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From November 15 to November 16, the pharmaceutical industry released a collection of important announcements, including a batch of drugs approved for clinical use, a batch of drugs passed a consistency policy, and pharmaceutical companies issued stock incentive plans
.
The author has briefly sorted this out
.
ASK120067 ASK120067 Tablets Marketing Authorization Application Accepted.
ASK Announced on November 16 that the wholly-owned subsidiary Jiangsu Aosaikang Pharmaceutical Co.
, Ltd.
has recently received the registration and marketing approval for domestic production of ASK120067 tablets issued by the State Food and Drug Administration.
Apply for "Notice of Acceptance"
.
ASK120067 tablets are used to treat EGFR-mutant non-small cell lung cancer (NSCLC), which will bring good news to Chinese lung adenocarcinoma patients
.
Huaheng Bio: Proposed 2021 Restricted Stock Incentive Plan On November 16, Huaheng Bio announced the 2021 Restricted Stock Incentive Plan (Draft).
The incentive plan intends to grant a total of 1.
021 million shares to incentive objects, accounting for approximately 0.
95% of the company’s total equity at the time of the announcement of the draft incentive plan
.
In this incentive plan, the first type of restricted stock grant price is 30.
00 yuan/share, and the second type of restricted stock grant price is 30.
00 yuan/share
.
The incentive plan includes a total of 30 people in the first category of restricted stocks and the second category of restricted stocks
.
Beida Pharmaceuticals: BPI-371153 Capsule Drug Clinical Trial Application Accepted On November 15th, Beida Pharmaceuticals announced that the company's BPI-371153 capsule drug clinical trial application has been accepted by the State Food and Drug Administration
.
BPI-371153 was independently developed by the company.
It is an innovative, oral small molecule PD-L1 inhibitor, intended to treat multiple cancer indications that are responsive to anti-PD-L1 therapy
.
Pien Tze Huang: Apixaban tablets received a drug registration certificate.
On November 15 news, Pien Tze Huang issued an announcement stating that the company had received a drug registration certificate for apixaban tablets approved and issued by the State Food and Drug Administration
.
The product is a potent, orally effective, reversible, direct and highly selective inhibitor of factor Xa active site
.
As of the announcement date, the total R&D investment (unaudited) of the drug project is about 17 million yuan.
Sinopharm Hyundai: Octreotide Acetate Injection Passed the Generic Drug Consistency Evaluation.
On November 15th, Sinopharm Hyundai issued an announcement that the company's holding subsidiary Sinopharm Yixin Received the “Approval Notice of Drug Supplement Application” for Octreotide Acetate Injection approved and issued by the National Food and Drug Administration, and approved the drug to pass the generic drug quality and efficacy consistency evaluation
.
Octreotide acetate is a synthetic octapeptide compound, which is suitable for acromegaly, some gastrointestinal carcinoids and neuroendocrine tumors that require long-term administration
.
The original research company of octreotide acetate was Novartis, which was listed in the United States in 1988
.
According to data from Minai.
com, the sales of octreotide acetate injection in public hospitals nationwide in 2020 will be 1.
524 billion yuan, and the sales revenue of octreotide acetate injection from China Medicine Yixin will be about 254 million yuan (excluding tax) in 2020
.
At present, in addition to Sinopharm Yixin, companies that have passed the consistency evaluation include Benxi Hengkang Pharmaceutical and Tianji Biopharmaceuticals
.
Junshi Bio: Teriplizumab was approved as an orphan drug by the FDA Junshi Bio announced on the evening of November 15.
Recently, the company's subsidiary TopAlliance Biosciences, Inc.
received an official reply letter from the US FDA, which is the FDA orphan drug.
Anti-Esophageal Cancer was approved by the FDA for orphan drug designation.
This is also the fourth FDA orphan drug designation for teriprizumab
.
