公司研 究 证 券研究 报 告 医药 2024年04月13日 乐 普生物-B（02157.HK）深度研究报告 强推 （首次） 目标价：6.6港元 ADC 管线丰富，IO+ADC 领先布局 当前价：3.83港元  乐普生物是一家聚焦于肿瘤治疗领域，尤其是靶向治疗及免疫治疗的创新型生 华创证券研究所 物制药企业。公司致力于通过先进的ADC技术开发平台开发创新型ADC，并 与公司已上市PD-1单抗普特利单抗开发IO+ADC联用疗法，充分发挥管线协 证券分析师：刘浩 同作用。此外，公司还通过合作引进溶瘤病毒产品，建立了丰富且差异化管线。 邮箱：liuhao@hcyjs.com 执业编号：S0360520120002  ADC管线丰富，靶点选择具备差异化。核心品种MRG003是国内进度最快的 证券分析师：张艺君 EGFR ADC，在鼻咽癌和头颈鳞癌中展现积极疗效，其中鼻咽癌的注册II期临 床已完成患者入组，将于今年申报上市；头颈鳞癌的III期临床也正在入组患 邮箱：zhangyijun@hcyjs.com 者。MRG004A是国内首款TF ADC，差异化布局胰腺癌适应症，已观察到初 执业编号：S0360524020 ...

Revenue and Financial Performance - Revenue increased by approximately 1,347.2% from RMB 15.6 million in 2022 to RMB 225.4 million in 2023[2] - Total revenue of RMB 225.4 million was achieved, with significant progress in product pipeline and business operations[3] - Total revenue for 2023 reached RMB 225.4 million, primarily from licensing business and commercialization of Puheng® (Puliximab Injection)[9] - Revenue for the year ended December 31, 2023, reached RMB 225.4 million, a 1,347.2% increase compared to RMB 15.6 million in 2022[29] - Revenue for 2023 increased significantly to RMB 225.352 million from RMB 15.572 million in 2022, with gross profit rising to RMB 197.075 million from RMB 13.567 million[50] - Revenue from pharmaceutical product sales and licensing income for the year ended December 31, 2023, was RMB 225.352 million, compared to RMB 15.572 million in 2022[60] - Licensing income from KYM Biosciences Inc. accounted for RMB 109.52 million, representing 48.60% of the company's total revenue in 2023[61] - The company's revenue from licensing agreements with AstraZeneca for CMG901 was approximately RMB 123.967 million in 2023[63] R&D Expenses and Clinical Trials - R&D expenses decreased by 12.6% from RMB 524.3 million in 2022 to RMB 458.1 million in 2023[2] - R&D expenses decreased to RMB 458.1 million in 2023 from RMB 524.3 million in 2022, with clinical research-related expenses decreasing by RMB 31.6 million[32][33][34] - R&D expenses for 2023 decreased to RMB 458.073 million from RMB 524.285 million in 2022[50] - Clinical research expenses decreased to RMB 173,425 thousand in 2023 from RMB 204,991 thousand in 2022, a decline of 15.4%[66] - Preclinical research costs decreased significantly to RMB 34,463 thousand in 2023 from RMB 71,211 thousand in 2022, a drop of 51.6%[66] - MRG003 completed patient enrollment for NPC IIb phase registration clinical study, with NDA expected to be filed in 2024[3] - MRG002 completed patient enrollment for HER2 high-expression BC liver metastasis II phase key clinical trial in China, with good data observed[3] - CG0070 completed patient enrollment for phase III clinical trial in the US and received FDA FTD and BTD in December 2023[4] - MRG004A received FDA ODD for the treatment of PC in December 2023[4] - MRG004A received FDA FTD for the treatment of relapsed or refractory pancreatic cancer in March 2024[4] - MRG003, an EGFR-targeted ADC, has shown high affinity and tumor cell-killing efficacy in clinical trials[10] - MRG002, a HER2-targeted ADC, is in clinical development for multiple indications, including NPC and HNSCC[7] - MRG004A, a TF-targeted ADC, has received FDA ODD and FTD for treating PC and is in clinical trials in the US[6] - MRG003 achieved an ORR of 47.4% and DCR of 79.0% in NPC patients previously treated with PD-1 (L1) and platinum-based chemotherapy as of March 15, 2023[11] - MRG003 received FDA IND approval and FTD for R/M NPC treatment in October and November 2023, respectively[11] - MRG003's 2.0mg/kg dose group showed an ORR of 39.3% and DCR of 71.4%, with mPFS of 7.3 months in NPC patients[11] - MRG003's 2.3mg/kg dose group demonstrated an ORR of 