Over 40 Pharma Applications Including ADCs Granted Breakthrough Therapy Designation in China This Year

　　【Pharmaceutical Network Industry DynamicsAccording to the website of the Center for Drug Evaluation, as of June 27, a total of 42 applications from pharmaceutical companies have officially been included in the list of breakthrough therapies this year (calculated by application number and deadline for public comments). In terms of drug types, small molecules and ADCs are predominant, while the therapeutic areas are still largely focused on cancer treatments.
 

According to reports, as an emerging large-molecule targeted drug, ADC has clinical advantages over single-agent antibodies, chemotherapy, and other therapies. In recent years, the ADC market in China has experienced explosive growth, with major deals constantly emerging and market competition becoming increasingly fierce.
 

This year, Hengrui Pharma, known as the "leading pharmaceutical company," has made a remarkable appearance on the list of breakthrough therapies, with several ADCs from the company included on the list.
 

For example, on June 5, Hengrui Pharma announced that the injectable SHR-A1811 developed by its subsidiary SUZHOU SUNCADIA BIOPHARMACEUTICALS CO.,LTD has been proposed for inclusion in the list of breakthrough therapies by the Center for Drug Evaluation under the National Medical Products Administration. The proposed indication for this breakthrough therapy designation is for patients with HER2-positive unresectable or metastatic biliary tract cancer who have previously received one or more treatment regimens.
 

It is reported that the injectable SHR-A1811 has received Breakthrough Therapy Designation for six indications. In February this year, the product was granted tentative inclusion as a Breakthrough Therapy by the Center for Drug Evaluation of the National Medical Products Administration for the indication of HER2-positive advanced gastric cancer or gastroesophageal junction adenocarcinoma that had failed prior anti-HER2 therapy.
 

On May 29, according to the CDE website, the drug "SHR-A1921 for Injection" jointly applied for by Hengrui Pharma and SUZHOU SUNCADIA BIOPHARMACEUTICALS CO.,LTD has been approved for inclusion in the breakthrough therapy drug program after review. The drug type is therapeutic biologic, with the proposed indication (or function): SHR-A1921 for Injection is used for treating platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
 

For instance, on April 17, Biokin announced that its self-developed bispecific antibody-drug conjugate (ADC) BL-B01D1, which is in the clinical stage and can simultaneously target EGFR and HER3, has been included in the list of breakthrough therapies by the Center for Drug Evaluation of the National Medical Products Administration. The indication is for the treatment of end-stage patients with locally advanced or metastatic nasopharyngeal carcinoma.
 

Notably, in a previous announcement, Biokin disclosed that its wholly-owned subsidiary SystImmune had reached a global strategic collaboration agreement with Bristol-Myers Squibb (BMS) for the development and commercialization rights of BL-B01D1. The two parties will collaborate to advance the drug's development and commercialization in the United States. BMS will pay SystImmune an upfront payment of 800 million US dollars, with a potential total transaction value of ≤8.4 billion US dollars. This deal not only sets a new high for the amount of overseas licensing of domestically produced innovative drugs in China but also establishes a new record for the largest upfront payment in the history of China's innovative drug licensing. Additionally, this drug has become the first successful overseas export of a domestically produced bispecific antibody ADC drug. In March 2024, Biokin announced that it had received the 800 million US dollars upfront payment from Bristol-Myers Squibb.
 

Huajin Securities stated that currently, 15 ADC drugs have been approved for marketing globally. The global ADC market is expected to increase from USD 7.9 billion in 2022 to USD 64.7 billion in 2030, at a high compound annual growth rate (CAGR) of 30.0%. The ADC market in China is still in its early stages, but it is believed that in the next 3-5 years, a group of excellent differentiated products will come to market. The ADC market in China is expected to grow from CNY 800 million in 2022 to CNY 66.2 billion in 2030, with a CAGR as high as 72.8%.
 

China Galaxy Securities estimates that the total global ADC drug sales in 2023 are expected to exceed the 10 billion USD mark. By 2030, the global and Chinese ADC market sizes are projected to reach 64.7 billion USD and 68.9 billion RMB, respectively. The rapid launch and scaling up of ADC products will drive continuous high growth in market size, offering promising long-term investment prospects.
 

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