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-Civio® (Celiniso, ATG-010) is the first product approved by Deck Pharmaceuticals in China after the Korean market in less than five years after its establishment
.
-The MARCH study conducted in China enrolled 82 patients with relapsed or refractory multiple myeloma.
The combination of Civio® and dexamethasone achieved good results, and achieved an overall remission rate of 29.
3% in these highly refractory patients (ORR), the median overall survival time (OS) was 13.
2 months
.
The ORR was 25% in patients who had previously received treatment and were refractory to at least one proteasome inhibitor, one immunomodulator, and one anti-CD38 monoclonal antibody, and the median OS was 11.
9 months
.
-Civio® is the first drug approved by the US FDA for the treatment of multiple myeloma and diffuse large B-cell lymphoma.
At present, 4 treatment options have been included in the Chinese Society of Clinical Oncology (CSCO) diagnosis and treatment guidelines: including The approved Sd (celinisol, dexamethasone) regimen for the treatment of myeloma, and the SVd (celinisol, bortezomib and dexamethasone) regimen for the second-line treatment
.
Shanghai, China and Hong Kong, December 18, 2021-Deqi Pharmaceutical Co.
, Ltd.
(abbreviated as "Deqi Pharmaceutical", Hong Kong Stock Exchange stock code: 6996.
HK) announced today that the National Medical Products Administration (NMPA) has approved The new drug application (NDA) of Civio® (Celinisol, ATG-010), through the combination with dexamethasone, the treatment of previous treatment and at least one proteasome inhibitor, an immunomodulator And an anti-CD38 monoclonal antibody refractory relapsed or refractory multiple myeloma (rrMM)
.
Image source | NMPA official website Sivio® is the first product launched by Deqi Pharmaceuticals in the world.
Its approval in China indicates that Deqi Pharmaceuticals has entered a new stage of commercialization, and it has also made China a successor to the United States.
, Israel, the European Union and South Korea, the world's fifth and the second in the Asia-Pacific region to approve this innovative drug for nuclear export protein (XPO1) inhibitors
.
Australia, Singapore, and Hong Kong, China, are also expected to be approved for listing in 2022, marking this innovative treatment option for the benefit of hematological tumor patients around the world
.
Multiple Myeloma (MM) is the second most common malignant tumor of the hematological system, accounting for about 10% of China's hematological malignancies, and the incidence is increasing year by year and tends to be younger
.
According to the latest statistics from the Global Cancer Epidemiology Database (GLOBOCAN), the number of new cases of MM in China in 2020 is as high as 21,116, and the number of deaths is 16,182
.
MM is an incurable disease, most patients will eventually relapse, and its treatment still faces great challenges
.
As the world's first and only oral XPO1 inhibitor, Civio® acts on the only clinically proven nuclear export protein target, and can be combined with other drugs to improve the efficacy and treat multiple hematological tumor diseases.
Very promising for treatment
.
In addition, the company’s rich R&D pipeline makes joint development of drugs in the pipeline possible.
At present, Deqi Pharmaceuticals is developing 10 clinical trials of Civio® for the treatment of relapsed or refractory hematological tumors and advanced solid tumors in mainland China.
Research (3 of which are jointly carried out by Deqi Pharmaceuticals and Karyopharm), the main progress is as follows:-3 for relapsed and refractory multiple myeloma (rrMM) and relapsed and refractory diffuse large B-cell lymphoma (rrDLBCL) ), the Chinese bridging study of indications approved by the US FDA: MARCH study, BENCH study and SEARCH study
.
MARCH study: The primary analysis result of the MARCH study confirmed that among Chinese RRMM patients who have received previous treatment and are refractory to IMiD, PI and end-line treatment, including IMiD, PI and anti-CD38 monoclonal antibodies, Sd (Sed) Linisolone, dexamethasone) programs have good effectiveness and controllable safety
.
BENCH study: Compare SVd (celinisol, bortezomib, dexamethasone) and Vd (bortezomib, dexamethasone) for Chinese rrMM patients who have previously received 1-3 anti-multiple myeloma treatment options Effectiveness and safety
.
