Antengene Enters into Commercialization Partnership with Hansoh Pharma for First/Only-in-Class XPO1 Inhibitor XPOVIO®(selinexor) in the Mainland of China

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-      Antengene and Hansoh Pharma to enter into collaboration agreement involving commercialization of XPOVIO^® in the mainland of China, broadening coverage and improving access of the drug to patients in the mainland of China

-      Antengene to receive up to RMB200 million in upfront payments, and up to RMB535 million in milestone payments from Hansoh Pharma

-      XPOVIO^® is approved in the mainland of China for relapsed/refractory multiple myeloma. Antengene plans to submit supplemental new drug application (sNDA) for XPOVIO^® as a monotherapy for the treatment of adult patients with relapsed /refractory diffuse large B-cell lymphoma in Q3 2023, and in combination for the treatment of adult patients with multiple myeloma who have received at least one prior therapy in H1 2024

-      Recent clinical data presentation showcased broad indication expansion potential in myelofibrosis and endometrial cancer

SHANGHAI and HONG KONG, Aug. 11, 2023 /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 therapeutics in hematology and oncology, and Hansoh Pharmaceutical Group Company Limited ("Hansoh Pharma" SEHK: 3692.HK), a leading innovation-driven pharmaceutical company with a focus on the treatment of major diseases including oncology, infectious diseases, CNS disorders, metabolic diseases, and autoimmune diseases, announced today the entrance into a collaboration agreement between Antengene and Hansoh Pharma for the commercialization of XPOVIO^® in the mainland of China.

"Our collaboration with Hansoh Pharma further strengthens our confidence in the market potential of the First and Only-in-class XPO1 inhibitor XPOVIO^® in the mainland of China," said Dr. Jay Mei, Founder, Chairman, and Chief Executive Officer of Antengene. "Through collaborating with Hansoh Pharma, we will leverage their well-established commercialization infrastructure to make XPOVIO^® more accessible to patients in the mainland of China. Given Antengene's plans to apply for inclusion into the National Reimbursement Drug List (NRDL) for XPOVIO^® in the near future, and the broad indication expansion potential of XPOVIO^®, it is crucial to ensure that XPOVIO^® could reach as many cities, hospitals and prescribers, and benefit as many patients as possible.  We believe this collaboration with Hansoh Pharma will not only enhance assess of XPOVIO^® but also lead to commercial success in the mainland of China."

"Hansoh Pharma is excited to enter into this partnership with Antengene and is committed to bringing XPOVIO^® to more patients in China," said Ms. Yuan Sun, Executive Director of Hansoh Pharma. "We believe that XPOVIO^® is a drug with great commercial potential, addressing huge unmet medical needs for those hematologic patients in China.  In addition to obtaining approvals in multiple countries and regions globally for multiple myeloma and diffuse large B-cell lymphoma, XPOVIO^® has indication expansion potential in myelofibrosis, endometrial cancer, as well as T/NK-cell lymphoma.  We look forward to collaborating with Antengene and make XPOVIO^® available to the widest possible number of Chinese patients with hematological malignancies."

Under the terms of the agreement, Antengene will continue to be responsible for research and development, regulatory approvals and affairs, product supply, and distribution of XPOVIO^®, while Hansoh Pharma will be exclusively responsible for commercialization of XPOVIO^® in the mainland of China. Antengene will receive up to RMB200 million of upfront payments, RMB100 million of which shall be received upon signing, and pursuant to the Agreement and subject to the terms and conditions thereof, Antengene shall be eligible to receive up to RMB100 million of the remaining upfront payments, and up to RMB535 million in milestone payments from Hansoh Pharma. Antengene will continue to record revenues from sales of XPOVIO^® in the mainland of China and Hansoh Pharma will charge a service fee to Antengene.

About Multiple Myeloma

Multiple myeloma (MM) is caused by the dysregulated proliferation of plasma cells. It is the second most common hematologic malignancy in many countries. Despite availability of a number of treatments for relapsed patients, MM is prone to relapse and most patients still succumb to their disease. MM is the second most common hematologic malignancy in China, with an estimated about 15,000 to 20,000 new MM patients and 10,300 deaths per year.¹

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 8 clinical studies of XPOVIO^® in 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]).

XPOVIO^® is approved in South Korea for the following two indications:

• In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.
• As a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy.

XPOVIO^® is approved in mainland of China for the following indication:

• In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have received prior therapies and whose disease is refractory to at least one proteasome inhibitor, at least one immunomodulatory agent, and an anti-CD38 monoclonal antibody.

XPOVIO^® is approved in Taiwan China for the following three indications:

• In combination with dexamethasone (Xd) for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors (PIs), at least two immunomodulatory agents (IMiDs), and an anti-CD38 monoclonal antibody.
• In combination with bortezomib and dexamethasone (XVd) for the treatment of adult patients with MM who have received at least one prior therapy.
• As a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy.

XPOVIO^® is approved in Hong Kong China, for the following indication:

• In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors (PIs), two immunomodulatory agents (IMiDs), an anti-CD38 monoclonal antibody (mAb), and who have demonstrated disease progression on the last therapy.

XPOVIO^® is approved in Australia for the following two indications:

• In combination with bortezomib and dexamethasone (XVd) for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy.
• In combination with dexamethasone (Xd) for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor (PI), at least one immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody (mAb).

XPOVIO^® is approved in Singapore for the following three indications:

• In combination with bortezomib and dexamethasone for treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy.
• In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.
• As a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy who are not eligible for haematopoietic cell transplant.

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, 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, 2022, and the documents subsequently submitted to the Hong Kong Stock Exchange.

Reference

[1]. Statistics released by the International Myeloma Foundation at https://www.myeloma.org/

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