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Ono Pharma Submits an Application for Approval of Ripretinib (DCC-2618) in Patients with Advanced Gastrointestinal Stromal Tumor in Japan

On March 26, 2026 Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President: Toichi Takino; "Ono") reported that Ono submitted an application for the manufacturing and marketing approval of ripretinib (DCC-2618), developed by Deciphera Pharmaceuticals, Inc. ("Deciphera"), for the indication of "gastrointestinal stromal tumor that has progressed following cancer chemotherapy."

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This application is based on the results of the INVICTUS study, a global Phase 3 clinical study, evaluating the efficacy of ripretinib compared to placebo in patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. In this study, ripretinib significantly prolonged the primary endpoint of progression-free survival (PFS) compared to placebo.

"GIST is recognized as a rare disease worldwide, and ripretinib, developed by Deciphera, has already been approved in more than 40 countries and regions, including the United States and Europe. This application for approval of ripretinib represents a significant advancement for patients with GIST in Japan," said Tatsuya Okamoto, Corporate Officer / Executive Director, Clinical Development of Ono. "Moving forward, we remain committed to developing and providing innovative medicines to meet the treatment needs of patients and the expectations of society."

"The application submission brings us one step closer to providing patients in Japan with advanced GIST a potential new treatment option. We anticipate that this submission may help address the issue of delayed access to new medicines, which remains a significant challenge for patients in Japan," said Ryota Udagawa, President and Chief Executive Officer of Deciphera. "As GIST is a rare type of tumor, the limited availability of disease information and current treatment options are likely to cause significant anxiety for patients. Together with our group companies, we will continue to make every effort to deliver ripretinib to patients in Japan suffering from advanced GIST as quickly as possible."

About the INVICTUS Study

The INVICTUS Phase 3 clinical study is a randomized, double-blind, placebo-controlled, international, multicenter study conducted in 12 overseas countries including US and EU to evaluate the safety, tolerability, and efficacy of ripretinib compared to placebo in 129 patients with advanced GIST who have received prior treatment with 3 or more kinase inhibitors, including imatinib. Patients were randomized 2:1 to either 150 mg of ripretinib or placebo once daily.

In the INVICTUS study, ripretinib significantly prolonged the primary endpoint of PFS determined by independent central radiologic review (a median PFS of 6.3 months in ripretinib arm compared to 1.0 month in the placebo arm, HR of 0.15, p<0.0001). 1)

About GIST

GIST is a mesenchymal tumor that arises from the muscular layer of the gastrointestinal tract and forms a mass that pushes up the mucosa from below. GIST is a rare disease, with an incidence of approximately 1 to 2 cases per 100,000 population per year. In Japan, the number of patients diagnosed with GIST between 2016 and 2018 was 4,475 over three years (approximately 1,492 cases per year; crude incidence rate: 1.18 cases per 100,000 population). 2) It is known that mutations in KIT (KIT proto-oncogene receptor tyrosine kinase) and PDGFRα (platelet-derived growth factor receptor α) are involved in the development of the majority of patients with GIST.

For unresectable, metastatic, or recurrent GIST, four agents—imatinib, sunitinib, regorafenib, and pimitespib—are currently approved in Japan. According to the Japanese clinical practice guidelines for GIST, these agents are recommended as first-line, second-line, third-line, and fourth-line treatments, respectively. 3)

About ripretinib

Ripretinib is an orally administered, tyrosine kinase inhibitor developed by Deciphera. Ripretinib inhibits primary and secondary KIT mutations in exons 9, 11, 13, 14, 17, and 18, which are involved in GIST. In addition, ripretinib inhibits primary PDGFRα mutations in exons 12, 14, and 18, including the exon 18 D842V mutation, which is present in a subset of GIST. The INVICTUS study has demonstrated the significant efficacy of ripretinib in patients with advanced GIST who have received prior treatment with 3 or more kinase inhibitors, including imatinib. Ripretinib was launched in the U.S. in 2020 under the brand name QINLOCK. As of March 2026, it is approved for the treatment of advanced GIST in more than 40 countries or regions, including the U.S. and European countries.