55.2% and DCR of 86.2% in NPC patients, with mPFS not yet mature[11] - MRG002 showed promising data in HER2-high BC liver metastasis, with patient enrollment completed for the Phase II trial in China[12] - MRG001 achieved a CR rate of 17.6% and ORR of 38.2% in CD20-positive DLBCL patients who failed second-line or above treatment as of July 28, 2023[15] - CMG901 demonstrated a confirmed ORR of 33% and DCR of 70% in CLDN18.2-positive GC/GEJ patients across three dose groups as of July 24, 2023[16] - CMG901's 2.2mg/kg dose group showed a confirmed ORR of 42% and mPFS of 4.8 months in CLDN18.2-positive GC/GEJ patients[16] - MRG004A received FDA ODD for PC treatment in December 2023, with Phase I data to be presented at the 2024 ASCO annual meeting[14] - CG0070 demonstrated a 75.7% overall CR rate in NMIBC patients who failed BCG treatment, with 68.2% and 63.6% CR rates at 3 and 6 months, respectively[19] - MRG003 combined with Puyouheng® showed promising preliminary data in solid tumors, with Phase II trials ongoing and data expected to be presented at ASCO 2024[21] - MRG002 combined with Puyouheng® demonstrated positive preliminary data in HER2-expressing solid tumors, with Phase II trials ongoing and data expected at ESMO 2024[21] - CG0070 combined with Puyouheng® received IND approval for Phase I/II trials in BCG-unresponsive NMIBC patients[21] - The company's Hi-TOPi platform for ADCs has advanced MRG006A to IND-enabling studies, with IND submission expected in Q2 2024[22] - The TOPAbody T-cell engager platform has progressed CTM012 to IND-enabling studies, with IND submission planned for 2024[23] - The company's clinical trials include Phase I, Phase II, and Phase III studies to evaluate safety, efficacy, and dosage[88] - The company's clinical trials aim to provide evidence for drug approval through registration trials[88] Net Loss and Financial Metrics - Net loss attributable to the company's owners decreased significantly by 96.8% from RMB 689.1 million in 2022 to RMB 22.1 million in 2023[2] - Adjusted net loss (non-IFRS) decreased from RMB 699.4 million in 2022 to RMB 250.6 million in 2023[2] - Net loss decreased significantly by approximately 95.7% compared to 2022[9] - The company's loss decreased from RMB 699.4 million in 2022 to RMB 30.3 million in 2023[37] - Adjusted net loss (non-IFRS measure) was approximately RMB 250.6 million for the year ended December 31, 2023, compared to RMB 699.4 million in 2022[37] - Net loss for 2023 was RMB 30.301 million, a substantial reduction from the net loss of RMB 699.441 million in 2022[50] - Net loss for the year ended December 31, 2023, was approximately RMB 30.3 million, with net cash used in operating activities of approximately RMB 250.8 million[56] - Fair value gains on financial liabilities measured at fair value through profit or loss were RMB 174,976 thousand in 2023, compared to a loss of RMB 62,816 thousand in 2022[67] - Dilution gain from an associate company amounted to RMB 116,388 thousand in 2023, with no comparable figure in 2022[68] - Gain from the sale of an investment in an associate company was RMB 103,874 thousand in 2023, with no comparable figure in 2022[68] Product Sales and Licensing - Sales revenue from Puheng® (Puliximab Injection) reached RMB 101.4 million in 2023[9] - Licensing revenue from KYM's agreement with AstraZeneca for CMG901 development and commercialization amounted to RMB 109.5 million[9] - Sales revenue from pharmaceutical products in 2023 was RMB 101.4 million, a 551.1% increase from 2022[29] - Puyouheng® (Pudilizumab Injection) achieved sales revenue exceeding RMB 100 million in 2023[25] - The company's licensing business generated