Financial Performance - Total revenue increased by 36.7% from RMB 738.5 million in 2023 to RMB 1,009.4 million in 2024, primarily driven by strong sales growth of Oubatinib[4] - Gross profit rose by 42.8% from RMB 610.1 million in 2023 to RMB 871.0 million in 2024, with a gross margin of 86.3%, up 3.7 percentage points from 82.6% in 2023[4] - The net loss decreased by 29.9% from RMB 645.6 million in 2023 to RMB 452.9 million in 2024, indicating improved financial performance[6] - Total revenue for the year ending December 31, 2024, was RMB 1,009.4 million, with revenue from Orelabrutinib exceeding RMB 1 billion for the first time, marking a 49.1% increase from the previous year[46] - Net sales of drugs rose by 49.7% from RMB 671.6 million in 2023 to RMB 1,005.6 million in 2024, driven by rapid growth in sales of the drug Oubatinib[146] Expenses and Costs - Operating expenses increased by 8.1% from RMB 1,311.6 million in 2023 to RMB 1,417.8 million in 2024, with sales and distribution expenses rising by 14.5%[5] - Research and development expenses rose to RMB 814.0 million in 2024, up from RMB 751.2 million in 2023, reflecting increased investment in technology platform innovation and clinical trials[5] - The ratio of sales and distribution expenses to drug sales decreased from 54.6% in 2023 to 41.8% in 2024, indicating improved operational efficiency[5] - Administrative expenses decreased from RMB 193.5 million in 2023 to RMB 183.9 million in 2024, mainly due to a one-time payment related to the termination of an intellectual property transfer agreement[156] Cash and Assets - Cash and cash equivalents as of December 31, 2024, were approximately RMB 7.76 billion, providing flexibility for clinical development and investment in competitive product lines[6] - The net current assets amounted to RMB 6,759.2 million as of December 31, 2024, supported by cash and bank balances of RMB 6,222.6 million[162] - The company recorded a loss of RMB 5.3 million from joint ventures in 2024, compared to a loss of RMB 4.9 million in 2023[160] - Trade receivables and bills increased from RMB 307.6 million as of December 31, 2023, to RMB 351.0 million as of December 31, 2024, with a significant rise in receivables within three months from RMB 248.9 million to RMB 345.9 million[163] Product Development and Clinical Trials - The company is advancing over 30 ongoing global trials across various clinical stages, focusing on a strong and diverse pipeline of products[9] - The company aims to establish leadership in the hematology field, with Oubatinib as a core therapy and plans for regulatory approval of Tanshitumomab in the first half of 2025[10] - The NDA for Obinutuzumab's use in first-line CLL/SLL treatment was accepted by the CDE in August 2024, with approval expected within the year[11] - The BLA for the combination therapy of Tazemetostat and Lenalidomide for treating relapsed/refractory DLBCL has been accepted for priority review by the NMPA, with approval anticipated in the first half of 2025[13] - The company has initiated a Phase III clinical trial for ICP-248 in CLL/SLL patients, with the first patient expected to be enrolled in March 2025[15] Market and Competitive Position - The global autoimmune disease treatment market is projected to reach $185 billion by 2029, growing at a CAGR of 3.7%, driven by rising prevalence and new product launches[19] - The company aims to become a leader in the hematological malignancies field, supported by a robust product portfolio including Obinutuzumab and Tanshinone Monoclonal Antibody[37] - The company is positioned to address unmet clinical needs in autoimmune diseases through innovative therapies targeting B and T cell signaling pathways[19] Innovations and Collaborations - The company has enhanced its commercialization capabilities by optimizing its management team and strategies, leading to improved operational efficiency and market penetration[11] - A licensing agreement for the development and commercialization of ICP-B02 has been established, with potential milestone payments totaling up to $502.5 million based on clinical and regulatory achievements[16] - The company is actively seeking licensing and clinical collaboration opportunities to complement its existing product pipeline and enhance operational efficiency[41] Regulatory and Approval Updates - Obinutuzumab has been approved as the first and only BTK inhibitor for treating relapsed/refractory Marginal Zone Lymphoma (MZL) in China, and is listed as a first-line recommendation in the CSCO guidelines for MZL treatment[11] - The company has reached an agreement with the FDA to initiate Phase III trials for Obinutuzumab in treating primary progressive multiple sclerosis (PPMS) and secondary progressive multiple sclerosis (SPMS) patients[20] - The combination therapy of Tazemetostat and Lenalidomide has received accelerated approval in the US and conditional approval in Europe for treating relapsed refractory DLBCL[67] Future Plans and Projections - The company plans to submit the IND application for ICP-B794 in the first half of 2025 and initiate clinical trials in the second half of 2025, aiming to enhance its oncology portfolio[40] - The company plans to submit the New Drug Application (NDA) for ICP-723 by the end of March 2025[29] - The company aims to accelerate the progress of its clinical trials to meet the urgent treatment needs of patients[84]

