Restore the core! Selinexor (ATG-010), a first-in-class drug for multiple myeloma, to be launched in Hainan Free Trade Port

Jan 11, 2021View PDF

In order to further enhance medication safety and meet urgent clinical needs of patients, Antengene Corporation limited (“Antengene”, SEHK: 6996.HK) and Hainan Chengmei Medicine Corporation limited (“Chengmei Medicine”) jointly held the “Restore of core – Special Permission to Import Selinexor in Boao Lecheng Pilot Zone for Multiple Myeloma Press Conference” in Haikou on January 9, 2021. Li Yunda, Deputy Director of the Hainan Medical Products Administration (MPA), Fu Zhu, Deputy Director of the Boao Lecheng International Medical Tourism Pilot Zone, Li Ping, L2 Research Fellow of Healthcare Industry International Cooperation Bureau, Hainan Health Commission, Ma Jun, Director of the Harbin Institute of Hematology & Oncology and Chief Supervisor of Supervisory Committee at the Chinese Society of Clinical Oncology (CSCO), Jay Mei, Founder, Chairman and CEO of Antengene, and Lin Shiquan, Chairman of Chengmei Medicine, Executive Director General of Hainan Cancer Hospital and General Manager of Boao Super Hospital, Yao Lijun, General Manager of Hainan Chengmei Medicine, attended the conference.


conference scene


Under the effective implementation of the Overall Plan for Construction of Hainan Free Trade Port, Antengene and Chengmei Medicine will jointly introduce selinexor, a drug for treatment of multiple myeloma, in Hainan Boao Lecheng International Medical Tourism Pilot Zone to build a convenient and efficient medication channel for patients in China. With the issuance and implementation of the Interim Measures for the Administration of the Use of Imported Drugs Urgently Needed for Clinical Use in the Hainan Boao Lecheng International Medical Tourism Pioneer Zone, Selinexor will become the first selective inhibitor for nuclear export (SINE) to be used by Chinese multiple myeloma patients simultaneously with other patients across the world.

As the second major hematological malignancy, multiple myeloma can hardly be cured by the currently limited therapeutic options. In China, the patients with multiple myeloma, who have received the treatment of multiple drugs but still relapse, are facing the clinical dilemma of no other drugs available. Selinexor (ATG-010) is the first-in-class clinically validated SINE, and its two major indications on hematological malignancies – multiple myeloma and diffuse large B-cell lymphoma (DLBCL), have been approved successively within one year. As the world’s first and only SINE for the two major indications, Selinexor’s five therapeutic options have been included in the NCCN guidelines. In December last year, FDA once again approved selinexor for frontline patients with multiple myeloma, which further expanded the prospect of selinexor’s clinical application. Thanks to the preferential policies issued by Hainan Free Trade Port, the Chinese patients with multiple myeloma are able to use the world-leading innovative therapy simultaneously with other patients across the world.

 



Fu Zhu, Deputy Director of the Boao Lecheng International Medical Tourism Pilot Zone, said that: “Lecheng Pilot Zone welcomes leading international pharmaceutical enterprises like Antengene to introduce the drugs urgently needed by domestic patients into Hainan, so that they can get international medical services and advanced drugs as soon as possible. We expect to maintain a long-term partnership with Antengene to import more new drugs approved overseas simultaneously in Hainan, and benefit Chinese patients with more cutting-edge international drugs and medical devices in a timely manner.”

 



Li Yunda, Deputy Director of the Hainan Medical Products Administration, said that: “As the only ‘special zone of medical services’ in China, Lecheng Pilot Zone has gradually set up a diagnosis and treatment specialty with distinctive advantages, and preliminarily achieved the ‘triple synchronization’ of healthcare technology, drugs and medical devices with the international level. We sincerely expect that Hainan First Investment Group, Hainan Chengmei Medicine and excellent enterprises like Antengene, who have outstanding sense of social responsibilities, will jointly introduce more new drugs worldwide to benefit the Chinese patients with timely and first-class healthcare services, and make new contributions to the development of Hainan Free Trade Port.”

 



Ma Jun, Director of the Harbin Institute of Hematology & Oncology and Chief Supervisor of Supervisory Committee at the Chinese Society of Clinical Oncology (CSCO), said that: “The practice of saving more patients through introducing innovative drugs conforms to the principle of ‘Life First’ advocated by our country. Based on the new policies, the patients in China can save and extend their lives by the innovative drugs introduced without waiting for their official approvals for launching in China. As selinexor is an oral drug, the patients can use it conveniently with high dependence. Through the current joint efforts, we are able to bring a faster, better and more timely new therapeutic option to greatly improve the accessibility for the Chinese patients. Thanks to the preferential medical policies issued by Boao Lecheng Pilot Zone, we believe that selinexor will greatly benefit the vast number of patients with cancers. As ‘medicine is inseparable from pharmacy’, the clinicians will also have more useful tools, and gradually align with the international standards in the choice of therapeutic options.”

 



Yao Hongxia, Director of Hematology Commission of Hainan Medical Association and Initial President of Hainan Society of Hematologists, said that: “As a medical practitioner working in the Pilot Zone of International Medical Tourism, I feel very honored to be able to participate in and witness the import of more novel drugs in China. Thanks to the great support from the State Council and Hainan Provincial Government, the preferential polices issued by Boao Lecheng have given me an opportunity to know the information about these new drugs earlierly, and I am also willing to contribute my own strength to enable the Chinese patients with hematological diseases to receive effective treatment in a timely manner. As a new mechanism of action, Selinexor’s indications for MM and DLBCL approved in the US have shown excellent efficacy. I believe that the import of selinexor is a great benefit for Chinese patients, and I am looking forward to seeing its efficacy in the Chinese population.”

