company anticipates key milestones in H2 2025, including announcing LAE102 Phase I results, completing AFFIRM–205 patient enrollment, and initiating LAE103 Phase I clinical studies - LAE102: Expected to announce **topline results** from the China Phase I MAD study and US Phase I clinical trial[15](index=15&type=chunk) - AFFIRM–205: Expected to complete **subject enrollment** for the China Phase III trial[16](index=16&type=chunk) - Other ActRII-targeted drugs: Expected to initiate **LAE103 Phase I clinical study**[17](index=17&type=chunk) [Financial Summary and Statements](index=5&type=section&id=%E8%B2%A1%E5%8B%99%E6%91%98%E8%A6%81%E8%88%87%E5%A0%B1%E8%A1%A8) This section details the company's financial performance, position, and cash flows for the reporting period, highlighting key changes in expenses and liquidity [Financial Summary](index=5&type=section&id=%E8%B2%A1%E5%8B%99%E6%91%98%E8%A6%81) For the six months ended June 30, 2025, R&D expenses decreased by 16.6% to RMB 105.2 million due to prior-period milestone payments, while administrative expenses increased by 39.1% to RMB 42.3 million, narrowing the period's loss to RMB 129.6 million Financial Summary (For the six months ended June 30) | Metric | 2025 (RMB '000) | 2024 (RMB '000) | Y-o-Y Change | | :--- | :--- | :--- | :--- | | R&D Expenses | 105,192 | 126,148 | -16.6% | | Administrative Expenses | 42,321 | 30,380 | +39.1% | | Loss for the Period | 129,637 | 143,706 | -9.8% | | Total Comprehensive Loss for the Period | 133,399 | 138,548 | -3.7% | - The decrease in R&D expenses was primarily due to a **RMB 17.8 million** milestone payment related to the AFFIRM-205 Phase III clinical trial in H1 2024, with no such expenses in the current reporting period[19](index=19&type=chunk) - The increase in administrative expenses was mainly attributable to higher **equity-settled share-based payment expenses**[20](index=20&type=chunk) [Consolidated Statement of Profit or Loss and Other Comprehensive Income](index=6&type=section&id=%E7%B6%9C%E5%90%88%E6%90%8D%E7%9B%8A%E5%8F%8A%E5%85%B6%E4%BB%96%E5%85%A8%E9%9D%A2%E6%94%B6%E7%9B%8A%E8%A1%A8) During the period, other income grew 40.7% to RMB 19.91 million, operating loss narrowed to RMB 127.6 million from RMB 142.4 million, and net loss was RMB 129.6 million, with basic and diluted loss per share at RMB 0.35 Key Items from Consolidated Statement of Profit or Loss (For the six months ended June 30) | Item | 2025 (RMB '000) | 2024 (RMB '000) | | :--- | :--- | :--- | | Other Income | 19,908 | 14,149 | | Administrative Expenses | (42,321) | (30,380) | | R&D Expenses | (105,192) | (126,148) | | Loss from Operations | (127,605) | (142,383) | | Loss Before Tax | (129,637) | (143,706) | | Loss for the Period | (129,637) | (143,706) | | Basic and Diluted Loss Per Share (RMB) | (0.35) | (0.40) | [Consolidated Statement of Financial Position](index=7&type=section&id=%E7%B6%9C%E5%90%88%E8%B2%A1%E5%8B%99%E7%8B%80%E6%B3%81%E8%A1%A8) As of June 30, 2025, the company reported total assets of RMB 913.4 million, total liabilities of RMB 200.6 million, and net assets of RMB 712.9 million, with cash and cash equivalents increasing to RMB 676.6 million Key Items from Consolidated Statement of Financial Position | Item | As of June 30, 2025 (RMB '000) | As of Dec 31, 2024 (RMB '000) | | :--- | :--- | :--- | | **Assets** | | | | Non-current Assets | 151,048 | 146,636 | | Current Assets | 762,362 | 813,401 | | Of which: Cash and Cash Equivalents | 676,562 | 636,422 | | **Liabilities and Equity** | | | | Current Liabilities | 194,705 | 148,473 | | Non-current Liabilities | 5,849 | 6,772 | | Net Assets | 712,856 | 804,792 | | Total Equity | 712,856 | 804,792 | [Condensed Consolidated Statement of Cash Flows](index=8&type=section&id=%E7%B0%A1%E6%98%8E%E7%B6%9C%E5%90%88%E7%8F%BE%E9%87%91%E6%B5%81%E9%87%8F%E8%A1%A8) Net cash outflow from operating activities significantly decreased to RMB 74.15 million, while investing activities generated RMB 105.9 million net cash inflow, and financing activities generated RMB 10.84 million, increasing period-end cash and cash equivalents to RMB 674.5 million Condensed Consolidated Statement of Cash Flows (For the six months ended June 30) | Item | 2025 (RMB '000) | 2024 (RMB '000) | | :--- | :--- | :--- | | Net Cash Used in Operating