In recent years, with the rapid development of the domestic pharmaceutical innovation industry and the continuous enhancement of innovation strength, more and more Chinese innovative pharmaceutical companies are on the road of accelerating "going to sea", opening up new channels for domestic pharmaceutical companies to develop, and at the same time providing more new drug options
for global patients.
On November 15, Yifan Pharmaceutical announced that Yiyi, a subsidiary of the Company, granted the exclusive distribution right of Ebegastim α Injection (hereinafter referred to as "F-627") in the United States to Acrotech Biopharma Inc.
(hereinafter referred to as "ACROTECH Company"), and the two parties recently signed an agreement
.
Under the agreement, ACROTECH will be responsible for the sale of the F-627 in the U.
S
.
market, and it will pay up to $236.
5 million in licensing fees (down payment, milestone payment) and double-digit tiered net sales royalties to the United States.
It is understood that F-627 is an innovative biological drug developed by Yifan Pharmaceutical based on the existing Di-KineTM bimolecular technology platform with independent intellectual property rights in the United States, which is mainly used to prevent and treat neutropenia caused by tumor patients during chemotherapy to prevent patients from dying of infection or other related complications
during chemotherapy.
Industry analysts believe that ACROTECH, as a wholly-owned subsidiary of Aurobindo Pharma Limited, one of the top three generic drug companies in India, has an extensive sales force and perfect sales network in 50 states in the United States, and has rich experience in selling products to community institutions and doctors, which is expected to quickly open the local market in the United States after the launch of F-627, improve its influence and market share in the global market, and promote the product to benefit patients around the world
。
In fact, in the past two years, China's innovative drugs have entered the outbreak period of "going to sea", and local innovative pharmaceutical companies are sailing to the "deep sea" of globalization in the form of "group army", of which the number of innovative drugs "going overseas" in the form of license out in 2020 has reached 39, and there have been 271 cross-border transactions between local pharmaceutical companies and overseas pharmaceutical companies
.
Since 2022, China's innovative drugs are still accelerating
.
In addition to license out, local pharmaceutical companies are also actively deploying overseas clinical trials and certification
.
For example, on the same day, Junshi Biologics announced that the company has submitted a marketing authorization application (MAA) for teripulimab (anti-PD-1 monoclonal antibody) to the European Medicines Agency (EMA) for the first-line treatment of patients with locally recurrent or metastatic nasopharyngeal carcinoma (NPC) in combination with cisplatin and gemcitabine, respectively; Teripulimab in combination with paclitaxel and cisplatin is used first-line therapy
in patients with unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma (ESCC).
Teripulimab is an anti-PD-1 monoclonal antibody drug independently developed by Junshi Biologics, and the submission of the marketing authorization application (MAA) to EMA means that after China and the United States, the global commercialization of teripulimab has begun to expand
to Europe.
It is worth mentioning that in order to accelerate the pace of internationalization, many domestic pharmaceutical companies are also frequently initiating acquisitions and factories overseas
.
In July this year, WuXi AppTec and WuXi Biologics both announced plans to build a new R&D and production base
in Singapore with S$2 billion, or about RMB9.
9 billion, over the next decade.
In June, Fosun Pharma acquired OncoCare
, Singapore's largest private oncology centre.
In February, Gloria announced that it had agreed to acquire Snapdragon Chemistry, Inc.
for approximately $57.
94 million, and upon completion of the merger, Snapdragon will continue to expand its laboratory and manufacturing facilities in Waltham, Massachusetts, USA, adding capacity to support larger pilot scale production.
.
.
In general, for local innovative pharmaceutical companies, internationalization will become an important theme for their long-term development, and only with real innovative R&D capabilities in the future can they better promote domestic innovative drugs to go overseas
.
Of course, in this context, it will also test the clinical trial design capabilities of pharmaceutical companies, the ability to promote clinical trials at home and abroad, and the ability
to communicate with regulators.
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