On April 24, 2025 Orion reported interim financial report (Presentation, Orion, APR 24, 2025, View Source [SID1234654277]).

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On April 24, 2025 Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, reported a strategic pipeline prioritization with workforce and cost reduction initiatives to focus resources on its lead oncology clinical programs CB-010 and CB-011, with clinical data disclosures now planned for H2 2025 (Press release, Caribou Biosciences, APR 24, 2025, View Source [SID1234652100]).

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"Broad patient access to life-changing CAR-T cell therapies is only achievable if healthcare systems have an off-the-shelf option. Caribou’s two lead Phase 1 clinical programs, CB-010 for large B cell lymphoma and CB-011 for multiple myeloma, continue to demonstrate encouraging efficacy and have the potential to serve this critical unmet need for individuals living with hematologic malignancies," said Rachel Haurwitz, PhD, Caribou’s president and CEO. "We recognize the challenges in the current market environment and believe the best approach is to present the most robust datasets for both programs. As a result, we now plan to disclose clinical data from CB-010 and CB-011 in the second half of this year."

"To ensure Caribou is strongly positioned to emerge from these challenging times and deliver these potentially value-generating datasets, we have made the difficult decision to strategically prioritize our resources on CB-010 and CB-011 for oncology indications," continued Dr. Haurwitz. "These strategic decisions resulted in a reduction in Caribou’s workforce, which include some of the industry’s most talented scientists and professionals. We are deeply grateful for their foundational contributions to Caribou’s technology and current clinical programs. We plan to honor that legacy as we work toward ushering in a new era of allogeneic CAR-T cell therapies that offer the potential for broad access and rapid availability to both patients and healthcare systems."

Clinical highlights
CB-010, a clinical-stage allogeneic anti-CD19 CAR-T cell therapy for B cell non-Hodgkin lymphoma
•Caribou is enrolling a 20-patient confirmatory cohort using the company’s HLA matching strategy in the ANTLER Phase 1 clinical trial in second-line large B cell lymphoma (2L LBCL). In H2 2025, Caribou expects to present data from this cohort with at least 6 months of follow up for the majority of patients.
•To date, data demonstrate that a single dose of CB-010 has the potential to drive outcomes that are on par with the safety, efficacy, and durability of approved autologous CAR-T cell therapies.
•Additionally, in H2 2025, Caribou expects to present data from a proof-of-concept cohort of CB-010 in up to 10 patients who have relapsed following any prior CD19-targeted therapy.

CB-011, a clinical-stage allogeneic anti-BCMA CAR-T cell therapy for multiple myeloma
•In the dose escalation portion of the CaMMouflage Phase 1 clinical trial for relapsed or refractory multiple myeloma (r/r MM), Caribou continues to observe encouraging efficacy in patients treated with CB-011 at multiple dose levels following a lymphodepletion regimen that includes a deeper dose of cyclophosphamide.
•Caribou is rapidly enrolling additional patients with the deeper lymphodepletion regimen to make a data-driven decision on the recommended doses for expansion. The company plans to present data in H2 2025 with at least three months of follow up on a minimum of 25 patients at multiple dose levels.

Pipeline prioritization with workforce and cost reduction initiatives
•Caribou is prioritizing its lead oncology programs, CB-010 and CB-011. Caribou is discontinuing the GALLOP Phase 1 trial of CB-010 for lupus prior to dosing the first patient. Caribou is also discontinuing the AMpLify Phase 1 clinical trial of CB-012 for relapsed or refractory acute myeloid leukemia (AML) as additional data would be needed to advance this program, taking time and resources that can be dedicated to CB-010 and CB-011. Patients treated in the AMpLify Phase 1 trial will continue to be followed as part of the company’s long-term follow up study. Additionally, the company is discontinuing preclinical research.
•The company is reducing its workforce by approximately 32%. Cash payments resulting from the reduction in force and strategic pipeline prioritization are estimated to be $2.5 to $3.5 million.
•These changes are expected to extend Caribou’s cash runway by one year, funding the company’s current operating plan into H2 2027, compared to into H2 2026 as previously reported.

Corporate update
$212.5 million in cash, cash equivalents, and marketable securities
•Based on preliminary unaudited financial information, Caribou expects to report $212.5 million in cash, cash equivalents, and marketable securities as of March 31, 2025.

