Investment Rating - The report maintains a "Buy" rating for the company, with a target price of HKD 21.89 per share, indicating a potential upside of 55% from the current price of HKD 14.12 [4][7][16]. Core Insights - The company is advancing its CD47xCD20 bispecific antibody, IMM0306, which shows promising results in clinical trials for autoimmune diseases, particularly systemic lupus erythematosus (SLE) [8][4]. - The IMM2510, a PD-L1xVEGF bispecific antibody, has demonstrated an objective response rate (ORR) of 23% in previously treated non-small cell lung cancer (NSCLC) patients, with expectations for further data release in late 2025 [10][11]. - The safety and efficacy of the CD47 fusion protein, IMM01, are highlighted, showing an ORR of 69.7% in relapsed/refractory classical Hodgkin lymphoma when combined with PD-1 antibodies [13][14]. Summary by Sections Clinical Development - IMM0306 is currently in Phase Ib trials for autoimmune diseases, with 10 patients enrolled in SLE trials and positive response rates expected to be reported in June [8]. - The company is the first globally to enter clinical trials with a CD47xCD20 bispecific antibody, which has shown an ORR of 88.2% and a complete response (CR) of 52.9% when used with lenalidomide for refractory follicular lymphoma [8]. Financial Projections - Revenue projections for the company from 2025 to 2027 are estimated at RMB 2.01 billion, RMB 1.22 billion, and RMB 3.12 billion, respectively, with net losses expected to decrease over the same period [4][16]. - The report anticipates a significant increase in revenue, with a year-on-year growth of 18912% in 2024 and 171.1% in 2025 [5][18]. Market Position - The company is positioned as a leader in the development of CD47 fusion proteins, with a competitive landscape that includes only a few other players in the CD47 target research [16]. - The report notes a growing interest in bispecific antibodies within the autoimmune sector, with significant business development (BD) opportunities anticipated due to the scarcity of innovative biological drugs in this field [8][16].

Core Viewpoint - The company, along with InstilBio, Inc., announced updates on the clinical status and future plans for IMM2510/AXN-2510, particularly focusing on its application in treating non-small cell lung cancer (NSCLC) Group 1: Clinical Trial Updates - The Phase 2 trial for IMM2510/AXN-2510 in combination with chemotherapy for first-line NSCLC is expected to complete patient enrollment of approximately 60 patients by Q3 2025 in China [1] - As of the end of March 2025, over 30 NSCLC patients have been enrolled, with more than 20 first-line NSCLC patients having received treatment [1] - Preliminary safety and efficacy results from this Phase 2 trial are anticipated to be announced in the second half of 2025 [1] Group 2: Single-Agent Treatment Data - The objective response rate (ORR) for IMM2510/AXN-2510 as a monotherapy for recurrent/refractory NSCLC is reported to be 23%, based on a data set similar to that of a competing PD-(L)1x VEGF bispecific antibody [2] Group 3: Future Clinical Plans - The company plans to initiate a Phase 3 trial for IMM2510/AXN-2510 in combination with chemotherapy for first-line NSCLC in mid-2026, pending discussions with regulatory authorities [3] - Preclinical experiments have demonstrated that IMM2510/AXN-2510 can synergistically bind with PD-L1 in the presence of VEGF in vitro [3] - Additional preclinical data indicating a potentially best-in-class mechanism of action for IMM2510/AXN-2510 is expected to be presented at future medical or scientific conferences [3]

Group 1 - The stock of I-Mab (01541) increased by over 10%, reaching HKD 7.66 with a trading volume of HKD 40.02 million [1] - I-Mab announced the approval of its clinical trial application for Tazlestobart (IMM27M) in combination with Osimertinib for EGFR-mutant locally advanced or metastatic non-squamous non-small cell lung cancer by the National Medical Products Administration (NMPA) [1] - The company received a second payment of USD 5 million from Axion Bio, bringing the total amount received for the collaboration on IMM2510 and IMM27M to USD 20 million [1] Group 2 - Guoyuan International highlighted I-Mab as a research-driven biotechnology company capable of systematically utilizing both innate and adaptive immunity [2] - I-Mab is developing two CD47×CD20 bispecific antibodies/fusion proteins, with IMM0306 being the first to enter clinical trials, showing an overall response rate (ORR) of 90.9% and a complete response (CR) of 27.3% in an Ib trial with 11 patients [2] - Clinical trials for autoimmune diseases are currently in the Ib phase, with the SLE trial enrolling six patients in the second dose group, showing promising response rates, and data is expected to be released mid-year [2]

