Decky Pharma announced that the Australian Medicines Agency has approved XPOVIO(R) for marketing

- XPOVIO® in combination with bortezomib and dexamethasone (XBd regimen) brings a new option to patients with relapsed refractory multiple myeloma.

- XPOVIO® combined with dexamethasone (Xd protocol) brings a new option to patients with three class of drug-intractable multiple myeloma, who often face a poor prognosis and limited options.

- XPOVIO® is the first Selective Nuclear Output (SINE) drug.

- In Australia, multiple myeloma accounts for 10% of all hematologic tumors and 1.6% of all tumors [1].

- In Australia, patients with multiple myeloma are in urgent need of more options, and the current five-year survival rate after diagnosis is only 53% [2].

- In Australia, there are about 2,400 cases of multiple myeloma each year, and the total number of patients with multiple myeloma who survive with the disease is about 20,000 [3]. Unfortunately, more than 1,000 patients are killed by this blood tumor every year. Therefore, these patients urgently need a drug with a completely new mechanism like XPOVIO®.

Shanghai and Hong Kong, China, 9 March 2022 – Deqi Pharmaceuticals Limited ("Deqi Pharmaceuticals"), a leading innovative biopharmaceutical company in the commercialization phase of the first and/or best-in-class blood and solid oncology therapies, to develop, manufacture and market the first and/or best-in-class blood and solid oncology therapies. HK) announced today that the Australian Department of Health's Medicines Agency (TGA) has approved XPOVIO® (Celinesso) for treatment for two indications: (1) in combination with bortezomib and dexamethasone (XBd regimen) for adult patients with multiple myeloma (MM) who have received at least 1 previous treatment; (2) in combination with dexamethasone (Xd regimen) for treatment of at least 3 previous treatments and for at least 1 proteasome inhibitor (PI), Adults with relapsing refractory multiple myeloma (R/R MM) resistant to 1 immunomodulatory drug (IMiD) and 1 anti-CD38 monoclonal antibody drug (mAb).

XPOVIO® is the first and only TGA-approved SINE drug that helps patients regain their tumor suppressor pathways [4].

Professor Hang Quach, a hematologist at St Vincent's Hospital in Melbourne, said: "As part of a team of investigators, I had the privilege of participating in the BOSTON study and participating in the drafting of several clinical research articles on the XBd protocol. I think that in the current high incidence of lenalidomide resistance, this tridrug combination regimen is undoubtedly the most effective therapy for patients who relapse early. Subgroup analyses showed that the tridrug regimen was effective for patients of all ages, regardless of whether they were physically weak or not, and was equally effective in patients with low creatinine clearance. It should be emphasized that the XBd regimen is particularly effective in patients with high cytogenetic risk. “

Professor Hang Quach added: "I think the initial third-line regimen largely determines the overall survival of MM patients, as in clinical practice, most patients do not have survival to reach the fourth and posterior lines. In addition, the use of the most effective therapies in the early stages of relapse can provide the greatest clinical benefit. Therefore, it is important for patients in the first to third line of treatment to have more options to choose the best treatment plan based on the patient's clinical characteristics. In Australia, more treatment options are urgently needed for MM patients with early relapses of lenalidomide resistance, and the approval of the XBd regimen will undoubtedly meet this clinical need. “

Professor Andrew Spencer, a haematologist at Alfred Hospital in Melbourne, said: "In Australia, there is an urgent need for effective treatment options for patients with myeloma who are refractory to three types of drugs: proteasome inhibitors, immunomodulatory drugs and anti-CD38 monoclonal antibodies. The advantage of XPOVIO® is that it is an oral drug with a completely new mechanism of action, which makes it ideal for the treatment of patients with three types of drugs that are difficult to treat. In the clinic, XPOVIO® can provide patients with significant remission and survival benefits. ”

Hayley Beer, interim co-ceo of the Myeloma Alliance of Australia, said: "It is significant to bring a new and new approach to frontline and backline treatment for patients with multiple myeloma. XPOVIO® is a novel drug with a unique mechanism of action, which means that patients can try new combination therapies rather than reuse previously used drugs. ”

Thomas Karalis, Group Vice President, Technice Pharma Asia Pacific, said: "This approval is an important milestone for both Archi Pharma and MM patients in Australia. We are delighted to have the opportunity to bring XPOVIO® to doctors and patients in Australia, bringing a new treatment strategy to the treatment of R/R MM." As our first product to be successfully registered and listed in Australia, this marks the continuous development of Deqi Pharmaceuticals in Australia. We remain committed to developing and commercializing breakthrough medicines for patients with oncology and other life-threatening diseases in Australia. ”