2025 Anticipated milestones
•CB-010 ANTLER: Caribou plans to present data from both the additional 2L and prior CD19 relapsed LBCL patient cohorts in H2 2025 and is interacting with the FDA on a potential pivotal trial to be initiated following alignment. This update is expected to include:
◦Initial safety and efficacy data on the confirmatory cohort (20 patients) with partial HLA matching, with a minimum of six months of follow up for the majority of patients, as well as an update on the larger, maturing dataset presented previously.
◦Pivotal trial design and timeline, contingent on positive data and FDA alignment.
•CB-011 CaMMouflage: Caribou plans to present dose escalation data and share the recommended doses for expansion from the ongoing CaMMouflage Phase 1 clinical trial in r/r MM in H2 2025. This update is expected to include:
◦Initial safety and efficacy data on a minimum of 25 patients at multiple dose levels using the deeper lymphodepletion regimen with at least three months of follow up.
◦Recommended doses for expansion and plans for dose expansion.

About CB-010
CB-010 is an allogeneic anti-CD19 CAR-T cell therapy being evaluated in patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL) in the ongoing ANTLER Phase 1 clinical trial. To Caribou’s knowledge, CB-010 is the first allogeneic CAR-T cell therapy in the clinic with a PD-1 knockout, a genome-editing strategy designed to enhance CAR-T cell activity by limiting premature CAR-T cell exhaustion. The FDA granted CB-010 Regenerative Medicine Advanced Therapy (RMAT), Orphan Drug, and Fast Track designations for B-NHL. Additional information on the ANTLER trial (NCT04637763) can be found at clinicaltrials.gov.

About CB-011
CB-011 is an allogeneic anti-BCMA CAR-T cell therapy being evaluated in patients with relapsed or refractory multiple myeloma (r/r MM) in the CaMMouflage Phase 1 trial. To Caribou’s knowledge, CB-011 is the first allogeneic CAR-T cell therapy in the clinic that is engineered to enable activity through an immune cloaking strategy with a B2M knockout and insertion of a B2M–HLA-E fusion protein to blunt immune-mediated rejection. CB-011 has been granted Fast Track and Orphan Drug designations by the FDA. Additional information on the CaMMouflage trial (NCT05722418) can be found at clinicaltrials.gov.

On April 24, 2025 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (6990.HK) reported that it will present results from six Kelun-led clinical studies at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, held in Chicago from May 30 to June 3 (Press release, Kelun, APR 24, 2025, View Source [SID1234652117]). Results include data from its TROP2 antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT), anti-PD-L1 mAb tagitanlimab, and RET inhibitor KL590586 (A400/EP0031). The abstracts for these studies will be published on the ASCO (Free ASCO Whitepaper)’s official website on May 22, 2025, local time.

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Detailed information on the studies selected for ASCO (Free ASCO Whitepaper) 2025 are as follows:

Title: Sacituzumab tirumotecan (sac-TMT) in patients (pts) with previously treated advanced EGFR-mutated non-small cell lung cancer (NSCLC): Results from the randomized OptiTROP-Lung03 study.
Presentation Type: Oral
Abstract Number: 8507
Session Date and Time: 6/1/2025 8:00 AM-11:00 AM CDT

Title: Tagitanlimab versus placebo in combination with gemcitabine and cisplatin as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (R/M NPC): Results from a randomized, double-blind, phase 3 study.
Presentation Type: Oral
Abstract Number: 6004
Session Date and Time: 5/31/2025 1:15 PM-4:15 PM CDT

Title: Sacituzumab tirumotecan (sac-TMT) as first-line treatment for unresectable locally advanced/metastatic triple-negative breast cancer (a/m TNBC): Initial results from the Phase II OptiTROP-Breast05 study.
Presentation Type: Rapid oral
Abstract Number: 1019
Session Date and Time: 5/30/2025 2:45 PM-4:15 PM CDT

Title: Sacituzumab tirumotecan (sac-TMT) in combination with tagitanlimab (anti-PD-L1) in first-line (1L) advanced non-small-cell lung cancer (NSCLC): Non-squamous cohort from the phase II OptiTROP-Lung01 study.
Presentation Type: Poster
Abstract Number: 8529
Session Date and Time: 5/31/2025 1:30 PM-4:30 PM CDT

