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To-be Listed
Name▼
/
Code▼
 Industry Offer Price Lot Size Entry Fee Closing Date
Grey Market Date▼
Listing Date▲
Haitian Flav
03288.HK		 Food Additives 35-36.3 100 3,667 2025/06/16 2025/06/18 2025/06/19
Sanhua
02050.HK		 Electrical Components & Equipment 21.21-22.53 100 2,276 2025/06/18 2025/06/20 2025/06/23
Bayzed Health
02609.HK		 Health Care Services 4.22-6.75 600 4,091 2025/06/18 2025/06/20 2025/06/23
TransThera-B
02617.HK		 Biotechnology - Pharmaceuticals 13.15 500 N/A 2025/06/18 2025/06/20 2025/06/23
Summary
Founded in 2018, we are a clinical stage biopharmaceutical company that focuses on the discovery, development and commercialization of biologics for the treatment of cancers and autoimmune diseases. We have three Core Products, IAH0968, IAP0971 and IAE0972, all of which are developed in-house. IAH0968 is an antibody-dependent cell-mediated cytotoxicity (“ADCC”) enhanced monoclonal antibody (“mAb”), and we have initiated Phase II clinical trials for biliary tract carcinoma (“BTC”) and colorectal cancer (“CRC”). IAP0971 and IAE0972 are both immunocytokines and we have completed Phase I clinical trials for advanced solid tumors including non-small cell lung cancer (“NSCLC”) and CRC. As of the Latest Practicable Date, we had nine pipeline products, in addition to our Core Products, three of which were in the clinical stage, also focusing on the treatment of cancer.

THERE IS NO ASSURANCE THAT WE WILL ULTIMATELY BE ABLE TO DEVELOP AND MARKET OUR CORE PRODUCTS OR ANY OF OUR PIPELINE PRODUCTS SUCCESSFULLY.

Our Business Model

Our core business model involves internally discovering, developing and commercializing immunocytokines and other immunotherapies that regulate immune microenvironment by directly modulating both the innate and adaptive immune systems to address the market needs in the fields of oncology and autoimmune diseases. We also recognize that partnerships will be a critical source to complement our internal resource and enable us to fully execute our global strategy. As such, we will actively seek collaboration opportunities with international leading pharmaceutical companies to advance clinical studies of our products abroad through out-licensing arrangements. We will also expand our international registration team to secure our global clinical development and registration plan, and strengthen our featured products, especially our immunocytokine pipeline products including IAP0971, IAE0972 and IBB0979.

OUR PRODUCT CANDIDATES

Our R&D capabilities cover development of candidates in the forms of mAbs, bispecific antibodies (“bsAbs”), and fusion proteins, some of which extend indications into treatment areas beyond oncology. Our Core Product IAH0968 is an ADCC enhanced mAb targeting human epidermal growth factor receptor 2 (“HER2”) with 100% fucose knock out, which greatly enhances the binding affinity of its fragment crystallizable (“Fc”) to its receptor FcRIIIa. ADCC is an immune mechanism through which Fc receptor-bearing effector cells including natural killer (“NK”) cells and CD+8 T cells can recognize and kill antibody-coated target cells expressing tumor- or pathogen-derived antigens on their surface. It is one of the most important methods for antibody drugs to kill tumor cells. The typical ADCC involves activation of NK cells by antibodies in a multi-tiered progression of immune control. A NK cell expresses Fc receptors (“FcR”). These receptors recognize and bind to the Fc domain of an antibody, and the antigen binding fragment (“Fab”) domain of which binds to the tumor associated antigen (“TAA”) on the tumor cell. When both TAA and FcR are engaged respectively by the Fab and Fc portions of the antibody, ADCC is initiated, since this creates a bridge from the tumor cell to the effector cell. However, the natural affinity between antibodies and FcR is relatively weak, and Fc engineering to enhance affinity has become a common method.

Our featured products, immunocytokines, are designed through our proprietary and internally developed Armed ImmunoCytokine Platform (“AICTM Platform”) by our core R&D team in researching antibody-cytokine fusion proteins. They function through diverse mechanisms of action yet share a similar structure comprising an antibody or quasi-antibody moiety that targets tumors and blocks signaling pathways regulating tumor growth and proliferation, and cytokine payloads that activate the immune system within the tumor microenvironment (“TME”). Such a design is expected to overcome drawbacks of conventional cytokine-based drugs, such as short half-lives, systemic cytotoxicity and modest efficacies due to cytokine pleiotropy and off-target effects. It is expected to achieve enhanced antitumor effects through the synergy between the antibody and cytokine payloads, which potentially address the needs of cancer patients who suffer from disease progression related to the immunosuppressive TME and drug resistance.

All of our Core Products are still at early stage of development and it is difficult to directly compare their clinical efficacy with other existing drugs and/or drug candidates at a similar stage.