total revenue of approximately RMB 124.0 million in 2023, including RMB 109.5 million received from KYM[25] - KYM Biosciences Inc. received a $63.0 million upfront payment and is eligible for up to $1,125.0 million in additional payments upon achieving development, regulatory, and commercial milestones[63] - KYM Biosciences Inc. entered into a global exclusive licensing agreement with AstraZeneca on February 23, 2023[86] Operational and Administrative Expenses - The company's sales and marketing expenses for 2023 were RMB 43.3 million, up significantly from RMB 1.7 million in 2022[30] - Administrative expenses decreased to RMB 86.7 million in 2023 from RMB 138.8 million in 2022, primarily due to reduced listing expenses[31] - Employee benefit expenses increased to RMB 198,906 thousand in 2023 from RMB 188,344 thousand in 2022, a rise of 5.6%[66] - Depreciation and amortization expenses rose to RMB 102,572 thousand in 2023 from RMB 95,446 thousand in 2022, an increase of 7.5%[66] - Total number of employees as of December 31, 2023, is 429, with total salary costs increasing to RMB 198.9 million from RMB 188.3 million in 2022 due to the expansion of the sales team following product commercialization[45] Financial Position and Liabilities - Cash and cash equivalents decreased from RMB 669.4 million in 2022 to RMB 426.0 million in 2023, mainly due to ongoing R&D activities[40] - Bank borrowings increased to RMB 694.3 million in 2023 from RMB 650.0 million in 2022, with unsecured loans totaling RMB 394.0 million[40] - The company's asset-liability ratio decreased to 62.73% in 2023 from 64.39% in 2022[41] - Capital commitments for property, plant, and equipment were RMB 456.6 million as of December 31, 2023, compared to RMB 482.0 million in 2022[42] - The company sold a 15% stake in Haoyang Biotech for RMB 125 million, reducing its ownership to 5.68%[41] - Total assets as of December 31, 2023, were RMB 2.384 billion, a slight decrease from RMB 2.529 billion in 2022[52] - Total liabilities as of December 31, 2023, were RMB 1.496 billion, down from RMB 1.628 billion in 2022[53] - Cash and cash equivalents as of December 31, 2023, were approximately RMB 426.0 million, with net current liabilities of approximately RMB 222.4 million[56] - Trade receivables stood at RMB 38,014 thousand as of December 31, 2023, with a provision for impairment of RMB 212 thousand[74] - Trade payables as of December 31, 2023, amounted to RMB 207,611 thousand, with RMB 196,909 thousand due within one year and RMB 10,702 thousand due within one to two years[81] - The fair value of the variable consideration payable as of December 31, 2023, includes 4.375% of the actual net sales of the PD-1 product in 2023 (approximately RMB 4,436,000) and 4.375% of the estimated net sales of the PD-1 product in 2024 (approximately RMB 6,015,000)[79] - The fair value of financial liabilities measured at fair value through profit or loss as of December 31, 2023, was RMB 272,625 thousand, compared to RMB 448,282 thousand as of December 31, 2022[80] Corporate Governance and Share Structure - The company has adopted and complied with the Corporate Governance Code and the Standard Code for Securities Transactions[45][46] - The company did not recommend the payment of a final dividend for the year ended December 31, 2023[47] - The company did not purchase, sell, or redeem any of its listed securities during the year ended December 31, 2023[47] - The company's shares include domestic shares, unlisted foreign shares, and H shares, each with a par value of RMB 1.00[89] - The company's board includes executive directors Dr. Zhongjie Pu (Chairman) and Dr. Ziye Sui (General