复宏汉霖(02696)：HLX22联合XELOX对比XELOX 联合或不联合帕博利珠单抗一线治疗HER2阳性局 部晚期或转移性胃食管交界部和胃癌的国际多中心3 期临床研究完成日本首例患者给药 本次研究是一项双盲、国际多中心随机对照3期研究，旨在比较HLX22联合曲妥珠单抗和化疗对比曲妥 珠单抗和化疗联合或不联合帕博利珠单抗，一线治疗HER2阳性局部晚期或转移性胃癌/胃食管交界部癌 患者的疗效和安全性。符合条件的受试者将以1:1的比例随机分配至试验组(接受HLX22(15 mg/kg)联合 曲妥珠单抗和化疗)或对照组(接受安慰剂联合曲妥珠单抗和化疗，联合或不联合帕博利珠单抗)。该研究 的主要终点为独立影像评估委员会 (IRRC)基于RECIST v1.1评估的无进展生存期(PFS)和总生存期(OS); 次要终点包括研究者评估的无进展生存期(PFS)、独立影像评估委员会(IRRC)或研究者评估的客观缓解 率(ORR)、下一线治疗的无进展生存期(PFS2)、缓解持续时间(DOR)、生活质量、安全性、免疫原性和 药代动力学特征。 智通财经APP讯，复宏汉霖(02696)发布公告，近日，一项HLX22(重组人源化抗 H ...

财报显示，复宏汉霖目前的营收主要依靠汉曲优、汉斯状以及汉利康3款产品，其2024年销售收入分别 为28.1亿元（同比增长2.7%）、13.1亿元（同比增长17.2%）以及5.3亿元（同比增长1.9%）。 相比于2023年，2024年复宏汉霖在汉曲优和汉斯状两款"现金牛"产品上的营收增速均有显著下滑。业绩 会上，公司首席商务官余诚对此解释称，主要还是因为2024年整个生物类似药市场有相当多国产竞品陆 续获批、实现商业化，因此造成市场竞争环境更加激烈。 同时，余诚还对复宏汉霖从甫康药业引进的汉奈佳（奈拉替尼）寄予厚望。资料显示，奈拉替尼用于 HER2（人表皮生长因子受体2）阳性的早期乳腺癌成年患者，在接受含曲妥珠单抗辅助治疗之后的强化 辅助治疗，于2024年6月正式在国内获批，上市销售3个多月获得了0.45亿元的收入。余诚认为，汉奈佳 有望重塑早期乳腺癌患者从辅助到强化辅助的市场格局，并能与汉曲优形成显著的协同效应。 每经记者 许立波 每经编辑 董兴生 3月24日，复宏汉霖（HK02696）发布2024年度业绩公告，公司于报告期内实现营业收入约57.244亿 元，同比增长6.1%；净利润约8.205亿元，同比增长 ...

复宏汉霖目前有三款非常有竞争力的创新产品。首先是 HRX10，即 PD-1 单抗， 用于治疗复发或难治性结直肠癌。中国每年新发病例超过 51 万，美国和日本每 年新发病例约 20 万。目前，难治性结直肠癌的一线治疗标准是贝伐珠单抗加化 疗，微卫星不稳定型患者可选择 K 药加贝伐珠单抗和化疗，但这种分型仅占 5%。 大部分患者仍使用贝伐珠单抗加化疗，存在极大未满足的临床需求。复宏汉霖 的临床试验显示 H2,410 联合 PD-1 单抗和化疗显著提高无进展生存期，达到了 10.8 个月，对照组为 10.7 个月，有望成为新的治疗选择。 其次是 HRX10，即 • H2,410 联合 PD-1 单抗和化疗在难治性结直肠癌的临床试验中，无进展生 存期达到 10.8 个月，虽与对照组 10.7 个月相比提升不明显，但有望为患 者提供新的治疗选择，尤其是在贝伐珠单抗加化疗效果不佳的情况下。 • HRX10（曲妥珠单抗）针对 HER2 阳性胃癌，通过 HRS22 创新药促进赫赛汀 内吞水平提高 40%-80%，临床试验显示联合用药显著提高生存期和抗肿瘤 反应，有望占据中国每年 36 万新发胃癌病例中 HER2 阳性患者（约 ...

❑ 差异化创新管线具备全球竞争力，具备挑战当前治疗标准的潜力。复宏汉霖 创新研发管线极具特色： 1）HLX10（PD-1 单抗）显著改善 1 线 mCRC（复发或无法根治切除的结直 肠癌）患者生存期，有望成为 1 线治疗新选择。结直肠癌基本负担沉重，中 国每年新发超过 51 万人，目前 1 线 mCRC 标准治疗方法为贝伐珠单抗+化疗， 存在极大的免疫疗法未满足临床需求。复宏汉霖 HLX10 与贝伐珠单抗+化疗 联用治疗 mCRC 与目前标准治疗方案相比极大提高了 mPFS（16.8m vs 10.7m，HR=0.58），临床结果亮眼，可能挑战当前标准治疗方案。 2）HLX22（HER2 单抗）具有改变目前 1 线胃癌治疗方案的潜力。胃癌我国 每年新发超过 36 万人，其中 HER2 阳性占比 15%。HLX22 与同为靶向 HER2 domain IV 的曲妥珠单抗的联合，可同时促进 HER2/HER2 同源二聚体和 HER2/EGFR 异源二聚体的内吞作用，将 HER2 的内吞提高 40-80%，临床研 究结果显示，在 HLX02+化疗的基础上加入 HLX22 可提高 HER2 阳性胃癌患 者 1 线治疗 ...

