Core Insights - The CD47 target was once highly sought after by global pharmaceutical companies, likened to the next PD-1, but has since faced significant challenges and failures in drug development [1][3][14] - Despite the setbacks, companies like I-Mab and Kangfang Biotech remain optimistic about the potential of CD47-targeted therapies, with ongoing clinical trials [5][9][14] Industry Overview - CD47 is a transmembrane glycoprotein expressed on various cancer cells, which helps tumors evade the immune system by sending a "don't eat me" signal to macrophages [3][5] - Major pharmaceutical companies, including Gilead and Pfizer, have made substantial investments in CD47-targeted therapies, with Gilead acquiring Forty Seven for $4.9 billion, but faced failures in clinical trials [3][5][12] - In China, over 20 clinical approvals for CD47-targeted drugs have been granted, but many companies, including Hengrui and Innovent, have halted their trials due to disappointing results [4][5][12] Company Developments - I-Mab is advancing two Phase III clinical trials for its CD47-targeted therapies, while Kangfang Biotech is conducting multiple trials for its drug, Lefanlimab [5][9] - I-Mab's approach to CD47 is distinct, as it utilizes a non-antibody drug that binds more selectively to cancer cells, potentially reducing toxicity and improving dosing [8][9] - Kangfang Biotech is optimizing its drug structure to minimize red blood cell aggregation, which is a significant issue with CD47 antibodies [9][12] Market Sentiment - The global pharmaceutical industry has invested nearly 100 billion RMB in CD47 research without a successful drug to date, leading to a cautious approach from investors and companies [5][12] - There is a growing sentiment that the investment climate for innovative drugs is improving, with increased activity from investment funds in the sector [11][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]

Group 1 - The Hong Kong pharmaceutical stocks are experiencing a strong performance, with notable gains in several companies [1] - Yiming Anke-B (01541.HK) has increased by 8.38%, while Cornerstone Pharmaceuticals-B (02616.HK) has risen by 7.82% [1] - Other companies such as Baijie Shenzhou (06160.HK), Jakes-B (01167.HK), and Ying'en Biotechnology-B (09606.HK) have also shown positive movements, with increases of 3.25%, 2.80%, and 2.68% respectively [1]

Group 1 - BeiGene (06160.HK) reported total revenue of $1.117 billion for Q1, a year-on-year increase of 49%; adjusted net profit reached $136 million, marking a turnaround from losses. The growth was primarily driven by increased sales of Brukinsa in the US and Europe [1] - Eddingpharm (01541.HK) received a second recent payment of $5 million from Axion Bio under a licensing and collaboration agreement. The company expects to receive up to $30 million in potential future payments [1] - Geely Automobile (00175.HK) submitted a non-binding offer letter to Zeekr, indicating an intention to propose privatization at a valuation of $2.566 per share or $25.66 per American depositary share [1] - Hong Kong Broadband (01310.HK) announced that China Mobile Hong Kong completed the acquisition of a 15.46% stake in the company [1] - Anta Sports (02020.HK) adjusted the conversion price of its €1.5 billion zero-coupon guaranteed convertible bonds to HK$102.62 per share [1] - Zhengrong Real Estate (06158.HK) reported a cumulative contract sales amount of approximately $1.496 billion for the first four months, a year-on-year decrease of 33.06% [1] - Ronshine China (03301.HK) recorded contract sales of $327 million in April, with a cumulative total of $1.42 billion from January to April [1] Group 2 - Qingdao Beer (00168.HK) plans to acquire all shares of Jimo Huangjiu held by Xinhua Jin Group and Lujin Group [2]

Core Viewpoint - The Hong Kong pharmaceutical stocks have experienced a decline, with notable drops in several companies' share prices, indicating a bearish trend in the sector [1] Company Performance - Kangfang Biotech (09926.HK) saw a significant drop of 15.07% in its share price [1] - Yiming Oncology-B (01541.HK) decreased by 9.75% [1] - Zai Lab (09688.HK) fell by 6.43% [1] - Akeso-B (01167.HK) experienced a decline of 5.37% [1] - Terns Pharmaceuticals-B (02137.HK) dropped by 5% [1]

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]

智通财经APP获悉，特朗普"对等关税"即将落地，港股三大指数早盘走高，恒科指数曾涨超2%，午后 涨幅显著收窄。截止收盘，恒生指数涨0.38%或87.26点，报23206.84点，全日成交额2502.31亿港元；恒 生国企指数涨0.24%，报8537.34点；恒生科技指数涨0.23%，报5407.38点。 交银国际表示，全球不确定性升温，港股以守待攻。该行指出，进入4月，后续消费、地产等各项基本 面的数据验证、以及关税等外生性影响将成为市场关注重点，也是4月底中央政治局会议会否释放更进 一步政策刺激信号的关键。 蓝筹股表现 2. 石油股普遍上扬。截至收盘，中海油(00883)涨2.7%，报19.02港元；中海油服(02883)涨2.5%，报6.57 港元；中石油(00857)涨2.07%，报6.42港元；中石化(00386)涨0.24%，报4.11港元。 美国总统特朗普周一表态，要求伊朗尽快达成核协议，并称考虑对俄罗斯能源出口实施新的制裁。这些 言论引发投资者对中东和东欧地缘冲突升温的担忧情绪，隔夜国际油价应声上涨。中信证券研报指出， 综合来看，考虑到近期美国对伊朗、委内瑞拉制裁及地缘扰动等多重因素影响，202 ...

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].