Clinical Trials and Efficacy - As of December 31, 2024, the clinical follow-up median time for IMM01 combined with Azacitidine as first-line treatment for high-risk Myelodysplastic Syndromes (MDS) reached 26.0 months, with an overall response rate (ORR) of 64.7%[12] - In the Phase II clinical trial for Chronic Myelomonocytic Leukemia (CMML), the median follow-up time was 21.0 months, achieving an ORR of 72.7%[13] - The Phase II trial for IMM01 combined with Tislelizumab in relapsed/refractory classical Hodgkin Lymphoma (cHL) reported an ORR of 69.7% and a complete response rate (CRR) of 24.2%[14] - The company has recruited a total of 107 patients for the clinical trial of IMM2510, showing promising efficacy and good safety profile[15] - As of December 31, 2024, the clinical trial of Amurivap α in combination with lenalidomide for R/R follicular lymphoma (FL) and marginal zone lymphoma (MZL) showed an overall response rate (ORR) of 90.9% and a complete response rate (CRR) of 27.3% among 11 evaluable patients[16] - The Phase II trial of IMM01 in combination with azacitidine for chronic myelomonocytic leukemia (CMML) reported an ORR of 72.7% among 22 evaluable patients, with results selected for presentation at ESMO 2024[22] - The company has initiated a Phase III clinical trial for IMM01 in combination with Tislelizumab for relapsed or refractory classical Hodgkin lymphoma (cHL), with 33 evaluable patients showing an ORR of 69.7%[22] - The company has initiated the IMM2510-002 study, combining IMM2510 with IMM27M for the treatment of relapsed/refractory solid tumors, with the first patient dosed in July 2024[26] - The company has received IND approval for the lupus nephritis (LN) Phase II trial and is preparing to submit an IND application for systemic lupus erythematosus (SLE) expected in the second half of 2025[32] - The company has initiated the first patient dosing in the Phase II trial for neuromyelitis optica spectrum disorder (NMOSD) as of December 2024[32] - The company has observed promising anti-tumor activity and manageable safety in the ongoing clinical trials, with detailed data expected to be disclosed at an international oncology conference in 2025[32] Business Development and Collaborations - The company achieved significant business development breakthroughs, including large international collaborations in 2024[11] - A licensing and collaboration agreement was reached with Axion Bio, Inc., allowing the introduction of proprietary PD-L1xVEGF bispecific molecule Amurivap α in Greater China, with potential payments up to $2.1 billion in development and commercial milestones, plus royalties on global sales[18] - The company is actively pursuing partnerships to expand its global market presence while continuing internal drug development efforts[19] - The company has established a collaboration agreement with Axion Bio, Inc., which includes potential payments of up to $50 million and additional milestone payments of up to $2.1 billion[30] Financial Performance - The company reported revenue of RMB 741 million for the year ending December 31, 2024, an increase of RMB 737 million compared to RMB 4 million for the year ending December 31, 2023, primarily due to upfront and milestone payments from the collaboration agreement with Axion Bio, Inc.[33] - The company recorded total revenue of RMB 74.1 million for the year ended December 31, 2024, compared to RMB 0.4 million for the previous year, primarily driven by licensing fees from the agreement with Axion Bio, Inc.[87] - The company reported a net loss of RMB 316.6 million for the year ended December 31, 2024, down from a loss of RMB 379.5 million in 2023[97] - Research and development expenses increased by 10.6% to RMB 322.8 million for the year ending December 31, 2024, compared to RMB 291.9 million for the previous year, mainly due to increased preclinical and CMC expenses[93] - Administrative expenses decreased by 19.4% from RMB 80.4 million in 2023 to RMB 64.8 million in 2024, attributed to a reduction in share-based payments[94] - The net cash used in operating activities for the year ended December 31, 2024, was RMB 128.0 million, a significant decrease from RMB 367.6 million in 2023[107] - The company's debt-to-asset ratio increased to 26.4% as of December 31, 2024, up from 14.4% in 2023, primarily due to an increase in bank borrowings of RMB 55.4 million[109] Product Pipeline and Development - The company has a pipeline of over ten innovative drug candidates and eleven ongoing clinical projects, reflecting its deep understanding of cutting-edge tumor biology and immunology[5] - The company is focused on developing innovative tumor immunotherapies and has made substantial progress in its pipeline products in 2024[11] - The new candidate drug IMM72/IMC-003 for pulmonary arterial hypertension (PAH) has received IND acceptance, with further development of the bispecific molecule IMM7220/IMC-010 for weight loss and muscle gain currently in animal testing[17] - The product pipeline includes several candidates in different stages, with a focus on innovative therapies targeting immune and metabolic diseases[36] - The company is actively exploring the therapeutic potential of IMM01 in other indications and