Manager), non-executive directors Ms. Jue Pu and Mr. Hongbing Yang, and independent non-executive directors Mr. Demin Zhou, Mr. Haifeng Yang, and Mr. Fengmao Hua[90] - The company's H-shares were listed on the Main Board of the Hong Kong Stock Exchange on February 23, 2022[86] - The company issued 126,876,000 H shares at a price of HKD 7.13 per share during the global offering in 2022[76] - The company issued an additional 899,000 H shares at HKD 7.13 per share as part of the over-allotment option exercise in 2022[77] Product Approvals and Market Penetration - Puheng® (Puliximab Injection) received conditional approval in China for MSI-H/dMMR and unresectable or metastatic melanoma[8] - The company's product Putrelimab (Puyouheng®) was included in the 2023 CSCO and CSGO guidelines for treating melanoma and MSI-H/dMMR solid tumors[26] - The company has completed bidding procedures on procurement platforms in 21 provinces and covers approximately 76 cities as of December 31, 2023[26] - The company plans to accelerate the NDA application for MRG003 and expects to submit the NDA in 2024[28] - The company aims to expand its commercialization team and deepen market penetration for Puyouheng® in 2024[29] Research and Development Platforms - The company is involved in the development of ADC (Antibody-Drug Conjugate) technology, specifically using valine-citrulline linkers that are stable in blood circulation and effectively cleaved by lysosomal cathepsins after ADC internalization[90] - The company's research includes the development of monoclonal antibodies and PD-1/PD-L1 inhibitors[87] - The company's products target diseases such as HNSCC, NHL, NMIBC, and NPC[87] - The company focuses on the discovery and development of innovative biologics in the fields of autoimmune and oncology therapies[86] - KYM Biosciences Inc. is a joint venture established in the United States by the company and AstraZeneca[86] Financial Income and Costs - Financial income decreased from RMB 45.9 million in 2022 to RMB 8.3 million in 2023, primarily due to reduced exchange gains[36] - Financial costs increased from RMB 8.6 million in 2022 to RMB 16.0 million in 2023, mainly due to higher interest on borrowings[36]

，乐普王 ID LEPU BIOPHARMA 樂普生物科技股份有限公司 LEPU BIOPHARMA CO.,LTD. (於中華人民共和國註冊成立的股份有限公司) 股份代號 : 2157 2023 中期報告 .... ..... ..... . . . 目 錄 | --- | --- | |-------|--------------------------| | | | | 2 | 公司資料 | | 4 | 財務概要 | | 5 | 管理層討論及分析 | | 20 | 其他資料 | | 27 | 中期財務資料的審閱報告 | | 28 | 中期簡明綜合全面虧損表 | | 29 | 中期簡明綜合資產負債表 | | 31 | 中期簡明綜合權益變動表 | | 32 | 中期簡明綜合現金流量表 | | 33 | 中期簡明綜合財務資料附註 | | 53 | 釋義及技術詞彙 | 樂普生物科技股份有限公司 二零二三年中期報告2 ... 公司資料 | --- | --- | |-------------------------------------------------|------------------------- ...

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） 截至2023年6月30日止六個月的 中期業績公告 董事會欣然宣佈本集團截至2023年6月30日止六個月的未經審核綜合中期業績， 連同2022年同期之比較數字。 | --- | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | 業務摘要 | | 於本公告日期，我們在推進產品管線及業務營運方面均取得重大進展： | ...

樂普生物科技股份有限公司 LEPU BIOPHARMA CO.,LTD. 股份代號 : 2157 （於中華人民共和國註冊成立的股份有限公司） 2022 年度報告 目 錄 | --- | |------------------------------| | | | 公司資料 | | 董事長報告 | | 管理層討論及分析 | | 董事、監事及高級管理人員履歷 | | 董事會報告 | | 監事會報告 | | 企業管治報告 | | 環境、社會及管治報告 | | 獨立核數師報告 | | 綜合全面虧損表 | | 綜合資產負債表 | | 綜合權益變動表 | | 綜合現金流量表 | | 財務報表附註 | | 財務概要 | | | 2 4 8 23 31 49 50 71 103 112 113 115 116 117 190 釋義及技術詞彙 191 公司資料 | --- | --- | |---------------------------|------------------------------------| | | | | 執行董事 | 聯席公司秘書 | | 蒲忠傑博士 （董事長） | 李昀軼女士 | | 隋滋野博 ...

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） 截至2022年12月31日止年度的 年度業績公告 董事會欣然宣佈本集團截至2022年12月31日止年度的經審核綜合年度業績，連同 2021年之比較數字。 | --- | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- ...