Financial Performance - Total revenue for the first half of 2024 reached approximately RMB 2,746.1 million, a 9.8% increase compared to RMB 2,500.5 million in the same period of 2023[9] - Net profit for the first half of 2024 was RMB 386.3 million, a significant increase from RMB 240.0 million in the same period of 2023[9] - Non-current assets increased to RMB 7,583,198,000 as of June 30, 2024, up from RMB 7,227,539,000 at the end of 2023, driven by growth in property, plant, and equipment (RMB 2,319,676,000) and intangible assets (RMB 4,819,859,000)[78] - Current assets decreased to RMB 2,396,562,000 as of June 30, 2024, compared to RMB 2,676,032,000 at the end of 2023, primarily due to a decline in cash and bank balances (RMB 649,449,000 vs. RMB 987,665,000)[78] - Net profit for the six months ended June 30, 2024, was RMB 386,301,000, contributing to a total comprehensive income of RMB 402,277,000[79] - Cash flow from operating activities for the six months ended June 30, 2024, was RMB 251,263,000, a decrease from RMB 332,460,000 in the same period of 2023[82] - The company's net asset value increased to RMB 2,578,257,000 as of June 30, 2024, up from RMB 2,192,301,000 at the end of 2023[78] - Total equity increased to RMB 2,578,257,000 as of June 30, 2024, compared to RMB 2,192,301,000 at the end of 2023, driven by retained earnings and other reserves[79] - Cash used in investing activities for the six months ended June 30, 2024, was RMB 663,655,000, primarily due to the acquisition of property, plant, and equipment (RMB 103,685,000) and intangible assets (RMB 344,798,000)[82] - The company's total liabilities decreased to RMB 7,401,503,000 as of June 30, 2024, from RMB 7,711,270,000 at the end of 2023, reflecting a reduction in both current and non-current liabilities[78] - The company's trade receivables increased to RMB 744,101,000 as of June 30, 2024, up from RMB 647,828,000 at the end of 2023, indicating higher sales on credit[78] - The company's inventory increased to RMB 783,331,000 as of June 30, 2024, compared to RMB 757,359,000 at the end of 2023, reflecting higher production or slower sales[78] - Net cash flow from financing activities was -145,815 thousand RMB, compared to 156,497 thousand RMB in the same period last year[83] - Cash and cash equivalents decreased by 558,207 thousand RMB, with a closing balance of 313,911 thousand RMB[83] - Revenue from external customers in Mainland China increased to 2,489,605 thousand RMB, up from 2,221,701 thousand RMB in 2023[90] - Total revenue for the six months ended June 30, 2024, was 2,746,109 thousand RMB, compared to 2,500,470 thousand RMB in 2023[90] - Revenue from sales of biopharmaceutical products reached 2,479,351 thousand RMB, up from 2,152,901 thousand RMB in 2023[91] - Revenue from licensing and R&D services was 14,258 thousand RMB and 251,014 thousand RMB, respectively[91] - Revenue recognized at a point in time was 2,498,899 thousand RMB, while revenue recognized over time was 245,809 thousand RMB[91] - The company's current liabilities net amount was 2,506,388 thousand RMB as of June 30, 2024[86] - Other income and gains totaled RMB 24,739 thousand, a decrease of 7.8% compared to RMB 26,837 thousand in the same period last year[92] - Interest income increased significantly to RMB 10,309 thousand, up 280% from RMB 2,712 thousand in the previous year[92] - Cost of goods sold increased to RMB 430,380 thousand, a 12.5% rise from RMB 382,617 thousand in 2023[93] - Financial costs rose to RMB 62,796 thousand, a 16.1% increase from RMB 54,084 thousand in 2023[94] - Current tax expense in Mainland China increased to RMB 9,417 thousand, up 138% from RMB 3,956 thousand in the previous year[96] - Profit attributable to ordinary equity holders of the parent for basic EPS calculation was RMB 386,301 thousand, a 61% increase from RMB 239,980 thousand in 2023[99] - Property, plant and equipment additions amounted to RMB 168,829 thousand, a decrease of 37.6% compared to RMB 270,346 thousand in the previous year[101] - Trade receivables increased to RMB 744,101 thousand, up 14.9% from RMB 647,828 thousand at the end of 2023[103] - Prepayments and other receivables decreased to RMB 174,921 thousand, down 12.9% from RMB 200,761 thousand at the end of 2023[104] - The company recovered a total of $30,640,000 from AMTD for the years ended December 31, 2020, 2021, and 2022, and an additional $20,000,000 for the year ended December 31, 2023[105] - As of December 31, 2023, and June 30, 2024, the outstanding principal balance of the AMTD account investment was $66,360,000 (equivalent to RMB 472,942,000)[105] - The company has fully provisioned for expected credit losses on the AMTD receivable, totaling $66,360,000 as of June 30, 2024, and December 31, 2023 (equivalent to RMB 472,942,000 and RMB 470,015,000, respectively)[105] - Trade payables as of June 30, 2024, amounted to RMB 617,145,000, with RMB 606,293,000 due within one year[106] - Total interest-bearing bank and other borrowings as of June 30, 2024, were RMB 4,054,089,000, with RMB 2,837,718,000 classified as current liabilities[108] - The company's lease liabilities as of June 30, 2024, amounted to RMB 263,471,000, with RMB 