Title: Sacituzumab Tirumotecan (sac-TMT) in patients (pts) with previously treated locally advanced or metastatic (LA/M) non-small cell lung cancer (NSCLC) harboring uncommon EGFR mutations: Preliminary results from a phase 2 study.
Presentation Type: Poster
Abstract Number: 8615
Session Date and Time: 5/31/2025 1:30 PM-4:30 PM CDT

Title: Results from a phase I study of KL590586 in patients with advanced RET-mutant medullary thyroid cancer.
Presentation Type: Poster
Abstract Number: 6098
Session Date and Time: 6/2/2025 9:00 AM-12:00 PM CDT

About Sac-TMT

Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as Non-small Cell Lung Cancer (NSCLC), breast cancer (BC), gastric cancer (GC), gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.

In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc., Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (includes Mainland China, Hong Kong, Macau, and Taiwan).

To date, two indications for sac-TMT have been approved and marketed in China for the treatment of adult patients with unresectable locally advanced or metastatic TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting) and EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy. Sac-TMT became the first domestic ADC with global intellectual property rights to be fully approved for marketing. It is also the world’s first TROP2 ADC to be approved for marketing in a lung cancer indication. In addition, the NDA application for sac-TMT for the treatment of adult patients with EGFR-mutant locally advanced or metastatic NSCLC who progressed after treatment with EGFR-TKI therapy was accepted by the National Medical Products Administration (NMPA), and was included in the priority review and approval process. As of today, Kelun-Biotech has initiated 8 registrational clinical studies in China. MSD has initiated 12 ongoing Phase 3 global clinical studies of sac-TMT as a monotherapy or with pembrolizumab or other agents for several types of cancer. These studies are sponsored and led by MSD.

About Tagitanlimab

Tagitanlimab is the first PD-L1 monoclonal antibody (mAb) globally to receive authorization for the first-line treatment of NPC. Previously, the National Medical Products Administration (NMPA) has approved the marketing in China of tagitanlimab used in combination with cisplatin and gemcitabine for the first-line treatment of patients with R/M NPC and monotherapy for the treatment of patients with recurrent or metastatic NPC who have failed after prior 2L+ chemotherapy, respectively.

About KL590586 (A400/EP0031)

A400, a novel next-generation selective RET inhibitor for NSCLC, MTC and other solid tumors with a high prevalence of RET alterations. We are currently conducting pivotal clinical study for both 1L and 2L+ advanced RET+ NSCLC as well as a phase 1b/2 clinical study for RET+ MTC and solid tumor in China.

In March 2021, we granted Ellipses Pharma, a U.K.-based international oncology drug development company, an exclusive license to develop, manufacture and commercialize this agent outside Greater China and certain Asian countries under the code EP0031.

In March 2024, it was announced that EP0031/A400 was granted Fast Track designation by the FDA for the treatment of RET-fusion positive NSCLC. In April 2024, EP0031/A400 was cleared by the FDA to progress into Phase 2 clinical development and is now open in the US, UK, EU and UAE.

On April 24, 2025 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported its financial results for the first quarter of fiscal year 2025 (Press release, Chugai, APR 24, 2025, View Source [SID1234652101]).

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"The first quarter of 2025 got off to a strong start with increased revenue and profit year-on-year. In Japan, despite the impact of NHI drug price revisions and generic penetration, our new products Phesgo and PiaSky, along with our mainstay product Vabysmo, performed well. Overseas sales increased, with exports of our mainstay products Hemlibra and Actemra growing significantly, driving overall growth. In development pipeline progress, LUNSUMIO, in-licensed from Roche, has been launched in Japan for the treatment of relapsed or refractory follicular lymphoma. For in-house projects, NEMLUVIO (nemolizumab), out-licensed to Galderma received approval in Europe, while orforglipron, out-licensed to Eli Lilly, met its primary endpoint in a Phase III clinical trial for type 2 diabetes, each making significant progress. NXT007, one of our most important development projects achieved Proof of Concept (PoC)* for hemophilia A, and we are accelerating preparations for the earliest possible initiation of Phase III trials. Additionally, three in-house projects of Enspryng, RAY121, and MINT91 initiated new clinical trials. We will continue to strongly promote our unique and innovative drug development to deliver new value to patients worldwide," said Dr. Osamu Okuda, Chugai’s President and CEO.

Chugai reported an increase in revenue of 21.8% and in operating profit of 36.6% year-on-year for the first quarter of 2025 (Core-basis), primarily driven by significant growth in overseas sales.

