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On November 10th, Tianjing Biological and Jichuan Pharmaceutical held a strategic cooperation signing ceremony, and reached a strategic cooperation in product development, production and commercialization of the former's Etan growth hormone (eftansomatropin alfa, TJ101)
.
It is reported that the total amount of this cooperation is as high as 2.
Set a new high in the Chinese biomedicine market and the global pediatric medicine field in recent years
What is unique about Etan Growth Hormone? Why did Tianjing Biological choose to jointly develop and commercialize this product? Why did Jichuan Pharmaceutical choose Tianjing Biological as its first partner in the field of biological medicine? After the signing ceremony, WuXi AppTec's content team immediately interviewed Dr.
Zang Jingwu , founder and chairman of Horizon Bio , Mr.
Zhu Jielun , Chief Strategy Officer of Horizon Bio , and Dr.
Liu Jun, Director and General Manager of Jichuan Pharmaceutical
.
Zang Jingwu, Founder and Chairman of Tianjing Biological, Chief Strategy Officer of Tianjing Biological, Zhu Jielun, Director and General Manager of Jichuan Pharmaceutical, Dr.
Jun Liu
Highly differentiated long-acting recombinant human growth hormone, plans to submit NDA in 2023
Highly differentiated long-acting recombinant human growth hormone, plan to submit NDA highly differentiated long-acting recombinant human growth hormone in 2023, plan to 2023 Childhood growth hormone deficiency (PGHD) is caused by insufficient growth hormone secreted by the pituitary gland.
The clinical manifestations of the patient are short stature and abnormal metabolism
.
In addition, PGHD may also cause problems such as psychosocial disorders, cognitive deficits and poor quality of life in children
Tianjing Bio's Etan growth hormone is a highly differentiated, long-acting recombinant human growth hormone developed based on innovative hybrid Fc fusion protein technology , with a brand-new molecular form
.
According to reports, the drug has a longer half-life, can extend the interval between administrations, and bring better treatment experience and effects to patients
Based on innovative hybrid Fc fusion protein technology development
The results of the completed early clinical studies (including the phase 2 clinical studies completed in Europe) showed that Etan growth hormone was administered once a week or once every two weeks .
The drugs are equivalent
.
At the same time, compared with other recombinant growth hormones that are administered once a day, itan growth hormone therapy is more convenient, and patient compliance will be higher
The clinical efficacy is comparable to that of rhGH drugs that require daily injections.
According to Dr.
Zang Jingwu, this phase 3 clinical study is expected to complete the enrollment of patients in the first quarter of 2022.
Tianjing Bioplans to submit a New Drug Application (NDA) for Etan Growth Hormone in China in 2023
.
.
Create a new model of cooperation
Create a new model of cooperationFor such a product with therapeutic advantages and at an advanced stage, why did Tianjing Biological choose to cooperate with Jichuan Pharmaceutical to develop and commercialize it?
“At present, the first step of Tianjing Bio’s commercialization is still focusing on the blood tumor product pipeline
.
Itan growth hormone is a pediatric specialty drug.
The company’s strategy is to find the strongest pediatric channel company in China to cooperate and use the advantages of both parties to maximize the value of the product instead of building a sales team from scratch
▲Dr.
Zang Jingwu, founder and chairman of Tianjing Bio (photo source: Provided by Tianjing Bio)
Zang Jingwu, founder and chairman of Tianjing Bio (photo source: Provided by Tianjing Bio)
In the view of Dr.
Zang Jingwu, the advantages of Jichuan Pharmaceutical in the field of pediatrics determine that they are ideal partners of Tianjing Bio.
"Jichuan Pharmaceutical has a strong pediatric drug sales team covering 30 provinces and municipalities across the country.
More than 23,000 hospitals at all levels
.
This cooperation will combine the advantages of Tianjing Biotechnology in innovative biological research and development and biopharmaceutical production, as well as Jichuan Pharmaceutical's broad coverage and mature experience in pediatric drug access and retail end, to grow Yitan The follow-up development of hormones and product commercialization lay a solid foundation"
It is worth mentioning that, as one of the channel companies in the field of pediatrics in China, although Jichuan Pharmaceutical has reached cooperation with many companies, in the field of biological medicine, Tianjing Bio is the first partner of Jichuan Pharmaceutical
.
In this regard, Dr.