98,369,000 due within one year[108] - The company's bank borrowings are secured by right-of-use assets with a net book value of RMB 190,488,000 and property, plant, and equipment with a net book value of RMB 1,033,164,000 as of June 30, 2024[109] - The company has contractual commitments for plant and machinery amounting to RMB 111,917,000 as of June 30, 2024[111] - The company has no contingent liabilities as of June 30, 2024[111] - The company has issued and fully paid-up ordinary shares totaling 543,494,853 shares as of June 30, 2024[110] - Revenue from licensing to Fosun Pharma Industrial Development increased to RMB 10,963 thousand in 2024 from RMB 10,851 thousand in 2023[114] - Services provided to Fosun Pharma Industrial Development surged to RMB 75,472 thousand in 2024 from RMB 21,774 thousand in 2023[114] - Sales of goods to Sinopharm Group reached RMB 1,062,754 thousand in 2024, up from RMB 900,069 thousand in 2023[114] - Total sales of goods to related parties amounted to RMB 1,342,731 thousand in 2024, compared to RMB 1,204,518 thousand in 2023[114] - Purchases of services/goods from related parties totaled RMB 18,426 thousand in 2024, slightly up from RMB 17,629 thousand in 2023[114] - Trade receivables from related parties stood at RMB 378,405 thousand in 2024, an increase from RMB 346,664 thousand in 2023[116] - Prepayments, other receivables, and other assets from related parties were RMB 4,702 thousand in 2024, up from RMB 4,172 thousand in 2023[116] - Trade payables to related parties were RMB 1,212 thousand in 2024, significantly higher than RMB 194 thousand in 2023[116] R&D and Product Development - R&D expenses for the first half of 2024 decreased to RMB 482.5 million, down from RMB 547.8 million in the same period of 2023[9] - HANQUYOU® (trastuzumab for injection) has benefited over 200,000 patients in China and received FDA approval in the US for breast cancer and gastric cancer treatment in April 2024[10] - HANQUYOU® received approval from Health Canada in August 2024 for early and metastatic breast cancer and metastatic gastric cancer treatment[10] - HANSIZHUANG® (serplulimab injection) received approval in Cambodia and Thailand for extensive-stage small cell lung cancer (ES-SCLC) treatment in 2024[10] - HANLIKANG® (rituximab injection) has benefited over 260,000 patients in China and received approval in Peru in May 2024[10] - Hansizhuang® (Serplulimab Injection) completed the first patient dosing in the Phase 3 portion of an international multicenter Phase 2/3 clinical trial for metastatic colorectal cancer in China in May 2024, and the Phase 3 trial was approved in Japan and Indonesia in July 2024[11] - HLX14 (Denosumab Biosimilar) achieved the primary endpoint in an international multicenter Phase 3 clinical trial for postmenopausal osteoporosis in April 2024, with MAAs submitted to EMA in May 2024 and NDSs submitted to Health Canada in September 2024[11] - HLX22 (Anti-HER2 Humanized Monoclonal Antibody) received FDA approval for a Phase 3 clinical trial in combination with trastuzumab and chemotherapy for HER2-positive advanced gastric cancer in May 2024[11] - HLX53 (Anti-TIGIT Fc Fusion Protein) in combination with Hansizhuang® and Hanbeitai® received IND approval in China for a Phase 2 clinical trial in April 2024, with the first patient dosed in August 2024[11] - HLX14 completed a Phase 1 clinical study in healthy male subjects in China in January 2024, achieving all predefined endpoints[11] - HLX42 (EGFR-Targeted Antibody-Drug Conjugate) completed the first patient dosing in a Phase 1 clinical trial for advanced/metastatic solid tumors in China in March 2024[11] - HLX6018 (Anti-GARP/TGF-β1 Humanized Monoclonal Antibody) received IND approval in China for idiopathic pulmonary fibrosis in March 2024, with the first subject dosed in April 2024[11] - HLX78 (Lasofoxifene Tablets) received IND approval in China in May 2024, following its licensing for an international multicenter Phase 3 clinical trial in January 2024[11] - HLX15 (Daratumumab Biosimilar) completed a Phase 1 clinical study in healthy male subjects in China in June 2024, achieving all predefined endpoints[11] - The company has a total of over 50 molecules and 14 R&D platforms, covering monoclonal antibodies, bispecific antibodies, ADCs, recombinant proteins, and small molecule conjugates[12] - The company's R&D activities are focused on research and development, with a reporting period ending June 30, 2024[151] Commercialization and Market Expansion - The company completed the acquisition of DDL, expanding its commercialization capabilities and business model[10] - The company signed an agreement with Fuhong Health Technology to introduce HANNAIJIA® (neratinib) for HER2-positive early breast cancer treatment in China[10] - The company's commercialization team has grown to nearly 1,500 people, driving the commercialization of 5 products in China, including Hanquyou® and Hansizhuang®[15] - Hanquyou® has benefited over 200,000 patients in China and has been approved in 48 countries and regions, including the US, UK, and Germany[17] - Hanquyou® became the first biosimilar monoclonal antibody approved in China, Europe, and the US for breast and