SEARCH study: To evaluate the efficacy, safety and tolerability of Celinisol as a single agent in the treatment of Chinese patients with rrDLBCL
.
-3 global studies for new indications: XPORT-DLBCL-030 study: a global, randomized, pivotal phase II/III study to evaluate celinisol in combination with rituximab and gemcitabine , Dexamethasone and Cisplatin (R-GDP program) are used to treat patients with relapsed and refractory diffuse large B-cell lymphoma who have received 1-2 previous treatments
.
SIENDO study: This randomized, double-blind, phase III study that aims to compare Celinisol with placebo for the maintenance treatment of advanced or recurrent endometrial cancer is expected to bring a new standard treatment strategy
.
XPORT-MF-035 study: A phase II clinical study designed to compare Celiniso with the treatment plan chosen by a physician for the treatment of patients with myelofibrosis who have received previous treatment
.
-1 TOUCH study on high-incidence diseases in Asia where existing therapies cannot meet clinical needs: ATG-010 combined with chemotherapy is used to treat relapsed and refractory T and NK cell lymphomas
.
-2 new combination therapies for the treatment of B-cell non-Hodgkin's lymphoma (B-NHL): MATCH study: ATG-010 combined with ATG-008 for the treatment of relapsed and refractory diffuse large B-cell lymphoma
.
SWATCH study: ATG-010 combined with lenalidomide and rituximab is used to treat relapsed and refractory diffuse large B-cell lymphoma and indolent lymphoma
.
-1 PORCH study of combined standard chemotherapy regimens for recurrent or metastatic cervical cancer, endometrial cancer and ovarian cancer
.
Up to now, several Civio® treatments for hematological tumors have been recommended and supported by guidelines/evidence-based studies: 4 treatments for myeloma and 1 treatment for lymphoma have been included in the National Comprehensive Cancer Network (NCCN) guidelines; Four treatments for myeloma and lymphoma were included in the Chinese Society of Clinical Oncology (CSCO) diagnosis and treatment guidelines; two treatments for myeloma were included in the European Society of Medical Oncology (ESMO) guidelines
.
Dr.
Mei Jianming, Founder, Chairman and CEO of Deqi Pharmaceuticals, said: Since Deqi Pharmaceuticals was put into operation in 2017, less than 5 years has ushered in the company’s first commercialization phase in two markets in the Asia-Pacific region.
Products, this approval has important historical significance for the company
.
With the original intention of “patient-centered”, Deqi people will always practice the mission of “medicine without boundaries, innovation and sustainability”, and develop and manufacture more innovative drugs with excellent “deqi speed” for the world’s Patients with hematological tumors create more miracles of life
.
About Civio® (Celiniso, ATG-010) Celiniso is currently the first and only oral XPO1 inhibitor approved by the US FDA and the first to be used for the treatment of multiple myeloma and diffuse Drugs for large B-cell lymphoma
.
By inhibiting the nuclear export protein XPO1, it promotes the nuclear storage and activation of tumor suppressor proteins and other growth regulatory proteins, and down-regulates the levels of multiple oncogenic proteins in the cytoplasm, and induces tumor cell apoptosis
.
Based on its unique mechanism of action, Celinisol can be combined with many other drugs to improve efficacy
.
Celiniso has been approved by the U.
S.
FDA for the treatment of relapsed and refractory multiple myeloma (rrMM) and relapsed and refractory diffuse large B-cell lymphoma (rrDLBCL); in July 2021, Deqi Pharmaceuticals has been in South Korea Obtained Celiniso’s marketing authorization through the priority review process; in December 2021, Civio® was approved by the National Medical Products Administration to be used in combination with dexamethasone to treat previous treatments and at least one proteasome Inhibitors, an immunomodulator and an anti-CD38 monoclonal antibody refractory relapsed or refractory multiple myeloma (rrMM)
.
About the MARCH trial The study is an open, one-arm, phase II clinical study, which aims to evaluate the effects of Celinisol combined with dexamethasone treatment (Sd) treatment on immunomodulators (IMiD) and protease inhibitors (PI) And the effectiveness and safety of RRMM patients who are refractory to the end-line treatment plan
.
