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，並明確表示概不會就因本公告全部或任何部分內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 LEPU BIOPHARMA CO., LTD. 樂普生物科技股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：2157） 內幕消息公告 美佑恒® （注射用維貝柯妥塔單抗）是一種由EGFR靶向單克隆抗體與強效的微 管蛋白抑制有效載荷一甲基澳瑞他汀E分子通過纈氨酸－瓜氨酸鏈接體偶聯 而成的ADC。其以高親和力特異性地結合腫瘤細胞表面的EGFR，通過內吞 及溶酶體蛋白酶裂解後釋放強效的有效載荷，從而導致腫瘤細胞死亡。EGFR 高表達於結直腸癌、肺癌、頭頸癌等多種惡性實體瘤中，89%的晚期NPC存 在EGFR表達。因此，EGFR是癌症治療的重要靶點。 1 美佑恒® （注射用維貝柯妥塔單抗）在既往經治過二線及以上系統性化療及 PD-(L)1抑制劑失敗後的患者中顯示出臨床意義的療效優勢，同時安全性可 控。美佑恒® （注射用維貝柯妥塔單抗）用於治療R/M NPC的關鍵註冊性臨床 研究結果於202 ...

Investment Rating - The report initiates coverage with an "Outperform" rating for Lepu Biopharma-B (2157) [4] Core Views - The company is a leading domestic innovative pharmaceutical enterprise focusing on ADC combined with IO in oncology, with expectations for rapid market penetration following the approval of MRG003 [1][4] - The product pipeline is expected to expand internationally, indicating strong long-term growth potential for the company [1] Financial Summary - Projected total revenue for 2024A, 2025E, 2026E, and 2027E is 368 million, 853 million, 1,204 million, and 1,665 million RMB respectively, reflecting growth rates of 63%, 132%, 41%, and 38% [3] - Gross profit is expected to increase from 292.97 million in 2024A to 1,415.20 million in 2027E, with a gross margin projected to be around 79.66% to 85% [3] - Net profit is forecasted to improve from -411 million in 2024A to -29 million in 2027E, indicating a significant reduction in losses [3] Company Overview - Lepu Biopharma was established in January 2018 and focuses on oncology, particularly targeted and immunotherapy [9] - The company has built a diverse product pipeline through acquisitions and partnerships, including PD-1 antibodies and ADCs [9] - The management team is experienced, with a high concentration of ownership, ensuring stability and strategic direction [13][15] Market Potential - The global and Chinese cancer immunotherapy market is expected to grow significantly, with a CAGR of 16.3% and 25.1% respectively from 2025 to 2030 [28][31] - The PD-1 therapy market in China is projected to reach 582 billion RMB by 2030, with a CAGR of 30.5% from 2020 to 2025 [33][35] ADC Market Growth - The global ADC market is anticipated to reach 66.2 billion USD by 2030, with a CAGR of 30.3% from 2023 to 2030 [41] - The ADC market in China is expected to grow at a CAGR of 72.6% from 2023 to 2028, reaching 38.3 billion RMB [44][45] Product Pipeline and Clinical Development - MRG003 is currently under NDA review and has shown promising results in clinical trials for R/M NPC, with a significant improvement in overall response rates compared to chemotherapy [56][61] - The company is actively exploring combination therapies with PD-1 inhibitors, which may enhance treatment efficacy [60][65]

Group 1 - The company is a leading domestic innovative pharmaceutical enterprise in the ADC and IO layout, with expectations for rapid market penetration of MRG003 upon approval [1] - The company has a robust product pipeline and is exploring business development opportunities abroad, indicating strong long-term growth potential [1] - The initial coverage rating is set to "Buy," with projected revenues of 853 million, 1.204 billion, and 1.665 billion yuan for 2025-2027, respectively [1] Group 2 - MRG003 has received priority review qualification from the CDE for the treatment of R/M NPC, with an NDA submission expected in March 2025, indicating a high likelihood of domestic approval soon [2] - In combination therapy, MRG003 has been officially included as a breakthrough therapy by the NMPA for patients with recurrent or metastatic nasopharyngeal carcinoma who have failed prior platinum and PD-1/L1 treatments [2]

