Investment Rating - The report maintains a "Buy" rating for the company [1][7] Core Insights - The company has shown significant revenue growth, achieving total revenue of 74.15 million yuan in 2024, a year-on-year increase of 19,110% [4][9] - The core pipeline, including the drug IMM01, is progressing steadily with two Phase III clinical trials expected to report mid-term data in 2026 [5][7] - The company is actively expanding business development (BD) collaborations, including partnerships for dual-specific antibodies targeting PD-L1/VEGF and CD47/CD20 [6][7] Financial Summary - The company is projected to generate revenues of 151 million yuan in 2025, followed by 139 million yuan in 2026, and a significant increase to 675 million yuan in 2027 [9][11] - The net profit attributable to the parent company is expected to be -227 million yuan in 2025, -456 million yuan in 2026, and -508 million yuan in 2027 [9][11] - The company’s cash and short-term financial assets amounted to 752 million yuan in 2024, reflecting a year-on-year growth of 23% [4][7]

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。 ImmuneOnco Biopharmaceuticals (Shanghai) Inc. 宜明昂科生物醫藥技術（上海）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：1541） 年度業績公告 截至2024年12月31日止年度 及建議變更所得款項用途 宜明昂科生物醫藥技術（上海）股份有限公司（「本公司」）董事（「董事」）會（「董 事會」）欣然公佈本公司及其附屬公司（統稱「本集團」）截至2024年12月31日止年 度的經審核綜合業績連同2023年同期的比較數字。該等年度業績已由審核委員 會審閱並經本公司核數師德勤‧關黃陳方會計師行同意。 在本公告內，「我們」及「我們的」均指本公司，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（如適用）。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。除另有界定外，本 ...

2024 年 09 月 27 日 公司深度研究 买入/首次 宜明昂科-B(01541) 昨收盘:5.00 医药 宜明昂科：全球首款 SIRPα-Fc 融合蛋白，CD47 靶点有望获突破 | --- | --- | --- | |-------------------------------------------------------------------------|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | | 走势比较 | | 报告摘要 | | 20% ...

IMM01 Clinical Trial Results - IMM01 combined with azacitidine achieved an ORR of 72.7% (16/22) and CRR of 27.3% (6/22) in CMML patients, with ORR increasing to 87.5% (14/16) and CRR to 37.5% (6/16) in patients treated for ≥4 months[5] - IMM01 combined with azacitidine achieved an ORR of 64.7% (33/51) and CRR of 33.3% (17/51) in HR MDS patients, with ORR increasing to 85.3% (29/34) and CRR to 50.0% (17/34) in patients treated for ≥4 months[5] - IMM01 combined with tislelizumab achieved an ORR of 66.7% and CRR of 24.2% in R/R cHL patients, with 8 CRs and 14 PRs observed in 33 evaluable patients[5] - IMM01 combined with azacitidine demonstrated an ORR of 85.3% (29/34) in MDS patients treated for ≥4 months, with 50.0% (17/34) achieving CR[19] - IMM01 combined with azacitidine demonstrated an ORR of 87.5% (14/16) in CMML patients treated for ≥4 months, with 37.5% (6/16) achieving CR[21] - IMM01 combined with azacitidine demonstrated an ORR of 89.7% (26/29) in MDS patients treated for ≥6 months, with 58.6% (17/29) achieving CR[19] - IMM01 combined with azacitidine demonstrated an ORR of 84.6% (11/13) in CMML patients treated for ≥6 months, with 46.2% (6/13) achieving CR[21] - IMM01 combined with tislelizumab showed no treatment-related adverse events leading to drug discontinuation or death in R/R cHL patients[23] IMM0306 Clinical Trial Results - IMM0306 combined with lenalidomide achieved an ORR of 90.9% and CRR of 27.3% in R/R B-NHL patients, with 3 CRs and 7 PRs observed in 11 evaluable patients[7] - IMM0306 monotherapy showed 5 CRs, 5 PRs, and 11 SDs in 48 patients who had previously received anti-CD20 therapy[27] - IMM0306 combined with lenalidomide showed an ORR of 90.9% and CRR of 27.3% in Ib phase trials, with 3 CR and 7 PR cases observed[30] - IMM0306 combined with lenalidomide in IIa phase trials showed an ORR of 100% and CRR of 66.7% in R/R FL patients[30] - IMM0306 monotherapy determined the RP2D to be 2.0 mg/kg with no dose-limiting toxicities observed[27] IMM2510 Clinical Trial Results - IMM2510 demonstrated promising anti-tumor activity with 3 confirmed PRs and 7 SDs, including 4 patients with tumor shrinkage >15%, in 33 advanced/metastatic solid tumor patients[8] - IMM2510 Phase I trial recruited 33 patients with no dose-limiting toxicity observed, and 3 confirmed PR cases were reported as of June 30, 2024[34] - IMM2510 combined with chemotherapy received IND approval for Phase II trials in November 2023[37] IMM27M Clinical Trial Results - IMM27M showed safety and tolerability in heavily pretreated advanced solid tumor patients, with 2 confirmed PRs observed[9] - IMM27M Phase I trial completed patient recruitment in September 2023, with 2 confirmed PR cases and 3 SD cases with tumor shrinkage observed[38] IMM2520 Clinical Trial Results - IMM2520 demonstrated safety and tolerability in 24 advanced solid tumor patients, with 1 PR and 2 SDs with tumor shrinkage >10% observed[10] - IMM2520 Phase I trial recruited 24 patients as of June 30, 2024, with 1 PR and 2 SD cases with