seeking collaboration opportunities[38] Management and Governance - The company has appointed several experienced professionals to its board, enhancing its governance and strategic oversight capabilities[129] - The board includes independent directors who provide independent advice and oversight, ensuring compliance and strategic direction[129] - The company aims to leverage its leadership team's extensive experience to drive innovation and market expansion in the biopharmaceutical industry[130] - The company has a supervisory board consisting of three members, with Ms. Tian serving as the chair since September 2024[138] Future Plans and Strategic Focus - The company plans to advance its core product, IMM01 (Tidepacitib), into Phase III clinical trials in 2025, with a median follow-up of 26 months showing an ORR of 64.7% in high-risk myelodysplastic syndromes (MDS)[22] - The company anticipates rapid progress in 2025, including the disclosure of interim data for several ongoing clinical trials in both oncology and non-oncology areas[19] - The company plans to optimize its strategic asset portfolio and enhance cash flow through the recent sale, aligning with its future development needs[102] - The company plans to expand its overseas footprint and develop tumor immunotherapy to capture significant market opportunities[85] Use of Proceeds from Global Offering - 40% of the net proceeds (HKD 100.5 million) is allocated to fund the core product IMM01, specifically for ongoing and planned clinical trials in China[189] - 28% of the net proceeds (HKD 70.4 million) is designated for funding core products IMM0306, IMM2902, and IMM2520, with specific trials planned in China and the US[189] - The company plans to allocate 10% of the net proceeds (HKD 25.1 million) for clinical trials of IMM47[189] - The remaining balance of unutilized net proceeds is HKD 66.6 million as of December 31, 2024[189] - The board believes that the proposed changes in the use of proceeds will enhance the company's R&D capabilities and align with shareholder interests[197]

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]

Clinical Trials and Efficacy - The overall response rate (ORR) for IMM01 in high-risk myelodysplastic syndromes (MDS) was 64.7%, with a complete response (CR) rate of 33.3% as of December 31, 2024[5]. - In the II phase trial for chronic myelomonocytic leukemia (CMML), the ORR was 72.7%, including a CR rate of 27.3%[5]. - For the II phase trial of IMM01 combined with pembrolizumab in relapsed/refractory classical Hodgkin lymphoma (cHL), the ORR was 69.7%, with a CR rate of 24.2%[6]. - A total of 33 patients were recruited for the IMM2510 I phase dose escalation study, showing promising anti-tumor activity with three confirmed partial responses (PR)[7]. - As of December 31, 2024, 74 patients were recruited for the Ib/II phase trial of IMM2510, indicating good safety and preliminary efficacy[7]. - The company initiated the IMM27M I phase dose escalation study, with initial data showing safety and good tolerability in heavily pre-treated advanced solid tumor patients[8]. - In the Ib phase trial of IMM0306 combined with lenalidomide for relapsed/refractory follicular lymphoma (FL), the overall response rate (ORR) was 90.9%[8]. - The Phase II clinical trial of IMM01 combined with Azacitidine for high-risk myelodysplastic syndromes (MDS) has recruited 57 patients, achieving an overall response rate (ORR) of 64.7%[23]. - In patients treated for at least 6 months, the ORR increased to 89.7%, indicating enhanced efficacy with prolonged treatment duration[23]. - The Phase II trial for IMM01 combined with Azacitidine in chronic myelomonocytic leukemia (CMML) has recruited 24 patients, with an ORR of 72.7%[25]. - The company has observed promising anti-tumor activity and manageable safety in the ongoing clinical trials for various cancer treatments[45]. Financial Performance - As of December 31, 2024, the company reported revenue of RMB 741 million, a significant increase of RMB 737 million compared to RMB 4 million for the year ended December 31, 2023, primarily due to upfront and recent payments received from the collaboration agreement with Axion Bio, Inc.[14]. - The company recorded total revenue of RMB 74.1 million for the year ended December 31, 2024, compared to RMB 0.4 million for the year ended December 31, 2023, primarily from licensing fees and collaboration development[58]. - The company reported a pre-tax loss of RMB 316,590,000 for the year ended December 31, 2024, an improvement from a loss of RMB 379,459,000 in the previous year[127]. - The total comprehensive loss for the year was RMB 316,600,000, compared to RMB 379,631,000 in the previous year, indicating a reduction in overall losses[127]. - The company’s basic and diluted loss per share improved to RMB 0.84 in 2024 from RMB 1.05 in 2023[127]. - The net loss for the year decreased from RMB 379.5 million for the year ended December 31, 2023, to RMB 316.6 million for the year ending December 31, 2024[67]. - Adjusted