浦银国际研究 公司研究 | 医药行业 信达生物（1801.HK）：运营效率提升 阳景 浦 推动净亏损好于预期 首席医药分析师 银 Jing_yang@spdbi.com 国 (852) 2808 6434 信达生物 2H23 收入符合我们预期，由于经营效率的提高，净亏损好 际 于我们预期。我们预计 2024年收入同比增速约为 25%。公司将心血管 胡泽宇 CFA 代谢、自身免疫、眼科三大业务合并为综合产品线，且新任的心血管 医药分析师 代谢商业化负责人之前有着丰富的中国市场 GLP-1 推广经验，显示出 ryan_hu@spdbi.com 公司正在稳步推进其非肿瘤业务商业化进程。受益于收入和运营效率 (852) 2808 6446 的进一步提升，我们认为公司目前正有条不紊地走在其之前设立的盈 利目标轨迹上（2025年实现 non-IFRS EBITDA 盈亏平衡）。重申我们的 2024年3月21日 “买入”评级和首选股票推荐，上调目标价至 60港元。 公 司  2H23 收入符合预期，净亏损好于我们预期：2H23 公司实现总收入 评级 研 人民币 35 亿元 （51.3% YoY/29.7% HoH），其中 ...

M N 22 Mar 2024 CMB International Global Markets | Equity Research | Company Update Innovent Biologics (1801 HK) More than obesity  Strong product sales in FY23. In FY23, Innovent recorded total revenue of Target Price HK$55.00 RMB6.21bn, including RMB5.73bn product sales revenue (+38.4% YoY), in line with (Previous TP HK$57.35) our expectation. Innovent had a strong 2H23, with product sales +33.1% HoH vs the Up/Downside 44.4% first half. As per Eli Lilly, total sales of sintilimab in FY23 reached US$393.3 ...

[Table_Page]公 告点评|制药、生物科技与生命科学 证券研究报告 [【Table_T广itle] 发 医 药 & 海 外 】 信 达 生 物 [公Tab司le_I评nves级t] 买入 当前价格 38.10港元 （01801.HK） 合理价值 58.45港元 前次评级 买入 商业化表现强劲，创新兑现驱动新增长 报告日期 2024-03-21 [ 核Tabl 心e_Su 观mm 点ary] ： 相[Ta对ble市_Pi场cQu表ote现] ⚫ 公司发布2023年年度业绩公告：公司23年实现收入62.06亿元，同 19% 比增长 36.2%；净亏损 10.28 亿元，同比大幅减亏 11.51 亿元。公司 9% 加强费用管理，持续提升研发和营销效率，23年研发开支22.28亿元 -1% 03/23 05/23 07/23 09/23 11/23 01/24 03/24 (yoy -22.4%)、行政费用7.50亿元(yoy -10.2%)、销售费用31.01亿元 -10% (yoy +19.7%)，销售费用占产品收入比例为54.1%(yoy -8.5pct)。 -20% ⚫ 商业化品种不断丰富，创新驱动业 ...

