Licensing-out highlights the analysis of domestic R&D strength

While the Licensing-in boom in the Chinese pharmaceutical market, domestic innovative drugs are also steadily advancing.

Recently, Rongchang Biologics independently developed the targeting HER2 ADC vedicitumumab (RC48), which was approved for marketing to treat advanced gastric cancer and became the first domestically-made ADC new drug to be marketed

Since 2021, domestic companies have had 15 licensing-out transactions, of which only one of Junshi Bio-AstraZeneca’s cooperation with AstraZeneca is a transaction for domestic market promotion, and the remaining 14 are for licensed products abroad.

It is worth mentioning that most of the authorized regions are North America, Europe, and global regions except Greater China

Most of the successful overseas drugs have been listed

PD-1, ADC refresh transaction

15 external authorized transactions involving 15 products, of which 6 have been approved for marketing, and drugs in the middle and late stages of clinical practice account for nearly 70%

BeiGene and Novartis reached a cooperation agreement at the beginning of the year to authorize Novartis for the development, production and commercialization of ralizumab in the United States, Canada and other countries.

Junshi Biosciences has two licensing-out transactions.

Prior to this, it is not uncommon for PD-1 monoclonal antibodies to successfully go overseas

At present, the experience of domestic companies from registration and development abroad to global commercialization is still immature.

The same logic is also reflected in the cooperation between Rongchang Bio and Seagen.

On the other hand, Seagen chose Rongchang Biotechnology to cooperate, which can fill the gap in the HER2 target in the pipeline, and the ADC technology of the two companies is similar.

Not only that, to attract Seagen to cooperate, RC48 also has its own strength

Rongchang Biological's first selected indication in China is gastric cancer, and the second recent NDA application is urothelial cancer.

According to the data released at the ASCO meeting in 2021, the objective response rate (ORR) of RC48 monotherapy for HER2-positive locally advanced or metastatic urothelial carcinoma is 50%, and the disease control rate (DCR) is 76.

Small molecule drugs are emerging

In the field of small molecules, Nuocheng Jianhua performed well, with a prepayment of US$125 million in the transaction with Biogen, a milestone amount of US$812.

Obutinib is a BTK inhibitor, which has been approved in China for the treatment of relapsed/refractory chronic lymphocytic leukemia (R/R CLL)/small lymphocytic lymphoma (R/R SLL), and relapsed/refractory chronic lymphocytic leukemia (R/R CLL)/small lymphocytic lymphoma (R/R SLL) Two indications for the treatment of mantle cell lymphoma (R/R MCL)

Another marketed product transaction is the third-generation EGFR-TKI drug vomitinib, which has been approved for the treatment of locally advanced or metastatic non-small cell lung cancer with positive EGFR T790M mutations
.
On June 30, Iris and ArriVent reached a cooperation agreement to license out the development and commercialization rights of vomitinib in overseas markets to the latter
.

Among the small molecule drugs, Luye Pharmaceutical has conducted two external authorization transactions within six months, respectively authorizing the rights and interests of Liss’ Mindo Day transdermal patch in Japan and four European countries to Towa Pharmaceutical and Italfarmaco
.
Liss' Mindo Day transdermal patch is a treatment for Alzheimer's disease, and its marketing application has passed the EU's non-centralized review process
.

Biosimilars are favored by overseas companies

There are also two biosimilars in the Licensing-out transaction in the first half of 2021, which shows that the R&D quality of domestic biosimilar products has gradually received international recognition
.

In January 2021, Cinda Biotech reached a partnership with Etana, and the latter obtained the exclusive license of bevacizumab biosimilar (Dyotong) in Indonesia
.
In January 2020, Cinda Bio has authorized Coherus BioSciences' commercialization rights in the United States and Canada.
Subsequently, on June 17, 2020, Cinda was approved by the NMPA for listing
.
Cinda Bio's move will further expand the commercialization interests of Dayoutong
.

Another biosimilar drug occurred between Biotec and Biogen.
The involved product is BAT1806.
A tocilizumab biosimilar drug targeting IL-6R is undergoing phase III clinical trials
.
On April 8, Biogen signed an agreement with Biogen, which obtained exclusive rights related to registration, production and commercialization in all countries around the world except China (including Hong Kong, Macau and Taiwan)
.
It is worth mentioning that Biogen has cooperated with domestic companies twice this year
.

Appendix:

As of now Licensing-out transactions in 2021