net loss for the year was RMB 254.98 million for 2024, compared to RMB 281.84 million for 2023[69]. Research and Development - Research and development expenses increased by 10.6% to RMB 322.8 million for the year ended December 31, 2024, up from RMB 291.9 million for the previous year, driven by increased preclinical and CMC expenses of RMB 43.6 million and salary-related costs due to team expansion of RMB 7.4 million[14]. - The company has a robust pipeline with over ten innovative drug candidates and 11 ongoing clinical projects, reflecting its commitment to advancing cancer immunotherapy[15]. - The company is preparing IND submissions for IMM01 for atherosclerosis treatment and anticipates IND approval for IMM72/IMC-003 by June 2025[11]. - The company has initiated dosing for the first patient in the systemic lupus erythematosus (SLE) Phase II trial in October 2024, with recruitment for the second dose group expected to start in February 2025[11]. - The company received IND approval for the lupus nephritis (LN) Phase II trial in December 2024 and plans to submit an IND application to the FDA for SLE in the second half of 2025[11]. - The company has completed the IND pre-submission for IMM72/IMC-003 and anticipates receiving IND approval by June 2025[51]. Collaborations and Agreements - The company entered into a licensing and collaboration agreement with Axion Bio, Inc. on August 1, 2024, which includes potential payments of up to $50 million and additional milestone payments of up to $2.1 billion[12]. - As of December 31, 2024, the company has received upfront and recent payments totaling $15 million[13]. - The company has received IND approval for multiple clinical trials, including those for IMM2510 and IMM27M, indicating ongoing expansion of its clinical pipeline[7][8]. Corporate Governance and Compliance - The company is currently reviewing and enhancing its corporate governance practices to ensure compliance with the corporate governance code[89]. - The company has confirmed compliance with the code of conduct regarding securities trading by directors and employees during the reporting period[90]. - The board believes that the current structure of having the same individual serve as both Chairman and CEO is beneficial for leadership consistency and effective strategy execution[88]. Cash Management and Financial Position - Cash and cash equivalents increased to RMB 752.1 million as of December 31, 2024, from RMB 608.6 million as of December 31, 2023, primarily due to an increase in revenue of RMB 73.7 million[74]. - Current assets amounted to RMB 867.9 million as of December 31, 2024, including cash and cash equivalents of RMB 477.6 million[74]. - The company has unutilized tax losses amounting to RMB 1,811,969,000 as of December 31, 2024, compared to RMB 1,446,377,000 in 2023[150]. - The company has no significant acquisitions or disposals of subsidiaries, associates, or joint ventures during the reporting period, aside from the aforementioned sale[72]. - The company has implemented internal control policies and procedures for cash management to optimize the use of excess cash[77]. Share Capital and Offerings - The company has issued a total of 407,307,695 shares, increasing from 374,157,695 shares, with H shares rising from 349,013,299 to 382,163,299 shares[92]. - The net proceeds from the global offering amounted to approximately HKD 251.3 million, after deducting underwriting commissions and related costs[93]. - The company plans to convert a total of 14,114,006 unlisted shares into H shares, pending approval from the China Securities Regulatory Commission[91]. - The company has completed a placement agreement for 33,150,000 new H-shares at a price of HKD 7.05 per share, raising approximately HKD 229.7 million net of expenses[111].

Investment Rating - The report assigns a "Buy" rating for the company [6]. Core Insights - The company is developing the world's first SIRPα-Fc fusion protein targeting CD47, which is expected to achieve breakthroughs in cancer treatment [3][11]. - The core product, IMM01, has shown promising results in clinical trials, with a peak sales potential estimated at 1.05 billion yuan [2][6]. - The company has multiple clinical-stage assets, including dual-specific antibodies, with a long-term sales peak potential of 3.17 billion yuan [3]. Company Overview - The company, established in June 2015, focuses on developing cancer immunotherapy and has received 29 IND approvals from NMPA and FDA, with 8 products currently in clinical trials [11][14]. - The major revenue source is from licensing fees, with a significant R&D expenditure of 1.19 billion yuan in the first half of 2024 [20]. Industry Situation - Cancer immunotherapy has emerged as a revolutionary treatment, with a global market size reaching 50.2 billion USD in 2022 [27]. - The report highlights the limitations of existing therapies, particularly those targeting T-cell immune checkpoints, and emphasizes the potential of innate immune cell-targeted therapies [23][26].