gastric cancer treatment[16] - Hansizhuang® has expanded its international presence, with approvals in Indonesia, Cambodia, and Thailand for extensive-stage small cell lung cancer (ES-SCLC) treatment[19] - Hansizhuang® is the first PD-1 targeted monoclonal antibody globally approved for first-line treatment of ES-SCLC, giving it a competitive edge in the PD-1 market[19] - Hanlikang® has been approved in Peru, marking the company's third self-developed product to gain overseas approval[20] - Handayuan® has received approval for all eight indications of the original adalimumab in China, including rheumatoid arthritis and Crohn's disease[20] - The company completed the acquisition of DDL, enabling the commercialization of more licensed products and expanding its business channels[15] - Hanquyou® has been approved in Brazil, the Philippines, and Uzbekistan, further expanding its global market reach[17] - The company introduced Hanlaijia® (neratinib) in China, targeting HER2-positive early breast cancer patients, and is pushing for its commercialization[15] Shareholder and Equity Information - Shareholder Zhu Jun holds 50,000 H shares, representing 0.03% of the H share class and 0.01% of the total shares[130] - Chen Qiyu holds 17,930,400 ordinary shares in Fosun International, representing 0.22% of the share class, and 18,450,000 share options, representing 0.23%[131] - Wu Yifang holds 373,000 H shares and 1,007,100 A shares in Fosun Pharma, representing 0.07% and 0.05% of the respective share classes[131] - Fosun Pharma holds 265,971,569 non-listed shares, representing 69.98% of the non-listed share class and 48.94% of the total shares[135] - Fosun International holds 291,365,387 non-listed shares, representing 76.66% of the non-listed share class and 53.61% of the total shares[135] - Fosun High-Tech holds 291,365,387 non-listed shares, representing 76.66% of the non-listed share class and 53.61% of the total shares[135] - Fosun International holds 32,331,100 H shares, representing 19.78% of the H share class and 5.95% of the total shares[135] - Wu Yifang holds a bond with a principal amount of $700,000,000 due on May 18, 2026, and another with a principal amount of $500,000,000[132] - Wenjie Zhang holds an 8.93% stake in HenLink, which directly holds 2.92% of the company's shares[133] - Zhu Jun holds a 3.09% stake in Shanghai Guoyun, which directly holds 0.99% of the company's shares[132] Share Incentive Plans - The 2018 Share Incentive Plan involved a total of 22,750,000 shares, representing approximately 4.19% of the company's total issued shares at the time, with 11,714,650 shares held by Shanghai Guoyun and 11,035,350 shares held by HenLink[143] - The 2020 Share Incentive Plan was adopted to purchase restricted interests from resigned 2018 participants, including 360,700 non-listed shares from Shanghai Guoyun and 2,420,000 non-listed shares from HenLink, representing approximately 0.51% of the company's total issued shares[146] - The 2018 Share Incentive Plan had three categories of participants with different vesting schedules: Category 1 participants had 60% of their shares vested by April 30, 2020, Category 2 had 35%, and Category 3 had 20%[145] - The 2020 Share Incentive Plan also had three categories of participants with different vesting schedules: Category 1 participants had 60% of their shares vested by April 30, 2021, Category 2 had 20%, and Category 3 had 55% by April 30, 2023[147] - All shares under the 2018 and 2020 Share Incentive Plans were fully vested by 2023, with no unvested or unallocated shares during the reporting period[148] - The company's H shares are listed and traded on the Hong Kong Stock Exchange with a par value of RMB 1.00 per share[150] - The global offering includes 6,469,600 H shares for the Hong Kong public offering and 58,225,800 H shares initially available for subscription[150] - The company's shares are held by shareholders, with each share having a par value of RMB 1.00[151] - The company's H shares are denominated in Hong Kong dollars and traded on the Hong Kong Stock Exchange[150] - The company's global offering includes an over-allotment option for 4,366,400 H shares[150] Production and Operations - The company has a production base in Songjiang District, Shanghai, with a total planned area of 200 mu for the "Henlius Biopharmaceutical Industrialization Base (II)"[152] - The company's production base in Xuhui District, Shanghai, is located on Yishan Road[152] - The company's production base in Songjiang District, Shanghai, is under construction with a total planned area of 200 mu[152] - The company operates in a single reportable segment, focusing on biopharmaceutical R&D, services, and production[89] - The

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。 Shanghai Henlius Biotech, Inc. 上海復宏漢霖生物技術股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：2696） 截至2024年6月30日止六個月的中期業績公告 上海復宏漢霖生物技術股份有限公司（「本公司」或「復宏漢霖」）董事會（「董事 會」）欣然宣佈根據國際財務報告準則（「國際財務報告準則」）編製的本公司及其附 屬公司（統稱「本集團」或「我們」）截至2024年6月30日止六個月（「報告期」）之未 經審計綜合財務業績。 | --- | --- | |-------|---------------------------------------------------------------------------------------------------------------------------------------------------- ...