The main research endpoint is the overall response rate (ORR) based on the independent review committee (IRC) assessment
.
The study enrolled 82 patients with relapsed and refractory multiple myeloma, and the Sd regimen achieved good results.
In these highly refractory patients, the overall remission rate was 29.
3%, and the median overall survival time was 13.
2 months; it has been received in the past.
The ORR of patients who were treated and refractory to at least one IMiD, one PI, and one anti-CD38 monoclonal antibody still reached 25%, and the median OS was 11.
9 months
.
The results of the MARCH study confirmed that the Sd regimen has good effectiveness and controllable safety in Chinese RRMM patients who are refractory to IMiD and PI two drugs and three drugs (+CD38 monoclonal antibody)
.
The results of the study are basically consistent with the STORM study (a clinical study that supports Celiniso's approval in the United States)
.
About Deci Pharmaceutical Deci Pharmaceutical Co.
, Ltd.
(abbreviated as "Deqi Pharmaceutical", Hong Kong Stock Exchange stock code: 6996.
HK) is a leading R&D-driven biopharmaceutical company, committed to providing the most advanced for patients in Asia-Pacific and even the world Therapies to treat tumors and other life-threatening diseases
.
Since its official operation in 2017, Deqi Pharmaceuticals has established a rich product pipeline that extends from pre-clinical to clinical stages through cooperative introduction and independent research and development
.
At present, Deck Pharmaceuticals has 15 products under development, of which 5 products have Asia-Pacific rights including the Greater China market, and 10 products have global rights
.
Deck Pharmaceuticals has obtained 20 clinical approval documents (IND) in the United States and multiple Asia-Pacific markets, and submitted 6 new drug listing applications (NDA), of which Celiniso has been approved for new drug listing applications in China and South Korea
.
With the vision of "Doctors have no boundaries, innovation and sustainability", Deqi Pharmaceuticals will focus on the early R&D, clinical research, drug production and commercialization of the first and best-in-class therapies to solve urgent clinical needs
.
.
-The MARCH study conducted in China enrolled 82 patients with relapsed or refractory multiple myeloma.
The combination of Civio® and dexamethasone achieved good results, and achieved an overall remission rate of 29.
3% in these highly refractory patients (ORR), the median overall survival time (OS) was 13.
2 months
.
The ORR was 25% in patients who had previously received treatment and were refractory to at least one proteasome inhibitor, one immunomodulator, and one anti-CD38 monoclonal antibody, and the median OS was 11.
9 months
.
-Civio® is the first drug approved by the US FDA for the treatment of multiple myeloma and diffuse large B-cell lymphoma.
At present, 4 treatment options have been included in the Chinese Society of Clinical Oncology (CSCO) diagnosis and treatment guidelines: including The approved Sd (celinisol, dexamethasone) regimen for the treatment of myeloma, and the SVd (celinisol, bortezomib and dexamethasone) regimen for the second-line treatment
.
Shanghai, China and Hong Kong, December 18, 2021-Deqi Pharmaceutical Co.
, Ltd.
(abbreviated as "Deqi Pharmaceutical", Hong Kong Stock Exchange stock code: 6996.
HK) announced today that the National Medical Products Administration (NMPA) has approved The new drug application (NDA) of Civio® (Celinisol, ATG-010), through the combination with dexamethasone, the treatment of previous treatment and at least one proteasome inhibitor, an immunomodulator And an anti-CD38 monoclonal antibody refractory relapsed or refractory multiple myeloma (rrMM)
.
Image source | NMPA official website Sivio® is the first product launched by Deqi Pharmaceuticals in the world.
Its approval in China indicates that Deqi Pharmaceuticals has entered a new stage of commercialization, and it has also made China a successor to the United States.
, Israel, the European Union and South Korea, the world's fifth and the second in the Asia-Pacific region to approve this innovative drug for nuclear export protein (XPO1) inhibitors
.
