Suzhou, China, And Rockville, Maryland, U.S.A., Dec. 1, 2021 /PRNewswire/ -- Axaphalus Pharmaceuticals (6855.HK) is a leading biopharmaceutical company developing innovative medicines in the therapeutic areas of oncology, hepatitis B and aging-related diseases. HK), together with Cinda Biopharmaceutical Group (HKEx Stock Code: 01801), a biopharmaceutical company dedicated to the research and development, production and sales of innovative drugs for the treatment of major diseases such as tumors, metabolic diseases, autoimmunity and other major diseases, jointly announced that the original Class 1 new drug orebatinib tablets (trade name: Nelik ®) of Guangzhou Shunjian Biopharmaceutical Technology Co., Ltd. (hereinafter referred to as Shunjian Pharmaceutical), a wholly-owned subsidiary of Yasheng Pharmaceutical, has officially obtained the listing approval of the State Drug Administration of China (NMPA), It is used to treat any tyrosine kinase inhibitor (TKI) resistant and diagnosed with a well-validated assay in adult patients with chronic myeloid leukemia (CML) chronic phase (CP) or accelerated phase (AP) with T315I mutations.
Nelik ® is a potential Best-in-class new drug developed by Yasheng Pharmaceutical, and is a special support variety for the national "major new drug creation". The variety will be commercialized and promoted by Yasheng Pharmaceutical and Innovent Biologics in China to benefit more patients and their families. As China's first three-generation BCR-ABL targeted drug-resistant CML treatment, The approval of Nelik ® will break the treatment bottleneck of China's patients with T315I mutation and solve the dilemma of no drug. Its approval also marks the official commercialization stage of Yasheng Pharmaceutical.
The Approval of Nelik ® is based on data from two Key Registration Phase II clinical studies, namely HQP1351CC201 study and HQP1351CC202 study. Clinical data show that Nelik ® has good efficacy and tolerability in TKI-resistant CML-CP and CML-AP patients with T315I mutation, and the response rate and depth of remission will further increase as the treatment time is extended.
CML is a malignancy associated with white blood cells. With the launch of TKI drugs targeting BCR-ABL, treatments for CML have been revolutionized, but acquiring resistance has been a major challenge for CML treatments. BCR-ABL kinase region mutations are one of the important mechanisms of acquired drug resistance, of which T315I mutations are one of the common types of resistance mutations, with an incidence of up to about 25% in drug-resistant CML. CML patients with T315I mutations are resistant to all current first- and second-generation BCR-ABL inhibitors and have therefore faced a predicament of no cure in the past.
Professor Huang Xiaojun, the principal investigator of the China clinical trial of Nelik ®, director of the Institute of Hematology of Peking University and director of the Department of Hematology of Peking University People's Hospital, said: "The effectiveness and safety data of past clinical studies continue to show us that Nelik ® has great potential in the field of unmet clinical needs of drug-resistant chronic myeloid leukemia, and it is very promising to become the 'Best-in-Class' drug for treatment in this field. In recent years, the clinical progress of this drug has also attracted the attention of the global hematology community. We are delighted to see Thatnellik ® approved for listing in China. This not only means that China's CML treatment has broken the original drug resistance dilemma and ushered in a new milestone; it also means that China's clinical strength in the field of hematology and tumors is gradually moving to the forefront of the world. ”
Professor Jiang Qian, the lead investigator of the Nerick ® China clinical trial and deputy director of the Department of Hematology of Peking University People's Hospital, said: "Once CML-CP and CML-AP patients have T315I mutations, all first- or second-generation TKIs are ineffective for these patients. Until today, this was an area with a high degree of unmet clinical needs. The approval of Nelik ® will solve this dilemma of no cure, which is of great significance to clinicians and patients. It is believed that with the listing of this drug, more CML patients can continue the excitement of life. ”
Dr. Zhai Yifan, Chief Medical Officer of Yasheng Pharmaceutical and President and CEO of Shunjian Pharmaceutical, said: "Thank you to the drug regulatory authorities at all levels and relevant institutions for their high attention to the treatment needs of drug-resistant CML patients, as well as their strong support for the development of local innovative drugs in China! Thanks to the dedication and full trust of many clinical experts and patients! Thanks to the perseverance of our team members, especially in overcoming various unprecedented challenges and difficulties under the epidemic! ® As China's first and the world's second approved third-generation BCR-ABL inhibitor, it can not only change the current situation that there is no drug for T315I mutant-resistant patients in China, but also hope to fill the unmet clinical gap in global CML treatment. ”