M N 2 May 2024 CMB International Global Markets | Equity Research | Company Update Henlius Biotech (2696 HK) Strong product sales in 1Q  Strong sales maintained in 1Q24. Henlius Biotech (Henlius) recorded total Target Price HK$20.33 revenue of RMB1.349bn in 1Q24, up 35% YoY. Of this, HANQUYOU’s sales in (Previous TP HK$18.67) China was RMB671mn (+25% YoY, -4% QoQ), which accounted for 23% of our Up/Downside 21.2% previous FY24 estimate. In 1Q24, serplulimab (PD-1) experienced robust Current Price HK$16.78 ...

Financial Performance - Henlius achieved its first full-year profit in 2023, marking a significant milestone in its journey to become a global innovative biopharmaceutical company[7] - Revenue in 2023 reached RMB 5,394.9 million, a 67.8% increase compared to RMB 3,214.7 million in 2022[11] - Net profit for 2023 was RMB 546.0 million, a significant turnaround from a loss of RMB 695.3 million in 2022[12] - R&D expenses in 2023 decreased to RMB 1,118.7 million from RMB 1,394.5 million in 2022, reflecting optimized resource allocation[12] - Total assets increased to RMB 9,903.6 million in 2023, up from RMB 8,924.3 million in 2022[14] - The company achieved operating revenue of approximately RMB 5,394.9 million, a year-on-year increase of 67.8%[55] - The company recorded gross profit of approximately RMB 3,918.8 million, an increase of RMB 1,548.7 million year-on-year, driven by the strong sales growth of Hanquyou® and Hansizhuang®[61] - The company recorded other income and gains of approximately RMB 68.9 million, including government subsidies and bank interest income[62] - Total revenue for the year ended December 31, 2023, was RMB 68,914 thousand, a decrease from RMB 105,552 thousand in 2022[63] - R&D expenses for 2023 were RMB 1,433.6 million, a decrease of RMB 749.6 million compared to RMB 2,183.2 million in 2022, due to project licensing and optimized resource allocation[65] - Administrative expenses increased to RMB 383.8 million in 2023 from RMB 354.0 million in 2022, driven by higher staff costs and operational expenses[66] - Sales and distribution expenses for 2023 were RMB 1,754.2 million, primarily due to increased sales of Han Qu You®, Han Si Zhuang®, and the launch of Han Bei Tai®[67] - The company reported a profit of RMB 546.0 million for 2023, a significant improvement from a loss of RMB 695.3 million in 2022[69] - Cash and bank balances increased to RMB 987.7 million in 2023 from RMB 680.5 million in 2022, reflecting a growth of RMB 307.2 million[70] - Trade receivables increased to RMB 647.8 million in 2023 from RMB 455.5 million in 2022, with no significant changes in accounting estimates or assumptions[72] - Total interest-bearing bank and other borrowings stood at RMB 3,819.6 million as of December 31, 2023, primarily for clinical trials, commercialization, and operational expenses[74] - The current ratio improved to 52.8% in 2023 from 43.8% in 2022, indicating better liquidity management[78] - The capital-to-debt ratio decreased to 59.5% in 2023 from 64.7% in 2022, reflecting a reduction in net debt relative to equity[78] Product Sales and Market Performance - Core product Han Qu You® generated sales of RMB 2,644 million in the Chinese market, benefiting over 180,000 patients[9] - H drug Han Si Zhuang® achieved sales of RMB 1,120 million in its first full year of sales, with 4 approved indications and a 5th under review[9] - The company has 5 products approved in China and 2 internationally, with over 560,000 patients benefiting globally[9] - Han Qu You® received approvals in multiple countries including Cambodia, Singapore, Thailand, Philippines, and Brazil in 2023[15] - Hanquyou® (Trastuzumab for Injection) achieved sales revenue of approximately RMB 2,644.4 million, a year-on-year increase of RMB 950.0 million, representing a growth rate of 56.1%[56] - Hansizhuang® (Serplulimab) achieved sales revenue of approximately RMB 1,119.8 million, a year-on-year increase of RMB 780.7 million, representing a growth rate of 230.2%[56] - Hanbeitai® (Bevacizumab) achieved sales revenue of approximately RMB 119.4 million since its commercialization in January 2023[56] - Hanlikang® (Rituximab) generated sales revenue of approximately RMB 518.6 million and licensing income of RMB 21.9 million under profit-sharing arrangements[56] - Handayuan® (Adalimumab) generated sales revenue of approximately RMB 58.6 million under profit-sharing arrangements[56] - The company recorded licensing income of RMB 6.0 million for Zercepac® in the European market[57] - The company confirmed R&D service income of RMB 311.8 million for HLX11 and HLX14 under the agreement with Organon LLC[57] - The company confirmed licensing income of RMB 111.1 million for Hansizhuang® under the agreement with Intas[58] Global Expansion and Commercialization - The company emphasized the importance of globalization, stating that going global is not an option but a