tumor shrinkage over 10% observed[40] IMC Series Development - IMC-002 received IND approvals for treating systemic lupus erythematosus (SLE) and neuromyelitis optica spectrum disorder (NMOSD) in June 2024[11] - IMC-001 is currently in IND preparation for treating atherosclerosis[11] - IMC-003 (ACTRIIA fusion protein) completed efficacy studies in a pulmonary arterial hypertension (PAH) mouse model, showing preliminary efficacy in increasing skeletal muscle[12] - IMC-004 (ACTRIIA × undisclosed target bispecific molecule) is undergoing in vivo efficacy studies and cell line development[13] - IMC-002 (IMM0306), a bispecific molecule targeting CD47 and CD20, received IND approvals for the treatment of systemic lupus erythematosus (SLE) and neuromyelitis optica spectrum disorder (NMOSD) in June 2024[43] - IMC-001 (IMM01), the first SIRPα-Fc fusion protein to enter clinical trials in China, is preparing for IND submission for the treatment of atherosclerosis[44] - IMC-003 (ACTRIIA fusion protein) has completed CMC development and is expected to submit an IND application within one year[45] - IMC-004, a bispecific molecule targeting ACTRIIA and an undisclosed target, is undergoing in vivo efficacy studies and cell line development for the treatment of osteoporosis and muscle mass increase[46] Licensing and Collaboration Agreements - The company entered a licensing and collaboration agreement with SynBioTx Inc. in August 2024, receiving an upfront payment of $15 million and potential milestone payments up to $2.1 billion, plus royalties on net sales outside Greater China[13] - The company signed an exclusive licensing and collaboration agreement with SynBioTx Inc. on August 1, 2024, granting rights for research, development, and commercialization of certain PD-L1 and VEGF bispecific antibodies (including IMM2510) and CTLA-4 monoclonal antibodies (including IMM27M) outside Greater China[152] - The company will retain development and commercialization rights for the licensed products within Greater China, including Mainland China, Hong Kong SAR, Macau SAR, and Taiwan[152] - The company will receive upfront payments, potential near-term payments, and milestone payments for commercial, development, and regulatory achievements, along with single-digit to low double-digit percentage royalties on net sales outside Greater China[153] - Royalty payments will continue on a product-by-product and country-by-country basis until the later of 10 years after first commercial sale, patent expiration, or regulatory exclusivity expiration[153] Financial Performance - R&D expenses decreased by 7.0% to RMB 119.1 million in the first half of 2024, primarily due to reduced clinical trial costs and lower share-based payments[14] - Net loss for the first half of 2024 was RMB 165.8 million, a decrease of RMB 5.0 million compared to the same period in 2023, mainly due to reduced R&D expenses[14] - Adjusted net loss increased by RMB 4.9 million to RMB 120.7 million in the first half of 2024, driven by higher administrative expenses[15] - Total revenue for the six months ended June 30, 2024, was RMB 77,000, compared to RMB 86,000 for the same period in 2023[50] - Other income decreased from RMB 6.4 million for the six months ended June 30, 2023, to RMB 4.3 million for the same period in 2024, primarily due to a decrease in bank interest income of RMB 1.6 million and a decrease in government grants of RMB 0.4 million[51] - R&D expenses decreased by 7.0% from RMB 128.1 million in the first half of 2023 to RMB 119.1 million in the first half of 2024, primarily due to reduced clinical trial expenses and lower share-based payments[54] - Clinical trial expenses decreased by RMB 11.7 million, mainly due to cost savings and increased utilization of internal resources[54] - Share-based payments decreased by RMB 9.0 million, driven by lower recognized expenses under IFRS[54] - Salaries and related benefits increased by RMB 7.2 million due to the expansion of the clinical team[54] - Preclinical and CMC expenses increased by RMB 4.6 million, driven by the advancement of R&D activities for IMM0306 and IMM2510[54] - Administrative expenses decreased by 27.1% from RMB 41.3 million in the first half of 2023 to RMB 30.1 million in the first half of 2024, mainly due to reduced share-based payments[55] - The company's cash and cash equivalents, term deposits, and financial assets at fair value totaled RMB 513.0 million as of June 30, 2024, down from RMB 608.6 million as of December 31, 2023[60] - The company's asset-to-liability ratio increased to 19.2% as of June 30, 2024, up from 14.4% as of December 31, 2023, primarily due to an increase in bank borrowings[61] - The company's net cash used in operating activities decreased by RMB 9.4 million to RMB 123.0 million in the first half of 2024, mainly due to reduced R&D payments[60] - The company's