Dr. Yang Dajun, Chairman and CEO of Yasheng Pharmaceutical, said: "As the company's first commercial product, the approval of Nilik ® is undoubtedly a major milestone event, which means that Yasheng Pharmaceutical has successfully made a leap from an R&D company to a company with a product listing, which has brought us great confidence. We will work with Cinda Bio to comprehensively accelerate the commercialization layout. furthermore. We are actively promoting cooperation with genetic testing companies, commercial insurance companies, Internet medicine and other parties, hoping to benefit more patients as soon as possible with this world-leading and Original Product in China. We will always adhere to the global innovation positioning and fulfill the mission of 'solving the unmet clinical needs of patients in China and even around the world'." In the future, Yasheng Pharmaceutical will further expand the new indications of this variety and promote overseas clinical practice, and continue to accelerate the global development of other varieties under research of the company, truly realizing 'from China to the world'. ”
Dr. Yu Dechao, Founder, Chairman and CEO of Innovent Biologics, said: "We are delighted that Nelik ® has been successfully approved in China to add a new generation of anti-tumor products to Cinda Biotech's deep layout in the field of hematology. In the field of anti-tumor, Innovent Biologics has a strong pipeline of 20 clinical stages, the industry's leading clinical development and registration team, extensive commercial channel coverage and a commercialization team of nearly 3,000 people. We look forward to working closely with AAQ on the coverage and commercialization of this product in the Chinese market to meet the urgent clinical needs of CML patients with TKI-resistant T315I mutations as soon as possible." ”
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About chronic myeloid leukemia
Chronic Myeloid Leukemia (CML), a malignant tumor formed by clonal proliferation of bone marrow hematopoietic stem cells, also known as chronic myeloid leukemia, is the most common type of chronic leukemia, accounting for 15% of adult leukemias[1]-[2]. The incidence of CML patients in China is younger than in the West, and epidemiological surveys have shown that the median age of onset of CML in China is 45 to 50 years old, and the median age of onset of CML in Western countries is 67 years [3].
With the launch of TKI drugs targeting BCR-ABL, treatments for CML have been revolutionized, but acquiring resistance has been a major challenge for CML treatments. BCR-ABL kinase region mutations are one of the important mechanisms of acquired drug resistance, of which T315I mutations are one of the common types of resistance mutations, with an incidence of up to about 25% in drug-resistant CML. CML patients with T315I mutations are resistant to all current first- and second-generation BCR-ABL inhibitors and have been an obstacle to long-term survival in the CML patient population in the past.
About Nelik ®
Nelik ® is the original class 1 new drug of Yasheng Pharmaceutical, which is an oral third-generation BCR-ABL inhibitor, and is the first third-generation BCR-ABL targeted drug-resistant CML treatment drug approved for marketing in China, which has a prominent effect on BCR-ABL and a variety of BCR-ABL mutants including T315I mutations, and has been supported by the national "major new drug creation" project.
In October 2020, Nelik ® was included in the NMPA New Drug Review Center (CDE) for priority review for the treatment of adult patients in the chronic or accelerated phase of CML after TKI resistance and accompanied by the T315I mutation; in March 2021, the variety was included in the CDE As a Breakthrough Therapeutic Variety. Overseas, the variety was approved by the FDA for clinical trials in July 2019 and directly entered the Phase IB clinical study; in May 2020, it was successively granted the orphan drug qualification and review fast track qualification granted by the US FDA; in November 2021, it was qualified as an ORPHAN DRUG in the EU; in addition, the clinical trial progress of the variety has been selected for the oral report of the American Society of Hematology (ASH) Annual Meeting for four consecutive years since 2018, and was nominated for the "Best Study" at the 2019 ASH Annual Meeting.
In July 2021, Asunit Pharma and Cinda Biopharmaceutical Group (1801. HK) has entered into a strategic cooperation on the joint development and co-commercialization of Nelik ® in the Chinese market.