Core Product IAH0968 – ADCC Enhanced Anti-HER2 mAb

Our Core Product IAH0968 is an internally developed, the first anti-HER2 antibody in clinical stage with 100% fucose-removal. Antibodies consist of two structural regions, Fab and Fc. Unlike Fab region, which defines the specific target of an antibody, Fc region mediates ADCC by activating the immune system through engaging various Fc receptors. Studies of the structure of the Fc region of antibodies and its receptor FcRIIIa complex revealed that the core fucose of the Fc region is accommodated at a place that interferes with the binding between the Fc region and FcRIIIa, and thus reducing the affinity between them and resulting in lower ADCC activity. Therefore, modifying to remove fucose is desirable to better recruit immune cells, resulting in enhanced ADCC activity. As a result, this approach has been widely attempted in the biopharmaceutical industry. However, despite numerous attempts by multiple players to modify antibodies through various approaches, such as Fc point specific mutation and fucose removal, most resulting antibodies still contain a certain percentage of core fucose. For more details on the mechanism of action of IAH0968, see “Business — Drug Candidates — Core Product: IAH0968 (ADCC enhanced anti-HER2 mAb) — Mechanism of Action” in this document.

The Phase I clinical trial showed that IAH0968 was well tolerated and exhibited antitumor activities in patients with advanced HER2+ malignant solid tumors including breast cancers, gastric cancers, CRC and BTC with drug resistance to trastuzumab, pertuzumab, cetuximab, docetaxel, oxaliplatin, capecitabine, irinotecan, nab-paclitaxel and apatinib, or anti-PD-1 mAbs. Data showed that only one DLT was found at dosage 10mg/kg, and no MTD was reached. While no head-to-head study was conducted, the Phase I clinical data showed that IAH0968 achieved significantly improved ORR and DCR in heavily pretreated metastatic CRC and BTC patients, when compared to the historical data of current treatments. For heavily pretreated metastatic CRC and BTC patients, the ORR was 40%, and DCR was 80%.

We obtained the IND approval for conducting Phase I and Phase II clinical trials of IAH0968 from the NMPA in October 2020, commenced the Phase I clinical trial in August 2021, and completed the Phase I clinical trial of using IAH0968 as a monotherapy for heavily pretreated patients with advanced HER2+ malignant solid tumors in March 2023. Based on the encouraging clinical data from the Phase I trial, we obtained IND approvals from the NMPA to conduct Phase II and Phase III clinical trials of using IAH0968 in combination with chemotherapy for first-line treatment of inoperable HER2+ advanced or metastatic CRC, and to conduct Phase II clinical trials of using IAH0968 in combination with chemotherapy for first-line treatment of HER2+ metastatic BTC patients in September 2022. We have dosed the first CRC patient of the Phase II trial in May 2023, and also have dosed the first BTC patient of the Phase II clinical trial in August 2023. We completed the Phase IIa trial in March 2024, entered a Phase IIb/III clinical trial for CRC in January 2024, and expect to complete the Phase IIb trial for CRC in the fourth quarter of 2024. We also expect to complete the Phase II clinical trial for BTC in the third quarter of 2025. For more details on the clinical development plan of IAH0968, see “Business — Drug Candidates — Core Product: IAH0968 (ADCC enhanced anti-HER2 mAb) — Clinical Development Plan” in this document.



Source: Sunho Biologics-B (02898) Prospectus (IPO Date : 2024/05/16)
Listing Market MAIN
Industry Biotechnology - Pharmaceuticals
Background Others
Major Business Area N/A
Corporate Information
Substantial Shareholders ZHANG Feng & Associates (63.83%)
Zhu Jinqiao & Associates (11.17%)
Directors ZHANG Feng (Chairman and Executive Director)
JIANG Xiaoling (Vice President and Executive Director)
YIN Liusong (Chief Executive Officer and Chief Scientific Officer and Executive Director)
FAN Rongkui (Non-Executive Director)
CHAN Heung Wing Anthony (Independent Non-Executive Director)
FENG Lan (Independent Non-Executive Director)
SHI Luwen (Independent Non-Executive Director)
Company Secretary WONG Hoi Ting
XU Chunqin
Principal Bankers Bank of Communications Co., Ltd.
China Merchants Bank
Industrial Bank Co., Ltd
Solicitors Jingtian & Gongcheng Law Firm
Venture Partner, LLC
O Melveny & Myers LLP
Maples and Calder (Hong Kong) LLP
Auditors Deloitte Touche Tohmatsu
Registered Office 31st Floor, Tower Two Times Square, 1 Matheson Street, Causeway Bay, Hong Kong
Share Registrars Computershare Hong Kong Investor Services Ltd. [Tel: (852) 2862-8628]
Share Registrars Tel No (852) 2862-8628
Internet Address http://www.sunho-bio.com.cn
Email Address [email protected]
Tel No (86 025) 8566-6008
Fax No
 
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