Sesen Bio Inc (NASDAQ:SESN) received approval for its drug – Vicineum from the CDE of China to treat BCG unresponsive NMIBC (non-muscle invasive bladder cancer).
Qilu to conduct the clinical trial in China
The company filed IND with the Chinese regulator through its China-based partner – Qilu Pharmaceutical, and received the approval before April 2021. Following the approval, Qilu can now conduct a clinical study to assess the safety and effectiveness of Vicineum in Chinese people suffering from BCG-unresponsive NMIBC.
Expecting a successful outcome of the trial, Qilu will apply for marketing of Vicineum in the year 2022. The company expects to receive the approval of the Chinese regulator in 2023.
CEO and President of Sesen, Thomas Cannell, said the IND’s receipt in China is a significant milestone. It helps the company to improve and save the lives of several patients across the world. The company can benefit from an enormous opportunity to treat BCG-unresponsive NMIBC in China.
Early approval for Vicineum shows a strong association between Sesen and its associate – Qilu. With the receipt of Phase 3 clinical study in the US and the experienced clinical team of Qilu, Cannell is optimistic about its clinical trial and speedy submission. Cannell said the company will continue to work with Qilu to bring world-class medicines to the local community.
Sesen to receive milestone payments
Sesen expects to receive a milestone payment of $3 million from Qilu soon. The company will receive balance milestone payments of $20 million in the future.
The market for Vicineum at $418 million
The market for Vicineum in China is huge. Sesen expects to achieve peak sales in the range of $155 million and $418 million. Sesen also expects Qilu to play a vital role in the supply of Vicineum for the global markets.
Sesen will complete the transfer of manufacturing technology in mid-2021 and qualify for additional milestone payments of $2 million from Qilu.
Inducement grants to employees
Sesen will offer inducement-related non-statutory stock options of 143,500 shares to newly inducted four employees. They will support the company in transforming it into a commercial-stage firm before August 18, 2021, the targeted PDUFA date for Vicineum.
