Summary of the Conference Call for Yingen Biotech Company Overview - **Company**: Yingen Biotech - **Key Projects**: - Hertu ADC for endometrial cancer and hormone-positive breast cancer - B7H3 ADC for multiple indications including liver cancer, melanoma, head and neck squamous cell carcinoma, cervical cancer, and platinum-resistant ovarian cancer Core Insights and Arguments - **Hertu ADC Project**: - Shows potential in second-line and later treatment for endometrial cancer and hormone-positive breast cancer - Key registration clinical trial results expected in 2026, with a sales team already established for commercialization [2][5] - **B7H3 ADC Project**: - Demonstrates significant efficacy across various indications with high Objective Response Rate (ORR) and Disease Control Rate (DCR) - No specific expression testing required, indicating broad application potential [2][6] - **Future Catalysts**: - Key clinical trial results for Hertu ADC and submission for market approval - Phase III registration clinical trial for B7H3 ADC in prostate cancer planned for 2026 [2][7] - **Safety Profile**: - B7H3 ADC shows significant safety advantages compared to similar drugs from Merck and Hansoh/GSK, with a lower incidence of interstitial pneumonia [2][9] - **DB1,303 (TOP2 ADC)**: - Comparable efficacy to AstraZeneca's drug and superior to Gilead's, but may face challenges in single-agent indications due to competition [2][10] - **HER3 ADC (DB1,310)**: - Shows significant potential in EGFR-mutant non-small cell lung cancer and hormone-positive breast cancer, with a PFS level of 15 months, outperforming other ADCs [2][11] - **PD-1 VEGF Dual Antibody + ADC Combination**: - Considered a key direction for future cancer treatment, showing good safety and efficacy [2][12] Industry Insights - **Chinese Innovative Drug Industry Outlook for 2026**: - Expected to be broad and optimistic due to the trend of Chinese innovative drugs going global, with companies leading in various technical fields [3] - **Investment Timing**: - Current valuation reflects only part of the potential of Hertu ADC and B7H3 ADC, suggesting significant upside potential as key clinical trial results are released [2][8] - **Global Competition for B7H3 ADC**: - Competitive landscape includes Merck and IDXD, with challenges faced by Merck due to safety issues leading to trial pauses [2][9] - **Upcoming ADC Data Releases in 2026**: - Multiple companies, including Yingen, are expected to release data on various ADC drugs, indicating a rich pipeline and potential industry trends [2][12] Additional Important Points - **Collaborations**: - Yingen collaborates with other companies for various ADC projects, which may yield initial data or enter registration clinical stages in the coming years [2][14][17] - **Early Pipeline Progress**: - Early pipeline projects like PDL1 B7H3 ADC show promising results in broad-spectrum efficacy and low toxicity, supporting further development [2][18]

Summary of Conference Call Notes Company and Industry Overview - The conference call discusses **Ying En Bio** and its clinical developments in the field of oncology, particularly focusing on **DB-1,311 (B7-H3 ADC)** for treating **castration-resistant prostate cancer (CRPC)** [2][5][14]. Key Points and Arguments DB-1,311 (B7-H3 ADC) Efficacy and Safety - **DB-1,311** shows significant anti-cancer activity in heavily pre-treated CRPC patients, including those who have undergone nuclear medicine treatment and those who have not received taxane therapy [2][4]. - The **FURTHER study** included 73 advanced or metastatic CRPC patients, demonstrating an overall objective response rate (ORR) of **31%** and a disease control rate (DCR) exceeding **90%** [2][8]. - The ORR for the 6 mg and 9 mg dose groups was **42%** and **43%**, respectively, indicating substantial and durable anti-tumor activity [8][10]. - Radiographic progression-free survival (PFS) data showed that only **20.6%** of patients experienced confirmed disease progression, with a **6-month RPFS rate of 67%** and a **9-month RPFS rate of 58%** [10]. Patient Demographics and Treatment Background - The 73 patients in the FURTHER study were from the US (44%), Australia (29%), and East Asia (27%), with a median treatment duration of **4.8 months** [7]. - These patients had undergone multiple lines of prior treatment, including hormone therapy, docetaxel, cabazitaxel, nuclear medicine, platinum-based chemotherapy, immunotherapy, and PARP inhibitors, indicating a poor prognosis and typically low response to new drugs [7][11]. Safety Profile - Among the 73 patients, the incidence of treatment-related grade 3 or higher adverse events was **42.5%**, with the 6 mg dose group showing a lower rate of **28.9%** compared to the 9 mg group at **60%** [13]. - The overall permanent discontinuation rate was low at **6.5%**, with gastrointestinal and hematological toxicities primarily at grade 1 or 2 [13]. Future Development and Research Directions - DB-1,311 has received **FDA Fast Track designation**, and further studies are ongoing to optimize dosing and evaluate its efficacy in various patient cohorts [5][6]. - The company is actively recruiting patients for ongoing studies, including those who have undergone nuclear medicine treatment and taxane-naive patients [6][14]. HER3 ADC Developments - The conference also highlighted the **DB1,310 project**, a novel ADC targeting HER3, which has shown promising results in heavily pre-treated advanced solid tumor patients, with an ORR of **31%** and a DCR of **84%** [15][16]. - The project is currently in clinical trials in the US and China, with a focus on optimizing dosing and evaluating safety [18][20]. Additional Important Insights - The waterfall plot analysis indicated that nearly all patients experienced some degree of tumor shrinkage, with many achieving partial response (PR) [9][27]. - The company is considering various strategies for maximizing drug value, including starting from later lines of treatment and gradually moving to earlier lines [32]. - The collaboration with **Biotech** for the development of DB-1,311 and the potential for joint commercialization is under discussion, reflecting the positive data observed so far [35][38]. This summary encapsulates the critical findings and future directions discussed during the conference call, emphasizing the promising developments in oncology therapeutics by Ying En Bio.