Investment Rating - The investment rating for the company is upgraded to "Buy" [2][3][15] Core Views - The company reported a larger-than-expected loss in 2023, but its main product sales revenue grew rapidly, with total revenue increasing by 36.2% year-on-year to 6.21 billion RMB [2][5] - The company is expected to maintain strong revenue growth, with a projected CAGR of 22.1% from 2023 to 2026 [2][5] - The target price has been adjusted to 46.00 HKD based on a revised DCF model [2][11] Summary by Sections Financial Performance - In 2023, the company's revenue reached 6.21 billion RMB, with a gross profit of 5.07 billion RMB, reflecting a gross margin increase of 39.8% year-on-year [2][5] - The net loss attributable to shareholders decreased by 52.8% to 1.03 billion RMB [2][5] - The company’s revenue forecast for 2024-25 has been slightly raised by 0.05% and 0.3% respectively, with expected revenues of 8.31 billion RMB and 9.90 billion RMB [2][5] Product Pipeline and Growth Drivers - The main product, 达伯舒 (Daboshu), is expected to see steady growth, with sales projected to increase from approximately 2.83 billion RMB in 2023 to 4.20 billion RMB in 2025 [2][5] - Other products have also shown rapid sales growth, with their contribution to total revenue rising from 26.6% in 2021 to 50.65% in 2023 [2][5] - Several products are expected to achieve significant milestones in 2024, including new drug applications and clinical trial advancements [2][7] Adjustments and Projections - The sales and marketing expenses forecast for 2024-25 has been increased due to management's commitment to promoting new products [2][5] - The net loss forecast for 2024 has been adjusted from 230 million RMB to 620 million RMB, while the net profit forecast for 2025 has been revised down from 550 million RMB to 180 million RMB [2][5] - The company’s financial metrics indicate a recovery path, with expectations of turning profitable by 2025 [2][5]

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，概不對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。 信 達 生 物 製 藥 INNOVENT BIOLOGICS, INC. （於開曼群島註冊成立的有限公司） （股份代號：1801） 截至2023年12月31日止年度 年度業績公告 信達生物製藥（「本公司」，連同其附屬公司統稱「本集團」）董事（「董事」）會（「董 事會」）欣然公佈本集團截至2023年12月31日止年度（「報告期」）的經審核綜合業 績，連同截至2022年12月31日止年度的比較數字。本集團於報告期的綜合財務報 表已獲本公司審核委員會（「審核委員會」）審閱及經本公司核數師德勤•關黃陳方 會計師行審核。 於本公告，「我們」及「我們的」指本公司，如文義另有所指，則指本集團。本公告 所載若干金額及百分比數字已約整或已四捨五入至小數點後一位或兩位數。任何 表格、圖表或其他地方所示總額與所列數額總和如有任何差異乃因四捨五入所致。 ...

智通财经APP讯，信达生物(01801)发布公告，公司研发的重组抗胰岛素样生长因子1受体(IGF-1R)抗体注射液(研发代号：IBI311)在中国甲状腺眼病(Thyroid Eye Disease,TED)受试者中开展的III期注册临床研究(RESTORE-1)达成主要终点。公司计划将向国家药品监督管理局(NMPA)药品审评中心(CDE)递交IBI311治疗TED的新药上市申请(NDA)。 RESTORE-1(CTR20223393)是一项在TED受试者中评估IBI311有效性和安全性的多中心、随机、双盲安慰剂对照的II/III期临床研究。研究结果显示，RESTORE-1的III期阶段主要研究终点顺利达成：第24周时，接受IBI311治疗的受试者研究眼的眼球突出应答率(研究眼相对于基线突眼度回退≥2mm，且不伴有对侧眼突眼度增加≥2mm的受试者比例)显著优于安慰剂组：IBI311组和安慰剂组研究眼的眼球突出应答率分别为85.8%和3.8%，两组差异为81.9%(95%CI：69.8%-93.9%，P<0.0001)。 此外，研究的关键次要研究终点如研究眼的眼球总体应答率(研究眼相对于基线突眼度回退≥2mm及研 ...

证券研究报告 | 公司点评 2024年02月20日 信达生物（01801.HK） IBI311 用于 TED 三期临床达主要终点，慢病布局进入收获期 信达生物宣布IBI311（IGF-1R）三期临床达主要终点，计划将递交上市申请。 买入（维持） 公司宣布重组抗胰岛素样生长因子 1 受体（IGF-1R）抗体注射液（研发代号： 股票信息 IBI311）在中国甲状腺眼病受试者中开展的III期注册临床研究（RESTORE-1）达 到主要终点，计划向NMPA递交新药上市申请。 行业 药品 前次评级 买入 观点：IBI311用于TED三期临床达主要终点，慢病布局进入收获期。 2月19日收盘价（港元） 38.75 国内甲状腺眼病暂无靶向药获批，IGF-1R 单抗具备重磅单品潜质。甲状腺眼病 总市值（百万港元） 62,875.09 （Thyroid Eye Disease, TED）为累及眼部组织的自身免疫性疾病，年发病率预估 总股本（百万股） 1,622.58 为16/100,000人（女性）和2.9/100,000人（男性），患病率为0.1-0.3%，目前 国内暂无靶向药物获批。IBI311可阻断IGF-1与IGF-1R ...

