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It is understood that ADC, as an emerging macromolecular targeted drug, has clinical advantages compared to monotherapy antibodies, chemotherapy and other therapies. In recent years, the domestic ADC market has shown explosive growth, with large transactions constantly emerging and market competition becoming increasingly fierce.

 

 

 

This year, Hengrui Pharmaceutical, the leading pharmaceutical company, has been included in the list of breakthrough therapeutic drugs, with several ADCs on the list.

 

 

 

For example, on June 5th, Hengrui Pharmaceutical announced that its subsidiary Suzhou Shengdiya Biopharmaceutical Co., Ltd.'s injection SHR-A1811 has been included in the list of breakthrough treatment varieties for public display by the Drug Evaluation Center of the National Medical Products Administration. The proposed indication for inclusion in the list of breakthrough treatment varieties is for HER2 positive unresectable or metastatic biliary tract cancer patients who have previously received one or more treatment regimens.

 

 

 

It is reported that six indications for injection of SHR-A1811 have been recognized as breakthrough therapies. Previously, in February, this product was used for HER2 positive advanced gastric cancer or gastroesophageal junction adenocarcinoma indications that had previously failed HER2 treatment. It has just been proposed to be included in the breakthrough treatment variety by the Drug Evaluation Center of the National Medical Products Administration.

 

 

 

On May 29th, according to the CDE website, the drug "SHR-A1921 for injection" jointly applied by Hengrui Pharmaceutical and Suzhou Shengdiya has been reviewed and approved for inclusion in the breakthrough treatment drug program. The drug type of this product is a therapeutic biological product, and the intended indication (or functional indication) is SHR-A1921 injection for the treatment of platinum resistant recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.

 

 

 

For example, on April 17th, Baili Tianheng announced that its independently developed bispecific antibody conjugated drug (ADC) BL-B01D1, which can simultaneously target EGFR and HER3 in the clinical stage, has been included in the list of breakthrough treatment varieties by the Drug Evaluation Center of the National Medical Products Administration, with indications for the treatment of locally advanced or metastatic nasopharyngeal carcinoma end-line patients.

 

 

 

It is worth mentioning that previously disclosed by Baili Tianheng, the wholly-owned subsidiary SystImmune and Bristol Myers Squibb (BMS) reached a global strategic cooperation agreement on the development and commercialization rights of BL-B01D1. The two sides will cooperate to promote the development and commercialization of the drug in the United States, and BMS will pay SystImmune a down payment of $800 million, with a potential total transaction amount of ≤ $8.4 billion. This transaction not only broke the record for a high amount of authorized domestic innovative drugs going abroad, but also set a new record for the down payment of authorized domestic innovative drugs going abroad. The drug also became the first domestically produced dual antibody ADC new drug to successfully go abroad. In March 2024, Baili Tianheng disclosed that the company had received a down payment of $800 million from Bristol Myers Squibb.

 

 

 

Huajin Securities stated that 15 ADC drugs have been approved for listing globally, and the global ADC market is expected to increase from $7.9 billion in 2022 to $64.7 billion by 2030 with a high compound growth rate of 30.0%. The domestic ADC is in its early stages, and it is believed that a batch of excellent differentiated products will be launched in the next 3-5 years. The Chinese ADC market is expected to increase from 800 million yuan in 2022 to 66.2 billion yuan by 2030, with a CAGR of up to 72.8%.

 

 

 

China Galaxy Securities predicts that the total global ADC drug sales are expected to exceed 10 billion US dollars in 2023, and the global and Chinese ADC market sizes are expected to reach 64.7 billion US dollars and 68.9 billion RMB respectively by 2030. The rapid listing and volume increase of ADC products will bring sustained and rapid market growth, and the long-term investment prospects are promising.