Activities | (74,149) | (143,382) | | Net Cash From Investing Activities | 105,926 | 101,835 | | Net Cash From Financing Activities | 10,841 | 5,575 | | Net Increase/(Decrease) in Cash and Cash Equivalents | 42,618 | (35,972) | | Cash and Cash Equivalents at Beginning of Period | 634,323 | 440,815 | | Cash and Cash Equivalents at End of Period | 674,542 | 407,331 | [Management Discussion and Analysis](index=17&type=section&id=%E7%AE%A1%E7%90%86%E5%B1%A4%E8%A8%8E%E8%AB%96%E5%8F%8A%E5%88%86%E6%9E%90) This section provides an overview of the company's strategic pipeline, financial performance, liquidity, and future development plans, including the use of proceeds [Overview and Pipeline Review](index=17&type=section&id=%E6%A6%82%E8%A7%88%E8%88%87%E7%AE%A1%E7%B7%9A%E5%9B%9E%E9%A1%A7) The company is a science-driven clinical-stage biopharmaceutical firm focused on metabolic diseases, cancer, and liver fibrosis, actively advancing its ActRII product portfolio and AKT inhibitor afuresertib through clinical trials and strategic partnerships - The company has established a comprehensive ActRII product portfolio in the metabolic field, with LAE102 showing promise as a potential drug for **muscle-preserving weight loss**[51](index=51&type=chunk) - In oncology, the core product LAE002 (afuresertib) is one of only two AKT inhibitors globally in late-stage clinical development for breast and prostate cancer, with a **Phase III pivotal study initiated in China**[52](index=52&type=chunk) - The Phase II trial of LAE002 combined with LAE001 for mCRPC showed a median rPFS of **8.1 months**, significantly outperforming standard therapy[68](index=68&type=chunk) - In the Phase I trial of LAE002 combined with LAE005 and chemotherapy for triple-negative breast cancer (TNBC), the objective response rate (ORR) was **35.7%**, and the disease control rate (DCR) was **64.3%**[74](index=74&type=chunk) [Financial Review](index=24&type=section&id=%E8%B2%A1%E5%8B%99%E5%9B%9E%E9%A1%A7) During the period, other income increased by 41.1% due to government grants, administrative expenses rose by 39.1% from equity-settled share-based payments, and R&D expenses decreased by 16.6% primarily due to the absence of prior-period milestone payments R&D Expense Breakdown (For the six months ended June 30) | Item | 2025 (RMB '000) | 2024 (RMB '000) | | :--- | :--- | :--- | | Staff Costs | 41,806 | 34,580 | | R&D Research Expenses | 30,392 | 13,140 | | Clinical Development Expenses | 28,052 | 54,417 | | Clinical Trial Milestone Payments | – | 17,758 | | Other | 4,942 | 6,253 | | **Total** | **105,192** | **126,148** | [Liquidity and Financial Resources](index=25&type=section&id=%E6%B5%81%E5%8B%95%E8%B3%87%E9%87%91%E5%8F%8A%E8%B2%A1%E5%8B%99%E8%B3%87%E6%BA%90) As of June 30, 2025, the company held RMB 743.8 million in cash and bank balances, with current assets of RMB 762.4 million and current liabilities of RMB 194.7 million, resulting in a current ratio of 3.92 and a net cash position - As of June 30, 2025, cash and cash equivalents were **RMB 676.6 million**, a **6.3% increase** from **RMB 636.4 million** at the end of 2024[81](index=81&type=chunk) - As of June 30, 2025, the current ratio was **3.92**, compared to **5.48** as of December 31, 2024[85](index=85&type=chunk) - The company is in a **net cash position**, thus the debt-to-asset ratio is not applicable[86](index=86&type=chunk) [Use of Net Proceeds](index=27&type=section&id=%E6%89%80%E5%BE%97%E6%AC%BE%E9%A0%8D%E6%B7%A8%E9%A1%8D%E7%94%A8%E9%80%94) The company detailed the use of net proceeds from its global offering and placing, with HKD 489.8 million utilized from the HKD 724.4 million global offering and HKD 51.6 million from the HKD 230.4 million November 2024 placing, primarily for LAE102 and ActRII drug R&D Use of Net Proceeds from Global Offering (As of June 30, 2025) | Intended Use | Allocated Amount (HKD Million) | Cumulative Utilized (HKD Million) | Unutilized Amount (HKD Million) | | :--- | :--- | :--- | :--- | | Core Product Clinical Development | 407.8 | 269.7 | 138.1 | | Other Pipeline Product R&D | 150.7 | 144.4 | 6.3 | | Enhance Production Capacity and Manufacturing Capabilities | 71.7 | 4.9 | 66.8 | | Business Development Activities | 55.1 | 26.7 | 28.4 | | Working Capital and Other | 39.1 | 39.1 | – | Use of Net