Australia, Singapore, and Hong Kong, China, are also expected to be approved for listing in 2022, marking this innovative treatment option for the benefit of hematological tumor patients around the world
.
Multiple Myeloma (MM) is the second most common malignant tumor of the hematological system, accounting for about 10% of China's hematological malignancies, and the incidence is increasing year by year and tends to be younger
.
According to the latest statistics from the Global Cancer Epidemiology Database (GLOBOCAN), the number of new cases of MM in China in 2020 is as high as 21,116, and the number of deaths is 16,182
.
MM is an incurable disease, most patients will eventually relapse, and its treatment still faces great challenges
.
As the world's first and only oral XPO1 inhibitor, Civio® acts on the only clinically proven nuclear export protein target, and can be combined with other drugs to improve the efficacy and treat multiple hematological tumor diseases.
Very promising for treatment
.
In addition, the company’s rich R&D pipeline makes joint development of drugs in the pipeline possible.
At present, Deqi Pharmaceuticals is developing 10 clinical trials of Civio® for the treatment of relapsed or refractory hematological tumors and advanced solid tumors in mainland China.
Research (3 of which are jointly carried out by Deqi Pharmaceuticals and Karyopharm), the main progress is as follows:-3 for relapsed and refractory multiple myeloma (rrMM) and relapsed and refractory diffuse large B-cell lymphoma (rrDLBCL) ), the Chinese bridging study of indications approved by the US FDA: MARCH study, BENCH study and SEARCH study
.
MARCH study: The primary analysis result of the MARCH study confirmed that among Chinese RRMM patients who have received previous treatment and are refractory to IMiD, PI and end-line treatment, including IMiD, PI and anti-CD38 monoclonal antibodies, Sd (Sed) Linisolone, dexamethasone) programs have good effectiveness and controllable safety
.
BENCH study: Compare SVd (celinisol, bortezomib, dexamethasone) and Vd (bortezomib, dexamethasone) for Chinese rrMM patients who have previously received 1-3 anti-multiple myeloma treatment options Effectiveness and safety
.
SEARCH study: To evaluate the efficacy, safety and tolerability of Celinisol as a single agent in the treatment of Chinese patients with rrDLBCL
.
-3 global studies for new indications: XPORT-DLBCL-030 study: a global, randomized, pivotal phase II/III study to evaluate celinisol in combination with rituximab and gemcitabine , Dexamethasone and Cisplatin (R-GDP program) are used to treat patients with relapsed and refractory diffuse large B-cell lymphoma who have received 1-2 previous treatments
.
SIENDO study: This randomized, double-blind, phase III study that aims to compare Celinisol with placebo for the maintenance treatment of advanced or recurrent endometrial cancer is expected to bring a new standard treatment strategy
.
XPORT-MF-035 study: A phase II clinical study designed to compare Celiniso with the treatment plan chosen by a physician for the treatment of patients with myelofibrosis who have received previous treatment
.
-1 TOUCH study on high-incidence diseases in Asia where existing therapies cannot meet clinical needs: ATG-010 combined with chemotherapy is used to treat relapsed and refractory T and NK cell lymphomas
.
-2 new combination therapies for the treatment of B-cell non-Hodgkin's lymphoma (B-NHL): MATCH study: ATG-010 combined with ATG-008 for the treatment of relapsed and refractory diffuse large B-cell lymphoma
.
SWATCH study: ATG-010 combined with lenalidomide and rituximab is used to treat relapsed and refractory diffuse large B-cell lymphoma and indolent lymphoma
.
-1 PORCH study of combined standard chemotherapy regimens for recurrent or metastatic cervical cancer, endometrial cancer and ovarian cancer
.
Up to now, several Civio® treatments for hematological tumors have been recommended and supported by guidelines/evidence-based studies: 4 treatments for myeloma and 1 treatment for lymphoma have been included in the National Comprehensive Cancer Network (NCCN) guidelines; Four treatments for myeloma and lymphoma were included in the Chinese Society of Clinical Oncology (CSCO) diagnosis and treatment guidelines; two treatments for myeloma were included in the European Society of Medical Oncology (ESMO) guidelines
.