Regarding revenue, domestic sales remained nearly flat with a slight decrease of 0.2% year-on-year. In the oncology field, sales decreased by 5.3% compared to the previous year. While our new product Phesgo performed well, this was offset by the decline in Perjeta and Herceptin along with the market penetration of Phesgo which includes the same active pharmaceutical ingredients. Additionally, products including our mainstay product Avastin were affected by NHI drug price revisions and biosimilars. In the specialty field, sales increased by 6.2% year-on-year, driven by the strong performance of our mainstay product Vabysmo and successful market penetration of our new product PiaSky. Overseas sales increased significantly by 54.7% year-on-year, driven by a substantial increase in exports of Hemlibra and Actemra to Roche. Other revenue decreased by 11.7%, despite the increase in royalty income related to Hemlibra, mainly due to a decrease in one-time income, etc.

Cost to sales ratio improved by 1.8 percentage points year-on-year to 33.7%, mainly due to a change in the product mix. Research and development expenses and selling, general and administration expenses remained at levels comparable to the previous year. Other operating income (expense) resulted in a gain of ¥0.3 billion. As a result, Core operating profit totaled ¥139.5 billion (+36.6%).

Chugai made good progress in both early and late-stage development activities.

In early-stage development of in-house products that will drive mid to long-term growth, Enspryng (for Duchenne muscular dystrophy) has initiated Phase II clinical trials. Additionally, RAY121 and MINT91 (for solid tumors) have each entered Phase I clinical trials. Furthermore, NXT007 (for hemophilia A) has achieved an important milestone by obtaining PoC. In-house products out-licensed to third parties excluding Roche also progressed steadily. Orforglipron, an oral GLP-1 agonist out-licensed to Eli Lilly, has shown favorable results in a Phase III clinical trial for type 2 diabetes. NEMLUVIO, being developed overseas by Galderma, has received approval in Europe for moderate-to-severe atopic dermatitis and prurigo nodularis.
For products in-licensed from Roche, LUNSUMIO has been launched in Japan for the treatment of relapsed or refractory follicular lymphoma. Tecentriq has received approval for an expanded indication for alveolar soft part sarcoma, while Vabysmo and Evrysdi have received approvals for new formulations. Trontinemab, under development for Alzheimer’s disease, has shown favorable results in Phase I/II clinical trials.

* Proof of Concept (A demonstration that the therapeutic effect conceived in the research stage is effective in humans)

[2025 first quarter results]

Billion JPY 2025
Jan – Mar 2024
Jan – Mar % change
Core results
　Revenue 288.5 236.9 +21.8%
　　Sales 259.7 204.5 +27.0%
　　Other revenue 28.7 32.5 -11.7%
　Operating profit 139.5 102.1 +36.6%
　Net income 99.2 76.0 +30.5%
IFRS results
　Revenue 288.5 236.9 +21.8%
　Operating profit 136.7 99.9 +36.8%
　Net income 97.2 74.4 +30.6%
[Sales breakdown]

Billion JPY 2025
Jan – Mar 2024
Jan – Mar % change
Sales 259.7 204.5 -29.8%
　Domestic sales 103.0 103.2 -0.2%
　　Oncology 53.1 56.1 -5.3%
　　Specialty 49.9 47.0 +6.2%
　Overseas sales 156.7 101.3 +54.7%
[Oncology field (Domestic) Top5-selling medicines]

Billion JPY 2025
Jan – Mar 2024
Jan – Mar % change
　Tecentriq 13.8 14.5 -4.8%
　Polivy 7.5 7.4 +1.4%
　Alecensa 7.5 6.6 +13.6%
　Phesgo 6.8 3.2 +112.5%
　Avastin 6.1 8.7 -29.9%
[Specialty field (Domestic) Top5-selling medicines plus Ronapreve]

Billion JPY 2025
Jan – Mar 2024
Jan – Mar % change
　Hemlibra 12.6 12.5 +0.8%
　Actemra 10.9 10.2 +6.9%
　Enspryng 6.1 5.8 +5.2%
　Vabysmo 5.4 4.0 +35.0%
　Evrysdi 3.4 3.4 +0.0%
[Progress in R&D activities from Jan 30th, 2025 to Apr 24th, 2025]

2024 Q1 R&D Progress
About Core results

Chugai discloses its results on a Core basis from 2013 in conjunction with its decision to apply IFRS. Core results are the results after adjusting Non-Core items to IFRS results. Chugai’s recognition of non-recurring items may differ from that of Roche due to the difference in the scale of operations, the scope of business and other factors. Core results are used by Chugai as an internal performance indicator, for explaining the underlying business performance both internally and externally, and as the basis for payment-by-results such as a return to shareholders.