unsecured bank loans increased to RMB 86.0 million as of June 30, 2024, up from RMB 60.0 million as of December 31, 2023, with fixed interest rates ranging from 3.00% to 3.60%[62] - Lease liabilities remained relatively stable at RMB 11.7 million as of June 30, 2024, compared to RMB 14.8 million as of December 31, 2023[62] - Capital commitments for property and equipment purchases decreased significantly to RMB 0.2 million as of June 30, 2024, from RMB 6.0 million as of December 31, 2023[63] - The company held four redeemable structured note financial products with a total fair value of RMB 266.2 million as of June 30, 2024, representing over 5% of the company's total assets[65] - The company recorded fair value gains of RMB 2.6 million, RMB 826,000, RMB 956,000, and RMB 930,000 on its financial products during the reporting period[65] - The company's total employee count was 150 as of June 30, 2024, with total compensation costs decreasing to RMB 60.8 million for the six months ended June 30, 2024, from RMB 80.1 million for the same period in 2023[66] - Revenue for the six months ended June 30, 2024, was RMB 77 thousand, compared to RMB 86 thousand in the same period in 2023[111] - Net loss for the six months ended June 30, 2024, was RMB 165.76 million, compared to RMB 170.83 million in the same period in 2023[111] - R&D expenses for the six months ended June 30, 2024, were RMB 119.14 million, a decrease from RMB 128.09 million in the same period in 2023[111] - Administrative expenses for the six months ended June 30, 2024, were RMB 30.06 million, down from RMB 41.26 million in the same period in 2023[111] - Basic and diluted loss per share for the six months ended June 30, 2024, was RMB 0.44, compared to RMB 0.48 in the same period in 2023[111] - The company did not recommend the payment of an interim dividend for the six months ended June 30, 2024, consistent with the same period in 2023[107] - The Audit Committee reviewed the unaudited interim financial results for the six months ended June 30, 2024, and found them to comply with applicable accounting standards and regulations[105] - The company did not purchase, sell, or redeem any of its listed securities during the reporting period[106] - Total assets decreased from RMB 758,682 thousand to RMB 623,492 thousand, a decline of 17.8%[113] - Net current assets dropped from RMB 570,792 thousand to RMB 462,820 thousand, a decrease of 18.9%[113] - Cash and cash equivalents fell from RMB 306,983 thousand to RMB 246,848 thousand, a reduction of 19.6%[113] - The company reported a net loss of RMB 165,760 thousand for the six months ended June 30, 2024[114] - Operating cash outflow was RMB 123,017 thousand, slightly improved from RMB 132,356 thousand in the same period last year[115] - Investment activities generated a net cash inflow of RMB 40,266 thousand, compared to a net outflow of RMB 38,402 thousand in the previous year[115] - Financing activities resulted in a net cash inflow of RMB 21,508 thousand, down from RMB 25,630 thousand in the prior year[115] - The company's total equity decreased from RMB 748,287 thousand to RMB 600,238 thousand, a decline of 19.8%[113] - Property, plant, and equipment decreased from RMB 59,157 thousand to RMB 31,886 thousand, a reduction of 46.1%[113] - The company's accumulated losses increased to RMB 876,105 thousand as of June 30, 2024[114] - Revenue from sales of cell lines and other products decreased to RMB 49,000 in the first half of 2024, down from RMB 86,000 in the same period in 2023, representing a 43% decline[120] - Testing services revenue was RMB 28,000 in the first half of 2024, compared to no revenue in the same period in 2023[120] - Total other income decreased to RMB 4,277,000 in the first half of 2024 from RMB 6,359,000 in the same period in 2023, a 32.7% decline[125] - Government grants decreased to RMB 642,000 in the first half of 2024 from RMB 1,038,000 in the same period in 2023, a 38.1% decline[125] - Bank interest income decreased to RMB 3,635,000 in the first half of 2024 from RMB 5,279,000 in the same period in 2023, a 31.1% decline[125] - Net other gains and losses showed a loss of RMB 19,487,000 in the first half of 2024, compared to a gain of RMB 6,106,000 in the same period in 2023[126] - Property and equipment impairment loss was RMB 27,398,000 in the first half of 2024, compared to no impairment loss in the same period in 2023[126] - Total employee costs decreased to RMB 60,846,000 in the first half of 2024 from RMB 80,129,000 in the same period in 2023, a 24.1% decline[127] - Basic and diluted loss per share improved to RMB 0.44 in the first half of 2024 from RMB 0.48 in the same period in 2023[129] - Trade receivables increased to RMB 48,000 as of June 30, 2024, from RMB 39,000 as of December 31, 2023[131] - Prepayments and other receivables decreased to RMB 69,510 thousand