*Note Nelik ® is a registered trademark of Asunyng pharma
About two key registration Phase II clinical studies
Chronic myeloid leukemia – HQP1351CC201 study in chronic phase patients
HQP1351CC201 is an open-label, multicenter, single-arm Phase II clinical trial designed to evaluate the safety and efficacy of orebatinib tablets in patients with CML-CP who develop t315I mutations after TKI treatment targeting BCR-ABL1. The primary efficacy endpoint of the trial was major cytogenetic response (MCyR).
As of August 25, 2020, the median follow-up time of orebatinib in patients with CML-CP was 13.0 months (range: 7.2 to 16.3). Of the 31 hematologic responses assessable, 31 (100%) had a complete hematologic response (CHR); of the 41 cytogenetically assessable subjects, 31 (75.6%) had a major cytogenetic response (MCyR), including 28 (68.3%) complete cytogenetic response (CCyR) and 3 (7.3%) partial cytogenetic response (PCyR); of the 41 subjects with assessable molecular response, 23 (56.1%) Obtain a major molecular reaction (MMR). The 12-month progression-free survival (PFS) rate was 85.7% (95% CI: [63.6% - 94.9%]) and the overall survival (OS) rate was 100% (95% CI: [100.0% - 100.0%]).
Chronic myeloid leukemia – HQP1351CC202 study in accelerated patients
HQP1351CC202 is an open,pluricentric, single-arm Phase II clinical trial designed to evaluate the safety and efficacy of translebatinib tablets in cmL-AP patients with TKI resistance with T315I mutations following TKI treatment with any BCR-ABL1.) The primary efficacy endpoint of the trial was the primary hematologic response rate (MaHR).
As of July 27, 2020, the median follow-up time of orebatinib in patients with CML-AP was 14.3 months (range: 6.6-15.2). Of the 17 assessable subjects, 12 (70.6%) received a major hematologic response (MaHR), including 11 (64.7%) complete hematologic response (CHR) and 1 (5.9%) without evidence of leukemia (NEL). Of the 17 assessable subjects, 8 (47.1%) obtained major cytogenetic responses (MCyR), including 8 (47.1%) complete cytogenetic responses (CCyR). Of the 17 assessable subjects, 7 (41.2%) received major molecular responses (MMRs). The 12-month PFS rate was 73.3% (95% CI: [43.3% - 89.1%]). 12-month OS was 88.2% (95% CI: [60.6% -96.9%]).
About Yasheng Pharmaceutical
Asunyng Pharma is a China-based, global-oriented biomedical company dedicated to the development of innovative drugs in the therapeutic areas of oncology, hepatitis B and aging-related diseases. On October 28, 2019, Aerson Pharmaceutical was listed on the Main Board of the Hong Kong Stock Exchange, stock code: 6855. HK。
Yasheng Pharmaceutical has its own self-constructed protein-protein interaction targeted drug design platform, which is at the forefront of new drug research and development of apoptosis pathways. The company has established 8 small molecule new drug product pipelines of 1 class 1 that have entered the clinical development stage, including inhibitors that inhibit key proteins of the apoptosis pathway such as Bcl-2, IAP or MDM2-p53; and a new generation of inhibitors for kinase mutants that appear in cancer treatment, etc., making it the only innovative company in the world that has clinical development varieties in the field of key proteins for apoptosis pathways. The company is currently conducting more than 40 Phase I/II clinical trials in China, the United States, Australia and Europe. Orepatinib (trade name: Nelik ®), the core variety used to treat drug-resistant chronic myeloid leukemia, has been included in the Priority Review and Breakthrough Treatment Variety by the New Drug Evaluation Center (CDE) of the State Drug Administration of China (NMPA), and has been approved in China, which is the company's first listed variety. The variety has also been approved by the US FDA Review Fast Track, orphan drug qualification, and EU orphan drug qualification. Up to now, the company has obtained 12 FDA and 1 EU orphan drug qualification for 4 new drugs under development. The company has undertaken a number of major national science and technology projects, including 5 special projects of "major new drug creation", including 1 "enterprise innovative drug incubation base" and 4 "innovative drug research and development", and 1 special project of "prevention and treatment of major infectious diseases".