智通财经APP获悉，2月2日，据CDE官网显示，信达生物(01801)IBI133国内首次申报临床。据悉，IBI133是信达生物布局的一款HER3 ADC，已在去年12月在澳大利亚启动了一项I/II期临床试验，针对实体瘤患者。 目前全球范围内尚未有HER3 ADC获批上市，据Insight数据库显示，当前仅10款产品进入临床阶段，其中仅靶向HER3的有8款。布局企业除信达外，还涉及第一三共、恒瑞、映恩生物等。 目前，在既往经EGFR-TKI治疗后进展的EGFR突变NSCLC患者中的关键III期临床HERTHENA-Lung02研究正在进行中。 国产企业中，恒瑞HER3 ADCSHR-A2009也已经亮相2023ESMO，仅次于第一三共成为第2个公布临床结果的同靶点ADC。此外，映恩生物、石药集团也均有布局。 值得一提的是，百利天恒布局的HER3/EGFR双抗BL-B01D1也已处于III期临床阶段。去年12月以8亿美元首付款，潜在总价值最高达84亿美元，将BL-B01D1授权给BMS，刷新国产ADC新药出海授权新纪录。 ...

Financial Performance - Revenue from customer contracts increased to RMB 2,701,532 thousand in the first half of 2023, up from RMB 2,239,599 thousand in the same period of 2022[7] - Gross profit rose to RMB 2,196,917 thousand in H1 2023, compared to RMB 1,768,071 thousand in H1 2022[7] - The company reported a net loss of RMB 139,149 thousand in H1 2023, significantly lower than the net loss of RMB 950,468 thousand in H1 2022[7] - Other income increased to RMB 232,421 thousand in H1 2023 from RMB 104,959 thousand in H1 2022[7] - Sales and marketing expenses decreased to RMB 1,347,414 thousand in H1 2023 from RMB 1,397,902 thousand in H1 2022[7] - The company's comprehensive loss for the period was RMB 188,601 thousand in H1 2023, compared to RMB 1,004,294 thousand in H1 2022[7] - Total revenue for the six months ended June 30, 2023, was RMB 2,701.5 million, a 20.6% increase compared to RMB 2,239.6 million in the same period in 2022[8] - Product revenue reached RMB 2,457.5 million, up 20.4% from RMB 2,040.9 million in the same period last year, driven by rapid sales growth and new product contributions[8] - Gross margin for product sales improved to 79.7%, up 2.8 percentage points from 76.9% in the same period in 2022, due to increased sales volume and production efficiency[8] - LBITDA improved significantly, with a loss of RMB 216.1 million, a 76.0% reduction from RMB 900.8 million in the same period in 2022[8] - Adjusted gross margin for product sales increased to 80.8%, up 2.2 percentage points from 78.6% in the same period last year[10] - Adjusted LBITDA was RMB 267.4 million, a 74.2% reduction from RMB 1,035.7 million in the same period in 2022[10] - Achieved strong revenue growth and improved core financial metrics in H1 2023, including a significant reduction in LBITDA[21] - Adjusted administrative expenses as a percentage of total revenue decreased to 10.1% in the first half of 2023, down from 14.1% in the same period of 2022[22] - Adjusted product sales gross margin improved to 80.8% in the first half of 2023, up 2.2 percentage points from 78.6% in the same period of 2022[22] - Adjusted sales and marketing expenses as a percentage of total product revenue decreased to 54.5% in the first half of 2023, down 12.2 percentage points from 66.7% in the same period of 2022[22] - Adjusted gross profit for the six months ended June 30, 2023, was RMB 2,224,082 thousand, compared to RMB 1,803,249 thousand in the same period in 2022[50] - Adjusted R&D expenses for the six months ended June 30, 2023, were RMB (826,251) thousand, compared to RMB (1,077,701) thousand in the same period in 2022[51] - Adjusted sales and marketing expenses for the six months ended June 30, 2023, were RMB (1,339,601) thousand, compared to RMB (1,361,590) thousand in the same period in 2022[52] - Adjusted administrative and other expenses for the six months ended June 30, 2023, were RMB (272,942) thousand, compared to RMB (314,859) thousand in the same period in 2022[53] - Adjusted LBITDA for the six months ended June 30, 2023, was RMB (267,388) thousand, compared to RMB (1,035,703) thousand in the same period in 2022[54] - Adjusted net loss for the six months ended June 30, 2023, was RMB (190,424) thousand, compared to RMB (1,085,325) thousand in the same period in 2022[55] - Total assets