More than 40 products into the clinical! Claudin18.2 Target, who will dominate?

According to statistics, 14 ADC drugs have been approved for marketing worldwide. In terms of targets, Claudin18.2 is one of the most competitive targets after PD-1/PD-L1 in China.

On October 22, the clinical trial application of the first ADC new drug BA1301 injection submitted by Boan Bio was accepted, which may add another fire to the ADC track.

BA1301 is a new ADC drug targeting Claudin18.2, which is indicated for gastric cancer, pancreatic cancer and esophageal cancer. It is one of the seven innovative antibodies under research by Boan Bio and the first ADC new drug declared by Boan Bio.

Crowding the deer claudin 18.2-ADC

ADC drugs are currently a hot track in the field of innovative drugs, and a large number of drugs are being developed globally and in China.

According to relevant statistics, in the four years from 2017 to 2021, the down payment of ADC drug transaction has increased by 2.5 times, and the total amount of transaction has increased by 3.84 times. Going forward, the market size of ADC drugs will exceed US $16.4 billion by 2026.

At present, 14 ADC drugs have been approved worldwide, with phase II to phase III product echelon distribution, and a large number of ADC drug candidates in phase I. In terms of domestic research and development progress, 5 ADC drugs have been approved for marketing, and as many as 13 ADC drug candidates are in phase Ⅲ. It is expected that the breakout period of ADC drugs will come in China within 2-3 years.

The target of Claudin18.2 is one of the most competitive targets after PD-1/PD-L1 in China.

The world more than 40 products in clinical stage, indications solid tumor, pancreatic cancer, stomach cancer, esophageal cancer, esophageal adenocarcinoma, biliary tract cancer, gallbladder, lung adenocarcinoma, colon cancer, etc., jun, then heaven realm of biology, Shanghai ding medicine, cinda biological, economic, and wins medicine, legendary creatures, and other enterprises in the column.

Claudin18.2-ADC has been laid out successively by 10 pharmaceutical companies such as Henrui Pharmaceutical, Shipharmaceutical, Xinda Biological, including LM-302, JS-107, CMG901 and other drugs under research.

What are the advantages of Boans?

Founded in 2013, Boan Bio specializes in the development of therapeutic antibodies, including common main therapeutic fields such as oncology, metabolism, autoimmunity and ophthalmology. It submitted a listing application to the Hong Kong Stock Exchange on May 13.

The product pipeline of Boan Bio covers innovative antibodies and biosimilars, with 1 commercial product, 5 biosimilars in development and 7 innovative antibodies in development.

7 innovative antibodies under research

Boan Bio has 7 innovative antibodies under research, distributed in the fields of tumor, autoimmunity and infectious diseases. Some of the innovative antibodies in the clinical stage include:

LY-CovMab is in phase II clinical stage in China.

The fully human monoclonal antibody BA1105 of Claudin18.2 (ADCC) is in phase I clinical stage in China, and its indications are advanced gastric cancer, metastatic pancreatic cancer and adenocarcinoma of the esophagogastric junction.

Anti-pd-l1 /TGF-β bifunction fusion protein BA1201 is the first bispecific antibody approved for clinical trials, and its indications are small cell lung cancer, non-small cell lung cancer, cervical cancer, urothelial cancer and advanced gastrointestinal cancer.

BA1106, a broad-spectrum immune tumor drug, is in phase I clinical stage in China.

The clinical trial application of BA1301 injection was accepted by the CDE today (October 22). BA1301 is an ADC new drug targeting Claudin18.2, and it is also the first ADC new drug declared by BoanBio.

In addition, BA1202, an anti-tumor CEA/CD3 dual antibody and BA1301, an anti-claudin18.2 antibody-drug conjugate (ADC), are in the preclinical stage, and BA2101, a long-acting IL4R molecular antibody in the field of autoimmune therapy, is in the IND stage.

5 biosimilars in development

Among the five biosimilar drugs under development, BA6101 (besumumab injection, Proliximab biosimilar) in the field of metabolism was accepted by the China Food and Drug Administration on October 14, 2021, and is currently under review and approval (supplementary task review). It is expected to be approved for marketing in the second half of 2022.

BA1102 (Angavie ® biosimilars) in oncology, BA9101 (Alliya ® biosimilars) in ophthalmology, and BA5101 (Dueldar ® biosimilars) in metabolism are in phase III clinical trials in China.

In addition, the overseas development of BA6101 and BA1102 is in phase 1 clinical stage.

Commercial product: Boyoono

The commercialized Boyonalol ® (Bevacizumab injection) was approved for marketing in April 2021, mainly for the treatment of metastatic colorectal cancer, advanced metastatic or recurrent non-small cell lung cancer, recurrent glioblastoma, epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer, and cervical cancer.

In 2021, it achieved sales revenue of 159 million yuan.

Conclusion

Although the competition of ADC drug circuit is fierce, different cancer microenvironment and targets are different.

The fundamental principle of ADC development is to base on the indication itself, achieve the organic unity of safety and efficacy, and improve the treatment window of patients as much as possible.

Therefore, new entrants in the pan-coupling era still have the opportunity to take a differentiated path.