Andrew Berens

Jessica Fye

Ziyi Chen

Reni Benjamin

Sean Laaman

Yigal Nochomovitz

Dingding Shi

Michael Schmidt

Gregory Renza

Kelly Shi

TD Cowen Analyst

Unknown Analyst

Yaron Werber

- BeOne Medicines presented **new positive data** from two pivotal Phase 3 studies (RATIONALE-307 and -312) for its PD-1 inhibitor **TEVIMBRA** (Tislelizumab) at the European Society of Medical Oncology 2025 (ESMO 2025) congress.  **[1651308_7b23ecb178404debb62d1cdfc77c0564_0]** 
- The data confirmed **consistent and durable efficacy** of TEVIMBRA in various lung cancer subtypes, including non-small cell lung cancer (NSCLC) and advanced small cell lung cancer (ES-SCLC), with a consistent safety profile.  **[1651308_7b23ecb178404debb62d1cdfc77c0564_0]** **[1651308_7b23ecb178404debb62d1cdfc77c0564_1]** 
- Early clinical data for BeOne's HPK1-inhibitor **BGB-26808**, both as monotherapy and in combination with TEVIMBRA, demonstrated **promising anti-tumor activity** and a controllable safety profile in patients with advanced solid tumors.  **[1651308_7b23ecb178404debb62d1cdfc77c0564_0]** **[1651308_7b23ecb178404debb62d1cdfc77c0564_1]** 
- The combination arm of BGB-26808 achieved an unconfirmed objective response rate (ORR) of **15.4%**, including one complete response and seven partial responses.  **[1651308_7b23ecb178404debb62d1cdfc77c0564_1]**

BeOne Medicines Presents New TEVIMBRA and BGB-26808 Data at ESMO 2025

- BeOne Medicines will present new data on its PD-1 inhibitor, **TEVIMBRA** (tislelizumabe), at ESMO 2025, reinforcing its clinical benefit in non-small cell lung cancer (NSCLC) and extensive-stage small cell lung cancer (ES-SCLC).  **[1651308_1539d5ef068a4cc3a338a1027bf8f18d_0]** 
- The new data from Phase 3 trials **RATIONALE-307** and **RATIONALE-312** demonstrate TEVIMBRA's consistent efficacy and safety in lung cancer subtypes, with long-term overall survival improvements.  **[1651308_1539d5ef068a4cc3a338a1027bf8f18d_0]** **[1651308_1539d5ef068a4cc3a338a1027bf8f18d_1]** 
- Initial clinical data for BeOne's experimental HPK1 inhibitor, **BGB-26808**, will also be presented, showing promising anti-tumor activity as a monotherapy and in combination with TEVIMBRA in advanced solid tumors.  **[1651308_1539d5ef068a4cc3a338a1027bf8f18d_0]** **[1651308_1539d5ef068a4cc3a338a1027bf8f18d_1]**  The combined group for BGB-26808 achieved an unconfirmed **objective response rate (ORR) of 15.4%**.  **[1651308_1539d5ef068a4cc3a338a1027bf8f18d_1]** 
- TEVIMBRA has recently received **European approval** for perioperative resectable NSCLC and has been approved in **47 markets**, treating over **1.7 million patients** globally.  **[1651308_1539d5ef068a4cc3a338a1027bf8f18d_0]** **[1651308_1539d5ef068a4cc3a338a1027bf8f18d_2]**

BeOne Medicines to Present New Lung Cancer Data at ESMO 2025

- BeOne Medicines' Sonrotoclax, a next-generation BCL2 inhibitor, has been granted **Breakthrough Therapy Status (BTD)** by the US FDA for adult patients with **relapsed or refractory (R/R) Mantle Cell Lymphoma (MCL)**.  **[1651308_d1ce52a41dd94c24ae76b40dfcf82dc3_0]** 
- The BTD was based on **positive early results** from the Phase 1/2 study (BGB-11417-201).  **[1651308_d1ce52a41dd94c24ae76b40dfcf82dc3_0]** 
- BeOne will also participate in the **FDA's Project Orbis program**, which facilitates simultaneous review of oncology products by global regulatory authorities to accelerate access.  **[1651308_d1ce52a41dd94c24ae76b40dfcf82dc3_0]** 
- This designation underscores Sonrotoclax's potential to become the **first and only BCL2 inhibitor** approved in the US for R/R MCL, with a **Phase 3 confirmatory study (CELESTIAL-RRMCL)** already underway.  **[1651308_d1ce52a41dd94c24ae76b40dfcf82dc3_0]**