necessity for biopharmaceutical companies[8] - Henlius is focusing on building a "globalizable" product portfolio, organizational capabilities, and localized commercial strategies to expand its global presence[8] - The company is strategically planning its production capacity with a forward-looking approach, incorporating advanced technologies and stringent quality management to support global product distribution[8] - The company has 5 products approved in China and 2 internationally, with over 560,000 patients benefiting globally[9] - Han Qu You® received approvals in multiple countries including Cambodia, Singapore, Thailand, Philippines, and Brazil in 2023[15] - The company signed agreements with Boston Oncology, LLC and PT Kalbe Genexine Biologics for commercialization of Hanlikang® and Hansizhuang® in the Middle East and North Africa regions in 2023[18] - The company signed an agreement with Intas for commercialization of Hansizhuang® in Europe and India in October 2023[18] - Hansizhuang® (PD-1) is approved for MSI-H solid tumors, squamous non-small cell lung cancer, extensive-stage small cell lung cancer, and esophageal squamous cell carcinoma in China[24] - Hanquyou® (trastuzumab) is approved for HER2-positive breast cancer and metastatic gastric cancer in over 40 countries, including China, the UK, Germany, France, and Australia[24] - Hanlikang® (rituximab) is approved for CD20-positive non-Hodgkin's lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis in China[24] - Handayuan® (adalimumab) is approved for TNF-α-related conditions such as rheumatoid arthritis, ankylosing spondylitis, psoriasis, and uveitis in China[24] - HANSIZHUANG® (serplulimab injection) has been approved for four indications in China, covering MSI-H solid tumors, sqNSCLC, ES-SCLC, and ESCC, and has initiated overseas sales[29][31] - HANSIZHUANG® has been approved in Indonesia for the treatment of ES-SCLC under the brand name Zerpidio®, marking its first overseas market approval[32] - HANSIZHUANG®'s production lines have received EU GMP certification, facilitating further expansion in overseas markets[32] - HANSIZHUANG® has been recommended in 9 clinical guidelines in China, including the CSCO guidelines for lung cancer, esophageal cancer, and colorectal cancer[30] - HANSIZHUANG®'s NDA for the treatment of non-squamous NSCLC in China has been accepted by the NMPA, marking its fifth indication in the country[31] - HANQUYOU® (trastuzumab for injection) has been approved in multiple countries, including Cambodia, Singapore, Thailand, the Philippines, and Brazil, with its BLA accepted by the FDA and NDS by Health Canada[28] - HANQUYOU® has been commercialized in China with a professional sales team covering approximately 1,800 hospitals and 36,000 doctors[27] - HANQUYOU® has established partnerships with international pharmaceutical companies, covering approximately 100 countries and regions globally[28] - HANSIZHUANG®'s MAA for ES-SCLC treatment has been accepted by the EMA, and it has received the Innovation Passport designation in the UK[32] - HANSIZHUANG® has submitted MAAs in Thailand, Singapore, and Malaysia, advancing its commercialization in Southeast Asia[32] - The company has signed licensing agreements with Boston Oncology, LLC, FBD Biologics Limited, PT Kalbe Genexine Biologics, and Intas for the commercialization of Hanlikang® and Hansizhuang® in the Middle East, North Africa, Europe, and India[35] R&D and Clinical Trials - The company is committed to innovation, continuously improving its internal R&D capabilities while leveraging partnerships to amplify its innovation value[8] - The company's product pipeline includes 59 molecules, with over 30 clinical trials ongoing globally[9] - HLX14 (denosumab biosimilar) met the primary endpoint in its international multicenter Phase 3 clinical study for postmenopausal osteoporosis in April 2024[19] - Hansizhuang® combined with chemotherapy achieved the primary endpoint in a Phase 3 clinical study for advanced non-squamous non-small cell lung cancer (nsNSCLC) in October 2023, demonstrating good efficacy and safety[20] - HLX15 (recombinant anti-CD38 fully human monoclonal antibody injection) completed the first subject dosing in a Phase 1 clinical study in healthy male subjects in China in February 2023[20] - HLX07 (recombinant anti-EGFR humanized monoclonal antibody injection) combined with chemotherapy completed a Phase 1b/2 clinical study in China, showing good safety and tolerability in advanced solid tumor patients in February 2023[20] - HLX208 (BRAF V600E inhibitor) was included in the Breakthrough Therapy Designation program by the CDE for treating BRAF V600E-mutated adult Langerhans cell histiocytosis (LCH) and Erdheim-Chester disease (ECD) in April 2023[20] - HLX13 (recombinant anti-CTLA-4 fully human monoclonal antibody injection) completed the first subject dosing in a Phase 1 clinical study in