Investment Rating - The report assigns a "Buy" rating to the company with a target price of HKD 8.25, indicating a potential upside of 35% from the current price of HKD 6.12 [1][39][23]. Core Insights - The company is an innovation-driven biopharmaceutical firm focusing on hematological malignancies, solid tumors, and autoimmune diseases, with a robust pipeline of 13 drugs, including 2 commercialized products and over 30 global clinical trials in various stages [7][10]. - The company has made significant advancements in the autoimmune disease sector, particularly with its product ICP-488, which has shown promising results in clinical trials for moderate to severe plaque psoriasis [3][8]. - The first commercial product, a BTK inhibitor named Aobutini, has been included in the national medical insurance directory and is expected to see continued demand growth as new indications are approved [11][39]. Summary by Sections Company Overview - The company is focused on drug discovery, development, and commercialization in the fields of hematological tumors, solid tumors, and autoimmune diseases, with a strong emphasis on innovative therapies [7][26]. Product Pipeline - The product pipeline includes 13 drugs, with 2 already commercialized, and over 30 ongoing global clinical trials. Key products include Aobutini for systemic lupus erythematosus (SLE) and a BCL2 inhibitor for various hematological cancers [4][10]. Clinical Trial Results - The phase II trial of ICP-488 demonstrated significant efficacy in treating moderate to severe plaque psoriasis, with PASI 75 response rates of 77.3% and 78.6% for the 6 mg and 9 mg doses, respectively, compared to 11.6% in the placebo group [3][8]. Financial Performance - The company reported a revenue of RMB 2.78 billion for Q3 2024, a year-on-year increase of 73.96%, and a net loss of RMB 2.75 billion for the first nine months of 2024, reflecting a narrowing loss of 47.1% [33][39]. - The gross margin for the first nine months of 2024 was 86.0%, an increase of 4.8 percentage points from the previous year [33]. Market Potential - The autoimmune disease market is vast, with over 150 diseases affecting more than 500 million patients globally, indicating significant growth potential for the company's products in this area [8][10].

Investment Rating - The report does not specify a clear investment rating for the company [1]. Core Insights - The company is initiating a restricted stock incentive plan, granting 12.34 million shares at a price of HKD 6.65 per share, reflecting confidence in its development [1][2]. - The performance targets for the incentive plan are ambitious, with revenue goals set at HKD 1.5 billion, HKD 1.75 billion, and HKD 2 billion for the years 2025-2028, indicating a projected growth rate of 50% to 100% [2]. - Strong sales growth of the drug Acalbrutinib, with Q3 sales reaching HKD 276 million, a 75.5% increase year-over-year, and total sales for the first three quarters at HKD 693 million, a 45% increase [3]. - The company is advancing its pipeline with two TYK2 inhibitors, with ongoing clinical trials showing promising results [3]. Summary by Sections Financial Performance - The company expects revenues of HKD 1.01 billion, HKD 1.54 billion, and HKD 2.09 billion for the years 2024, 2025, and 2026, respectively, with growth rates of 37.08%, 52.53%, and 35.54% [5][10]. - The net profit attributable to the parent company is projected to improve from a loss of HKD 631.26 million in 2024 to a profit of HKD 232.04 million in 2026, indicating a significant turnaround [5][10]. Product Pipeline - Acalbrutinib is the first and only BTK inhibitor approved for MZL in China, with ongoing clinical trials for various indications, including PPMS and ITP [3]. - The company is in the first tier of domestic development for TYK2 inhibitors, with two products making significant progress in clinical trials [3]. Market Position - The report highlights the company's strong market position in the hematology field and its potential to lead in the treatment of autoimmune diseases [3][9].