Dr. Mei Jianming, Founder, Chairman and CEO of Tekki Pharma, said: "In the past six months, XPOVIO's® approvals in China, South Korea, Singapore and this time in Australia have highlighted its future potential. There are about 2,400 new cases of MM in Australia each year, and there is still a significant unmet medical need for MM treatment in Australia. The Australian Medicines Agency's approval of XPOVIO® will set a whole new standard of treatment for these disease-ridden patients. In the future, we will continue to work hard to bring innovative drugs and therapies to patients with tumors and other life-threatening diseases in the Asia-Pacific region and the world at the "speed of Deqi". Now that our commercialization team is in place, they will combine XPOVIO's® marketing experience in China, Singapore and South Korea to bring this new drug to as many MM patients as possible. ”

Deqi Pharma is bringing XPOVIO® to patients in Australia as soon as possible. The company will also work closely with multiple parties to ensure the accessibility of the drug.

About Civio ®/ATG-010/Selinisso

Selinisso is currently the first and only oral XPO1 inhibitor approved by the U.S. Food and Drug Administration (FDA) and the first drug to be used to treat multiple myeloma and diffuse large B-cell lymphoma. By inhibiting the nuclear output protein XPO1, it promotes the intranuclear storage and activation of tumor suppressor proteins and other growth regulatory proteins, and downregulates the levels of multiple oncogenic proteins in the cytoplasm. Based on its unique mechanism of action, Selinisole can be combined with multiple other drugs to improve efficacy.

Selinisso has been approved by the U.S. FDA for the treatment of relapsed refractory multiple myeloma (R/R MM) and relapsed refractory diffuse large B-cell lymphoma (R/R DLBCL).

Deqi Pharmaceuticals obtained marketing authorization for selinisole for the treatment of R/R MM in China in December 2021 and plans to officially launch the drug in the second quarter of 2022. In addition, the Company obtained marketing authorization for Celinesol for the treatment of R/R MM and R/R DLBCL in Korea and Singapore in July 2021 and March 2022 respectively, and selinisole for the treatment of R/R MM in Australia in March 2022. Deqi Pharmaceutical is currently conducting 10 clinical studies in China (3 of which were jointly conducted by Deqi Pharmaceutical and Karyopharm) for recurrent refractory hematologic tumors and advanced solid tumors.

About Deqi Pharma

Deqi Pharmaceuticals Limited ("Deqi Pharmaceuticals", Stock Exchange, HkEx Stock Code: 6996. HK) is a R&D-driven and commercialized biopharmaceutical leader committed to providing the most advanced therapies for patients in Asia Pacific and around the world to treat oncology and other life-threatening diseases. Since its official operation in 2017, Deqi Pharmaceutical has established a rich product pipeline that continues to expand from preclinical to clinical stage through cooperative introduction and independent research and development. At present, Deqi Pharmaceutical has 15 products under research, of which 5 products have Asia-Pacific interests including the Greater China market, and 10 products have global interests. Deqi Pharmaceuticals has obtained 22 Clinical Approvals (INDs) in the United States and several Asia-Pacific markets, and has submitted 6 New Drug Applications (NDAs), of which Seliniso/ATG-010/XPOVIO® has been approved for new drug listing applications in China, South Korea, Singapore and Australia. With the vision of "Boundless Physicians, Sustainable Innovation", Deqi Pharmaceutical will focus on the early research and development, clinical research, drug production and commercialization of the first and best therapies of the same kind, and solve the urgent clinical needs to be met.

Forward-Looking Description

Forward-looking statements made herein relate only to events or information as of the date on which such statements are made herein. Except as required by law, we are under no obligation to update or publicly revise any forward-looking statements or unforeseen events, whether new information, future events or otherwise occur on the date of the forward-looking statements. Please read this article carefully and understand that our actual future results or performance may differ materially from those anticipated. Statements or references herein regarding the intentions of any Director or the Company are made on the date of publication of this article. Any such intentions are subject to change due to future developments. For further discussion of these and other factors that could cause future results to differ materially from any forward-looking statements, please refer to the section entitled "Risk Factors" in our periodic reports submitted to the Hong Kong Stock Exchange and other risks and uncertainties described in our Annual Report for the year ended 31 December 2020, as well as subsequent filings with the Hong Kong Stock Exchange.

Resources

[1]. Joshua, D.E., et al., Biology and therapy of multiple myeloma. Med J Aust, 2019. 210(8): p. 375-380.

[2]. Australian Government Cancer Australia. Myeloma in Australia statistics. 2020 [cited March 2022]; Available from: https://myeloma-cancer.canceraustralia.gov.au/statistics

[3]. Australian Government Cancer Australia. Myeloma in Australia statistics. 2020 [cited March 2022]; Available from: https://myeloma-cancer.canceraustralia.gov.au/statistics

[4]. Azmi AS, Uddin MH, Mohammad RM. The nuclear export protein XPO1 - from biology to targeted therapy. Nat Rev Clin Oncol.2021;18(3):152-169.