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The so-called "one year's plan lies in the spring", when the spring flowers are blooming in March, the pharmaceutical industry has also heard good news that a large number of drugs have been approved for marketing or clinical trials
.
For example, Antengene and Legend Bio have announced that their drugs have been approved for marketing, and a subsidiary of Fosun Pharma announced that the clinical trial of lymphoma treatment products has been approved
.
Antengene Announces the Approval of XPOVIO(R) in Singapore On March 2, Antengene announced that XPOVIO® (Selinisol) has been approved by the Singapore Health Sciences Authority (HSA) for three indications Treatment for: Relapsed and refractory multiple myeloma (R/R MM) – Selinexor in combination with bortezomib and dexamethasone in patients with R/R MM who have received at least 1 prior therapy; relapsed and refractory multiple myeloma Myeloma (R/R MM) – Selinexor in combination with dexamethasone with at least 4 prior therapies and response to at least two proteasome inhibitors, two immunomodulators, and one anti-CD38 monoclonal antibody Adults with refractory R/R MM; relapsed-refractory diffuse large B-cell lymphoma (R/R DLBCL) – Selinexor monotherapy for at least 2 prior therapies and incapable of receiving hematopoietic stem cells Transplanted adult patients with R/R DLBCL
.
On March 1, Legend Bio, a U.
S.
-listed company, announced that its product, cilta-cel (R&D code: LCAR-B38M), had applied for listing in the United States (BLA).
) is FDA-approved for the treatment of adults with relapsed/refractory multiple myeloma (MM)
.
Cedarquiorenza has become an FDA-approved cell therapy product and an approved CAR-T cell immunotherapy targeting BCMA
.
According to Chuanshen Bio, the approval of Sidaki Aurex is mainly based on the results of the pivotal clinical phase 1b/2 CARTITUDE-1 study
.
The data show that Cilta-cel has shown up to 98% of patients with relapsed or refractory multiple myeloma who have received four or more previous treatments, including proteasome inhibitors, immunomodulators and anti-CD38 monoclonal antibodies.
overall response rate
.
Junshi Bio-Adalimumab Injection Drug Registration Approved On March 2, Junshi Bio-Pharmaceutical announced that it was informed from the website of the State Food and Drug Administration that the adalimumab injection (project code: UBP1211, trade name: Junshi) submitted by the company Mai Kang R) for the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriasis drug marketing authorization application has been in the "approval completed - pending certification" stage, indicating that the State Food and Drug Administration has completed the approval, the corresponding administrative department is in the process of approval.
Preparation of drug registration approval documents
.
The announcement shows that in August 2017, Junshi Bio and Taikang Bio, a wholly-owned subsidiary of Maiwei Bio, entered into a cooperative research, development and commercialization agreement to jointly develop Junmaikang R and enjoy all related intellectual property rights
.
In November 2020, Junshi Biology entered into a supplemental agreement with Maiwei Bio and Taikang Biology, stipulating that the joint venture company jointly invested by the company and Maiwei Biotech after the listing of Junmai Kang R will be the drug marketing authorization holder (MAH).
The company's profits are distributed 50:50 between the company and Maiwei Bio, and Maiwei Bio or its holding subsidiary will be responsible for the production and sales of Junmaikang
R.
On March 2, Fosun Pharma’s subsidiary Fosun Kite announced that it had received approval from the State Drug Administration for the approval of its CD19-targeted autologous CAR-T cell therapy product FKC889.
Approval for a clinical trial in adult patients with relapsed or refractory mantle cell lymphoma after prior second-line therapy or more
.
As of January this year, Fosun Kite has invested a total of 11.
92 million yuan in research and development of this product
.
According to the data, FKC889 is a CAR-T cell therapy drug that Fosun Kite introduced from Kite (a company of Gilead) to industrialize and commercialize Tecartus (brexucabtagene autoleucel) in China.
CAR-T cell therapy drug
.
FKC889 is a chimeric antigen receptor CAR-T cell therapy and a personalized treatment method that uses the body's own immune system to target cancer cells
.
Hengrui Medicine: The company currently has a total of 5 ADC drugs approved for clinical trials On March 1, Hengrui Medicine stated on the investor interaction platform that the company currently has a total of 5 ADC drugs (SHR-A1811, SHR-A1904, SHR-A1912, SHR -A2009, SHR-A1921) were approved for clinical use; in response to the failure of iodixanol injection to win the bid, the company will actively promote the sales and promotion of the product in other channels, and continue to do a good job in the sales of similar products
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
.
