The big transformation of Shandong pharmaceutical enterprises!

A few days ago, Shandong New Times Pharmaceuticals CD47 monoclonal antibody IND was contracted by CDE, which is the company's third category 1 biological drug

According to data, Shandong New Times Pharmaceutical is a subsidiary of Lunan Pharmaceutical

Win 7 heavyweight varieties! 10 new products on the road

According to data from Meinenet, seven varieties of Shandong New Times Pharmaceutical have been approved for listing since the beginning of this year

In addition, New Times Pharmaceutical's PEGylated recombinant human granulocyte stimulating factor injection is the fourth domestic long-acting whitening medicine

Products approved for listing by New Times Pharmaceuticals since 2021

Source: Meinenet MED2.

At present, there are 9 new registered classification varieties (11 acceptance numbers) under review by New Era Pharmaceuticals, and they will be deemed to have passed the consistency evaluation after being approved for production

New Era Pharmaceutical's listing application is under review

Source: Meinenet MED2.

Among them, two varieties of sapropterin hydrochloride hydrochloride tablets and voronola fumarate green tablets have not been approved for generic drugs in the domestic market.

The listing application for Dasatinib tablets of New Era Pharmaceutical was undertaken by CDE on August 5.

In the field of digestion, New Era Pharmaceuticals has also deployed a long-acting human insulin analogue-insulin glargine

12 varieties have been reviewed! 3 major injections grab the first review

Up to now, New Era Pharmaceuticals has 12 varieties (15 grades) passed/deemed to pass the consistency evaluation, including 4 digestive system and metabolic drugs, anti-tumor and immunomodulators

New Era Pharmaceuticals passed/deemed passed consistency evaluation drugs

Source: Meinenet MED2.

In terms of application for consistency evaluation, New Era Pharmaceutical has 8 other varieties in the "under review and approval" status, of which 7 are injections

Three injections such as imipenem and cilastatin sodium for injection, somatostatin for injection, and argatroban injection have not been reviewed by companies.

New Era Pharmaceutical Industry Consistency Evaluation Application for Drugs Under Review

Source: Meinenet MED2.

Attack biological drugs! 3 new class 1 drugs unveiled

Innovative research and development has become the main theme of the pharmaceutical industry, and the new era pharmaceutical industry is unwilling to be absent from it

PEGylated recombinant human granulocyte stimulating factor injection is the first biological product approved for marketing in the New Era Pharmaceutical Industry.
The company’s second biological product, recombinant insulin glargine injection, is under review.
Both biological products are Biosimilar drugs
.

According to data from Minaiwang, since this year, New Era Pharmaceuticals has declared 4 biologic drugs for clinical application, including Class 1 new drug CD47 monoclonal antibody, PD-1 monoclonal antibody, BCMA/CD3 double antibody, and biosimilar CD20 monoclonal antibody
.

From 2021 to the present, New Era Pharmaceuticals declares clinical new drugs

Source: Meinenet MED2.
0 Chinese Drug Evaluation Database

PD-1 monoclonal antibody and CD20 monoclonal antibody are intended to be combined to treat relapsed and refractory diffuse large B-cell lymphoma
.
At present, 7 PD-1 monoclonal antibodies have been approved for production in the domestic market, including 5 domestically produced PD-1 monoclonal antibodies and 2 imported PD-1 monoclonal antibodies
.
Recombinant anti-CD20 human-mouse chimeric monoclonal antibody injection is a biosimilar drug of rituximab
.
The product has been approved for marketing by Fuhong Henlius and Xinda Biological .

The BCMA/CD3 double antibody of New Times Pharmaceutical is the first domestically produced BCMA/CD3 double antibody.
The double antibody was developed by New Times Pharmaceutical and Anyuan Pharmaceutical.
The company announced the BCMA/CD3 double antibody at the 2019 ESMO conference.
Preclinical research data
.
At present, domestic companies that develop BCMA/CD3 dual antibodies against multiple myeloma mainly include New Era Pharmaceuticals, BeiGene and Anmai Bio
.

The CD47 monoclonal antibody clinical application of New Era Pharmaceutical was undertaken by CDE on August 13
.
CD47 is also a big star target, and the competition is fierce.
There are already several companies in both monoclonal and double antibodies
.
Currently, CD47 monoclonal antibody layout companies, including Hengrui Medicine, Kangfang Sheng was the letter of biology, biotechnology and other day environment
.