License-in "not fragrant"? Another IPO of the science and technology innovation board of pharmaceutical companies was pressed the "pause button"

【Pharmaceutical Network Market Analysis】In recent years, with the normalization of centralized procurement, medical insurance control fees and other policies, the domestic pharmaceutical industry has actively shifted from follow-up innovation to original research innovation transformation, of which License-in is the traditional business model in the innovation and transformation process of many local pharmaceutical companies, and license-in foreign unlisted new drugs are also considered to be a very suitable project for domestic pharmaceutical companies
.
However, this model was later controversial in the industry, because of too many follow-up innovations characterized by "Me-too", and even labeled as "capital shortcuts"
.
Recently, the IPO of Xi'an Xintong Drug Research Co.
, Ltd.
(hereinafter referred to as "Xintong Drug") (first offering) on the science and technology innovation board was pressed the "pause button", making license-in once again attract the attention of the industry
。 It is reported that the Listing Committee of the Shanghai Stock Exchange asked two questions about Xintong Drugs on the spot: on the one hand, the Listing Committee invited representatives of Xintong Drugs to combine HepDirect technology, the technical basis of Xintong Drugs' liver-targeted innovative drug R&D platform, and the four core products PDV, MB07133, HTS, and CE fosphenytoin sodium injection, all from authorized introduction, indicating the specific embodiment of Xintong drug innovation, and whether Xintong drug meets the relevant requirements
of scientific and technological innovation attributes and positioning of the science and technology innovation board.
Ask the sponsor representative to express a clear opinion
.
On the other hand, the representative of Xintong Drug is requested to further explain whether the clinical data information disclosure such as the efficacy, safety, and drug resistance of the liver-targeted drug PDV is true and accurate, and whether there are potential safety risks
in future products of Xintong Drug based on the fact that no drugs developed using HepDirect technology have been approved for marketing in the world.
Ask the sponsor representative to express a clear opinion
.
Based on this, the Listing Committee requires Xintong Drugs to further explain the specific embodiment of the issuer's innovation, and whether Xintong Drugs meets the relevant requirements
of scientific and technological innovation attributes and positioning of the Science and Technology Innovation Board.
In this regard, some insiders believe that the License-in model is no longer "fragrant"
.
It can be seen from the prospectus of Xintong Drug that its technology platform and many products rely on License-in
.
For example, the two products of paradefovir mesylate tablets and MB07133 for injection, the patent for hypnoforvir fumarate tablets compound and HepDirect technology were all introduced from LGND in January 2011 by Kaihua, a subsidiary of Xintong Pharmaceuticals
.
The analysis pointed out that pharmaceutical companies with almost license-in may not meet the requirements
of scientific and technological innovation attributes and "hard technology" on the science and technology innovation board.
In recent years, the science and technology innovation board has significantly tightened
the focus on pharmaceutical companies that rely on license-in.
In addition to Xintong Drugs, for example, on September 17, 2021, Haihe Pharmaceutical's IPO was rejected, becoming the first pharmaceutical company under the registration system to be rejected for the second time, which the industry believes is because Haihe Pharma has relied too much on the license-in model
since its establishment.
The projects it owns have almost no self-developed patents, except for the HH3806 project, all others come from authorized introduction or cooperative research and development
.
For example, in December 2020, Eteng Jingang was listed on the Science and Technology Innovation Board, a comprehensive pharmaceutical company
with products covering three core therapeutic areas of anti-infection, cardiovascular disease and respiratory system.
Industry insiders believe that its core product is a pure license-in model, which does not meet the attributes of
the science and technology innovation board.
The volatility of policy winds has long been transmitted to the primary market, reminding investors to be cautious about the license-in model
.
Since the beginning of this year, the domestic license-in model has also cooled
down significantly.
According to industry statistics, in the first ten months of 2022, the number of cross-border licenses for domestic pharmaceutical companies was 58, down nearly 50%
from the same period last year.
In terms of total amount, the threshold for shortlisted cross-border license In transactions 1-10 in 2022 has been greatly reduced, only 161 million US dollars, and the total amount this year has reached nearly 4 billion US dollars
.
Among them, the top single transaction amount is East China Medicine and Heidelberg up to 930 million US dollars
.
It can be seen that the license in of domestic pharmaceutical companies tends to be more cautious
.
Disclaimer: Under no circumstances does the information or opinions expressed herein constitute investment advice
to anyone.