The internationalization of the pharmaceutical company accelerated, and the application for marketing authorization of innovative drugs in the UK was accepted!

Recently, CStone Pharmaceuticals announced that the marketing authorization application (MAA) for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in combination with sugemalimab was accepted by the UK Medicines and Healthcare Supplies Agency (MHRA
).
The marketing authorization application for sugemalimab is based on the GEMSTONE-302 study to evaluate the efficacy of sugemalimab plus chemotherapy versus placebo plus chemotherapy as first-line treatment for metastatic non-small cell lung cancer, which has met the primary and key secondary endpoints
of progression-free survival and overall survival, respectively.
In China, China's National Medical Products Administration (NMPA) approved the marketing of sugemalimab in 2021, combined with chemotherapy for the first-line treatment
of patients with metastatic squamous and non-squamous non-small cell lung cancer.
Accepted by MHRA, it is the first marketing authorization application for sugemalimab outside China, which means that this CStone Pharmaceutical's self-developed tumor immunotherapy skeleton drug is very close to landing in the vast European market
.
It is understood that CStone Pharmaceutical's international layout began two years ago
.
In the second half of 2020, CStone entered into a strategic partnership agreement with EQRx to acquire exclusive rights to develop and commercialize sugemalimab and anti-PD-1 monoclonal antibody CS1003 outside Greater China for up to US$1.
3 billion
.
In October 2021, EQRx and the National Health Service (NHSE) signed a Memorandum of Understanding (MoU) to establish a long-term strategic partnership to bring innovative, high-quality, affordable oncology medicines
to patients in England as early as possible.
In 2021, sugemalimab was granted the "Innovation Passport" certification by ILAP partner organizations including MHRA in the UK through ILAP
.
Once the drug is approved from the UK to the EU, the industry expects to reach one billion dollars in sales within three to five years, and CStone Pharmaceuticals may use this to obtain tens of millions of dollars in marketing authorization milestone payments and hundreds of millions of dollars in annual sales shares
.
It is worth noting that under the background of the unsatisfactory landing of domestic new drugs in the US market, the European market is obviously gradually becoming the main position for the layout of domestic pharmaceutical companies and domestic new drugs going overseas
.
At present, in addition to CStone Pharmaceutical, many pharmaceutical companies such as Fosun Pharma, Porton, BeiGene, and Junshi Biologics have also announced that they have "broken through" the European market
.
Among them, BeiGene, an innovative pharmaceutical company, has recently partnered with Novartis to start promoting its PD-1 antibody new drug application
in Europe.
On April 6, BeiGene announced that the European Medicines Agency had accepted the marketing application for tislelizumab for two cancers, respectively for the treatment of esophageal squamous cell carcinoma and non-small cell lung cancer
.
Subsequently, it also successively issued announcements on the listing of its product zebratinib capsules in the EU
.
In addition, on November 24, Junshi Biologics also announced that the company has recently submitted a marketing authorization application
for the anti-PD-1 monoclonal antibody drug teripulimab to the UK Medicines and Healthcare Products Agency (MHRA).
The indications declared this time are: 1) teripulimab combined with cisplatin and gemcitabine for first-line treatment in patients with locally recurrent or metastatic nasopharyngeal carcinoma (NPC); 2) Teripulimab in combination with paclitaxel and cisplatin for first-line treatment
in patients with unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma (ESCC).
Previously, Junshi Biologics has submitted marketing authorization applications
for these two indications to the European Medicines Agency (EMA).
Industry analysts believe that under the background of many domestic innovative pharmaceutical companies paying more attention to the European market, CStone Pharmaceuticals has laid out ahead of time, so that its sugemalimab has ILAP qualification, or is likely to become the first domestic PD-(L)1 monoclonal antibody
approved in the UK.
Disclaimer: Under no circumstances does the information or opinions expressed herein constitute investment advice
to anyone.