as of June 30, 2024, compared to RMB 78,097 thousand as of December 31, 2023[132] - Financial assets at fair value through profit or loss increased to RMB 266,189 thousand as of June 30, 2024, from RMB 259,085 thousand as of December 31, 2023[132] - Cash and cash equivalents decreased to RMB 246,848 thousand as of June 30, 2024, from RMB 306,983 thousand as of December 31, 2023[132] - Trade and other payables for R&D expenses decreased to RMB 4,883 thousand as of June 30, 2024, from RMB 10,804 thousand as of December 31, 2023[135] - Unsecured bank loans increased to RMB 85,990 thousand as of June 30, 2024, from RMB 59,980 thousand as of December 31, 2023[137] - The company issued 18,065,000 ordinary shares with a face value of RMB 1 per share during the global offering and over-allotment exercise in 2023[139] - The company's bank balances were subject to market interest rates ranging from 0.01% to 5.33% as of June 30, 2024[132] - The average credit period for the company's procurement of goods/services is 45 days[135] - The company's trade payables aged 0 to 30 days decreased to RMB 4,461 thousand as of June 30, 2024, from RMB 10,746 thousand as of December 31, 2023[136] - The company's bank loan interest rates ranged from 3.00% to 3.60% per annum as of June 30, 2024[138] - The company's restricted share plan under Jiaxing Changxian Enterprise Management Center (Jiaxing Changxian) had no changes in the six months ended June 30, 2024, with a registered capital of RMB 345,000 (equivalent to RMB 15,525,000 in share capital as of June 30, 2024)[141] - The restricted share plan under Jiaxing Changyu Enterprise Management Center (Jiaxing Changyu) also had no changes in the six months ended June 30, 2024, with a registered capital of RMB 330,000 (equivalent to RMB 14,850,000 in share capital as of June 30, 2024)[141] - The company's restricted share plan under Halo Biomedical Investment II Limited (Halo Investment II) had a registered capital of RMB 400,000 (equivalent to RMB 18,000,000 in share capital as of June 30, 2024)[141] -

| --- | --- | |-------------------------|-----------------------------------------------------------------------------------------------------------------------------| | 即时点评 | 核心产品 IMM01 数据优秀，创新药管线储备丰富 | | 宜明昂科-B（1541.HK） | 2024-08-27 星期二 | | | 事件： | | | 公司公布半年业绩，截至 2024 年 6 月 30 日半年度亏损同比缩窄， | | | 录得股东应占亏损 1.66 亿元，上年同期亏损 1.71 亿元；总营收 7.7 | | | 万元，同比减少 10.47%；每股净资产为 1.6042 元。 | | | 点评观点： | | | ➢ 研发效率提升： | | 相关报告 | 公司是全球少数能够对先天性免疫和适应性免疫系统进行系统性利用的生物技术公司之一。公司 24 年中期研发开支减少，主要因为 1) | | | 临床试验开支减少人民币 11.7 百万元，由于节约 ...

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。 ImmuneOnco Biopharmaceuticals (Shanghai) Inc. 宜明昂科生物醫藥技術（上海）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：1541） 中期業績公告 截至2024年6月30日止六個月 宜明昂科生物醫藥技術（上海）股份有限公司（「本公司」）董事（「董事」）會（「董 事會」）欣然公佈本公司及其附屬公司（統稱「本集團」）截至2024年6月30日止六 個月的未經審計綜合中期業績連同2023年同期的比較數字。該等中期業績已由 本公司審計委員會審閱。 在本公告內，「我們」及「我們的」均指本公司，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（如適用）。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。除另有界定外，本公告所使用詞彙與本公司日期為 2023年8月24日的招 ...

Investment Rating - The report on ImmuneOnco is classified as NOT RATED [2][10]. Core Insights - ImmuneOnco has successfully established an overseas licensing partnership with SynBioTx for its PD-L1xVEGF bispecific molecule IMM2510 and anti-CTLA-4 antibody IMM27M, which could yield up to US$50 million in near-term payments and over US$2.1 billion in potential milestone payments, along with royalties on global ex-China net sales [2]. - The Phase 1 clinical trial data for IMM2510 indicates promising antitumor activity, particularly in treating relapsed/refractory non-small cell lung cancer (R/R NSCLC) and thymus adeno-squamous carcinoma, with three patients achieving confirmed partial responses (PR) and seven achieving stable disease (SD) [3]. - Early pre-clinical studies of IMM27M show it has significantly stronger anti-tumor activity compared to ipilimumab, with two patients achieving confirmed PR in a Phase 1 trial for HR+ breast cancer [4]. - The company’s key asset, timdarpacept (IMM01), is advancing through clinical trials with favorable efficacy and safety profiles demonstrated in Phase 2 studies for higher risk myelodysplastic syndromes (MDS) and relapsed/refractory classical Hodgkin lymphoma (cHL) [5]. Financial Summary - For the fiscal year ending December 31, 2023, ImmuneOnco reported revenues of RMB 0 million, R&D expenses of RMB -292 million, administrative expenses of RMB -80 million, and a net loss of RMB -379 million [6]. - The year-end cash balance for 2023 was RMB 609 million [6]. Stock Data - The current market capitalization of ImmuneOnco is HK$ 4,714 million, with a current stock price of HK$ 12.60 [7]. - The stock has shown a 1-month performance increase of 17.7% and a 3-month increase of 6.1%, but a decline of 33.1% over the past 6 months [7].