In Japan, ripretinib was designated as an orphan drug by the Ministry of Health, Labour and Welfare on March 19, 2026, for the treatment of GIST that have progressed following cancer chemotherapy. In addition, ripretinib was determined as a drug with high medical needs at the "67th Evaluation Committee on Unapproved or Off-label Drugs with High Medical Needs" held by Ministry of Health, Labour and Welfare, aiming to eliminate drug losses in Japan.

(Press release, Ono, MAR 26, 2026, View Source [SID1234663917])

Jecho Laboratories, Inc. to Present Preclinical Oncology Abstract at the 2026 AACR Annual Meeting

On March 25, 2026 Jecho Laboratories, Inc. reported it will present emerging preclinical data on JLC062, a novel B7-H3/PD-L1 bispecific antibody drug conjugate (bsADC) at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026. B7-H3 is a tumor-associated antigen highly expressed in solid tumors, while PD-L1 plays a key role in suppressing immune responses. JLC062 is composed of a fast-internalizing anti-B7-H3 arm and a non-internalizing anti-PD-L1 arm, which enables targeted delivery of a cytotoxic payload to tumors and disrupts immunosuppressive signaling while minimizing toxicity to immune cells. JLC062 is a promising therapeutic modality that integrates immune checkpoint inhibition with targeted cytotoxic delivery that may yield deep and durable antitumor responses.

The AACR (Free AACR Whitepaper) Annual Meeting will be held April 17-22, 2026 in San Diego, CA.

Details on the presentation are below. The full abstract can be found on the AACR (Free AACR Whitepaper) website.

Abstract 6561 /27: Rational design of a B7-H3/PD-L1 bsADC combining checkpoint blockade with targeted cytotoxicity for improved antitumor efficacy

Session Name: Clinical Research Track, Immune Checkpoint Blockade, PO.CL05.04
Session Time: Tuesday, April 21, 2026 2 – 5 p.m. PST
Location: San Diego Convention Center, Poster Section 44

(Press release, Jecho Laboratories, MAR 25, 2026, View Source [SID1234664150])

Boehringer Ingelheim delivers on late-stage pipeline with two key launches, grows sales by 7.3%* in a successful 2025

On March 25, 2026 Boehringer Ingelheim reported the company successfully delivered on key launches in its Human Pharma business in 2025, bringing two medicines with FDA Breakthrough Therapy designation for lung cancer and pulmonary fibrosis to market in H2, 2025. Group sales rose by 7.3%* to EUR 27.8 billion ($31.4 billion) for the full year, supported by both the Human Pharma and Animal Health business. In 2025, Boehringer increased Research and Development (R&D) investments to EUR 6.4 billion ($7.2 billion), representing 22.9% of group net sales. The company reached 70 million patients in 2025, delivering innovative medicines to more patients than ever before.

"2025 reinforced the strength of our pipeline and underscored the impact of our long-term investment in R&D. With two newly launched medicines in oncology and respiratory, we are addressing high unmet medical needs of patients, while also driving the renewal of our portfolio. Our pipeline positions us well to continue to make a real difference across important disease areas, and to bring innovative therapies to more patients than ever," said Shashank Deshpande, Chairman of the Board of Managing Directors and responsible for Human Pharma. "As 2026 unfolds with pivotal Phase III programs and readouts as well as new launches ahead, we strive to improve the lives of patients, animals, and communities worldwide."

Frank Hübler, Member of the Board of Managing Directors responsible for Finance, added: "In volatile markets and amid regional challenges, our business proved resilient as we focused on what we do best: bringing more medicines to patients and animals. We are investing more than ever in innovation, which reflects our ambition for the next years."

Human Pharma: JARDIANCE (empagliflozin tablets) and OFEV (nintedanib capsules) continue to grow; HERNEXEOS and JASCAYD launched
Human Pharma sales rose 7.4%* to EUR 22.7 billion ($25.6 billion), supported by strong performance in its core brands. JARDIANCE (empagliflozin tablets), for the treatment of chronic kidney disease, type 2 diabetes and heart failure, grew 8.7%* to EUR 8.8 billion ($9.9 billion). OFEV (nintedanib capsules), used to treat idiopathic pulmonary fibrosis and other progressive fibrosing interstitial lung diseases, increased 5.4%* to EUR 3.8 billion ($4.3 billion).