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] -

Investment Rating - The report suggests a positive outlook on the company, recommending active attention due to its strong clinical data and rich pipeline reserves [1]. Core Insights - The company is one of the few biotechnology firms globally capable of systematically utilizing both innate and adaptive immune systems [1]. - The core product, IMM01, has shown excellent clinical data and possesses a unique mechanism of action, indicating a broad market potential [1]. - The company has reduced R&D expenses in the first half of 2024, primarily due to decreased clinical trial costs and reduced share-based payments [1]. Summary by Sections Financial Performance - For the six months ending June 30, 2024, the company reported a narrowed loss attributable to shareholders of 166 million yuan, compared to a loss of 171 million yuan in the same period last year; total revenue was 77,000 yuan, a decrease of 10.47% year-on-year; net asset value per share was 1.6042 yuan [1]. Product Development - IMM01 is the first clinical-stage SIRP α-Fc fusion protein in China, designed to activate macrophages through a dual mechanism while avoiding binding to human red blood cells [1]. - The product has received orphan drug designation from the FDA for use in combination with azacitidine for treating CMML, with an overall response rate (ORR) of 72.7% in 22 evaluable patients [1]. - In a Phase II clinical trial for high-risk myelodysplastic syndromes, the overall response rate was 64.7% among 51 evaluable patients, with improved efficacy observed with longer treatment durations [1].

Clinical Trials and Drug Development - As of June 30, 2024, the overall response rate (ORR) for IMM01 combined with Azacitidine as a first-line treatment for Chronic Myelomonocytic Leukemia (CMML) reached 72.7% (16/22), with a complete response rate (CRR) of 27.3% (6/22) among evaluable patients [3]. - For patients treated for at least 4 months, the ORR for IMM01 combined with Azacitidine in higher-risk Myelodysplastic Syndromes (MDS) was 85.3% (29/34), with a CRR of 50.0% (17/34) as of June 30, 2024 [3]. - The company received approval for the Phase III clinical trial of IMM01 combined with Pembrolizumab for PD-(L)1 refractory classical Hodgkin Lymphoma (cHL) in April 2024, with the first patient dosed on July 1, 2024 [4]. - The company initiated the Phase I clinical trial for IMM2510 in September 2023, enrolling 33 patients with advanced/metastatic solid tumors, showing promising anti-tumor activity [5]. - As of June 30, 2024, the ORR for IMM0306 combined with Lenalidomide in R/R CD20 positive B-cell Non-Hodgkin Lymphoma (B-NHL) was 90.9% (10/11), with a CRR of 27.3% (3/11) [4]. - The company completed patient recruitment for the Phase I trial of IMM27M in September 2023, with initial data indicating good safety and tolerability [5]. - The company reported that among patients treated for at least 6 months with IMM01 in higher-risk MDS, the ORR was 89.7% (26/29) and the CRR was 58.6% (17/29) as of June 30, 2024 [3]. - The company has initiated the Phase I trial for IMM2520 in multiple advanced solid tumors, with 24 patients enrolled as of June 30, 2024, showing initial safety and tolerability [5]. - The company plans to complete the IMM2520 trial by the end of 2024, with preliminary data showing one partial response and two stable disease cases [5]. - The company has made significant progress in its drug pipeline, with multiple clinical trials ongoing and new product developments expected in the near future [2]. - The company has initiated Phase II trials for the CD47xCD20 bispecific antibody starting in Q2 2023 [9]. - The company has received IND approval for IMM47 (CD24 monoclonal antibody) in October and December 2023 in China and the US, with Phase I trials commencing in September 2023 in Australia [9]. - The company has completed patient recruitment for the Phase II clinical trial of IMM01 combined with Azacitidine, enrolling 57 patients [12]. - The company has initiated a Phase II trial for IMM2510 in combination with chemotherapy for solid tumors, with IND approval received in November 2023 [48]. - IMM0306, a bispecific molecule targeting CD47 and CD20, has recruited 48 patients with no dose-limiting toxicities observed, achieving a CR in 5 patients and a PR in 5 patients [27]. - The company has observed preliminary efficacy in mouse models for IMC-003, a next-generation ACTRIIA fusion protein, with expectations to submit an IND application within a year [56]. - IMM2902 is currently in the dose escalation phase of clinical trials for advanced HER2-positive and HER2-low expressing solid tumors, with the 8th cohort at a dose of 5.0 mg/kg [52]. Financial Performance - Loss for the six months