Proceeds from Placing (As of June 30, 2025) | Intended Use | Allocated Amount (HKD Million) | Cumulative Utilized (HKD Million) | Unutilized Amount (HKD Million) | | :--- | :--- | :--- | :--- | | Accelerate LAE102 and ActRII Drug R&D | 230.4 | 51.6 | 178.7 | [Future Developments](index=30&type=section&id=%E6%9C%AA%E4%BE%86%E7%99%BC%E5%B1%95) The company plans to expand its metabolic and oncology portfolios, focusing on ActRII product development, aiming to advance one candidate to clinical stage annually, and seeking strategic collaborations to accelerate clinical development and commercialization - The company will continue to build and expand its ActRII product portfolio to maximize the development value of ActRII receptor targeting[98](index=98&type=chunk) - The goal is to advance **one candidate drug into clinical stage annually** and continuously explore the potential for combination therapies[99](index=99&type=chunk)[100](index=100&type=chunk) - Following the collaboration with Eli Lilly, the company plans to establish **strategic partnerships with more global leading pharmaceutical companies** to accelerate asset clinical development and commercialization[101](index=101&type=chunk) [Corporate Governance and Other Information](index=31&type=section&id=%E4%BC%81%E6%A5%AD%E7%AE%A1%E6%B2%BB%E7%9B%B8%E9%97%9C%E8%B3%87%E6%96%99) This section outlines the company's adherence to corporate governance principles, the Audit Committee's review, and the Board's decision regarding interim dividends [Corporate Governance and Compliance](index=31&type=section&id=%E4%BC%81%E6%A5%AD%E7%AE%A1%E6%B2%BB%E8%88%87%E5%90%88%E8%A6%8F) The company adopted and complied with the Corporate Governance Code, with the exception of the Chairman and CEO roles being held by the same individual, Dr. Lu Xiangyang, an arrangement the Board believes benefits strategic execution - The company complied with all relevant provisions of the Corporate Governance Code during the reporting period, with **one deviation**[102](index=102&type=chunk) - The deviation is that the roles of Chairman and Chief Executive Officer are not separated, both held by founder **Dr. Lu Xiangyang**, an arrangement the Board believes benefits strategic execution and communication efficiency[103](index=103&type=chunk) [Audit Committee and Interim Results Review](index=32&type=section&id=%E5%AF%A9%E8%A8%88%E5%A7%94%E5%93%A1%E6%9C%83%E5%8F%8A%E4%B8%AD%E6%9C%9F%E6%A5%AD%E7%B8%BE%E5%AF%A9%E9%96%B1) The company's Audit Committee, comprising independent non-executive and non-executive directors, reviewed the unaudited interim financial information, which was also independently reviewed by KPMG - The Audit Committee has reviewed the Group's accounting principles, policies, and **unaudited interim financial information** with management[108](index=108&type=chunk) - Independent auditor **KPMG** has reviewed the interim financial information in accordance with Hong Kong Standard on Review Engagements 2410[108](index=108&type=chunk) [Dividends](index=32&type=section&id=%E8%82%A1%E6%81%AF) The Board did not recommend the payment of any interim dividend for the six months ended June 30, 2025 - The Board does not recommend the payment of any interim dividend for the six months ended June 30, 2025[110](index=110&type=chunk)

Investment Rating - The report assigns an "Accumulate" rating to the company, with a target price of HKD 29.19 [5][15]. Core Insights - The report highlights that the company focuses on high-quality fat reduction and muscle gain in weight loss, as well as unmet needs in oncology, indicating a globally competitive pipeline in these areas [2][10]. - The company is positioned as a science-driven, clinical-stage biopharmaceutical firm, aiming to provide innovative therapies for metabolic diseases, cancer, and liver fibrosis [20][19]. Financial Summary - The projected financials for the company indicate no revenue until 2025, with expected revenues of RMB 280 million in 2027. The net profit is forecasted to be negative in the coming years, with estimates of -RMB 369 million in 2023, improving to -RMB 190 million by 2027 [4][15]. - The company’s financial ratios show a significant increase in the price-to-book (PB) ratio from 9.66 in 2024 to 429.89 in 2027, reflecting the anticipated growth in valuation