as of June 30, 2023, were RMB 17,897,036 thousand, compared to RMB 17,588,845 thousand as of December 31, 2022[56] - Bank balances and cash decreased from RMB 9,166.0 million as of December 31, 2022, to RMB 8,526.5 million as of June 30, 2023, primarily due to ongoing R&D projects and capacity expansion[57] - The company had unused long-term bank loan facilities of approximately RMB 2,177.4 million as of June 30, 2023[57] - The company had pledged property, plant, and equipment totaling RMB 823.8 million, land use rights of RMB 276.9 million, and bank deposits of RMB 875.5 million as collateral for loans and bank financing as of June 30, 2023[60] - The company had no significant contingent liabilities as of June 30, 2023[61] - The majority of the company's transactions are settled in RMB, with most bank balances and cash held in USD as of June 30, 2023[61] - Total employee compensation costs for the six months ended June 30, 2023, were RMB 1,358.8 million, compared to RMB 1,436.9 million for the same period in 2022[62] - Revenue from customer contracts increased to RMB 2,701,532 thousand, up 20.6% compared to RMB 2,239,599 thousand in the same period last year[101] - Gross profit rose to RMB 2,196,917 thousand, a 24.3% increase from RMB 1,768,071 thousand in the previous year[101] - Net loss for the period improved significantly to RMB 139,149 thousand, compared to a net loss of RMB 950,468 thousand in the same period last year[101] - Total assets increased to RMB 15,024,572 thousand, up 6.6% from RMB 14,089,647 thousand at the end of 2022[102] - Trade receivables grew to RMB 1,015,502 thousand, a 76.5% increase from RMB 575,269 thousand at the end of 2022[102] - Bank balances and cash decreased to RMB 7,655,657 thousand, down 16.5% from RMB 9,162,823 thousand at the end of 2022[102] - Non-current liabilities increased to RMB 4,241,355 thousand, up 26.2% from RMB 3,359,698 thousand at the end of 2022[103] - Total equity slightly increased to RMB 10,783,217 thousand, up 0.5% from RMB 10,729,949 thousand at the end of 2022[103] - Total comprehensive loss for the six months ended June 30, 2023, was RMB 188,601 thousand, compared to RMB 1,004,294 thousand in the same period in 2022[104] - Net cash used in operating activities for the six months ended June 30, 2023, was RMB 622,891 thousand, a decrease from RMB 806,699 thousand in the same period in 2022[106] - Net cash generated from investing activities for the six months ended June 30, 2023, was RMB 725,040 thousand, compared to RMB 379,414 thousand in the same period in 2022[107] - Net cash generated from financing activities for the six months ended June 30, 2023, was RMB 244,686 thousand, compared to RMB 223,725 thousand in the same period in 2022[107] - Cash and cash equivalents increased by RMB 346,835 thousand for the six months ended June 30, 2023, compared to a decrease of RMB 203,560 thousand in the same period in 2022[107] - Total equity as of June 30, 2023, was RMB 10,783,217 thousand, compared to RMB 9,591,090 thousand as of June 30, 2022[104] - Share-based payment expenses for the six months ended June 30, 2023, were RMB 226,990 thousand, compared to RMB 261,175 thousand in the same period in 2022[104] - Depreciation of property, plant, and equipment for the six months ended June 30, 2023, was RMB 136,028 thousand, compared to RMB 88,285 thousand in the same period in 2022[106] - Amortization of intangible assets for the six months ended June 30, 2023, was RMB 36,223 thousand, compared to RMB 16,913 thousand in the same period in 2022[106] - Bank interest income for the six months ended June 30, 2023, was RMB 190,015 thousand, compared to RMB 89,833 thousand in the same period in 2022[106] - Pharmaceutical product sales revenue increased to RMB 2,457.459 million