On August 10, 2023 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, reported the entrance into a collaboration agreement between Antengene and Hansoh Pharma for the commercialization of XPOVIO in the mainland of China (Press release, Antengene, AUG 10, 2023, View Source [SID1234634235]).

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"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.