Selinexor

- XPOVIO® is the first XPO1 inhibitor approved for reimbursement by South Korea's National Health Insurance Service (NHIS) for the treatment of adult patients with relapsed/refractory multiple myeloma (R/R MM). - The approval of XPOVIO® by the NHIS in South Korea is the fourth national reimbursement in the Antengene markets after mainland of China, Australia and Singapore. - Additional reimbursements of XPOVIO® in APAC markets are expected. - Antengene has also submitted the new drug applications (NDAs) in additional ASEAN markets, including Thailand, Malaysia and Indonesia, where approvals are expected in the H2 of 2024. SHANGHAI and HONG KONG, June 26, 2024 /PRNewswire/ -- Antengene Corporation Limited (" Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for cancer, today announced that South Korea's National Health Insurance Service (NHIS) has approved the reimbursement of XPOVIO® (selinexor) for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM). XPOVIO® will be officially included into the national reimbursed drugs list of South Korea on July 1, 2024. MM, the second most common hematologic malignancy, is caused by the dysregulated proliferation of plasma cells. Patients with MM face a range of challenges including a high relapse rate, short survival, and limited treatment options. According to market data, the global MM market has exceeded US$17 billion in 2023 and is expected to reach US$ 26 billion by 2028, with a compound annual growth rate (CAGR) of 8.7%[1]. With a novel mechanism of action, XPOVIO® is the world's first approved orally-available, selective XPO1 inhibitor. XPOVIO® has a global commercial presence with approvals in over 40 countries and regions. To date, XPOVIO® has already been included for health insurance coverage in mainland of China, Australia and Singapore in the APAC markets. With the latest approval from the NHIS in South Korea, XPOVIO® is poised to be a novel treatment option and will bring clinically meaningful survival benefits to more patients in need . Antengene has already submitted NDAs for XPOVIO® in Thailand, Malaysia and Indonesia for the treatment of patients with R/R MM and R/R diffuse large B-cell lymphoma (R/R DLBCL). About XPOVIO® (selinexor) XPOVIO® is the world's first approved orally-available, selective inhibitor of the nuclear export protein XPO1. It offers a novel mechanism of action, synergistic effects in combination regimens, fast onset of action, and durable responses. By blocking the nuclear export protein XPO1, XPOVIO® can promote the intranuclear accumulation and activation of tumor suppressor proteins and growth regulating proteins, and down-regulate the levels of multiple oncogenic proteins. XPOVIO® delivers its antitumor effects through three mechanistic pathways: 1) exerting antitumor effects by inducing the intranuclear accumulation of tumor suppressor proteins; 2) reducing the level of oncogenic proteins in the cytoplasm by inducing the intranuclear accumulation of oncogenic mRNAs; 3) restoring hormone sensitivity by activating the glucocorticoid receptors (GR) pathway. To utilize its unique mechanism of actions, XPOVIO® is being evaluated for use in multiple combination regimens in a range of indications. At present, Antengene is conducting multiple clinical studies of XPOVIO® in the mainland of China for the treatment of relapsed/refractory hematologic malignancies and solid tumors (3 of these studies are being jointly conducted by Antengene and Karyopharm Therapeutics Inc. [Nasdaq:KPTI]). About Antengene Antengene Corporation Limited ( "Antengene", SEHK: 6996.HK) is a leading commercial-stage R&D-driven global biopharmaceutical company focused on the discovery, development, manufacturing and commercialization of innovative first-in-class/best-in-class therapeutics for the treatment of hematologic malignancies and solid tumors, in realizing its vision of "Treating Patients Beyond Borders". Since 2017, Antengene has built a pipeline of 9 oncology assets at various stages going from clinical to commercial, including 6 with global rights, and 3 with rights for the APAC region. To date, Antengene has obtained 29 investigational new drug (IND) approvals in the U.S. and Asia, and submitted 10 new drug applications (NDAs) in multiple Asia Pacific markets, with the NDA for XPOVIO® (selinexor) already approved in Mainland of China, Taiwan China, Hong Kong China, Macau China, South Korea, Singapore and Australia. Forward-looking statements The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, please see the other risks and uncertainties described in the Company's Annual Report for the year ended December 31, 2023, and the documents subsequently submitted to the Hong Kong Stock Exchange. Reference: [1] Global Multiple Myeloma Treatment Market Size, Share & Trends Analysis Report by Treatment Type (Chemotherapy, Targeted Therapy, Immunotherapy, Stem Cell Transplantation), by Region, and Segment Forecasts, 2023-2028. For more information, please contact: Investor Contacts: Donald Lung E-mail: [email protected] Mobile: +86 18420672158 PR Contacts: Peter Qian E-mail: [email protected] Mobile: +86 13062747000 SOURCE Antengene Corporation Limited