Trademarks used or mentioned in this release are protected by law.

On April 24, 2025 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported that the U.S. Food and Drug Administration (FDA) has approved its differentiated PD-1 monoclonal antibody, penpulimab-kcqx, in combination with cisplatin or carboplatin and gemcitabine for the first-line treatment of adult recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (NPC) (Press release, Akeso Biopharma, APR 24, 2025, View Source [SID1234652118]). FDA also approved penpulimab-kcqx as a single agent for adults with metastatic non-keratinizing NPC with disease progression on or after platinum-based chemotherapy and with least one other prior line of therapy. Penpulimab-kcqx was developed independently by Akeso, with further development and commercialization managed through a joint venture with Chia Tai-Tianqing Pharmaceutical Group.

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This milestone marks penpulimab-kcqx as Akeso’s first internally developed innovative biologic to receive FDA approval. The approval underscores the robust clinical research behind penpulimab-kcqx and marks Akeso’s successful entry into the United States regulatory system for the first time. This achievement highlights the company’s innovative drug development capabilities and its commitment to adhering to the highest international standards in pharmaceutical quality management.

The FDA’s approval of penpulimab-kcqx validates Akeso’s international drug development strategy and expansion capabilities. This approval lays a strong foundation for Akeso’s continued clinical development efforts in the global therapeutics markets.

Penpulimab-kcqx has been approved in China for two indications: 1. first-line treatment of advanced NPC, and 2. second or later line treatment of advanced NPC. The recent FDA approval of penpulimab-kcqx offers a new, immunotherapy option for advanced NPC patients in the US.

The FDA approval is based on the international Phase III clinical trial AK105-304 and the pivotal AK105-202 study, which supported the two Biologics License Application (BLA) for penpulimab-kcqx. These studies demonstrated the drug’s clinical benefits and favorable safety profile across two stages of treatment for metastatic NPC. AK105-304 is a randomized, double-blind, international Phase III trial that enrolled NPC patients of diverse ethnicities. The data will be presented at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. Previously, the FDA granted penpulimab-kcqx Breakthrough Therapy Designation (BTD), Orphan Drug Designation (ODD), and Fast Track Designation (FTD) for NPC treatment, highlighting the critical unmet need for this therapy.

According to the WHO 2020 Global Cancer Statistics, over 133,000 new NPC cases are diagnosed annually worldwide, with more than 70% of the patients presented with locally advanced disease. Recurrent or metastatic NPC has a poor prognosis and limited survival. Penpulimab-kcqx’s FDA approval will expand the number of NPC patients that can benefit from its treatment.

Prof. Chaosu Hu, Principal Investigator of penpulimab-kcqx from Fudan University Shanghai Cancer Center, commented: "This milestone enhances international treatment guidelines for advanced NPC and extends the benefits of China’s innovations to global patients, ultimately reshaping the treatment landscape for metastatic NPC worldwide."

Prof. Xiaozhong Chen, Investigator of penpulimab-kcqx from Zhejiang Cancer Hospital, added: "The FDA approval of penpulimab-kcqx confirms its high efficacy and low toxicity, positioning China’s innovative drug development in alignment with international standards."

Dr. Yu Xia, Founder, Chairwoman, President & CEO of Akeso, expressed: "We are very excited by the approval of penpulimab-kcqx’s approval in the US FDA for first line and later line NPC. Beyond reaching our first international regulatory milestone, this approval also provides an important immunotherapy treatment option for patients with NPC in the United States. The FDA approval of penpulimab-kcqx not only highlights the quality of our innovation but also underscores Akeso’s focus on delivering treatments for difficult to treat cancers for patients around the world. We are deeply grateful to all the researchers, participants, and patients who have contributed to this success. Akeso will continue to advance first and best in class therapies, including bispecific antibodies and CD47 inhibitors, challenge global standards of care and unlocking the full potential of our pipeline for cancer patients everywhere."