as the company progresses [4][11]. Pipeline and Market Focus - The company’s pipeline includes several clinical trials targeting obesity and cancer, with a focus on LAE102, LAE002 (afuresertib), and LAE001, which are positioned to address unmet medical needs in these therapeutic areas [23][24]. - The report emphasizes the growing global market for weight loss drugs, projected to exceed USD 115 billion by 2030, driven by increasing obesity rates and demand for effective treatments [34][32]. Management and Team Experience - The management team possesses extensive experience in the pharmaceutical industry, with key members having backgrounds in leading global pharmaceutical companies, which enhances the company’s capability in drug development and clinical trials [30][25]. Competitive Landscape - The report notes that the company is innovating in the "fat reduction + muscle gain" space, which is becoming a critical focus in the weight loss drug market, with several multinational corporations also investing in this area [45][48].

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 | | | 致：香港交易及結算所有限公司 公司名稱: 來凱醫藥有限公司 FF301 II. 已發行股份及/或庫存股份變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02105 | 說明 | | | | | | | | | 已發行股份（不包括庫存股份）數目 | | 庫存股份數目 | | 已發行股份總數 | | | 上月底結存 | | | 407,736,350 | | 0 | | 407,736,350 | | 增加 / 減少 (-) | | | 0 | | 0 | | | | 本月底結存 | | | 407,736,350 | | 0 | | 407,736,350 | 呈交日期: 2025年8月5日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | 是 | ...

Group 1 - The core viewpoint is that CICC has initiated coverage on Lai Kai Pharmaceutical-B (02105) with an "outperform" rating and a target price of HKD 27.02, indicating a potential upside of 43.7% from the current stock price, based on DCF valuation [1] - Lai Kai is a global biopharmaceutical company focusing on metabolic and oncology diseases, recognized as a rising player in the domestic fat loss and muscle gain sector [1] - The market perceives Eli Lilly's Bimagrumab data as strong, revealing the drug's potential for fat loss and muscle gain through targeting the ActRII receptor, which aligns with the clinical demand for higher quality weight loss solutions [2][3] Group 2 - The global market for GLP-1 receptor agonists (GLP-1RA) is rapidly expanding, projected to reach USD 14.7 billion in 2024, accounting for 86.6% of the global obesity drug market, with an expected increase to 93.9% by 2034, reaching USD 54.1 billion [2] - There are concerns regarding muscle loss associated with GLP-1RA weight loss drugs, as studies indicate that over 40% of the weight lost may come from lean body mass, highlighting the need for therapies that promote fat loss while preserving muscle [2] - LAE102, a monoclonal antibody developed by Lai Kai targeting ActRIIA, shows promise in promoting muscle regeneration and reducing fat, with ongoing Phase I clinical trials in China and the US [3]

Group 1: Company Overview - Company is a global biopharmaceutical technology firm focusing on metabolic and oncology diseases, recognized as a rising player in the domestic fat reduction and muscle gain sector [1] - Company’s LAE102 is a monoclonal antibody targeting ActRIIA, showing potential for muscle regeneration and fat reduction, with ongoing Phase I clinical studies in China and the US [4] Group 2: Market Insights - The global market for GLP-1 receptor agonists (GLP-1RA) is rapidly expanding, projected to reach $14.7 billion in 2024, accounting for 86.6% of the global obesity and overweight drug market, with an expected increase to 93.9% by 2034, reaching $54.1 billion [2] - Concerns regarding muscle loss associated with GLP-1RA weight loss drugs have emerged, highlighting the clinical need for targeted solutions like ActRII to achieve quality weight loss [3] Group 3: Clinical Development and Potential Catalysts - LAE102's multi-dose escalation study data is anticipated to be released, with overseas clinical data also expected to provide significant insights [4] - Company has signed an agreement with Eli Lilly to advance clinical trials for obesity in the US, with preliminary data from multi-dose escalation trials expected by September 2025 [4]