healthy male subjects in China in December 2023[20] - HLX04-O (recombinant anti-VEGF humanized monoclonal antibody injection) showed good safety, tolerability, and preliminary efficacy in a Phase 1/2 clinical study for wet age-related macular degeneration (wAMD) in July 2023[20] - HLX42 (targeting EGFR antibody-novel DNA topoisomerase I inhibitor conjugate) received Fast Track Designation from the FDA for treating EGFR-mutated advanced or metastatic NSCLC in December 2023[20] - HLX14 (recombinant anti-RANKL fully human monoclonal antibody injection) completed a Phase 1 clinical study in healthy male subjects in China in January 2024, showing high similarity in pharmacokinetics and pharmacodynamics to marketed denosumab[20] - The company's pipeline includes 59 molecules (48 innovative drugs and 11 biosimilars) and 18 R&D platforms, covering monoclonal antibodies, bispecific antibodies, antibody-drug conjugates, recombinant proteins, and small molecule conjugates[22] - The company is advancing multiple Phase III trials, including HLX10 (PD-1) for ES-SCLC and HLX11 (pertuzumab) for HER2-positive breast cancer[24] - HLX14 (RANKL) achieved the primary endpoint in an international multicenter Phase 3 clinical study for osteoporosis (OP) in April 2024[42] - HLX208 (BRAF V600E) was officially included in the breakthrough therapy drug program by the CDE in April 2023 for the treatment of adult Langerhans cell histiocytosis (LCH) and Erdheim-Chester disease (ECD)[43] - HLX42 (EGFR ADC) completed the first patient dosing in its Phase 1 clinical study for solid tumors in March 2024[43] - The company's pipeline includes 59 molecules (48 innovative drugs and 11 biosimilars) and 18 R&D platforms, covering monoclonal antibodies, bispecific antibodies, ADCs, recombinant proteins, and small molecule conjugates[46] - HLX42 (EGFR ADC) received Fast Track Designation from the FDA for treating advanced or metastatic NSCLC patients with EGFR mutations[44] - HLX43 (PD-L1 ADC) has entered clinical trials in China after receiving approvals from both the NMPA and FDA[45] - HLX13 (CTLA-4) has entered clinical trials for liver cancer treatment after receiving NMPA approvals[44] - The company is advancing its Hanjugator platform for developing high-safety, high-selectivity, and high-efficacy ADC products[46] - The company is focusing on oncology and autoimmune diseases, aiming to deepen product innovation and international collaboration in 2024[50] Production and Capacity - The company's production capacity reached 48,000 liters across two GMP-certified facilities, supporting global supply[10] - The company has a total commercial production capacity of 48,000 liters, including 24,000 liters at the Xuhui base and 24,000 liters at the Songjiang base (Phase 1)[23] - The company is constructing a new production base, Songjiang Base (II), in Shanghai with an investment of up to RMB 2.54 billion to meet the anticipated market demand for its drug pipeline, enhancing its monoclonal antibody R&D and production capabilities[79] - As of December 31, 2023, the company had capital commitments of approximately RMB 209.3 million for machinery and equipment, primarily related to the purchase of machinery, laboratory renovations, and capitalized R&D expenses[81] - The company reported total construction-in-progress assets of RMB 572.055 million as of December 31, 2023, compared to RMB 712.240 million in the previous year[80] - The Songjiang Base (Phase II) is under construction, with a planned capacity of 36,000 liters for its first two phases, and the third phase has commenced above-ground construction[48] - The Xuhui Base has obtained GMP certifications from China and the EU, enabling dual-market supply and supporting overseas market expansion[48] Corporate Governance and Leadership - Wenjie Zhang resigned as CEO on July 17, 2023, and Zhu Jun was appointed as the new CEO on the same date[157] - The company deviated from the Corporate Governance Code by having Wenjie Zhang serve as both Chairman and CEO until July 17, 2023[158] - The Board of Directors consists of a balanced mix of executive, non-executive, and independent non-executive directors to ensure strong independent judgment[156] - The company has established mechanisms to ensure the Board receives independent views and opinions, including access to all company data and professional advice[160] - All directors, including non-executive and independent non-executive directors, have extensive and valuable business experience and expertise[161] - The company has adopted a standard code for securities transactions, and no violations were reported during the reporting period[155] - The Board is responsible for leading and monitoring the company, overseeing strategy implementation, and ensuring robust internal controls and risk management[161] - Independent non-executive directors provide balanced and independent judgment on corporate