Investment Rating - The report maintains an "Accumulate" rating for the company [5][3]. Core Views - The revenue for the first three quarters of 2024 reached 698 million, representing a year-on-year growth of 29.9%. Product revenue grew by 45.0%, with a gross margin of 86.0%, driven primarily by the high-margin product, Orelabrutinib [5][3]. - The net loss narrowed to 285 million, a reduction of 254 million year-on-year, attributed to cost control measures [5]. - The company has a strong cash reserve of approximately 7.8 billion, indicating robust liquidity [5]. - The revenue forecast for 2024-2026 has been revised upwards to 989 million, 1.33 billion, and 1.81 billion respectively, from previous estimates of 963 million, 1.316 billion, and 1.781 billion [5]. Summary by Sections Revenue and Growth - Orelabrutinib's revenue for Q1-Q3 2024 was 693 million, with a year-on-year increase of 30%. The quarterly breakdown shows revenues of 164 million, 254 million, and 276 million, with year-on-year growth rates of 9%, 49%, and 76% respectively [5]. - The inclusion of the exclusive indication for MZL in the medical insurance system has led to accelerated sales growth [5]. Pipeline Development - The company is progressing well in its pipeline, with several innovative products expected to launch in the next 1-3 years. The domestic ITP Phase III registration clinical trial for Orelabrutinib is expected to complete enrollment by Q1 2025 [5]. - The company has also initiated international Phase III clinical trials for PPMS and plans to start SPMS trials in H1 2025 [5]. - The BLA for Tafasitamab for r/r DLBCL has been accepted, with approval expected in 2025 [5]. Financial Performance - The financial summary indicates a significant increase in operating income from 1.04 billion in 2023 to projected figures of 989 million, 1.33 billion, and 1.81 billion for 2024, 2025, and 2026 respectively [7]. - The gross profit is expected to rise from 610 million in 2023 to 856 million in 2024, with net losses projected to decrease over the next few years [7].

Fund Utilization - The net proceeds from the global offering amount to approximately HKD 2,415.67 million, with about HKD 1,568.33 million (64.9%) already utilized[4] - 50% of the utilized funds are allocated for clinical trials and potential commercial launch of Orelabrutinib in China and the US, with an expected full utilization by the second half of 2026[5] - 40% of the funds are designated for other clinical candidates, with full utilization expected by the second half of 2026[5] - 10% of the funds are for working capital and general corporate purposes, with full utilization expected by the second half of 2026[5] - The company has received approximately HKD 3,041.44 million from subscription agreements, with about HKD 1,967.09 million (64.7%) already utilized[7] - Funds from the subscription are intended for R&D costs, talent acquisition, and operational expenses, with all remaining funds expected to be utilized by 2027[8] - The company plans to enhance its capabilities in discovery, clinical, business development, and commercialization through talent acquisition, with an allocation of HKD 672.77 million[8] - The company reserves funds for potential external collaborations and licensing opportunities, amounting to HKD 273.63 million[8] - The total amount of subscription proceeds is HKD 3,041.44 million, with HKD 1,074.35 million remaining unutilized[8] - Any unutilized proceeds may be temporarily invested in financial products with a maturity of no more than 12 months, in accordance with the company's best interests[9] Financial Performance - The company's core product, Oubatinib (Yinokai®), achieved sales revenue of RMB 276 million in Q3 2024, representing a year-on-year growth of 75.5%[14] - For the first nine months of 2024, total revenue reached RMB 698 million, an increase of 29.8% compared to the same period last year[14] - The gross profit margin for the first nine months of 2024 was 86.0%, up from 81.2% in the same period last year, reflecting an improvement of 4.8 percentage points[14] - The net loss for the first nine months of 2024 was RMB 285 million, a reduction of 47.1% compared to the previous year[14] - The company's operating revenue for the current reporting period increased by 73.96% compared to the same period last year[19] - Pharmaceutical sales revenue for the current reporting period rose by 76.30%, primarily due to the continuous increase in sales volume of Oubutini[19] - The total amount of non-recurring gains and losses for the current period was 938,089.74 RMB, while the cumulative amount from the beginning