Investment Rating - The report does not provide a specific investment rating for ImmuneOnco, indicating it is currently "NOT RATED" [5]. Core Insights - ImmuneOnco is a clinical-stage biotech company focusing on innate immune systems with a differentiated CD47-based portfolio and a rich pipeline of 8 drug candidates in clinical studies [2]. - The key product asset, Timdarpacept (IMM01), has shown promising results in Phase 2 studies and has moved to Phase 3 studies for various indications [2]. - The company has received approvals to conduct Phase 3 clinical trials for IMM01 in high-risk myelodysplastic syndromes (MDS) and classical Hodgkin lymphoma (cHL) [2]. Financial Summary - Revenue for FY21 was RMB 5 million, FY22 was RMB 1 million, and FY23 was RMB 0 million [3]. - R&D expenses increased from RMB 176 million in FY21 to RMB 292 million in FY23 [3]. - The net loss for FY23 was RMB 379 million, with a year-end cash balance of RMB 609 million [3]. Clinical Trial Results - In the Phase 2 trial of IMM01 combined with azacitidine for high-risk MDS, the overall response rate (ORR) was 64.7%, with a complete response (CR) rate of 33.3% among 51 evaluable patients [2]. - For patients who received initial treatment for 4 months or more, the ORR increased to 85.3%, with a CR rate of 50.0% [2]. - In the Phase 2 trial of IMM01 combined with tislelizumab for anti-PD-1 failed cHL, the ORR was 66.7%, with a CR rate of 24.2% among 33 evaluable patients [2]. Market Data - The market capitalization of ImmuneOnco is HK$ 5,403 million [4]. - The stock has shown a 1-month absolute performance of 4.3% and a 6-month performance decline of 52.2% [5].

Investment Rating - The report does not provide a specific investment rating for ImmuneOnco [1] Core Insights - ImmuneOnco is a clinical-stage biotechnology company focused on the innate immune system, with a differentiated product portfolio based on CD47, demonstrating good safety and efficacy [2] - The company has a robust pipeline with eight drug candidates in clinical research, including its lead asset Timdarpacept (IMM01), which has advanced to Phase 3 studies [2] - Recent promising results from the ASCO conference highlighted the efficacy of IMM01 in combination with azacitidine for high-risk myelodysplastic syndromes (MDS) and with tislelizumab for classical Hodgkin lymphoma (cHL) [2] Summary by Sections Company Overview - ImmuneOnco specializes in developing therapies targeting the innate immune system, particularly through CD47-based products [2] Clinical Trials and Results - IMM01 combined with azacitidine showed an overall response rate (ORR) of 64.7% in 51 evaluable MDS patients, with a complete response (CR) rate of 33.3% [2] - In patients receiving initial treatment for at least 4 months, the ORR increased to 85.3%, and for those treated for at least 6 months, it reached 89.7% [2] - The combination of IMM01 and tislelizumab in cHL patients demonstrated an ORR of 66.7% and a CR rate of 24.2% [2] Future Prospects - The promising efficacy and safety profile observed in Phase 2 trials support the initiation of Phase 3 studies for IMM01 [2] - The company has received approval from the CDE to conduct Phase 3 clinical trials for IMM01 in high-risk MDS, PD-1 failed cHL, and in combination with azacitidine for chronic myelomonocytic leukemia (CMML) [2] - A Biologics License Application (BLA) for IMM01 is expected to be submitted in 2026, potentially making it the first CD47-targeted therapy in China [2] Financial Overview - The company reported revenues of 5 million RMB in FY21, which decreased to 1 million RMB in FY22 and 0 in FY23 [3] - Research and development expenses increased from 176 million RMB in FY21 to 292 million RMB in FY23 [3] - The year-end cash balance decreased from 676 million RMB in FY21 to 609 million RMB in FY23 [3]

Clinical Trial Results - IMM01 combined with azacitidine achieved an ORR of 64.7% (33/51) and a CRR of 29.4% (15/51) in a Phase II clinical trial for high-risk MDS, with ORR increasing to 89.3% (25/28) and CRR to 53.6% (15/28) in patients treated for ≥6 months[6] - IMM01 combined with azacitidine achieved an ORR of 72.7% (16/22) and a CRR of 27.3% (6/22) in a Phase II clinical trial for CMML, with ORR increasing to 84.6% (11/13) and CRR to 46.2% (6/13) in patients treated for ≥6 months[6] - IMM01 combined with tislelizumab achieved an ORR of 66.7% and a CRR of 24.2% in a Phase II clinical trial for R/R cHL, with 8 CRs and 14 PRs observed in 33 evaluable patients[6] - IMM0306 combined with lenalidomide achieved an ORR of 71.4% and a DCR of 85.7% in an ongoing Ib/IIa clinical trial for R/R CD20-positive B-NHL, with 1 CR, 4 PRs, and 1 SD observed in 7 evaluable patients[8] - IMM01 achieved an overall response rate (ORR) of 