IAH0968 / SunHo BioPharma - LARVOL DELTA

To Evaluate IAH0968 in Combination With CAPEOX in HER2-positive Gastric Cancer (clinicaltrials.gov) - P2/3 | N=90 | Recruiting | Sponsor: SUNHO（China）BioPharmaceutical CO., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Gastric Cancer • Oncology • Solid Tumor

A novel anti-HER2 monoclonal antibody IAH0968 in HER2-positive heavily pretreated solid tumors: results from a phase Ia/Ib first-in-human, open-label, single center study. (PubMed, Front Immunol) - P1/2 | "In HER2-positive heavily pretreated metastatic patients, IAH0968 demonstrated promising clinical activity with durable responses and tolerable safety profiles. ClinicalTrials.gov, identifier NCT04934514."

Journal • P1 data • Cardiovascular • Oncology • Solid Tumor • Ventricular Tachycardia

Novel anti-HER2 monoclonal antibody IAH0968 in the treatment of HER2-positive refractory solid tumors: results of a first-in-human, open-label, single-center, phase IA/Ib study (CSCO 2024) - No abstract available

Clinical • P1 data • Oncology • Solid Tumor

INTERIM RESULTS ANNOUNCEMENT FOR THE SIX MONTHS ENDED JUNE 30, 2024 (HKEXnews) - "Our Core Product IAH0968 is an internally developed...We 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....We plan to initiate a Phase II clinical trial for IAP0971 in China in the third quarter of 2024."

New P2 trial • Trial status • Biliary Tract Cancer • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HER-2

To Evaluate IAH0968 in Combination With CAPEOX in HER2-positive Gastric Cancer (clinicaltrials.gov) - P2/3 | N=90 | Not yet recruiting | Sponsor: SUNHO（China）BioPharmaceutical CO., Ltd.

New P2/3 trial • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

"New Stock" Shenghe Biotechnology (02898.HK) opened in the dark market at 14.02 yuan, 3.8% higher than the listing price [Google translation] (iis.aastocks.com) - "Shenghe Biotech sold 34.1518 million shares globally, with Hong Kong public offering accounting for 10% and international offering accounting for 90%. The sole sponsor is CICC. This listing introduced ETD Future as a cornerstone investor, subscribing for US$5.4 million (approximately HK$42.2 million) of the company's shares. This listing is expected to raise net proceeds of approximately 392 million yuan, of which approximately 28.2% will be used for the ongoing and planned clinical trials of IAH0968 in China; 35.8% will be used for the ongoing and planned clinical trials of IAP0971 in China; 36% will For use in ongoing and planned clinical trials of IAE0972 in China. (mn/k)..."

Financing • Hematological Malignancies • Oncology • Solid Tumor

Shenghe Biotech-B (02898.HK) is expected to be listed on May 24th and will introduce EMD as the cornerstone. [Google translation] (Sina Corp) - "Based on the offer price of HK$13.50 per share, the company estimates that it will receive net proceeds from the global offering of approximately HK$391.6 million. The company plans to use 28.2% of the net proceeds from the global offering, or approximately HK$110.4 million, for the ongoing and planned clinical trials of IAH0968 in China (mainly including the costs of raw materials and consumables used in clinical trials...approximately HK$140.1 million will be used for ongoing and planned clinical trials of IAP0971 in China...approximately HK$141.1 million will be used for ongoing and planned clinical trials of IAE0972 in China..."

Financing • Biliary Tract Cancer • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Shenghe Biotech's Hong Kong stock IPO resubmission form: none of its products have been commercialized. Investors suddenly bought shares and attracted the attention of the China Securities Regulatory Commission. [Google translation] (Eastmoney.com) - "The prospectus shows that Shenghe Biotech’s current pipeline includes 9 products, mainly covering non-small cell lung cancer, head and neck squamous cell cancer, bladder cancer, biliary tract cancer, colorectal cancer, and hepatitis B virus. Among them, three are listed as the core products of Shenghe Biotech, namely IAP0971, IAE0972 and IAH0968....The reporter noticed that the above nine products under development are all in the preclinical and clinical trial stages. Among them, the one with the fastest progress is IAH0968, which is currently in the clinical phase II trial stage; the research on colorectal cancer indications in IAH0968 will enter the clinical phase III stage in the first quarter of 2024."

Clinical • New P3 trial • Colorectal Cancer • Gastrointestinal Cancer • Hematological Malignancies • Oncology • Solid Tumor

Clinical Study of IAH0968 in Patients With HER2-positive Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=97 | Recruiting | Sponsor: SUNHO（China）BioPharmaceutical CO., Ltd. | Trial completion date: Dec 2024 ➔ Mar 2025 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor • HER-2

IAH0968 in Combination With GC for the Treatment of HER2-Positive Unresectable Advanced/Metastatic Malignant Tumors (clinicaltrials.gov) - P1/2 | N=136 | Recruiting | Sponsor: SUNHO（China）BioPharmaceutical CO., Ltd.

Combination therapy • Metastases • New P1/2 trial • Biliary Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2

Clinical Study of IAH0968 in Patients With HER2-positive Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=97 | Recruiting | Sponsor: SUNHO（China）BioPharmaceutical CO., Ltd. | Not yet recruiting ➔ Recruiting | Trial completion date: Jun 2024 ➔ Dec 2024 | Trial primary completion date: Jun 2023 ➔ Dec 2023

Enrollment open • Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor • HER-2

To Evaluate IAH0968 in Combination With CAPEOX in HER2-positive Metastatic Colorectal Cancer (clinicaltrials.gov) - P2/3 | N=279 | Recruiting | Sponsor: SUNHO（China）BioPharmaceutical CO., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • HER-2 • KRAS • MSI • NRAS

A novel anti-HER2 monoclonal antibody IAH0968 in HER2-positive, heavily pretreated solid tumors: Results from a phase Ⅰa/Ⅰb, first-in-human, open-label, single-center study. (ASCO 2023) - P1/2 | "Background: IAH0968 is an afucosylated anti-epidermal growth factor receptor 2 (HER2) monoclonal antibody which possessing the same binding properties to HER2 as trastuzumab and improving antibody-dependent cellular cytotoxicity (ADCC) activity and superior anti-tumor efficacy. In heavily pretreated metastatic pts with HER2 positive, IAH0968 demonstrated promising clinical activity and tolerable safety profiles. IAH0968 will be further assessed in Phase Ⅱ study in combination treatment. Clinical trial information: NCT04934514."

Clinical • P1 data • Atrial Fibrillation • Cardiovascular • Oncology • Solid Tumor

To Evaluate IAH0968 in Combination With CAPEOX in HER2-positive Metastatic Colorectal Cancer (clinicaltrials.gov) - P2/3 | N=279 | Not yet recruiting | Sponsor: SUNHO（China）BioPharmaceutical CO., Ltd.

Combination therapy • Metastases • New P2/3 trial • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • HER-2 • KRAS • MSI • NRAS