With the continuous improvement of the innovation vitality of Chinese pharmaceutical companies, the momentum of 'going to sea' is rising rapidly

Recently, Legend Bio announced that Japan's Ministry of Health, Labor and Welfare (MHLW) has approved CARVYKTI® (Ciltacabtagene Autoleucel, referred to as Cilta-cel) for the treatment of relapsed or refractory multiple myeloma (R/R MM) adult patients, it is understood that the new drug listing application was submitted
by Legend Bio partner Yang Sen.

In December 2017, Legendary Biologics signed an exclusive global licensing and cooperation agreement with Janssen Corporation to develop and commercialize Cilta-cel
.

The approval is based on the results of the critical Phase 1b/2 CARTITUDE-1 study, which included 97 patients
who had previously received median six-line therapy (range 3-18), including PI, IMiD, and anti-CD38 monoclonal antibodies.

It is worth mentioning that in addition to the approval in Japan, in February this year, CARVYKTI® (Siddaki Olensai) has been approved for listing by the US Food and Drug Administration (FDA), and in May it also obtained the European Commission (EC) conditional marketing authorization
.

In fact, in order to cope with the intensification of competition in the pharmaceutical market, the price reduction pressure brought about by domestic collection, and the continuous squeeze of the return space after the listing of innovative drugs, many local innovative pharmaceutical companies with strength in China have long been accelerating the international layout
of new drugs.

For example, on September 26, Frontier Biologics mentioned at the performance statement that Aikenin has obtained the Malaysian drug marketing registration license and submitted drug registration applications
in 7 countries.

The company said that in the future, it will continue to actively promote the commercialization process of Econine overseas in close connection with the business plan formulated in order to realize the overseas business income
of Acronin.

On June 7, Zhejiang Pharmaceutical announced that it had recently received the marketing authorization of ciprofloxacin hydrochloride tablets 250mg and 500mg approved by the British Medicines and Health Products Administration (MHRA), and MHRA agreed to approve the grant of marketing authorization
.

According to the announcement, ciprofloxacin hydrochloride is a third-generation quinolone antibacterial drug suitable for the treatment of lower respiratory tract infections caused by gram-negative bacteria in adults, bronchopulmonary infections in cystic fibrosis bronchiectasis, pneumonia, chronic purulent otitis media, urinary tract infections, complex urinary tract infections, etc
.

On April 6, BeiGene announced that its PD-1 monoclonal antibody tirarizuzumab has been accepted by the European Medicines
Agency for marketing in Europe.

It is worth mentioning that BeiGene announced on February 19 that zebutinib has also been approved by the Swiss Food and Drug Administration for the treatment of adults with Fahrenheit macroglobulinemia (WM) who have previously received at least one treatment, or as a first-line treatment option
for patients with WM who are not suitable for chemoimmunotherapy.

At the end of February, the CAR-T cell therapy product of Kingsray subsidiary Legend Biologics was approved in the United States, becoming the first cell therapy product to successfully "go to sea".
.
.
Analysts believe that from the above, it can be clearly seen that with the introduction and landing of a series of policies to encourage new drug research and development, the innovation vitality of China's biomedical industry is constantly improving, and it has begun to play an increasingly important role
in the global pharmaceutical innovation map.

In this context, the industry expects that in the future, affected by the acceleration of domestic pharmaceutical innovation, the momentum of Chinese biomedical enterprises 'going to sea' will continue to rise
.
"
But at the same time, in terms of innovative drugs going overseas, how local pharmaceutical companies choose more suitable partners and reduce market challenges with the help of external forces will also become particularly critical
.

Disclaimer: Under no circumstances does the information herein or the opinions expressed in this article constitute investment advice
to any person.