of the year to the end of the reporting period was -8,323,549.99 RMB[18] - The company reported a net profit attributable to shareholders of the listed company for the current period, with specific figures not disclosed in the summary[20] - The company recognized a loss of 5,946,104.68 RMB in other non-recurring gains and losses, primarily related to the fair value changes of convertible loans issued by the group[18] - The company received government subsidies amounting to 958,038.57 RMB during the current period, contributing to its financial performance[18] Assets and Liabilities - As of September 30, 2024, the company held approximately RMB 7.8 billion in cash and cash equivalents, ensuring sufficient liquidity for ongoing projects[16] - The total assets as of the end of the reporting period were RMB 9.46 billion, a decrease of 4.66% from the previous year-end[16] - The equity attributable to shareholders of the listed company was RMB 6.80 billion, down 4.88% from the previous year-end[16] - The total liabilities as of September 30, 2024, were ¥2,635,567,475.81, slightly down from ¥2,739,290,198.68 at the end of 2023, a decrease of about 3.8%[26] - The company’s total equity decreased to ¥6,822,030,630.95 as of September 30, 2024, from ¥7,180,705,653.78 at the end of 2023, a decline of about 5%[26] Research and Development - Research and development expenses for Q3 2024 totaled RMB 194 million, accounting for 69.63% of revenue, a decrease of 48.34 percentage points year-on-year[16] - Research and development expenses as a percentage of operating revenue decreased by 48.34 percentage points in the current reporting period due to a significant increase in operating revenue compared to the previous year[20] - Research and development expenses increased to ¥614,983,375.71 in 2024, compared to ¥549,716,988.65 in 2023, indicating a rise of approximately 11.8%[27] - The company experienced a decrease of 14.16 percentage points in R&D expenses as a percentage of operating revenue from the beginning of the year to the end of the reporting period[20] Cash Flow - Cash and cash equivalents as of September 30, 2024, were ¥6,839,240,725.79, down from ¥8,287,136,644.81 at the end of 2023, a decrease of about 17.4%[25] - The net cash flow from financing activities was -261,692,786.26 CNY in Q3 2024, compared to a positive cash flow of 7,832,072.06 CNY in Q3 2023[31] - Cash flow from operating activities was -333,136,181.63 CNY for the first three quarters of 2024, an improvement from -446,143,350.48 CNY in the same period of 2023[30] - The company reported cash inflow from investment activities of 4,648,580,477.88 CNY in the first three quarters of 2024, slightly down from 4,686,238,569.10 CNY in 2023[30] Shareholder Information - The total number of ordinary shareholders at the end of the reporting period was 16,139, with the top ten shareholders holding a total of 1,328,000,000 shares, accounting for approximately 75.4% of the total shares[22] - The total number of shares issued by the company was 1,762,567,202, with 84.89% listed in Hong Kong and 15.11% on the Shanghai Stock Exchange[21]

Investment Rating - The investment rating for the company is "Accumulate" [2][15]. Core Views - The clinical data for Tyk2 (ICP-488) in treating moderate to severe plaque psoriasis is excellent, showing significant efficacy and safety [5][6]. - The company is advancing its chronic disease pipeline rapidly, with promising developments in hematological malignancies and autoimmune diseases [6]. Summary by Sections Clinical Data - Tyk2 (ICP-488) has demonstrated superior efficacy in Phase II clinical trials for moderate to severe plaque psoriasis, achieving multiple efficacy endpoints with good tolerability and safety [6]. - The PASI75 improvement values for ICP-488 at doses of 6mg and 9mg once daily were 65.7% and 67.0%, respectively, while PASI90 values were 36.4% and 50.0% [6][11]. - Compared to BMS's treatment, ICP-488 shows better efficacy in a shorter observation period [6][11]. Pipeline Progress - The company is making significant progress with its innovative pipeline, including the expected approval of Tafasitamab for r/r DLBCL in 2025 and the initiation of Phase III trials for ICP332 in Alzheimer's disease [6]. - ICP-723 for advanced solid tumors is also advancing rapidly, with an NDA submission expected in Q1 2025 [6]. Financial Overview - The projected revenue for 2024 is 1,043 million RMB, with a growth rate of 30% compared to the previous year [10]. - The net profit is expected to improve gradually, with estimates of -594 million RMB in 2024 and -266 million RMB in 2025 [10].