Dr.
Mei Jianming, Founder, Chairman and CEO of Deqi Pharmaceuticals, said: Since Deqi Pharmaceuticals was put into operation in 2017, less than 5 years has ushered in the company’s first commercialization phase in two markets in the Asia-Pacific region.
Products, this approval has important historical significance for the company
.
With the original intention of “patient-centered”, Deqi people will always practice the mission of “medicine without boundaries, innovation and sustainability”, and develop and manufacture more innovative drugs with excellent “deqi speed” for the world’s Patients with hematological tumors create more miracles of life
.
About Civio® (Celiniso, ATG-010) Celiniso is currently the first and only oral XPO1 inhibitor approved by the US FDA and the first to be used for the treatment of multiple myeloma and diffuse Drugs for large B-cell lymphoma
.
By inhibiting the nuclear export protein XPO1, it promotes the nuclear storage and activation of tumor suppressor proteins and other growth regulatory proteins, and down-regulates the levels of multiple oncogenic proteins in the cytoplasm, and induces tumor cell apoptosis
.
Based on its unique mechanism of action, Celinisol can be combined with many other drugs to improve efficacy
.
Celiniso has been approved by the U.
S.
FDA for the treatment of relapsed and refractory multiple myeloma (rrMM) and relapsed and refractory diffuse large B-cell lymphoma (rrDLBCL); in July 2021, Deqi Pharmaceuticals has been in South Korea Obtained Celiniso’s marketing authorization through the priority review process; in December 2021, Civio® was approved by the National Medical Products Administration to be used in combination with dexamethasone to treat previous treatments and at least one proteasome Inhibitors, an immunomodulator and an anti-CD38 monoclonal antibody refractory relapsed or refractory multiple myeloma (rrMM)
.
About the MARCH trial The study is an open, one-arm, phase II clinical study, which aims to evaluate the effects of Celinisol combined with dexamethasone treatment (Sd) treatment on immunomodulators (IMiD) and protease inhibitors (PI) And the effectiveness and safety of RRMM patients who are refractory to the end-line treatment plan
.
The main research endpoint is the overall response rate (ORR) based on the independent review committee (IRC) assessment
.
The study enrolled 82 patients with relapsed and refractory multiple myeloma, and the Sd regimen achieved good results.
In these highly refractory patients, the overall remission rate was 29.
3%, and the median overall survival time was 13.
2 months; it has been received in the past.
The ORR of patients who were treated and refractory to at least one IMiD, one PI, and one anti-CD38 monoclonal antibody still reached 25%, and the median OS was 11.
9 months
.
The results of the MARCH study confirmed that the Sd regimen has good effectiveness and controllable safety in Chinese RRMM patients who are refractory to IMiD and PI two drugs and three drugs (+CD38 monoclonal antibody)
.
The results of the study are basically consistent with the STORM study (a clinical study that supports Celiniso's approval in the United States)
.
About Deci Pharmaceutical Deci Pharmaceutical Co.
, Ltd.
(abbreviated as "Deqi Pharmaceutical", Hong Kong Stock Exchange stock code: 6996.
HK) is a leading R&D-driven biopharmaceutical company, committed to providing the most advanced for patients in Asia-Pacific and even the world Therapies to treat tumors and other life-threatening diseases
.
Since its official operation in 2017, Deqi Pharmaceuticals has established a rich product pipeline that extends from pre-clinical to clinical stages through cooperative introduction and independent research and development
.
At present, Deck Pharmaceuticals has 15 products under development, of which 5 products have Asia-Pacific rights including the Greater China market, and 10 products have global rights
.
Deck Pharmaceuticals has obtained 20 clinical approval documents (IND) in the United States and multiple Asia-Pacific markets, and submitted 6 new drug listing applications (NDA), of which Celiniso has been approved for new drug listing applications in China and South Korea
.
With the vision of "Doctors have no boundaries, innovation and sustainability", Deqi Pharmaceuticals will focus on the early R&D, clinical research, drug production and commercialization of the first and best-in-class therapies to solve urgent clinical needs
.
