Shandong pharmaceutical companies won 7 blockbuster varieties!

Medical Network News on August 18 A few days ago, Shandong New Times Pharmaceutical's CD47 monoclonal antibody IND was contracted by CDE.
This is the company's third category 1 biological drug
.
Since the beginning of this year, New Era Pharmaceuticals has been approved for 7 varieties, including the first domestic imitated axitinib tablet and the fourth domestically produced long-acting Baiyao
.
At present, the company has already reviewed 12 varieties (5 are exclusive), 9 new registration classification varieties are listed on the market and 7 injections consistency evaluation applications are under review
.
The company focuses on the innovative research and development of biological drugs.
The application for the marketing of long-acting human insulin analogues is under review.
Resist
.
According to data, Shandong New Times Pharmaceutical is a subsidiary of Lunan Pharmaceutical
.
As a traditional pharmaceutical company, Lunan Pharmaceutical Group started out as a traditional Chinese medicine.
Its current products are mainly traditional Chinese medicine and chemical medicine.
The long-acting Shengbaiyao approved this year is the group's first biological product
.
With the rise of the industry's innovative research and development wave, Shandong New Times Pharmaceutical has also joined it.
Generic drugs are the first to be imitated and the first to be reviewed.
Innovative drugs focus on antibody drugs
.

　　Win 7 heavyweight varieties! According to the data of 10 new products on Lulu
Mi Nei.
com, 7 products of Shandong New Times Pharmaceutical have been approved for listing since the beginning of this year
.
Among them, axitinib, rivaroxaban, lipoic acid, epirubicin, oxaliplatin, tenofovir disoproxil and other 6 varieties have been approved for production under the new registration classification, which are deemed to have passed the same Sexual evaluation
.
Axitinib tablets of New Era Pharmaceuticals was the first domestic imitation + first review, epirubicin hydrochloride injection was the first domestic review, and rivaroxaban tablets (15mg) were successfully selected for the fifth batch of centralized procurement
.
In addition, New Times Pharmaceutical's PEGylated recombinant human granulocyte stimulating factor injection is the fourth domestic long-acting whitening medicine
.
According to data from Mi Nei.
com, public hospitals in Chinese cities in 2020, County-level public hospitals, urban community centers, and township health centers (Chinese public medical institutions for short) terminal domestically produced long-acting baiyao market scale has exceeded 5 billion yuan
.
Among them, the sales of pegylated recombinant human granulocyte stimulating factor were close to 4 billion yuan, a year-on-year increase of 27.
46%; Hengrui Medicine's sales of Thiopefilgrastim exceeded 1 billion yuan, a year-on-year increase of 257.
32%
.
From 2021 to the present, the source of products approved for listing by New Era Pharmaceuticals: Meinenet MED2.
0 Chinese Drug Evaluation Database Currently, there are 9 new registration classifications under review by New Era Pharmaceuticals (11 acceptance numbers), which have been approved for production Afterwards, it will be deemed to have passed the consistency evaluation
.
From the perspective of the treatment field, there are 4 and 3 of the digestive system and metabolic drugs, anti- tumor and immunomodulators, respectively
.
New Era Pharmaceuticals listing application is under review.
Source: Meinenet MED2.
0 Chinese drug review database.
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.
, New Era Pharmaceutical is the first company to submit a listing application, with a high probability of winning the first imitation
.
Sapropterin hydrochloride tablets is a rare disease drug for the treatment of phenylketonuric acid; voronola fumarate green tablets are a new type of acid suppressant.
The global sales of the original drug in 2020 will be close to 800 million U.
S.
dollars (according to the 2020 average exchange rate)
.
The listing application for Dasatinib tablets of New Era Pharmaceutical was undertaken by CDE on August 5.
Prior to this, the product has been approved by two companies, Zhengda Tianqing Pharmaceutical Group and CSPC.
Currently, only New Era Pharmaceutical is currently in the market.
Trial
.
Ivabradine hydrochloride tablets were first imitated by Beijing Baiao Pharmaceutical, and New Era Pharmaceuticals will compete with Southwest Pharmaceutical for the second domestic product
.
In the field of digestion, New Era Pharmaceuticals has also deployed a long-acting human insulin analogue-insulin glargine
.
According to data from Meinenet, the sales of terminal insulin glargine in China's public medical institutions will exceed 6.
8 billion yuan in 2020, a year-on-year increase of 13.
34%
.
There are 4 manufacturers of insulin glargine in the domestic market, including Sanofi, Ganli Pharmaceutical, United Laboratories and Tonghua Dongbao
.
At present, in addition to New Era Pharmaceuticals, the companies under review for insulin glargine listing applications include Wanbang Pharmaceutical, Dongyang Pharmaceutical, Liaoning Boao Biopharmaceutical and Eli Lilly
.

　　12 varieties have been reviewed! Three major injections grab the first review
As of now, New Era Pharmaceuticals has passed/deemedly passed the consistency evaluation of 12 varieties (15 grades), including 4 for digestive system and metabolic drugs, anti-tumor and immunomodulators.
a
.
5 varieties are exclusive reviews, including axitinib tablets, etodolac capsules, omeprazole enteric-coated tablets, ketorolac tromethamine tablets and epirubicin hydrochloride injection
.
New Era Pharmaceuticals passed/deemedly passed the consistency evaluation drug source: Meinenet MED2.
0 Chinese drug review database consistency evaluation application, New Era Pharmaceuticals also has 8 varieties in the "under review and approval" status, of which There are 7 injections
.
The terminal sales of 4 injections in Chinese public medical institutions in 2020 will exceed 1 billion yuan: Pemetrexed sales will exceed 4 billion yuan, imipenem and cilastatin sodium and somatostatin will exceed 2 billion yuan.
The sales of tromethamine tromethamine exceeded 1 billion yuan
.
Three injections such as imipenem and cilastatin sodium for injection, somatostatin for injection, and argatroban injection have not been reviewed by companies.
New Era Pharmaceuticals will compete with many companies for the first review
.
Only one company has reviewed epirubicin hydrochloride for injection and ketorolac tromethamine injection, and the consistency evaluation of epirubicin hydrochloride for injection is only under review by New Times Pharmaceutical, which is likely to become the second company.
Over-rated companies
.
New Era Pharmaceuticals Consistency Evaluation Application for Drugs Under Review Source: Meinenet MED2.
0 Chinese Drug Evaluation Database Attacks
　　Biological Drugs! 3 new class 1 drugs unveiled,
innovative research and development has become a medicineThe main theme of the industry, the new era pharmaceutical industry is not willing to be absent in it
.
Since the beginning of this year, the company has made frequent efforts in the field of innovative drugs and has focused on the research and development of innovative biological drugs
.
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, the source of new drugs declared by the New Era Pharmaceutical Industry: Meinenet MED2.
0 Chinese Drug Evaluation Database PD-1 monoclonal antibody and CD20 monoclonal antibody are proposed 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 human-mouse chimeric anti-CD20 monoclonal antibody rituximab injection bio-similar drugs, complex macros Hanlin, Cinda biological two companies that have been approved to market the product
.
New Times Pharmaceutical’s BCMA/CD3 double antibody 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 meeting.
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
.