Financial Performance - InnoCare Pharma reported a revenue of RMB 500 million for the first half of 2024, representing a 25% increase year-over-year[4]. - InnoCare expects to achieve a revenue target of RMB 1.2 billion for the full year 2024, indicating a projected growth of 20% compared to 2023[4]. - The company reported a gross margin of 65% for the first half of 2024, reflecting improved operational efficiency[4]. - In the first half of 2024, the company made significant progress with a rich pipeline of 13 valuable drugs and 2 commercialized products[19]. - Revenue for the six months ended June 30, 2024, increased by 11.2% to RMB 419.7 million compared to RMB 377.5 million for the same period in 2023, primarily driven by a 30.0% increase in sales of Obinutuzumab[39]. - Gross profit rose by 19.3% to RMB 359.6 million for the six months ended June 30, 2024, with a gross margin of 85.7%, up 5.8 percentage points from 79.9% in the same period of 2023[40]. - The loss for the six months ended June 30, 2024, decreased by 37.6% to RMB 268.0 million from RMB 429.2 million for the same period in 2023[41]. - The total loss for the six months ended June 30, 2024, was RMB (267,952) thousand, a decrease from RMB (429,184) thousand in the same period of 2023, reflecting improved operational performance[43]. Research and Development - The company has allocated RMB 200 million for research and development in 2024, focusing on innovative therapies for hematological malignancies[4]. - The company is conducting over 30 ongoing global trials at various clinical stages, maintaining a strong operational system in R&D, manufacturing, commercialization, and collaboration[19]. - The company aims to establish leadership in the hematology field, leveraging Obinutuzumab as a core therapy alongside a rich pipeline of investigational drugs[20]. - The company is focused on developing competitive drug combinations for solid tumors by integrating targeted therapies and immunotherapy approaches[34]. - The company is actively seeking licensing and clinical collaboration opportunities to complement its existing product portfolio and enhance operational efficiency[50]. - The company is focused on the research and development of new candidate drugs, which are currently in preclinical or clinical development stages[173]. Product Pipeline and Clinical Trials - The company is advancing its clinical pipeline with three new drug candidates expected to enter Phase III trials by the end of 2024[4]. - ICP-248, a selective BCL-2 inhibitor, is currently in a Phase II/III trial for 1L CLL/SLL, showing an ORR of 71.4% in patients previously treated with BTK inhibitors[24]. - ICP-B02, a CD20×CD3 bispecific antibody, has shown a 100% ORR in patients treated with doses ≥6 mg, indicating strong efficacy in relapsed/refractory NHL[25]. - The combination therapy of Tanshizhuo monoclonal antibody and Lenalidomide has received priority review for treating adult relapsed/refractory DLBCL patients, with BLA approval expected in the first half of 2025[23]. - The company has initiated a Phase III trial for obinutuzumab in treating primary progressive multiple sclerosis (PPMS) patients, with the first patient recruited in October 2023[29]. - The company plans to start patient recruitment for the Phase III trial of ICP-332 in atopic dermatitis in Q4 2024[30]. - The ongoing Phase II study for ICP-488 in psoriasis aims to achieve topline results by the end of 2024[31]. Market Expansion and Strategy - InnoCare plans to expand its market presence in Southeast Asia, targeting a 15% market share in the region by 2025[4]. - Strategic initiatives have been implemented to expand market coverage, optimize sales operations, and strengthen the commercial team, resulting in increased market penetration and revenue growth for Obinutuzumab[19]. - The company aims to leverage Oubatinib and a rich pipeline of investigational drugs to establish leadership in the hematological oncology field, targeting NHL, MM, and leukemia[57]. - The company is exploring potential mergers and acquisitions to enhance its product portfolio, with a budget of up to RMB 500 million for strategic investments[4]. Financial Position and Investments - Cash and cash equivalents as of June 30, 2024, amounted to approximately RMB 7.99 billion, providing flexibility for clinical development and investment in competitive product lines[41]. - The company has committed to reducing greenhouse gas emissions intensity, energy usage intensity, and industrial wastewater discharge intensity by 10% by 2028 based on 2023 levels[130]. - The company plans to expand its production capacity by an additional 30,000 square meters to support ongoing drug development and business expansion[128]. - The company has raised funds through various share issuances, including a total of 250,324,000 shares at HKD 8.95 per share during its IPO[166]. Governance and Compliance - The company has established an audit committee to oversee financial reporting and internal controls, comprising one non-executive director and two independent non-executive directors[192]. - The company confirmed compliance with the standard code of conduct for securities trading by all directors during the reporting period[186]. - The company has adopted a series of risk management policies to identify, assess, and monitor significant risks related to its strategic objectives[175].