in H1 2023, up from RMB 2,040.886 million in H1 2022, representing a growth of 20.4%[117] - Licensing fee revenue decreased significantly to RMB 1.525 million in H1 2023 from RMB 20.944 million in H1 2022, a decline of 92.7%[117] - R&D service revenue surged to RMB 8.196 million in H1 2023, compared to RMB 0.241 million in H1 2022, marking a substantial increase[117] - Total revenue from external customers reached RMB 2,701.532 million in H1 2023, up from RMB 2,239.599 million in H1 2022, a growth of 20.6%[117] - Revenue from the United States increased significantly to RMB 234.375 million in H1 2023 from RMB 18.707 million in H1 2022, a growth of 1,152.8%[123] - Foreign exchange gains decreased to RMB 278.265 million in H1 2023 from RMB 396.032 million in H1 2022, a decline of 29.7%[124] - Employee costs totaled RMB 1,358.804 million in H1 2023, slightly down from RMB 1,436.870 million in H1 2022[126] - Basic loss per share attributable to equity holders of the company was RMB 0.091 in H1 2023, compared to RMB 0.649 in H1 2022[128] - The company's total assets are primarily located in China, with the majority of revenue also derived from China, amounting to RMB 2,463.745 million in H1 2023[123] - The company incurred construction costs of approximately RMB 535.0 million for the six months ended June 30, 2023, compared to RMB 240.7 million for the same period in 2022, primarily for new production facilities and machinery[130] - Trade receivables from customer contracts increased to RMB 1,015,502 thousand as of June 30, 2023, up from RMB 575,269 thousand as of December 31, 2022[132] - The fair value loss on equity instruments designated at fair value through other comprehensive income was RMB 30.9 million for the six months ended June 30, 2023, compared to RMB 42.7 million for the same period in 2022[131] - Prepayments and other receivables totaled RMB 777,600 thousand as of June 30, 2023, up from RMB 529,579 thousand as of December 31, 2022[134] - The company recognized RMB 14.3 million in bonus expenses for the six months ended June 30, 2023, compared to RMB 12.9 million for the same period in 2022[135] - Investment notes classified as financial assets at amortized cost amounted to RMB 870,837 thousand as of June 30, 2023, with interest rates ranging from 4.9% to 5.9% annually[137] - The company's listed equity securities investments decreased to RMB 171,657 thousand as of June 30, 2023, from RMB 202,570 thousand as of December 31, 2022[131] - The average credit period provided to trade customers is 45 to 60 days[132] - Loans provided to individuals for exercising share options amounted to RMB 3,809 thousand as of June 30, 2023, with an annual interest rate of 3.5%[136] - Prepaid bonuses to directors totaled RMB 122,992 thousand as of June 30, 2023, up from RMB 117,411 thousand as of December 31, 2022[134] - The company recognized a fair value gain of RMB 4,145,000 on its investment in a US-based private entity, increasing its cumulative stake to 1.285%[138] - The company recorded a fair value loss of RMB 3,213,000 on its Hong Kong-listed equity warrants during the six months ended June 30, 2023[139] - Cash and cash equivalents increased to RMB 1,332,265,000 as of June 30, 2023, up from RMB 1,016,165,000 at the end of 2022[140] - The company's trade payables decreased to RMB 182,150,000 as of June 30, 2023, compared to RMB 267,942,000 at the end of 2022[143] - R&D expenses accounted for RMB 618,161,000 of the accrued expenses as of June 30, 2023, down from RMB 706,815,000 at the end of 2022[146] - The company's total borrowings increased to RMB 3,338,566,000 as of June 30, 2023, up from RMB 3,103,433,000 at the end of 2022[148] - The company's fixed-rate borrowings have an actual interest rate range of 2.60% to 4.90%[150] - The