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On February 24, Yifan Pharmaceutical announced that its subsidiary Yiyi Bio’s long-acting whitening drug “ Elbegrastim α Injection” ( proposed trade name: Yilishu ) has been officially accepted by the CDE for the listing application .
From: Announcement of Yifan Pharmaceuticals
On August 26, 2021, Yiyi Bio has reached a cooperation with Chia Tai Tianqing on F-627, with a down payment of 30 million yuan + a milestone payment of up to 180 million yuan + graded net sales commission fee to put F-627 in F-627.
It took eleven years of research and development, and it has been declared for listing in Europe and the United States in 2021
Ebergrastim αinjection ( previous name: recombinant human granulocyte colony-stimulating factor-Fc fusion protein, R&D code: F-627 ) is based on the existing Di-KineTM bi-molecular technology platform of Yiyi Biotech with independent intellectual property rights.
According to theInsight database , the F-627 project started clinical research and development as early as 2010, and the first domestic clinical application was submitted in early 2011
Click here for details of Bergstin's domestic projects
From: Insight database (http://db.
In terms of global listing , F-627 has already applied for listing in the United States and the European Union in 2021
Key Nodes in Global Development of F-627 Program
G-CSF is the first chemoradiotherapy-related neutropenia drug recommended by clinical guidelines at home and abroad, with a broad market
.
According to a population-based study published online in The Lancet Oncology in 2019, it is estimated that there will be 19.
29 million cancer patients worldwide in 2019, and about26million cancer patients worldwide by 2040, of which China is expected to reached 6.
25 million .
Although cancer therapy is constantly iterating, chemotherapy is still an important treatment option, and there is a huge demand for treatment of chemotherapy-induced neutropenia
.
G-CSF includes short-acting and long-acting types , the former needs to be administered 1-2 times a day in each chemotherapy cycle , while the latter usually only needs to be administered once in a chemotherapy cycle
.
In 2020, the overall market has a scale of about 8.
093 billion yuan, and the long - term market share is accelerating , rising from 999 million yuan (25%) in 2017 to 5.
271 billion yuan (65%) in 2020
.
In addition to its own huge market demand, for large domestic pharmaceutical companies with rich anti-tumor pipelines and sales networks, long-acting whitening drugs and their own pipelines can form a good synergy
.
The world's first long-acting rhG-CSF is Neulasta (pefilgrastim) developed by Amgen .
The sales of this product was close to that of Neupogen in the second year on the market, and it became Amgen's blockbuster drug, reaching its peak sales in 2016 (47.
15%).
US$3 billion), although sales have declined in the past three years, they have remained above US$3 billion
.
In China, a total of 4 long-acting Baiyao products have been approved for marketing, including Jinyouli from CSPC , Xinruibai from Qilu Pharmaceutical, Aido (19K for short) from Hengrui Medicine, and recombinant human granulocytes from Shandong New Era.
stimulating factor
.
Among them, Jinyouli of CSPC and Xinruibai of Qilu are biosimilars of pegfilgrastim, while Aido of Hengrui is a PEGylated G-CSF independently developed by Hengrui Medicine.
Refer to Amgen pegfilgrastim, PEGylated G-CSF
.
Due to the new structural characteristics, its Chinese generic name is "thiopefilgrastim"
.
The ebegrastim α of Chia Tai Tianqing/Yiyi Bio is the first non-pegylated long-acting G-CSF
.
The domestic Shengbaiyao market has huge space, but the competition is fierce
.
However, long-acting rhG-CSF growth is more certain in the long run, as the listing of long-acting rhG-CSF has replaced short-acting products
.
At present, the domestic long-acting rhG-CSF market is in a situation of three rivalries.
Taking Jinyouli of CSPC as an example, the sales in 2020 will be about 2.
178 billion yuan, an increase of 45.
2% over 2019
.
In addition to the above-mentioned long-acting rhG-CSF that has been approved, according to Insight, there are many domestic companies in this field.
Among them, Shuanglu Pharmaceutical's pegfilgrastim has submitted a listing application on December 27, 2021 ; Hangzhou Jiuyuan Genetic Engineering Co.
, Ltd.
has also launched Phase III clinical trials in November 2020
.