股 票 研 究 股票研究 /[Table_Date] 2024.09.09 海 外 公 司 （ 中 国 香 港 ） 证 券 研 究 报 告 MS III 期获 FDA 批准，海外空间打开 诺诚健华(9969) [Table_Industry] 医药 [Table_Invest] 评级： 增持 ——诺诚健华跟踪点评 | --- | --- | --- | --- | --- | --- | |----------|-----------------------------------|----------|-------|--------------------------|-------| | | | | | | | | | [table_Authors] 丁丹 ( 分析师 ) | 付子阳 ( | | 研究助理 | | | | 0755-23976735 | | | 0755-23976666 | | | | dingdan@gtjas.com | | | fuziyang028496@gtjas.com | | | 登记编号 | S0880514030001 | | | S0880123100022 | | ...

奥布替尼加速放量，创新管线推进顺利 诺诚健华(9969) [Table_Industry] 医药 [Table_Invest] 评级： 增持 ——诺诚健华 2024H1 点评 | --- | --- | --- | --- | |----------|-------------------|----------------------------|--------------------------| | | 丁丹(分析师) | 甘坛焕(分析师) | 付子阳(研究助理) | | | 0755-23976735 | 021-38675855 | 0755-23976666 | | | dingdan@gtjas.com | gantanhuan028803@gtjas.com | fuziyang028496@gtjas.com | | 登记编号 | S0880514030001 | S0880523080007 | S0880123100022 | 本报告导读： 奥布替尼凭借 MZL 独家适应症加速放量，全年收入增长指引上调至 35% 。自免和 实体瘤管线拓展顺利，创新管线有望未来 1-2 年陆续获批上市，维 ...

[ T able_StockInfo] 2024 年 08 月 21 日 证券研究报告•2024 年半年报点评 当前价：4.48 港元 诺诚健华（9969.HK）医疗保健 目标价：——港元 业绩超预期，建立血液瘤领域的领导地位 [Table_Summary 事件：8月 20 ]日，诺诚健华公布 2024年中期业绩，2024年上半年营业收入为 4.2亿元（+11.2%），其中奥布替尼实现强劲增长，销售额为 4.2亿元（+30%）， 业绩超预期。 奥布替尼销售强劲增长，血液瘤和自身免疫病推进顺利。奥布替尼上半年销售 额为 4.2亿元（+30%），其中 Q2同比增长 48.8%。奥布替尼是中国首个且唯一 获批针对 MZL的 BTK 抑制剂。奥布替尼在美国针对复发或难治性 MCL的注册 性Ⅱ期临床试验已完成患者招募，美国 NDA 的提交计划正在讨论中。自免适应 症上，ITP 处于临床Ⅲ期，预计 2024 年末或 2025 年初完成患者招募。系统性 红斑狼疮（SLE）Ⅱb 期临床试验正在进行中，截至 2024 年 8 月 20 日患者招 募已接近完成。 TYK2抑制剂国内研发第一梯队，两款产品研发进展顺利。公司拥有两款 ...