actions and operations[161] - The company has a corporate governance framework and policies in place to strengthen the Board's ability to govern and oversee the company's business conduct[154] - The company complies with the requirement to have at least three independent non-executive directors, with at least one possessing appropriate professional qualifications[159] - The company provided training courses for directors, covering topics such as director responsibilities and corporate governance, with all training costs borne by the company[163] - The Audit Committee held 4 meetings during the reporting period to review financial performance, risk management, and internal control systems[166] - The Remuneration Committee held 5 meetings to review and approve compensation policies and equity incentive plans for directors and senior management[167] - The Nomination Committee held 4 meetings to review the structure, size, and composition of the Board, as well as the independence of independent non-executive directors[169] - The company established five Board committees, including Audit, Remuneration, Nomination, Strategy, and ESG Committees, each with clearly defined terms of reference[165] - Newly appointed directors received comprehensive induction materials to ensure a proper understanding of the company's operations and legal responsibilities[162] - The Audit Committee met with external auditors 3 times during the reporting period to discuss audit-related matters[166] - The Nomination Committee considers various factors when evaluating director candidates, including character, qualifications, diversity, and independence[169] - The company encourages all directors to participate in relevant training courses and provides internal briefings and reading materials for continuous professional development[163] - The Remuneration Committee ensures transparency in setting compensation policies and prevents directors from participating in decisions regarding their own remuneration[167] - The Strategic Committee held a total of 2 meetings during the reporting period[170] - The Environmental, Social, and Governance (ESG) Committee held a total of 2 meetings during the reporting period[171] - The Board achieved a female director ratio of 9.1% (1 out of 11 members)[172] - The company's senior management has a female ratio of 57.1% (4 out of 7 members)[173] - The overall employee gender ratio is 51.2% female (1,861 out of 3,637 employees)[173] - The Board held a total of 22 meetings, with all directors maintaining a 100% attendance rate except for newly appointed members[176] - The company held 4 shareholder meetings during the reporting period, including 1 annual general meeting and 1 extraordinary general meeting[177] - The company's Board diversity policy aims to consider factors such as gender, age, cultural background, and professional experience when appointing directors[172] - The ESG Committee is responsible for setting the company's ESG vision, goals, strategies, and framework[171] - The Strategic Committee focuses on long-term development strategies, major investment decisions, and significant capital operations[170] - The company has established an internal audit department to oversee and manage business operations, ensuring compliance with internal and external regulatory requirements[178] - The company's risk management and internal control systems are designed to maintain the highest standards of corporate governance and identify and mitigate potential risks[178] - The board of directors has reviewed and confirmed the effectiveness of the risk management and internal control systems for the year ending December 31, 2023[179] - The company has implemented control procedures to strictly prohibit unauthorized access and use of insider information[179] - The company revised its "Fund Business Management System" in September 2023

港股公司报告 | 公司点评 复宏汉霖（02696） 证券研究报告 2024年03月 24日 投资评级 产品持续放量，加速海外市场开拓 行业 医疗保健业/药品及生 物科技 事件 6个月评级 买入（维持评级） 当前价格 14.16港元 2024 年 3 月 21 日复宏汉霖公布2023 年年度报告：2023 全年实现营业收 目标价格 港元 入53.95亿元（yoy+67.82%）；归母净利润5.46亿元（2022年为-6.95 亿元）； 依靠核心品种（曲妥珠单抗及斯鲁利单抗）高速放量，公司在 2023H1 首 基本数据 次实现盈利后全年业绩维持高增长。 港股总股本(百万股) 543.49 核心品种销售高速增长，商业化能力得到认证 港股总市值(百万港元) 7,695.89 2023全年曲妥珠单抗国内实现收入26.4亿元（yoy+56.1%），海外收入0.93 每股净资产(港元) 4.45 亿元（yoy+162.3%），保持高速增长；斯鲁利单抗实现收入 11.20 亿元 资产负债率(%) 77.86 （yoy+230.2%）增长态势迅猛；贝伐珠单抗实现收入1.19亿元、利妥昔单 一 年内最高/最低(港元) 17.40 ...

M N 25 Mar 2024 CMB International Global Markets | Equity Research | Company Update Henlius Biotech (2696 HK) Anticipating sustained profitability  Profit turnaround driven by core business operations. Henliu’s FY23 revenue Target Price HK$18.67 increased 67.8% YoY to RMB5.40bn, driven by strong sales of HANQUYOU (Previous TP HK$18.67) (trastuzumab biosimilar) and serplulimab (PD-1). HANQUYOU recorded Up/Downside 31.8% RMB2.74bn revenue in FY23, +58% YoY. We think HANQUYOU may be free from Current Price HK ...