Boehringer Ingelheim expanded its portfolio with the launch of two innovative therapies in 2025: HERNEXEOS (zongertinib tablets), an oral treatment for HER2-mutant advanced non-small cell lung cancer, was launched in the U.S. in August 2025. The company also launched JASCAYD (nerandomilast tablets), which was approved in the U.S. and China for idiopathic pulmonary fibrosis (IPF) in October 2025, and for progressive pulmonary fibrosis (PPF) in December 2025. JASCAYD represents the first new innovative therapy for IPF coming to market in more than a decade.

Human Pharma R&D investments came in at EUR 5.8 billion ($6.6 billion) or 27.4% of the unit’s net sales. The company continued to advance its pipeline across cardiovascular, renal and metabolic diseases (CRM), oncology, respiratory and immunology, mental health, and eye health. The pipeline today includes more than 80 projects, representing over 50 new molecular entities. Ongoing advances in Boehringer’s growing mid‑ and late‑stage pipeline are building towards a sustained wave of potential launches, positioning the company to deliver transformative impact for patients in the years to come.

Animal Health: preventing the spread of transboundary animal diseases
In 2025, the Animal Health business demonstrated resilience and impact, with sales rising 6.5%* to EUR 4.9 billion ($5.5 billion). Growth was driven by pet parasiticides and therapeutics, poultry, and ruminant segments, with NEXGARD growing 8.5%* to EUR 1.4 billion ($1.6 billion), cementing its position as the industry’s top-selling parasiticide brand.

The company worked side by side with farmers, veterinarians, and governments, to help combat livestock diseases such as avian influenza, foot-and-mouth disease, and bluetongue virus. Boehringer received EU Marketing Authorization under Exceptional Circumstances for two poultry vaccines, supporting producers in keeping their poultry flocks healthy and increasing preparedness for avian influenza outbreaks. In addition to the VAXXINACT H5 avian influenza vaccine, VAXXITEK HVT+IBD+H5 is a new trivalent vaccine protecting chickens and turkeys against Marek’s disease, Infectious Bursal Disease and H5 avian influenza.

Outlook
In 2026, Boehringer expects to build on the momentum of recent years with continued progress across the Animal Health and Human Pharma pipelines and critical inflection points particularly in CRM, oncology and eye health.
* sales growth numbers are adjusted for currency effects.

(Press release, Boehringer Ingelheim, MAR 25, 2026, View Source [SID1234663998])

Io Therapeutics, Inc. announces publication in Scientific Reports – Nature, of studies showing synergistic efficacy of its RXR agonist IRX4204 with the standard of care drug lenalidomide against multiple myeloma.

On March 25, 2026 Io Therapeutics, Inc., a privately held pharmaceutical company headquartered in Spring, Texas; reported publication online in Scientific Reports – Nature, of collaborative studies with Duke University scientists on effects of the company’s anti-cancer compound IRX4204, on human multiple myeloma, a fatal form of bone marrow cancer. The studies were conducted under the leadership of Professor of Medicine Yubin Kang, M.D., in his laboratory at Duke.

The publication reports data from preclinical studies in in vitro and xenograft mouse models demonstrating effectiveness of IRX4204, a retinoid X nuclear receptor (RXR) agonist compound, against human multiple myeloma. IRX4204 also had synergistic efficacy against human multiple myeloma in combination with a standard of care anti-myeloma drug lenalidomide.

The paper reports data showing that IRX4204 induces ferroptosis (a mechanism of cell death) in multiple myeloma cells via the HMOX1/GPX4 axis and thereby enhances lenalidomide efficacy. The studies demonstrated that IRX4204 promotes ferroptosis in human multiple myeloma plasma cells by activating the PPARα/RXRα-HMOX1 axis and suppressing GPX4/SLC7A11-mediated antioxidant defense. This effect synergistically enhances the therapeutic efficacy of IRX4204 with lenalidomide. In vivo, combination treatment with IRX4204 and lenalidomide significantly reduced tumor growth compared to lenalidomide alone and significantly prolonged median survival in the xenograft mouse model without increased systemic toxicity. Tumor analysis confirmed increased HMOX1 and decreased GPX4 expression in combination-treated mice.