For example, Antengene and Legend Bio have announced that their drugs have been approved for marketing, and a subsidiary of Fosun Pharma announced that the clinical trial of lymphoma treatment products has been approved
.
Antengene Announces the Approval of XPOVIO(R) in Singapore On March 2, Antengene announced that XPOVIO® (Selinisol) has been approved by the Singapore Health Sciences Authority (HSA) for three indications Treatment for: Relapsed and refractory multiple myeloma (R/R MM) – Selinexor in combination with bortezomib and dexamethasone in patients with R/R MM who have received at least 1 prior therapy; relapsed and refractory multiple myeloma Myeloma (R/R MM) – Selinexor in combination with dexamethasone with at least 4 prior therapies and response to at least two proteasome inhibitors, two immunomodulators, and one anti-CD38 monoclonal antibody Adults with refractory R/R MM; relapsed-refractory diffuse large B-cell lymphoma (R/R DLBCL) – Selinexor monotherapy for at least 2 prior therapies and incapable of receiving hematopoietic stem cells Transplanted adult patients with R/R DLBCL
.
On March 1, Legend Bio, a U.
S.
-listed company, announced that its product, cilta-cel (R&D code: LCAR-B38M), had applied for listing in the United States (BLA).
) is FDA-approved for the treatment of adults with relapsed/refractory multiple myeloma (MM)
.
Cedarquiorenza has become an FDA-approved cell therapy product and an approved CAR-T cell immunotherapy targeting BCMA
.
According to Chuanshen Bio, the approval of Sidaki Aurex is mainly based on the results of the pivotal clinical phase 1b/2 CARTITUDE-1 study
.
The data show that Cilta-cel has shown up to 98% of patients with relapsed or refractory multiple myeloma who have received four or more previous treatments, including proteasome inhibitors, immunomodulators and anti-CD38 monoclonal antibodies.
overall response rate
.
Junshi Bio-Adalimumab Injection Drug Registration Approved On March 2, Junshi Bio-Pharmaceutical announced that it was informed from the website of the State Food and Drug Administration that the adalimumab injection (project code: UBP1211, trade name: Junshi) submitted by the company Mai Kang R) for the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriasis drug marketing authorization application has been in the "approval completed - pending certification" stage, indicating that the State Food and Drug Administration has completed the approval, the corresponding administrative department is in the process of approval.
Preparation of drug registration approval documents
.
The announcement shows that in August 2017, Junshi Bio and Taikang Bio, a wholly-owned subsidiary of Maiwei Bio, entered into a cooperative research, development and commercialization agreement to jointly develop Junmaikang R and enjoy all related intellectual property rights
.
In November 2020, Junshi Biology entered into a supplemental agreement with Maiwei Bio and Taikang Biology, stipulating that the joint venture company jointly invested by the company and Maiwei Biotech after the listing of Junmai Kang R will be the drug marketing authorization holder (MAH).
The company's profits are distributed 50:50 between the company and Maiwei Bio, and Maiwei Bio or its holding subsidiary will be responsible for the production and sales of Junmaikang
R.
On March 2, Fosun Pharma’s subsidiary Fosun Kite announced that it had received approval from the State Drug Administration for the approval of its CD19-targeted autologous CAR-T cell therapy product FKC889.
Approval for a clinical trial in adult patients with relapsed or refractory mantle cell lymphoma after prior second-line therapy or more
.
As of January this year, Fosun Kite has invested a total of 11.
92 million yuan in research and development of this product
.
According to the data, FKC889 is a CAR-T cell therapy drug that Fosun Kite introduced from Kite (a company of Gilead) to industrialize and commercialize Tecartus (brexucabtagene autoleucel) in China.
CAR-T cell therapy drug
.
FKC889 is a chimeric antigen receptor CAR-T cell therapy and a personalized treatment method that uses the body's own immune system to target cancer cells
.
Hengrui Medicine: The company currently has a total of 5 ADC drugs approved for clinical trials On March 1, Hengrui Medicine stated on the investor interaction platform that the company currently has a total of 5 ADC drugs (SHR-A1811, SHR-A1904, SHR-A1912, SHR -A2009, SHR-A1921) were approved for clinical use; in response to the failure of iodixanol injection to win the bid, the company will actively promote the sales and promotion of the product in other channels, and continue to do a good job in the sales of similar products
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