64.7% (33/51) and a complete response rate (CRR) of 29.4% (15/51) in a Phase II trial for high-risk myelodysplastic syndrome (MDS) as of December 31, 2023[10] - IMM01 demonstrated an ORR of 72.7% (16/22) and a CRR of 27.3% (6/22) in a Phase II trial for chronic myelomonocytic leukemia (CMML) as of December 31, 2023[10] - IMM01 combined with tislelizumab showed an ORR of 66.7% and a CRR of 24.2% in a Phase II trial for relapsed/refractory classical Hodgkin lymphoma (cHL) as of March 1, 2024[10] - IMM0306 combined with lenalidomide achieved an ORR of 71.4% and a disease control rate (DCR) of 85.7% in a Phase Ib/IIa trial for relapsed/refractory CD20-positive B-cell non-Hodgkin lymphoma (B-NHL) as of January 5, 2024[12] - IMM2510 showed promising anti-tumor activity in a Phase I trial, with 3 confirmed partial responses (PR) and 7 stable disease (SD) cases, including tumor shrinkage of over 15% in 4 patients as of December 31, 2023[14] - IMM27M demonstrated safety and tolerability up to 7.5 mg/kg, with 2 confirmed PR cases in heavily pretreated advanced hormone receptor-positive breast cancer patients[15] - IMM2520 showed tumor shrinkage of over 10% in 3 patients, including a 26.3% reduction in a small cell lung cancer (SCLC) patient after 4 treatment cycles as of January 2024[16] - IMM01 combined with azacitidine achieved an ORR of 64.7% (33/51) in high-risk MDS patients, with 29.4% (15/51) achieving CR and 15.7% achieving mCR+HI[26] - In CMML patients, IMM01 combined with azacitidine showed an ORR of 72.7% (16/22), with 27.3% (6/22) achieving CR and 13.6% achieving mCR+HI[27] - IMM01 combined with tislelizumab achieved an ORR of 66.7% (22/33) in R/R cHL patients, with 24.2% (8/33) achieving CR[29] - IMM0306, a CD47×CD20 bispecific molecule, showed 5 CRs and 5 PRs in 48 patients treated with doses between 0.8 mg/kg to 2 mg/kg[33] - IMM01 combined with azacitidine demonstrated an ORR of 85.3% (29/34) in high-risk MDS patients treated for ≥4 months, with a CRR of 44.1% (15/34)[26] - In CMML patients treated for ≥4 months, IMM01 combined with azacitidine achieved an ORR of 87.5% (14/16) and a CRR of 37.5% (6/16)[27] - IMM0306 combined with lenalidomide showed an ORR of 71.4% and a DCR of 85.7% in R/R FL and MZL patients at a dose of 1.6 mg/kg, with 1 CR, 4 PR, and 1 SD observed in 7 evaluable patients[36] - IMM2510 monotherapy demonstrated promising anti-tumor activity with 3 confirmed PRs and 7 SDs, including tumor shrinkage of 46%, 32%, and 53% in NSCLC and thymic squamous carcinoma patients[40] - IMM27M showed 2 confirmed PRs with tumor shrinkage of 62.5% and 41.0% in hormone receptor-positive breast cancer patients, and 3 SDs with tumor shrinkage of 22.9%, 18.5%, and 10.3%[44] - IMM2520 (CD47 × PD-L1) demonstrated safety and tolerability up to 2.0 mg/kg, with tumor shrinkage observed in 3 out of 10 evaluable patients, including a 21.1% shrinkage in a cervical cancer patient at 0.1 mg/kg and a 26.3% shrinkage in a SCLC patient at 2.0 mg/kg[47] Drug Development and IND Applications - The company plans to submit IND applications for IMM01 in atherosclerosis and IMM0306 in autoimmune diseases, including SLE, LN, and NMOSD, within the year[8] - The company has developed a new candidate drug, IMM72 (ACTRIIA fusion protein), currently in the preclinical stage for weight loss while maintaining muscle mass and treating PAH, with plans to submit a pre-IND application within the year[8] - The company has further developed a bispecific molecule, IMM7211b, for treating osteoporosis and increasing muscle mass, currently in the preclinical development stage[8] - IMM01 (IMM01) is in IND preparation for the treatment of atherosclerosis[20] - IMM72 (ACTRIIA fusion protein) showed preliminary efficacy in increasing skeletal muscle in PAH mouse models[20] - IMM7211b (ACTRIIA×undisclosed target bispecific molecule) completed candidate screening and proof-of-concept studies[20] - IMM01 + azacitidine received approval for Phase III clinical trials in China for MDS, AML, and CMML[24] - IMM0306 monotherapy entered Phase II trials in 2023 for R/R FL and MZL[24] - IMC-002 (IMM0306) submitted IND application to NMPA in March 2024 for SLE, LN, MN, NMOSD, and MG[24] - IMM67 (recombinant human hyaluronidase) is expected to be registered with NMPA by the end of 2024[24] - IMM01 received orphan drug designation from the FDA for CMML treatment in combination with azacitidine in November 2023[26] - IMM01 combined with tislelizumab completed Phase II recruitment for R/R cHL with 33 patients enrolled, and Phase III trial approval was obtained in April 2024[29] - IMM0306 completed Phase I patient recruitment and initiated Phase II trials in Q2 2023[35] - IMM01 is being explored for potential use in treating atherosclerosis through blocking the