The authors also reported that bioinformatic analysis of multiple myeloma patients show that high HMOX1 expression in their plasma cells correlates with significantly improved overall survival (HR=0.51, p<0.001), while advanced-stage multiple myeloma patient plasma cells show progressively lower HMOX1 levels.

Dr. Kang stated: "These studies have multiple important clinical implications. The data identify a druggable ferroptosis pathway in multiple myeloma and provide a mechanistic rationale for combining RXR agonists such as IRX4204 with established therapies such as lenalidomide. Further, our finding of a strong statistical correlation between HMOX1 expression in myeloma patient plasma cells and patient survival suggests potential for biomarker-guided therapy selection.

While multiple myeloma remains largely incurable, treatments such as the standard of care drug lenalidomide and CAR-T cells effectively prolong survival. But almost all myeloma patients eventually relapse and succumb to the disease. Using new combinations of effective treatments including an RXR agonist such as IRX4204 is a rational approach to improving patient outcomes, including potentially cure in more patients."

Martin E. Sanders, M.D., Chief Executive Officer of Io Therapeutics stated "IRX4204 is a clinical stage compound which was invented by Vidyasagar Vuligonda, Ph.D., Chief Science Officer of Io Therapeutics. IRX4204 more potently and more selectively activates RXR than earlier generation RXR agonists. It has demonstrated an excellent chronic dosing safety profile in clinical trials in patients with various types of cancer. The IRX4204 safety profile likely will be suitable for chronic treatment of multiple myeloma in combination with lenalidomide. IRX4204 previously showed anti-cancer activity in animal models and in phase I and II clinical trials in patients with solid tumor malignancies including lung, breast, prostate and other cancers. The new findings that IRX4204 has synergistic efficacy against multiple myeloma, a hematologic cancer of bone marrow, when combined with a standard of care anti-myeloma drug lenalidomide, adds to the drug’s scope of potential clinical utilities, and may result in increases of the proportions of multiple myeloma patients achieving cure or long-term maintenance of complete responses of their cancers."

(Press release, Io Therapeutics, MAR 25, 2026, View Source [SID1234663922])

Ascentage Pharma Reports Full Year 2025 Unaudited Financial Results and Provides Business Updates

On March 25, 2026 Ascentage Pharma Group International (Ascentage Pharma) (NASDAQ: AAPG; HKEX: 6855) (referred hereinto as "Ascentage Pharma," the "Company," "we," "us" or "our"), a global, commercial stage, integrated biopharmaceutical company engaged in the discovery, development and commercialization of novel, differentiated therapies to address unmet medical needs in cancer, reported its unaudited financial results for the year ended December 31, 2025, and provided updates on key ongoing clinical programs and commercial activities.

Dr. Dajun Yang, Chairman and Chief Executive Officer of Ascentage Pharma, said, "2025 was a year of significant execution in advancing our mission to deliver innovative therapies to patients worldwide. We advanced our commercialization strategy as Olverembatinib gained significant traction after receiving NRDL coverage expansion, which has markedly enhanced affordability and accessibility for patients in China. We launched Lisaftoclax in China in late July 2025 shortly after receiving regulatory approval and are gaining market adoption as we actively pursue the inclusion of Lisaftoclax in China’s NRDL."

Dr. Yang continued, "Multiple advancements are continuing across our de-risked late-stage pipeline. For our third-generation tyrosine kinase inhibitor Olverembatinib, three global registrational Phase III trials, of which two are U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) cleared, are underway. Our Bcl-2 selective inhibitor, Lisaftoclax, with its highly differentiated daily dose ramp up, is being evaluated in ongoing global registrational Phase III trials, including two cleared by the FDA and EMA."

Key Commercial Product and Pipeline Updates

Olverembatinib (HQP1351) is a novel, next-generation TKI and the first third-generation BCR-ABL1 TKI approved in China for treatment of patients with chronic myeloid leukemia (CML) in chronic-phase (-CP) or CML in accelerated phase (-AP) with T315I mutations, and in CML-CP that is resistant and/or intolerant to first and second-generation TKIs.