Previously, the monoclonal antibody product for the treatment of mucosal melanoma, nasopharyngeal carcinoma, and soft tissue sarcoma has been approved by the FDA as an orphan drug
.
.
The author has briefly sorted this out
.
ASK120067 ASK120067 Tablets Marketing Authorization Application Accepted.
ASK Announced on November 16 that the wholly-owned subsidiary Jiangsu Aosaikang Pharmaceutical Co.
, Ltd.
has recently received the registration and marketing approval for domestic production of ASK120067 tablets issued by the State Food and Drug Administration.
Apply for "Notice of Acceptance"
.
ASK120067 tablets are used to treat EGFR-mutant non-small cell lung cancer (NSCLC), which will bring good news to Chinese lung adenocarcinoma patients
.
Huaheng Bio: Proposed 2021 Restricted Stock Incentive Plan On November 16, Huaheng Bio announced the 2021 Restricted Stock Incentive Plan (Draft).
The incentive plan intends to grant a total of 1.
021 million shares to incentive objects, accounting for approximately 0.
95% of the company’s total equity at the time of the announcement of the draft incentive plan
.
In this incentive plan, the first type of restricted stock grant price is 30.
00 yuan/share, and the second type of restricted stock grant price is 30.
00 yuan/share
.
The incentive plan includes a total of 30 people in the first category of restricted stocks and the second category of restricted stocks
.
Beida Pharmaceuticals: BPI-371153 Capsule Drug Clinical Trial Application Accepted On November 15th, Beida Pharmaceuticals announced that the company's BPI-371153 capsule drug clinical trial application has been accepted by the State Food and Drug Administration
.
BPI-371153 was independently developed by the company.
It is an innovative, oral small molecule PD-L1 inhibitor, intended to treat multiple cancer indications that are responsive to anti-PD-L1 therapy
.
Pien Tze Huang: Apixaban tablets received a drug registration certificate.
On November 15 news, Pien Tze Huang issued an announcement stating that the company had received a drug registration certificate for apixaban tablets approved and issued by the State Food and Drug Administration
.
The product is a potent, orally effective, reversible, direct and highly selective inhibitor of factor Xa active site
.
As of the announcement date, the total R&D investment (unaudited) of the drug project is about 17 million yuan.
Sinopharm Hyundai: Octreotide Acetate Injection Passed the Generic Drug Consistency Evaluation.
On November 15th, Sinopharm Hyundai issued an announcement that the company's holding subsidiary Sinopharm Yixin Received the “Approval Notice of Drug Supplement Application” for Octreotide Acetate Injection approved and issued by the National Food and Drug Administration, and approved the drug to pass the generic drug quality and efficacy consistency evaluation
.
Octreotide acetate is a synthetic octapeptide compound, which is suitable for acromegaly, some gastrointestinal carcinoids and neuroendocrine tumors that require long-term administration
.
The original research company of octreotide acetate was Novartis, which was listed in the United States in 1988
.
According to data from Minai.
com, the sales of octreotide acetate injection in public hospitals nationwide in 2020 will be 1.
524 billion yuan, and the sales revenue of octreotide acetate injection from China Medicine Yixin will be about 254 million yuan (excluding tax) in 2020
.
At present, in addition to Sinopharm Yixin, companies that have passed the consistency evaluation include Benxi Hengkang Pharmaceutical and Tianji Biopharmaceuticals
.
Junshi Bio: Teriplizumab was approved as an orphan drug by the FDA Junshi Bio announced on the evening of November 15.
Recently, the company's subsidiary TopAlliance Biosciences, Inc.
received an official reply letter from the US FDA, which is the FDA orphan drug.
Anti-Esophageal Cancer was approved by the FDA for orphan drug designation.
This is also the fourth FDA orphan drug designation for teriprizumab
.
Previously, the monoclonal antibody product for the treatment of mucosal melanoma, nasopharyngeal carcinoma, and soft tissue sarcoma has been approved by the FDA as an orphan drug
.