BeOne Medicines' Sonrotoclax Receives FDA Breakthrough Therapy Status

- BeOne Medicines' sonrotoclax has been granted **Breakthrough Therapy Designation (BTD)** by the U.S. FDA for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (R/R MCL).  **[1651308_84edb45a08844a2db77ec1950cb2aab8_0]** 
- This designation is based on **positive early results** from the Phase 1/2 study (BGB-11417-201).  **[1651308_84edb45a08844a2db77ec1950cb2aab8_0]** 
- BeOne will also participate in the **Project Orbis** program, which aims to accelerate global access to oncology products.  **[1651308_84edb45a08844a2db77ec1950cb2aab8_0]** 
- This marks the **first BTD for sonrotoclax** and the second for BeOne's hematology program, highlighting its potential as a significant advancement in B-cell malignancies.  **[1651308_84edb45a08844a2db77ec1950cb2aab8_1]**

BeOne Medicines' Sonrotoclax Receives FDA Breakthrough Therapy Designation

- BeOne Medicines' **sonrotoclax**, a BCL2 inhibitor, has been granted **Breakthrough Therapy Designation (BTD)** by the U.S. FDA for the treatment of adult patients with **relapsed or refractory Mantle Cell Lymphoma (MCL)**.  **[1651308_522fca0801d34738bc78fde173c9a34e_0]** 
- The BTD was based on **positive initial results** from the **Phase 1/2 study (BGB-11417-201)**, which evaluated sonrotoclax in R/R MCL patients.  **[1651308_522fca0801d34738bc78fde173c9a34e_0]** 
- BeOne will participate in the **Project Orbis program**, an initiative to accelerate global access to sonrotoclax.  **[1651308_522fca0801d34738bc78fde173c9a34e_0]** 
- Sonrotoclax also holds **Fast Track Designation** for MCL and Waldenström macroglobulinemia, and **Orphan Drug Designation** for MCL, Waldenström macroglobulinemia, multiple myeloma, and acute myeloid leukemia.  **[1651308_522fca0801d34738bc78fde173c9a34e_1]** 
- A confirmatory **Phase 3 study (CELESTIAL-RRMCL)** for sonrotoclax in R/R MCL is currently underway.  **[1651308_522fca0801d34738bc78fde173c9a34e_0]**

- BeOne Medicines' **sonrotoclax** has been granted **Breakthrough Therapy Designation (BTD)** by the U.S. FDA for the treatment of adult patients with **relapsed or refractory mantle cell lymphoma (R/R MCL)**.  **[1651308_8b4129a4a06c4b648fc24e94697c9229_0]** 
- The BTD was based on **positive preliminary results** from the **Phase 1/2 BGB-11417-201 study**.  **[1651308_8b4129a4a06c4b648fc24e94697c9229_0]** 
- BeOne will participate in the **Project Orbis program**, an initiative designed to accelerate global access to treatment for sonrotoclax.  **[1651308_8b4129a4a06c4b648fc24e94697c9229_0]** 
- This is the **first BTD for sonrotoclax** and the second for BeOne's hematology program, highlighting its potential as a significant advancement in B-cell malignancies.  **[1651308_8b4129a4a06c4b648fc24e94697c9229_1]**

- **BeOne Medicines' sonrotoclax** has been granted **Breakthrough Therapy Designation (BTD)** by the U.S. FDA for the treatment of adult patients with **relapsed or refractory (R/R) mantle cell lymphoma (MCL)**.  **[1651308_d44b28f737db4a358b7050f928c8fbc6_0]** 
- The FDA's decision was based on **positive early results** from the Phase 1/2 BGB-11417-201 study.  **[1651308_d44b28f737db4a358b7050f928c8fbc6_0]** 
- BeOne will also participate in **Project Orbis**, an FDA initiative to facilitate concurrent submission and review of oncology products among global health authorities, potentially accelerating access to sonrotoclax.  **[1651308_d44b28f737db4a358b7050f928c8fbc6_0]** 
- This marks the **first BTD for sonrotoclax** and the second for BeOne's hematology program, reinforcing its position as a potential advancement in B-cell malignancies.  **[1651308_d44b28f737db4a358b7050f928c8fbc6_1]**

- BeOne Medicines Ltd. has entered into a **Royalty Purchase Agreement** with Royalty Pharma to sell its royalty rights on worldwide sales (excluding China) of **IMDELLTRA** (tarlatamab-dlle) for up to **$950 million**.  **[1651308_0001628280-25-041082_a20250825formxprojecttarot.htm:0]** **[1651308_0001628280-25-041082_bgne-20250825.htm:1]** 
- The agreement includes an **upfront payment of $885 million** to BeOne, with an option to sell remaining royalties for up to an additional **$65 million** within 12 months.  **[1651308_0001628280-25-041082_a20250825formxprojecttarot.htm:0]** **[1651308_0001628280-25-041082_bgne-20250825.htm:1]** 
- **IMDELLTRA** is a first-in-class DLL-3 targeting bispecific T-cell engager approved in the U.S. for adult patients with extensive-stage small cell lung cancer (ES-SCLC).  **[1651308_0001628280-25-041082_a20250825formxprojecttarot.htm:0]** 
- This transaction is expected to **accelerate value realization** and provide BeOne with **increased operational and strategic flexibility**.  **[1651308_0001628280-25-041082_a20250825formxprojecttarot.htm:0]**

BeOne Medicines (ONC)