Commercial progress

Revenue from sales of Olverembatinib in China increased 80.6% to US$62.2 million for the year ended December 31, 2025, compared to US$33.0 million for the year ended December 31, 2024.

All approved indications for Olverembatinib have been covered since January 2025 by China’s NRDL, which has bolstered the affordability and accessibility of Olverembatinib.

The number of hospitals where Olverembatinib is on formulary in Direct-to-Patient, or DTP, pharmacies reached 825 as of December 31, 2025, a 12.4% increase compared to 734 as of December 31, 2024. In particular, the number of hospitals where Olverembatinib is on formulary increased approximately 36.5% over the same period to 355 hospitals as of December 31, 2025 from 260 hospitals as of December 31, 2024.

Clinical progress

Enrollment continues in a FDA and EMA-cleared, global registrational Phase III clinical trial of Olverembatinib in combination with chemotherapy versus investigator choice TKI in combination with chemotherapy in first-line Philadelphia chromosome-positive ALL (Ph+ ALL) patients (POLARIS-1). The Part 1 data from POLARIS-1 was presented at the 67th 2025 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and demonstrated an MRD-negative CR rate of 64.2% by the end of the induction therapy and a favorable safety profile to date.

Enrollment continues in a FDA and EMA-cleared, global Phase III registrational clinical trial of Olverembatinib for previously treated CML-CP patients, both with and without T315I mutation (POLARIS-2).

Enrollment continues in a multinational registrational Phase III clinical trial of Olverembatinib for the treatment of patients with succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumor (GIST) who have not responded to prior systemic treatment (POLARIS-3).

Continue to evaluate Olverembatinib in combination with the Bcl-2 inhibitor Lisaftoclax in early phase clinical trials.

Upcoming milestones

Continue to advance enrollment in the POLARIS-1, POLARIS-2, and POLARIS-3 trials.

Lisaftoclax (APG-2575) is a novel, oral B-cell lymphoma 2 (Bcl-2) inhibitor developed to treat a variety of hematologic malignancies and solid tumors by selectively blocking Bcl-2 to restore the normal apoptosis process in cancer cells.

Commercial progress

Commercial sales of Lisaftoclax commenced in China on July 25, 2025 as the first batch of prescriptions were filled on July 25, 2025 shortly after receiving approval on July 10, 2025 from China’s National Medical Products Administration (NMPA) for the treatment of adult patients with CLL/SLL who have previously received at least one systemic therapy including BTK inhibitors, which makes Lisaftoclax the first Bcl-2 inhibitor to receive conditional approval and marketing authorization for the treatment of patients with CLL/SLL in China, and the second Bcl-2 inhibitor approved globally.

Revenue from sales of Lisaftoclax was US$10.1 million for 2025 for the five-month period from August 2025 to December 2025.

Clinical progress

Enrollment continues in a FDA and EMA-cleared global Phase III registrational clinical trial of Lisaftoclax in combination with AZA for the treatment of front-line HR-MDS patients (GLORA-4).

Enrollment continues in a multinational Phase III registrational clinical trial of Lisaftoclax for the treatment of front-line elderly or unfit patients with acute myeloid leukemia (AML) (GLORA-3).

Enrollment continues in a registrational Phase III clinical trial to evaluate Lisaftoclax in combination with the BTK inhibitor, acalabrutinib, versus immunochemotherapy in treatment-naïve patients with CLL/SLL, to validate a fixed duration of combination regimen as a first-line treatment (GLORA-2).

Enrollment continues in a FDA and EMA-cleared global Phase III clinical trial of Lisaftoclax in combination with BTK inhibitors in patients with CLL/SLL previously treated with BTK inhibitors (GLORA).

Enrollment continues Phase Ib/II studies of Lisaftoclax as a single agent or in combination with other therapies for the treatment of patients with AML/MDS, including patients resistant to venetoclax, in China.

Enrollment continues in the Phase Ib/II clinical trials of Lisaftoclax in combination therapies for the treatment of patients with multiple myeloma (MM) in the United States.