Investment Rating - The report assigns an "Accumulate" rating to the company [5]. Core Insights - The company is a leading domestic innovative pharmaceutical enterprise focusing on ADC combined with IO, with expectations for rapid growth following the approval of MRG003 [2]. - The product pipeline includes plans for international business development, indicating a positive long-term outlook for the company [2]. Financial Summary - Projected total revenue for 2024A is 368 million RMB, with a growth rate of 63%. By 2027E, revenue is expected to reach 1,665 million RMB, with a growth rate of 38% [4]. - The company is projected to achieve a net profit of -411 million RMB in 2024A, improving to -29 million RMB by 2027E [4]. - The price-to-earnings (PE) ratio is expected to improve from -10.04 in 2024A to -389.49 in 2027E, while the price-to-book (PB) ratio is projected to increase from 5.87 to 18.86 over the same period [4]. Company Overview - The company was established in January 2018 and focuses on innovative treatments for cancer, particularly targeted therapies and immunotherapies [13]. - The company has built a robust product pipeline through acquisitions and partnerships, including PD-1 antibodies and ADC drugs [13][15]. - The management team is experienced, with a high concentration of ownership, ensuring stability and strategic direction [15][19]. Market Potential - The global and Chinese cancer immunotherapy market is expected to grow significantly, with a projected CAGR of 16.3% and 25.1% respectively from 2025 to 2030 [30]. - The PD-1 therapy market in China is anticipated to reach 582 billion RMB by 2030, with a CAGR of 30.5% from 2020 to 2025 [33]. Product Pipeline and Development - The company has multiple tumor product pipelines covering immunotherapy, ADC targeted therapy, and oncolytic virus drugs [20]. - MRG003 is currently under NDA review for treating R/M NPC, with potential for significant market impact [22]. - The company is also exploring combination therapies with PD-1 antibodies, which may enhance treatment efficacy [20]. Sales Growth - The company's first commercial product, the PD-1 antibody, has seen rapid sales growth, achieving 300 million RMB in revenue in 2024, three times the revenue of 2023 [23][36]. - The company has expanded its sales network across 118 cities in China, enhancing its market presence [36].

Core Viewpoint - Cathay Securities has initiated coverage on Lepu Biopharma-B (02157) with a "Buy" rating, projecting significant revenue growth from 2025 to 2027, driven by a robust product pipeline and imminent approval of MRG003 [1][2] Group 1: Financial Projections - Revenue forecasts for Lepu Biopharma are set at 853 million, 1.204 billion, and 1.665 billion yuan for 2025, 2026, and 2027 respectively [1] - The company is assigned a target price of 9.55 to 10.38 HKD based on a cautious approach using both PS and PB valuation methods [1] Group 2: Product Pipeline and Development - Lepu Biopharma has developed a diverse pipeline of oncology products, focusing on immunotherapy, ADC targeted therapy, and oncolytic virus drugs [1] - The cornerstone of the company's immunotherapy is an anti-PD-1 antibody candidate, with advanced ADC technology being utilized for innovative drug development [1] Group 3: Regulatory Approvals and Clinical Trials - MRG003 has received priority review qualification from the CDE for the treatment of R/MNPC, with an NDA submission expected in March 2025 [2] - MRG003 has also been included in the list of breakthrough therapy drugs by the NMPA for use in combination with PD-1 antibody for specific cancer indications [2]

Core Viewpoint - Cathay Securities has initiated coverage on Lepu Biopharma-B (02157) with a "Buy" rating, projecting significant revenue growth from 2025 to 2027, driven by a robust product pipeline and imminent approval of MRG003 [1][2] Group 1: Financial Projections - Revenue forecasts for Lepu Biopharma are set at 853 million, 1.204 billion, and 1.665 billion yuan for 2025, 2026, and 2027 respectively [1] - The company is assigned a 2025 price-to-sales (PS) ratio of 23X, leading to a reasonable valuation of 10.87 yuan/11.81 HKD [1] - A price-to-book (PB) ratio of 25X is also applied, resulting in a valuation of 9.55 yuan/10.38 HKD [1] Group 2: Product Pipeline and Development - Lepu Biopharma has established a diverse pipeline in oncology, focusing on immunotherapy, ADC targeted therapy, and oncolytic virus drugs [1] - The cornerstone of its immunotherapy is the anti-PD-1 antibody candidate, with advanced ADC technology being utilized for innovative drug development [1] - The company is also exploring combination therapies involving PD-L1 and ADC drugs [1] Group 3: Regulatory Approvals - MRG003 has received priority review qualification from the CDE for the treatment of recurrent/metastatic nasopharyngeal carcinoma (R/MNPC) and is expected to be approved domestically soon [2] - MRG003, in combination with the PD-1 antibody, has been officially included as a breakthrough therapy by the NMPA for specific treatment indications [2]