CD47/SIRPα signaling pathway[32] - IMM2510 combined with IMM27M received IND approval for Phase I clinical trials in advanced solid tumors, with trials expected to begin in Q2 2024[43] - IMM2510 combined with chemotherapy received IND approval for Phase II clinical trials as first-line treatment for NSCLC or TNBC[43] - IMM0306 is being developed for autoimmune diseases, with an IND application submitted to the NMPA in March 2024[38] - IMM2510 Phase I dose escalation study completed with 33 patients, showing no dose-limiting toxicities and an RP2D of 20 mg/kg every two weeks[40] - IMM2510 Phase II clinical trial for R/R STS in China began patient dosing in November 2023[42] - IMM27M Phase I dose escalation study completed with no dose-limiting toxicities observed up to 7.5 mg/kg, and an RP2D of 5 mg/kg every three weeks[44] - IMM2902 (CD47 × HER2) is in dose escalation at 4.0 mg/kg in China, with the dose escalation expected to be completed by the end of 2024[48] - IMM47 (CD24 monoclonal antibody) received IND approvals from both the Chinese NMPA and the US FDA for the treatment of advanced solid tumors and R/R B-NHL in 2023[49] - IMM72 (ACTRIIA fusion protein) showed preliminary efficacy in increasing skeletal muscle in a PAH mouse model, with IND expected to be filed in 2024[50] - IMM7211b (ACTRIIA × undisclosed target) completed candidate drug screening and proof-of-concept studies, with cell line development ongoing[51] - IMM67 (recombinant human hyaluronidase) completed development as a pharmaceutical excipient in small-scale bioreactors, with pilot-scale production expected to be completed by the end of 2024[52] Financial Performance - R&D expenses increased by 5.3% from RMB 277.3 million in 2022 to RMB 291.9 million in 2023, driven by clinical trial expenses and salary-related costs[21] - Net loss for 2023 decreased to RMB 379.5 million from RMB 402.9 million in 2022, primarily due to reduced losses from financial liabilities[21] - Adjusted net loss for 2023 increased to RMB 281.8 million from RMB 225.8 million in 2022, reflecting continued investment in R&D[22] - The company's total revenue for 2023 was RMB 386 thousand, a decrease from RMB 538 thousand in 2022, primarily from the sale of cell lines and testing services[54][55] - Other income increased from RMB 14.7 million in 2022 to RMB 18.2 million in 2023, driven by a RMB 2.2 million increase in government subsidies and a RMB 1.3 million increase in bank interest income[56] - Other gains and losses turned from a loss of RMB 29.4 million in 2022 to a gain of RMB 1.8 million in 2023, primarily due to a RMB 55.5 million decrease in losses from financial liabilities and a RMB 26.0 million decrease in foreign exchange gains[57] - Administrative expenses decreased by 13.3% from RMB 92.8 million in 2022 to RMB 80.4 million in 2023, primarily due to a reduction in share-based payments[61] - Listing expenses amounted to RMB 26.0 million during the reporting period[62] - Financial costs increased from RMB 0.8 million in 2022 to RMB 1.5 million in 2023, mainly due to higher interest on borrowings[63] - The company reported a net loss of RMB 379.5 million in 2023, down from RMB 402.9 million in 2022[64] - Adjusted net loss for 2023 was RMB 281.8 million, compared to RMB 225.8 million in 2022, after excluding certain non-cash items and listing expenses[66] - Cash and cash equivalents decreased to RMB 608.6 million as of December 31, 2023, from RMB 635.2 million in 2022, primarily due to cash outflows for daily business operations and R&D activities[68] - Current assets totaled RMB 686.7 million as of December 31, 2023, including RMB 307.0 million in cash and cash equivalents, RMB 42.5 million in time deposits, and RMB 259.1 million in financial assets at fair value[68] - Net cash used in operating activities increased to RMB 367.6 million in 2023, up from RMB 238.7 million in 2022, driven by business expansion and clinical trial progress[68] - Net cash used in investing activities rose to RMB 294.8 million in 2023, compared to a net cash inflow of RMB 49,000 in 2022, mainly due to the purchase of financial assets at fair value[68] - Net cash from financing activities increased to RMB 331.0 million in 2023, up from RMB 179.4 million in 2022, primarily due to proceeds from global offerings and unsecured bank borrowings[68] - The company's asset-liability ratio increased to 14.4% as of December 31, 2023, from 7.2% in 2022, mainly due to an increase in bank borrowings of RMB 60.0 million[70] - The company holds unsecured bank borrowings of RMB 60.0 million as of December 31, 2023, with interest rates ranging from 3.0% to 3.4%[71] - The company invested in four redeemable structured note financial products with expected annualized returns of 1.5% to 