Upcoming milestones

Plan to initiate clinical studies to confirm Lisaftoclax’s potential to overcome venetoclax resistance in patients who have failed venetoclax treatment.

Continue to advance enrollment in GLORA, GLORA-2, GLORA-3, GLORA-4 trials.

Plan to actively advance the inclusion of Lisaftoclax in China’s National Reimbursement Drug List (NRDL) in 2026.

BTK Degrader APG-3288 is the first novel, highly potent and selective BTK degrader developed utilizing Ascentage Pharma’s proprietary proteolysis-targeting chimera (PROTAC) technology platform.

Progress

Received IND clearance from the FDA and from China’s Center for Drug Evaluation (CDE) in the first quarter of 2026.

Upcoming milestones

Plan to commence a global, multicenter, open-label Phase I study designed to evaluate the safety, tolerability, pharmacokinetic (PK) profile, and preliminary efficacy of APG-3288 in patients with relapsed/refractory hematologic malignancies.

Full Year 2025 Unaudited Financial Results

Revenue for the year ended December 31, 2025 was US$82.1 million, compared to US$134.3 million for the year ended December 31, 2024, which represented a decrease of US$52.2 million, or 41.5%. The decrease was primarily due to intellectual property revenue of US$92.9 million recorded during the year ended December 31, 2024. Product sales of Olverembatinib in China increased 80.6% to US$62.2 million for the year ended December 31, 2025, compared to US$33.0 million for the year ended December 31, 2024. Product sales of Lisaftoclax in China were US$10.1 million during the last five months of 2025 as prescriptions were filled starting at the end of July following approval by China’s NMPA in early July.

Selling and distribution expenses for the year ended December 31, 2025 were US$50.6 million, compared to US$26.9 million for the year ended December 31, 2024, which represented an increase of US$23.7 million, or 80.4%. The increase was attributable to increased commercialization activities for Lisaftoclax and Olverembatinib.

Research and development expenses for the year ended December 31, 2025 were US$162.7 million, compared to US$129.8 million for the year ended December 31, 2024, which represented an increase of US$32.9 million, or 20.1%. The increase was attributable to increased clinical trial expenses.

Administrative expenses for the year ended December 31, 2025 were US$35.2 million, compared to US$25.6 million for the year ended December 31, 2024, which represented an increase of US$9.6 million, or 31.6%. The increase was mainly due to additional staff hiring.

Finance costs for the year ended December 31, 2025 were US$7.7 million, compared to US$8.8 million for the year ended December 31, 2024, which represented a decrease of US$1.1 million, or 16.1%. The decrease was due to the decrease in interest rates in relation to bank borrowings.

Other expenses for the year ended December 31, 2025 were US$10.5 million, compared to US$1.2 million for the year ended December 31, 2024. The increase of US$9.3 million was primarily attributable to the increase in fair value loss of contingent consideration in 2025 related to the acquisition of Guangzhou Healthquest Pharma Co., Ltd.

Loss for the year ended December 31, 2025 was US$177.7 million, compared to the US$55.6 million for the year ended December 31, 2024.

Cash and bank balances as of December 31, 2025, were US$353.2 million, compared to US$172.8 million as of December 31, 2024, which represented an increase of US$180.4 million, or 95.9% on a constant currency basis. The increase was primarily due to the net proceeds of US$132.5 million from the U.S. initial public offering in January 2025 and net proceeds of US$190.1 million from the follow-on offering in July 2025.

Investor Conference Call and Webcast

Ascentage Pharma will be holding investor webcasts to discuss its full year 2025 unaudited annual results.

Ascentage Pharma will host the Chinese (Mandarin) investor event with simultaneous conference call and webcast at 10:00 pm EDT on March 25, 2026 / 10:00 am HKT on March 26, 2025. To access the Chinese language investor event or conference call, please register in advance here.

The English language investor conference call and webcast will be held at 8:00 am EDT / 8:00 pm HKT on March 26, 2026. To access the English language webcast, please register in advance here. The webcast replay for English language conference call and presentation will also be available on the News & Events page of the Ascentage Pharma website.

(Press release, Ascentage Pharma, MAR 25, 2026, View Source [SID1234663921])