Core Insights - Lepu Biotech's MRG006A, a targeted GPC3 antibody-drug conjugate (ADC), has successfully completed the first patient enrollment in a Phase II clinical trial for advanced hepatocellular carcinoma (HCC), marking it as the first GPC3 ADC to enter this stage globally [1][2] - MRG006A utilizes Lepu Biotech's Hi-TOPi ADC technology platform, which allows for precise targeting of GPC3-positive tumor cells, thereby releasing toxins specifically within the tumor to achieve targeted cell destruction [1] - GPC3 is a cancer embryonic antigen that is highly expressed in 70%-80% of HCC cases but has minimal expression in normal tissues, making it a promising target for precision therapy [1] Clinical Development - The Phase I clinical trial of MRG006A showed promising results, with significant tumor shrinkage observed in GPC3-positive patients during the dose-escalation study, indicating strong therapeutic potential [2] - The advancement of MRG006A into Phase II clinical research represents a significant breakthrough in Lepu Biotech's ADC pipeline and has the potential to address unmet clinical needs in HCC treatment [2]

Core Insights - Lepu Biotech's MRG006A, a targeted GPC3 antibody-drug conjugate (ADC), has successfully completed the first patient enrollment in a Phase II clinical study for advanced hepatocellular carcinoma (HCC), marking it as the first GPC3-targeted ADC to enter Phase II globally [1][2] - MRG006A utilizes Lepu Biotech's Hi-TOPi ADC technology platform, which allows for precise targeting of GPC3-positive tumor cells, releasing toxins specifically within tumors to achieve targeted cell destruction [1] Group 1: Clinical Development - MRG006A is positioned as a significant innovation in the treatment of HCC, a prevalent malignancy where most patients are diagnosed at advanced stages, and treatment options are limited after first-line therapy failure [1] - The GPC3 antigen, which is expressed in 70%-80% of HCC cases but minimally in normal tissues, is considered a "golden" target for precision therapy [1] - Clinical data indicate that adverse reactions primarily involve liver function abnormalities and mild bone marrow suppression, which are manageable, supporting the feasibility of its clinical application [1] Group 2: Clinical Trial Results - In Phase I trials, MRG006A demonstrated promising results, with significant tumor shrinkage observed in GPC3-positive patients, exceeding expectations during dose escalation studies [2] - The advancement of the Phase II study for MRG006A represents a crucial breakthrough in Lepu Biotech's ADC pipeline and has the potential to address unmet clinical needs in HCC treatment [2]

Group 1 - A-shares and Hong Kong stocks in the innovative pharmaceutical sector have rebounded, with significant gains in related stocks and ETFs [1][3][5] - The largest medical ETF in A-shares (512170) saw a trading volume of 589 million yuan, recovering 1.34% on the day [1] - The innovative drug sector is experiencing a collective rise, with notable stocks like Huahai Pharmaceutical increasing by 7.59% [3] Group 2 - The Hong Kong innovative drug ETF (520880) rose by 2.12%, with 35 out of 37 constituent stocks gaining, led by Green Leaf Pharmaceutical with an 8.31% increase [5][7] - Recent funding trends indicate a significant inflow into the innovative drug sector, with over 1.29 billion yuan added in the last three days [7] - Upcoming catalysts include the European Society for Medical Oncology (ESMO) annual meeting, which may showcase significant research results from Chinese innovative drugs [7] Group 3 - Investment strategies suggest focusing on innovative drugs, with specific ETFs like the Hong Kong innovative drug ETF (520880) and the A-share drug ETF (562050) highlighted for their potential [8] - The medical ETF (512170) is noted for its inclusion of CXO companies, which account for 26.77% of its weight [8] - The medical ETF is the largest in the market, with a scale of 26.4 billion yuan, while the drug ETF is the only one tracking the China Pharmaceutical Index [9]

Group 1 - The article discusses the innovative approach of a company in Wuhan, Hubei, which is utilizing viruses to treat cancer, highlighting its potential in the biotechnology sector [1] - The company is preparing for an IPO, indicating strong investor interest and potential for growth in the market [1] - The involvement of Lepu Biopharma as an investor suggests confidence in the company's technology and future prospects [1] Group 2 - The article emphasizes the significance of the biotechnology industry in developing novel cancer therapies, reflecting a growing trend towards personalized medicine [1] - It notes the increasing investment in innovative drug development, which is crucial for advancing treatment options for cancer patients [1] - The potential market size for such therapies is substantial, indicating a lucrative opportunity for investors in the biotech field [1]