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【Pharmaceutical Network Industry News】Henlius announced on the evening of November 17 that the company and Fosun Pharma have jointly agreed to grant Fosun Pharma exclusive licenses
to commercialize licensed products in the region and in the field based on the company's intellectual property rights.
This cooperation will enable the company to further expand the overseas market of licensed products and improve the accessibility and recognition of the company's products in the international market, which will contribute to the sustainable development
of the company.
It is reported that the product of this cooperation is Hans-like (serplulimab injection), an innovative anti-PD-1 monoclonal antibody independently developed by Henlius, which was approved for marketing in China in March 2022 for the treatment of adult patients with advanced solid tumors
with unresectable or metastatic microsatellite highly unstable ("MSI-H") who have failed standard therapy 。 Henlius has also announced that the marketing registration application (NDA) for the first-line treatment of inoperably advanced or metastatic squamous non-small cell non-small cell lung cancer (sqNSCLC) in combination with carboplatin and albumin paclitaxel has been approved
by the NMPA.
This indication is the second indication
approved for marketing in Chinese mainland.
It is reported that in addition to the above two approved indications, Henlius is also actively expanding its differentiated advantages around Hans-like, covering a wide range of high-incidence large cancers such as lung cancer, esophageal cancer, head and neck squamous cell carcinoma and gastric cancer, and comprehensively deploying the first-line treatment
of lung cancer.
Among them, the two new indication applications of the drug in the first-line treatment of small cell lung cancer and esophageal squamous cell carcinoma were also accepted
by the State Food and Drug Administration in April and August this year, respectively.
In addition, the drug has also been granted orphan drug designation by the US Food and Drug Administration (FDA) for the indication of extensive-stage small cell lung cancer, and Henlius plans to submit a marketing application
for this indication in the United States in the first half of 2024.
The industry believes that after the O drug and K drug have successively withdrawn the marketing application for small cell lung cancer in the United States, the drug is expected to become the world's first first-line PD-1 product
for the treatment of small cell lung cancer.
Fosun Pharma, which cooperates with the company, has a professional, branded, digital and compliant marketing system that matches existing products and products to be listed, with more than 1,400 overseas professional marketing teams in Africa, Europe and the United States, and has built a comprehensive support system
in medical affairs, market access, medical strategic alliances and brand promotion.
The company believes that this cooperation will help the company expand overseas markets
.
Under the agreement, Fosun Pharma is required to pay Henlius an initial payment of RMB1 billion, a one-off regulatory milestone payment of US$50 million (approximately RMB358 million), a maximum of US$650 million (approximately RMB4.
652 billion) of sales milestone payments, and royalties
.
In addition to Hans, Henlius has also carried out more than 20 clinical trials worldwide on 13 products and 11 immune combination regimens, covering the mainstream biopharmaceutical markets in Europe and the United States and many emerging markets
.
In the first half of this year, Henlius completed four overseas licensing transactions with a total value of US$603 million
.
According to the 2022 interim results report, Henlius achieved operating income of approximately RMB1,289.
4 million in the first half of 2022, a year-on-year increase of approximately 103.
5%, mainly due to sales revenue and licensing revenue from the commercialization of a number of products
.
At the same time, the company continued to increase its innovation and R&D, and during the reporting period, the company's R&D expenditure was about 827.
4 million yuan, a year-on-year increase of 11.
9%.
As of the close of trading on November 17, Henlius quoted 10.
9 yuan, down slightly by 1.
27%, with a turnover rate of 0.
07%, a volume of 114,100 shares and a turnover of 1,242,500 yuan
.
Disclaimer: Under no circumstances does the information or opinions expressed herein constitute investment advice
to anyone.