ABBV-383 is a B-cell maturation antigen (BCMA) bispecific antibody T-cell engager being evaluated in relapsed/refractory multiple myeloma (r/r MM) The CERVINO Phase 3 trial will evaluate the efficacy, safety, and tolerability of ABBV-383 monotherapy compared with standard available therapies (SATs) in patients with r/r MM who have received at least two lines of prior therapy NORTH CHICAGO, Ill., June 5, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the first patient has been treated with investigational ABBV-383 in the CERVINO Phase 3 study. ABBV-383 is a distinctive B-cell maturation antigen (BCMA) and CD3 bispecific antibody T-cell engager composed of bivalent BCMA-binding domains allowing for high BCMA-avidity and a low-affinity CD3 binding domain.1 ABBV-383 is being evaluated in a Phase 3, multicenter, randomized, open-label study compared with standard available therapies in patients with r/r MM who received at least two lines of prior therapy. "Despite notable advances in treatment, most patients with multiple myeloma will eventually relapse. Patients with advanced disease, especially in the community setting, often have limited access to novel treatment options and existing options have a high treatment burden, including frequent dosing," said Dr. Peter Voorhees, clinical professor of medicine, director of plasma cell disorders, Atrium Health Levine Cancer Institute. "The CERVINO Phase 3 trial is designed to evaluate the efficacy of ABBV-383 with monthly dosing and we look forward to seeing the data as it emerges." Multiple myeloma is a blood cancer characterized by abnormal proliferation of plasma cells, which can cause end-organ damage and is the second most commonly occurring blood cancer in the world.2 An estimated 176,000 people globally were diagnosed with multiple myeloma in 2020, and 117,000 people died from the disease.3 "The start of the CERVINO Phase 3 trial marks an important step forward in AbbVie's continued commitment to advance new oncology treatments and elevate the standard of care for blood cancer patients," said Mariana Cota Stirner, M.D., vice president, therapeutic area head oncology, hematology, AbbVie. "ABBV-383 is being evaluated with monthly dosing from the beginning of treatment, with the goal of maximizing treatment simplicity for physicians and patients, if proven in the clinical trials." About the CERVINO Study CERVINO (NCT06158841) is a global, Phase 3, multicenter, randomized, open-label, parallel-group study evaluating ABBV-383 in adult patients (≥18 years) with r/r MM and an Eastern Cooperative Oncology Group performance status ≤2 who received at least two prior lines of therapy, including exposure to a PI, an IMiD, and an anti-CD38 mAb. Patients who received prior BCMA-targeted therapy will be excluded. Patients will be randomized 1:1 to receive intravenous ABBV-383 60mg Q4W or the investigator's choice of SAT (carfilzomib + dexamethasone, elotuzumab + pomalidomide + dexamethasone, or selinexor + bortezomib + dexamethasone), and will continue treatment until confirmed progressive disease or other discontinuation criteria are met. The dual primary end points are progression-free survival and overall response rate. Secondary end points include overall survival, complete response (CR) or better, very good partial response or better, rate of minimum residual disease negativity, and change in disease symptoms and physical functioning. Approximately 140 sites globally will enroll approximately 380 total patients. Additional information about the study can be found at under the identifier NCT06158841. About ABBV-383 ABBV-383 is an investigational distinctive BCMA x CD3 bispecific antibody T-cell engager composed of bivalent high-avidity BCMA-binding domains, a low-affinity CD3-binding domain designed to reduce cytokine release, and a silenced Fc tail designed for an extended half-life that may support once every 4-week (Q4W) dosing. Clinical relevance of these structure activity relationships has not been established. BCMA is highly expressed on the surface of malignant plasma cells in multiple myeloma, making it an ideal target for therapy. BCMA plays a crucial role in the survival of myeloma cells by promoting their growth and inhibiting their apoptosis (programmed cell death).4 About AbbVie in Oncology At AbbVie, we are committed to transforming standards of care for patients living with difficult-to-treat cancers. We are advancing a dynamic pipeline of investigational therapies across a range of cancer types in both blood cancers and solid tumors. We are focusing on creating targeted medicines that either impede the reproduction of cancer cells or enable their elimination. We achieve this through various, targeted treatment modalities including Antibody Drug Conjugates (ADCs), Immuno-Oncology, and bi-specific and CAR-T platforms. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines. Today, our expansive oncology portfolio is comprised of approved and investigational treatments for a wide range of blood and solid tumors. We are evaluating more than 20 investigational medicines across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit us at . About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube. Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2023 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. 1 Foureau DM, Bhutani M, Robinson M, et al: Ex vivo efficacy of BCMA-bispecific antibody TNB-383B in relapsed/refractory multiple myeloma. EJHaem 1:113-121, 2020 2 International Myeloma Foundation. What is Multiple Myeloma? 3 Cancer.Net. Multiple Myeloma: Statistics. . 4 Cho SF, Anderson KC, Tai YT: Targeting B Cell Maturation Antigen (BCMA) in Multiple Myeloma: Potential Uses of BCMA-Based Immunotherapy. Front Immunol 9:1821, 2018 SOURCE AbbVie