Investment Highlights - Company is a global biopharmaceutical technology firm focusing on metabolic and oncology diseases, recognized as a new player in the domestic fat loss and muscle gain sector [1] - The global market for GLP-1 receptor agonists (GLP-1RA) is rapidly expanding, projected to reach USD 14.7 billion in 2024, accounting for 86.6% of the global obesity drug market, with an expected increase to 93.9% by 2034, reaching USD 54.1 billion [1] Product Development - GLP-1RA weight loss may lead to muscle loss, with studies indicating that over 40% of weight lost may come from lean body mass, raising concerns about muscle loss [2] - Targeting ActRII shows potential for fat loss and muscle gain, addressing the clinical need for higher quality weight loss solutions [2] - Company’s LAE102, a monoclonal antibody targeting ActRIIA, is in Phase I clinical trials in China and the US, with preliminary data expected by September 2025 [2] Market Positioning - Company differentiates itself from market expectations by focusing on the potential of ActRII for fat loss and muscle gain, with LAE102 expected to offer advantages in selectivity, administration convenience, and safety [3] - Anticipated catalysts include data readouts from LAE102's multi-dose escalation studies and overseas clinical data [3] Financial Projections - Company forecasts net losses of RMB 289 million and RMB 309 million for 2025 and 2026, respectively [3] - Based on DCF valuation, the company is rated as outperforming the industry with a target price of HKD 27.02, indicating a potential upside of 43.7% from the current stock price [3]

Investment Rating - The report maintains a positive outlook on the pharmaceutical and biotechnology industry, emphasizing the transition from "Made in China" to "Created in China" for innovative drugs [10]. Core Insights - The report highlights that domestic innovative drugs are gaining global competitiveness and are currently in the first and second stages of international expansion, primarily through licensing agreements and partnerships [10][12]. - The report identifies key areas of focus for investment, including PD-(L)1 plus, ADCs, and GLP-1 drugs, which are expected to drive future growth and business development (BD) opportunities [10][51]. Summary by Sections Section 1: Transition from "Manufacturing" to "Innovation" - The policy reforms initiated in 2015 have stimulated a shift from generic to innovative drug development in China, with significant increases in R&D investment since 2018 [19][21]. - The number of First-in-Class (FIC) drugs developed in China has risen from 9 in 2015 to 120 in 2024, indicating a substantial increase in innovation [25][26]. Section 2: Continued BD Opportunities - PD-(L)1 plus is identified as a cornerstone for next-generation cancer treatments, with significant demand and potential for new products [51]. - The report notes that ADCs are transitioning towards more differentiated targets, focusing on unmet clinical needs, with promising candidates like PD-L1, DLL3, and EGFR [51]. - The GLP-1 market is experiencing rapid growth, with a focus on multi-target, oral, combination, and long-acting formulations [51]. Section 3: Investment Recommendations - For PD-(L)1 plus, companies such as Kangfang Biotech, Shansheng Pharmaceutical, and Junshi Biosciences are recommended for investment due to their strong pipelines [5]. - In the ADC space, companies like Fuhong Hanlin and Zai Lab are highlighted for their potential in addressing unmet clinical needs [5]. - In the GLP-1 sector, firms such as Borui Pharmaceutical and Zai Lab are noted for their promising developments [5].

Group 1 - The core point of the article is that Lai Kai Pharmaceutical-B (02105.HK) has received FDA approval for the IND of LAE103, which is aimed at providing precision treatment for patients with metabolic diseases who require new therapeutic options [1] Group 2 - The company is focused on developing innovative treatment solutions for metabolic diseases [1]

Core Viewpoint - The company has received FDA approval for LAE103's IND, aiming to provide innovative treatments for patients with metabolic diseases requiring new therapeutic options [1] Group 1 - LAE103 is a selective antibody targeting ActRIIB [1] - The company is actively advancing this candidate drug into clinical research [1] - The goal is to offer innovative therapies for sarcopenic obesity and other muscle-related diseases [1]