 



Lin Shiquan, Chairman of Chengmei Medicine, Executive Director General of Hainan Cancer Hospital and General Manager of Boao Super Hospital, said that: “The official release of the Overall Plan for Construction of Hainan Free Trade Port is a further breakthrough in the pilot program for global innovative therapies in Hainan. As the first drug approved by FDA for the treatment of multiple myeloma and diffuse large B-cell lymphoma, the introduction of selinexor is another successful practice of preferential policies in the Pilot Zone. Chengmei Medicine will work with leading domestic and overseas biopharmaceutical company like Antengene to continuously introduce more international innovative drugs and medical devices to benefit the Chinese patients.”

 



Jay Mei, Founder, President and CEO of Antengene, said that: “The introduction of selinexor into Hainan Free Trade Port as a drug urgently needed in clinical practice means that the patients in China will share this advanced therapy with other patients across the world. As the first-in-class SINE compound, Selinexor will be used in clinical treatment for more diversified and broader groups. Based on the mission of ‘Treating Patients beyond Borders’, Antengene will enhance independent R&D and clinical study capabilities, and focus on the diseases with high incidences in China and APAC to further explore the potential of our products. In addition, Antengene will work closely with the governments, hospitals and relevant social sectors to jointly create a diversified and open pharmaceutical innovation ecosystem, and apply the cutting-edge innovative therapies to Chinese patients as soon as possible.”

 



signing ceremony



At the press conference, the “Signing ceremony of special permission to import selinexor in Boao Lecheng Pilot Zone for Multiple Myeloma” was held simultaneously. Dr. Jay Mei, Chairman of Antengene, and Ms. Yao Lijun, General Manager of Hainan Chengmei Medicine, signed a strategic cooperation agreement.

In the future, Antengene will provide the multiple myeloma patients in urgent needs with a convenient healthcare channel and an affordable therapeutic approach based on the preferential policies issued by the Free Trade Port as well as the medical and technical resources in the Lecheng Pilot Zone. Through standardized project management, systematic patient education and multi-channel training model, Antengene will ensure the safe and reliable medication for patients.

About Selinexor (ATG-010, XPOVIO®)

Selinexor (ATG-010, XPOVIO®) is the world’s first and only oral SINE compound developed by Karyopharm Therapeutics Inc. (NASDAQ: KPTI). Through the exclusive authorization by Karyopharm, Antengene has acquired the exclusive development and commercialization rights and benefits of Selinexor in several APAC markets including Greater China, South Korea, Australia, New Zealand and ASEAN.

In July 2019, the U.S. Food and Drug Administration (FDA) approved the therapy of Selinexor combined with low-dose dexamethasone for the treatment of patients with relapsed and refractory multiple myeloma (rrMM). In June 2020, FDA once again approved Selinexor as a single-agent oral therapy for the treatment of patients with relapsed and refractory diffuse large B-cell lymphoma (rrDLBCL). In addition, a marketing authorization application (MAA) of Selinexor has been submitted to the European Medicines Agency (EMA) for conditional approval of Selinexor for rrMM. In December 2020, FDA approved the supplemental New Drug Application (sNDA) for extended indications of Selinexor for the multiple myeloma patients who have previously received at least first-line therapies. Selinexor is currently the first and only oral SINE compound approved by FDA for the treatment of multiple myeloma and diffuse large B-cell lymphoma. In addition, Selinexor has undergone multiple mid-stage and late-stage clinical trials for multiple solid tumor indications, including liposarcoma and endometrial cancer. In November 2020, Karyopharm, a partner of Antengene, reported the positive data of the Phase III SEAL trial at the 2020 Annual Conference of Connective Tissue Oncology Society (CTOS 2020). SEAL is a randomized, double-blind, placebo-controlled crossover trial designed to compare the efficacy of oral single-agent Selinexor with placebo in patients with liposarcoma. In addition, Karyopharm recently announced that the phase III SIENDO trial of Selinexor for the treatment of patients with endometrial cancer has completed the planned interim inefficacy analysis, and the Data Security Monitoring Board (DSMB) recommended that the SIENDO trial can proceed as planned with no modification. The primary data and results of the SIENDO trial are expected to be announced in the second half of 2021.

Antengene is currently implementing a phase II registrational clinical trial of Selinexor for relapsed and refractory multiple myeloma (code name: MARCH) and a phase II registrational clinical trial of Selinexor for relapsed and refractory diffuse large B-cell lymphoma (code name: SEARCH) in China. At the same time, for the tumors with high incidences in APAC, Antengene has launched the clinical trial of Selinexor for the treatment of peripheral T-cell lymphoma, NK/T cell lymphoma (code name: TOUCH) and KRAS mutant non-small cell lung cancer (code name: TRUMP).

About Antengene

Antengene Corporation Limited (“Antengene” for short, SEHK: 6996.HK), a clinical-stage biopharmaceutical company in the Asia-Pacific region focusing on innovative anti-tumor drugs, aims to provide the most cutting-edge and innovative anti-tumor therapies for the patients in China, in the Asia-Pacific region, or even across the world. Since the date of establishment, Antengene has set up a diversified product pipeline covering 12 clinical and preclinical innovative drugs, and obtained 11 approvals for clinical trials in the Asia-Pacific region. Based on the vision of “Treating Patients beyond Borders”, Antengene strives to meet the unmet clinical needs of patients in Asia-Pacific region and even across the world through specialized studies and marketization for the first-in-class/best-in-class therapies.

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