company's total pledged assets amounted to RMB 1,976,222,000 as of June 30, 2023, down from RMB 2,070,715,000 at the end of 2022[151] R&D and Pipeline - R&D expenses decreased to RMB 922,817 thousand in H1 2023 from RMB 1,174,450 thousand in H1 2022[7] - The company has a robust pipeline with 35 high-value products, including 10 marketed products and 7 in Phase III or pivotal clinical studies[4] - The company has 1 product under NDA review by NMPA and over 20 molecules in early-stage clinical development[4] - R&D expenses decreased by RMB 251.7 million to RMB 922.8 million, primarily allocated to late-stage and priority pipeline clinical trials[8] - The company's R&D pipeline includes 35 high-value products covering multiple disease areas such as oncology, cardiovascular and metabolic diseases, autoimmune diseases, and ophthalmology[27] - The company has multiple products in various stages of development, including IND, Phase 1, Phase 1b/2, Phase 2/3, and approved products for indications such as 1L non-small cell lung cancer, 1L lung squamous cell carcinoma, 1L liver cancer, 1L gastric cancer, 1L esophageal cancer, 2L EGFRm non-small cell lung cancer, and Hodgkin lymphoma[28] - Approved products include treatments for ankylosing spondylitis, rheumatoid arthritis, psoriasis, pediatric plaque psoriasis, juvenile idiopathic arthritis, uveitis, and adult and pediatric Crohn's disease[28] - The company has products approved for lung cancer, colorectal cancer, liver cancer, glioblastoma, cervical cancer, ovarian cancer, non-Hodgkin lymphoma, chronic lymphocytic leukemia, 2L cholangiocarcinoma, 2L TKI-resistant chronic myeloid leukemia, 2L gastric cancer, 2L liver cancer, RET+ non-small cell lung cancer/medullary thyroid cancer, and r/r multiple myeloma[28] - The company has submitted an NDA for r/r follicular lymphoma and is developing treatments for 2L KRAS+ non-small cell lung cancer, 1L KRAS+ non-small cell lung cancer/3L colorectal cancer, 2L ROS1+ non-small cell lung cancer, and 2L CEACAM5+ non-small cell lung cancer[28] - The company's pipeline includes treatments for malignant tumors, primary hypercholesterolemia, mixed dyslipidemia, obesity (6mg), type 2 diabetes (6mg), obesity (9mg), psoriasis, inflammatory bowel disease, and other inflammatory diseases[28] - The company is developing treatments for neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and gout[28] - The company's therapeutic areas include oncology, autoimmune diseases, cardiovascular and metabolic diseases, and ophthalmology, with global and regional rights in China, Hong Kong, Macau, and Taiwan[28] - The company's product forms include monoclonal antibodies, small molecules, cell therapies, antibody-drug conjugates, bispecific antibodies, and immunocytokines[28] - The company's targets include PD-1, VEGF-A, CD20, FGFR1/2/3, BCR-ABL, VEGFR-2, BCMA, CAR-T, PI3K, KRAS G12C, ROS1, CEACAM5, LAG3, TIGIT, CTLA-4, LAG3/PD-L1, CD47, PD-L1/CD47, PD-1/IL-2, IL-2, CLDN18.2, HER2, TROP2, EGFR/B7H3, TNF-α, PCSK9, GLP-1R/GCGR, IL-23p19, VEGF/Complement, VEGF-A/ANG-2, VEGF-A/VEGF-C, PDE4, and XOI[28] - The company's candidate drugs/reference drugs include sintilimab, bevacizumab, rituximab, pemigatinib, olverembatinib, ramucirumab, 伊基奧侖賽注射液, selpercatinib, IBI376 (paxalisib hydrochloride), IBI351 (fulzeras

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，概不對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。 信 達 生 物 製 藥 INNOVENT BIOLOGICS, INC. （於開曼群島註冊成立的有限公司） （股份代號：1801） 截至2023年6月30日止六個月 中期業績公告 信達生物製藥（「本公司」或「 信達生物」，連同其附屬公司統稱「本集團」）董事 （「董事」）會（「董事會」）欣然公佈本集團截至2023年6月30日止六個月（「報告期」） 的未經審核簡明綜合業績。該等中期業績已經本公司審核委員會（「審核委員會」） 及本公司核數師德勤•關黃陳方會計師行審閱。 於本公告，「我們」及「我們的」指本公司，如文義另有所指，則指本集團。本公告 所載若干金額及百分比數字已約整或已四捨五入至小數點後一位或兩位數。任何 表格、圖表或其他地方所示總額與所列數額總和如有任何差異乃因四捨五入所致。 ...