With strong R&D capabilities, AQ has carried out intellectual property layout around the world and has reached global partnerships with leading biotechnology and pharmaceutical companies and academic institutions such as UNITY, MD Anderson, Mayo Medical Center and Dana-Farber Cancer Institute, Merck, AstraZeneca, and Pfizer. The company has established an international talent team with rich experience in the development and clinical development of original innovative drugs, and at the same time, the company is building a commercial production and marketing team in the later stage with high standards. Yasheng Pharmaceutical will continue to improve its R&D capabilities, accelerate the clinical development progress of the company's product pipeline, and truly implement the mission of "solving the unmet clinical needs of patients in China and even around the world" to benefit more patients.
Forward-looking Statements by ASUN Pharmaceuticals
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. All statements contained herein are made as of the date of publication of this article and are subject to change due to future developments.
About Innovent Biologics
"Starting from the letter, reaching the line", developing high-quality biological drugs that the people can afford is the ideal and goal of Xinda Biology. Founded in 2011, Innovent Biologics is committed to developing, producing and marketing innovative drugs for the treatment of major diseases such as tumors, autoimmune, metabolic diseases and so on. On October 31, 2018, Cinda Biopharma was listed on the Main Board of The Stock Exchange of Hong Kong Limited under stock code: 01801.
Since its inception, the company has stood out from the crowd of biopharmaceutical companies with innovative achievements and an international operating model. A product chain including 26 new drug varieties has been established, covering multiple disease fields such as tumors, metabolic diseases, and autoimmunity, of which 7 varieties have been selected as the national "major new drug creation" special project. The company has 6 products (sindili maclizumab injection, trade name: Daboshu ®, English trademark: TYVYT®; bevacizumab biosimilar, trade name: Dayoutong ®, English trademark: BYVASDA®; adalimumab biosimilar, trade name: Su Lixin ®, English trademark: SULINNO®; rituximab biosimilar, trade name: Dabova, ® English trademark: HALPRYZA®;p emigatinib oral inhibitor, trade name: dabotan ® , English trademark: PEMAZYRE®; orebatinib tablets trade name: Nelik ®) was approved for listing, the listing application of sindilimab in the United States was accepted by the FDA, 5 varieties entered phase III or critical clinical research, and 15 other products have entered clinical research.
Innovent Biologics has set up a high-end biopharmaceutical development and industrialization talent team with international advanced level, including many returnee experts, and has reached strategic cooperation with international partners such as Eli Lilly Pharmaceutical, Adimab, Incyte, MD Anderson Cancer Center and Hanmi of South Korea. Innovent Biotechnology hopes to work with everyone to improve the development level of China's biopharmaceutical industry to meet the people's access to drugs and the people's pursuit of good wishes for life and health. For details, please visit the Company's website: www.innoventbio.com or the Company's LinkedIn account number.
Cinda Bio-Forward-Looking Statements
The information published in this press release may contain certain forward-looking statements. These statements are inherently risky and uncertain. When expressing the words "anticipates," "believes," "forecasts," "expects," "intends," and other similar words, anything relating to the Company is intended to indicate that it is forward-looking. The Company undertakes no obligation to update these predictive statements on an ongoing basis.
These forward-looking statements are based on the Company's management's existing views, assumptions, expectations, estimates, projections and understandings of future matters at the time of making such statements. These statements are not guarantees of future development and are subject to risks, inaccuracies and other factors, some of which are beyond the Company's control and difficult to predict. As a result, subject to future changes and developments in our business, competitive environment, political, economic, legal and social circumstances, actual results may differ materially from the information contained in the forward-looking statements.
Neither the Company nor its directors nor employee agents assume any obligation to (a) correct or update forward-looking statements contained in this website; and (b) any liability arising out of the inability or error of any forward-looking statements.
[1] National Comprehensive Cancer Network.NCCN Clinical Practice Guidelines in Oncology: Chronic Myelogenous Leukemia, V.2.2008[DB/OL]. NCCN Web Site. 8-28-2007.[2007-10-25]
[2] HehlmannR, HochhausA, BaccaraniM, et al. Chronic myeloid leukaemia[J]. Lancet, 2007, 370（9584）: 342-350.
[3] Guidelines for the Diagnosis and Treatment of Chronic Myeloid Leukemia in China (2020 Edition). Chinese Journal of Hematology. 2020, 41(5): 353-364.
This article originated from PR Newswire