Liu Jun, the director and general manager of Jichuan Pharmaceutical, said that the choice of Tianjing Bio-Itan Growth Hormone was mainly based on two considerations: "On the one hand, Tianjing Bio has very good innovative resources and very powerful Innovative ability, which can provide guarantee for the follow-up development and upgrade iteration of Etan growth hormone; on the other hand, the potential efficacy of Etan growth hormone is accurate, the safety is high, and patient compliance is relatively good, which is very in line with Jichuan The fields and development directions covered by the pharmaceutical channels
.
"Dr.
▲Dr.
Jun Liu, Director and General Manager of Jichuan Pharmaceutical ( Image source: Provided by Tianjing Bio)
Jun Liu, Director and General Manager of Jichuan Pharmaceutical ( Image source: Provided by Tianjing Bio)
Under the framework of this strategic cooperation, Tianjing Bio will continue to lead the phase 3 clinical trials of the product for the treatment of children's growth hormone deficiency, as well as the production, continuous process optimization and the development of new dosage forms, and will work closely with Jichuan Pharmaceutical , Share the cost
.
At the same time, Tianjing Bio will be responsible for submitting the listing application of Etan Growth Hormone to the National Food and Drug Administration (NMPA) of China as the applicant, and supplying the medicine to Jichuan Pharmaceutical
.
And Jichuan Pharmaceutical will cooperate to expand other new indications for Etan growth hormone , and will be responsible for commercializing the product in the Chinese market after the product is approved.
Tianjing Bio will provide support in clinical, production, and academic aspects.
.
According to the terms of the agreement, Tianjing Bio will receive a total payment of up to 2.
016 billion yuan from Jichuan Pharmaceutical, including a down payment of 224 million yuan and a cumulative development, registration and sales milestone payment of 1.
792 billion yuan
.
At the same time, Tianjing Bio will share the commercialization income of the product in the Chinese mainland market in accordance with the 50:50 principle, and under this principle will be entitled to an authorization commission that is a low double-digit percentage of annual net sales
.
" The transaction amount of our cooperation has not only set a new high in the Chinese biomedical market and the global pediatric medicine field in recent years, but also is one of the most expensive cooperations in the single-variety cooperation of domestic biomedical companies in recent years
.
" Chief of Tianjing Bio Said Mr.
Zhu Jielun, the strategy officer
.
In Mr.
Zhu Jielun's view, this cooperation between Tianjing Biological and Jichuan Pharmaceutical also has reference significance for other companies in China's biomedical industry
.
"The cooperation between our two parties is not a simple authorization, but a comprehensive and in-depth cooperation based on product development and commercialization
.
This cooperation has created a new type of cooperation model between Chinese biomedical companies, that is, focusing on the research and development of new drugs.
Biopharmaceutical companies in China can cooperate with companies that already have very mature sales channels and mature sales teams in China .
Both parties can make full use of their respective advantages and resources to maximize the value of their products
.
" Mr.
Zhu Jielun said, "Hope Tianjing Bio The cooperation with Jichuan Pharmaceutical can also bring some enlightenment and reference to other companies in the industry
.
"
Reference materials:
Reference materials: [1] Tianjing Biotech announced that it has reached a strategic commercial cooperation with Jichuan Pharmaceutical on Yitan growth hormone.
Retrieved Nov 10, 2021, from https://mp.
weixin.
qq.
com/s/zAHJKjF9Bh3kJ7eRFMmNlA
Retrieved Nov 10, 2021, from https://mp.
weixin.
qq.
com/s/zAHJKjF9Bh3kJ7eRFMmNlA
[2] Announcement on the wholly-owned subsidiary signing the exclusive development, production and sales cooperation agreement of Etan Growth Hormone (TJ101).
Retrieved Nov 10, 2021, from http://static.
sse.
com.
cn/disclosure/listedinfo/ announcement/c/new/2021-11-11/600566_20211111_2_skjweexh.
pdf
Retrieved Nov 10, 2021, from http://static.
sse.
com.
cn/disclosure/listedinfo/ announcement/c/new/2021-11-11/600566_20211111_2_skjweexh.
[3] Tianjing Biopharmaceuticals announced that the Phase 3 registered clinical study of Etan Growth Hormone Alpha has completed the first patient administration.
Retrieved Feb 25, 2021, from https:// aspx
Retrieved Feb 25, 2021, from https:// aspx