4.5%, totaling RMB 123.0 million, RMB 45.8 million, RMB 45.2 million, and RMB 45.1 million as of December 31, 2023[73] - Total employee compensation costs decreased to RMB 155.7 million in 2023, down from RMB 173.1 million in 2022, primarily due to a reduction in non-cash share-based payments[75] Corporate Governance and Leadership - The company's board consists of 8 directors, including 2 executive directors, 3 non-executive directors, and 3 independent non-executive directors[76] - Dr. Tian Wenzhi, the founder and CEO, has over 30 years of experience in the biomedical industry and holds 28 authorized patents[76] - Dr. Tian Wenzhi was appointed as an executive director on June 14, 2022, and oversees the company's strategic planning, business management, and R&D activities[76] - Li Song, appointed as an executive director on June 14, 2022, leads the company's preclinical R&D efforts and has over 10 years of experience in the biopharmaceutical industry[77] - Song Ziyi, the CFO and executive director, will resign on March 2, 2024, to focus on other business endeavors[77] - Dr. Xu Cong, a non-executive director since June 14, 2022, provides advice on the company's business plans, major decisions, and investment activities[78] - Dr. Xu Cong has approximately 10 years of experience in the biomedical and finance industries and serves as a director for multiple biotech companies[78] - The company's R&D efforts are driven by a strong focus on innovation, with Dr. Tian Wenzhi playing a key role in research-oriented development[76] - The company has established subsidiaries, including Yiming Tanke, Yiming Angke Shanghai, Macroimmune, ImmuneOnco Hong Kong, and Yiming Kaier, under Dr. Tian Wenzhi's leadership[76] - The company's leadership team combines extensive industry experience with a strong academic background, contributing to its strategic growth and innovation[76][77][78] - The company's board of supervisors consists of three members, with Mr. Gu Jiefeng serving as the chairman since March 1, 2016[84] - Mr. Gu Jiefeng has over 10 years of experience in investment and financing, and currently serves as the rotating general manager of Shanghai Zhangke Herun Venture Capital Co., Ltd since August 2021[84] - Ms. Tian Miao, aged 32, was appointed as a supervisor in July 2017 and currently serves as the supervisor of the company's subsidiary, Yiming Tanke[85] - Mr. Zhao Zimeng, aged 33, was appointed as the employee representative supervisor in January 2022 and currently serves as the supervisor of the company's subsidiary, Yiming Angke Shanghai[85] - Mr. Zhang Ruliang, aged 40, was appointed as the company's senior vice president in January 2023, responsible for CMC and global clinical registration[86] - Dr. Lu Qiying, aged 50, was appointed as the company's chief medical officer and senior vice president in March 2022, responsible for clinical strategy and direct clinical development[87] - Dr. Xiong Zikai, aged 44, was appointed as the company's senior vice president in March 2022, responsible for business development[88] - Dr. Xiong Zikai has over 14 years of experience in business development and other key functions in the biomedical and pharmaceutical industries[88] - The company did not recommend paying a final dividend for the fiscal year ending December 31, 2023 (2022: none)[94] - The company has no distributable reserves as of December 31, 2023[95] - The company faces intense competition in drug development and commercialization, which could delay or hinder its progress[97] - The company relies heavily on the success of its clinical-stage and preclinical-stage drug candidates, and failure in development or regulatory approval could severely impact its business[97] - Delays in recruiting clinical trial participants could adversely affect the company's clinical development activities[97] - Regulatory approval processes for drug candidates are lengthy, costly, and unpredictable, which could harm the company's business if approvals are delayed or denied[98] - The company may seek accelerated approval pathways for its drug candidates, but failure to utilize these could result in additional trials and increased costs[98] - Non-compliance with regulatory standards or adverse actions by regulatory bodies could negatively impact the company's reputation and business[98] - The company's business is focused on developing tumor immunotherapy, with no significant changes in its primary business nature since its listing[93] - The company's financial performance and operational metrics for the fiscal year ending December 31, 2023, are detailed in the "Management Discussion and Analysis" section of the annual report[96] - Top five suppliers accounted for 38.9% of the company's total procurement in 2023, up from 30.