ended June 30, 2024, was RMB 165.8 million, a decrease of RMB 5.0 million compared to RMB 170.8 million for the six months ended June 30, 2023, mainly due to the reduction in R&D expenses [7]. - Adjusted loss increased by RMB 4.9 million to RMB 120.7 million for the six months ended June 30, 2024, compared to RMB 115.8 million for the six months ended June 30, 2023, primarily due to an increase in administrative expenses [7]. - Revenue for the six months ended June 30, 2024, was RMB 77,000, a decrease of 10.5% from RMB 86,000 for the same period in 2023 [61]. - Other income decreased from RMB 6,359,000 in the six months ended June 30, 2023, to RMB 4,277,000 in the same period in 2024, primarily due to a reduction in bank interest income by RMB 1,644,000 [62]. - Research and development expenses decreased by 7.0% from RMB 128.1 million for the six months ended June 30, 2023, to RMB 119.1 million for the six months ended June 30, 2024, primarily due to a reduction in clinical trial expenses by RMB 11.7 million and a decrease in share-based payment expenses by RMB 9.0 million [7]. - The company recorded a significant impairment loss of RMB 27,398,000 on property and equipment during the six months ended June 30, 2024 [63]. - The company’s total equity as of June 30, 2024, was RMB 600,238,000 (thousand), down from RMB 748,287,000 (thousand) at the end of 2023 [91]. - The total comprehensive loss for the period was RMB 165,750,000 (thousand), compared to RMB 170,748,000 (thousand) in the previous year, indicating a decrease of 2.92% [90]. - Basic and diluted loss per share was RMB 0.44, an improvement from RMB 0.48 in the same period of the previous year [90]. - The company did not recommend the payment of an interim dividend for the six months ending June 30, 2024, consistent with the previous year [87]. Strategic Initiatives and Collaborations - The company entered into a licensing and collaboration agreement with SynBioTx Inc. on August 1, 2024, for the global rights (excluding Greater China) to its proprietary PD-L1xVEGF bispecific molecule IMM2510 and a next-generation anti-CTLA-4 antibody (ADCC+) IMM27M, receiving an upfront payment of $10 million [6]. - The potential near-term payments from the agreement with SynBioTx could exceed $40 million, along with potential additional development, regulatory, and commercial milestone payments of up to $2.1 billion [6]. - The company plans to explore the therapeutic potential of IMM01 in additional indications and seek collaboration opportunities [11]. - The company aims to expand its market presence through strategic initiatives and potential mergers and acquisitions [112]. - The company plans to expand its overseas footprint and accelerate clinical research in China to leverage market opportunities [60]. - The company aims to enhance its pipeline by evaluating innovative therapies targeting other innate immune checkpoints [60]. Corporate Governance and Compliance - The company has confirmed compliance with the corporate governance code, although the roles of Chairman and CEO are held by the same individual, Dr. Tian [79]. - The audit committee has reviewed the interim financial performance for the six months ending June 30, 2024, and discussed financial reporting matters with management [85]. - The company is committed to enhancing its corporate governance practices to ensure compliance with applicable codes [80]. - The company operates under the International Financial Reporting Standards, ensuring compliance and transparency in financial reporting [112]. - The company has established a standard code for securities trading among its directors, promoting ethical practices [112]. - The board of directors includes a diverse team with both executive and independent non-executive members, ensuring a balanced governance structure [113]. Assets and Liabilities - As of June 30, 2024, the company's cash and cash equivalents totaled RMB 513.0 million, down from RMB 608.6 million as of December 31, 2023, primarily due to cash outflows for daily operations and R&D activities [71]. - The company's total current assets as of June 30, 2024, amounted to RMB 582.6 million, which includes financial assets at fair value of RMB 266.2 million and cash and cash equivalents of RMB 246.8 million [71]. - The company's debt-to-asset ratio increased to 19.2% as of June 30, 2024, from 14.4% as of December 31, 2023, mainly due to an increase in bank borrowings of RMB 26.0 million [73]. - As of June 30, 2024, the company had unutilized bank loan facilities of approximately RMB 90.0 million [72]. - The company has no contingent liabilities or pledged assets as of June 30, 2024 [76]. - The company has a single operating segment, and no further analysis of this segment is provided in the report [100].