BeiGene has recently received approval for its second-generation Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib) from the China National Medical Products Administration (NMPA). The China-based biotech firm’s experience of commercializing partner Celgene’s (now Bristol Myers Squibb) drugs will help in devising effective launch strategy for Brukinsa, says GlobalData, a leading data analytics and research company.

Brukinsa is indicated for the treatment of adult patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) /small lymphocytic lymphoma (SLL), and adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy, thus becoming the second BTK inhibitor in China to get the approval.

Pivotal Phase 2 trial of zanubrutinib conducted in 91 R/R CLL/SLL patients showed the overall response rate (ORR) of 62.6% and a partial response (PR) rate of 59.3%. Another pivotal Phase 2 trial conducted in 86 R/R MCL patients in China showed the ORR of 83.7% and a PR of 15.1%.

According to GlobalData Pharma Intelligence Center, Brukinsa is currently involved in five Phase III trials and six Phase II ongoing trials for other oncology indications both in China and globally. This approval can be said to be the first of a series and approval of other oncology indications that will further propagate Brukinsa’s influence in the coming years.

Prashant Khadayate, Pharma Analyst at GlobalData, comments: “Brukinsa has higher selectivity against BTK than Imbruvica (ibrutinib) and is associated with less toxicity. Additionally, a high ORR in R/R CLL/SLL and R/R MCL was observed. Notably, zanubrutinib has a superior safety profile and this could potentially help it overtake Imbruvica in the same patient subgroups as a second generation BTK inhibitor.

“Currently approved indications R/R CLL/SLL and R/R MCL patients’ population is limited. However, the overall future of Brukinsa will be led by the first line CLL/SLL indication, which is still undergoing testing in a Phase III trial (Sequoia). Moreover, the success of Brukinsa is dependent on its inclusion in China’s National Drug Reimbursement List. Brukinsa will face competition from new BTK inhibitor Orelabrutinib, which was filed in November 2019 in China and accepted for review with priority review status.”

In 2017, BeiGene initiated the commercialization of drugs in China by acquiring domestic rights to Celgene’s cancer drugs Revlimid, Abraxane and Vidaza. BeiGene more than quadrupled the size of its Chinese oncology commercial team from around 200 in Q2 2018 to about 900 as of December 2019.

Khadayate concludes: “BeiGene has acquired commercialization experience in China primarily through its rights to Celgene’s cancer drugs. Additionally, in Q1 2020, it has already launched its first internally developed drug tislelizumab in China in classical Hodgkin’s lymphoma (cHL) patients who have received at least two prior therapies. Through these learnings, BeiGene can develop comprehensive commercialization strategy by focussing on physicians, and the patients need along with devising the effective pricing strategy for Brukinsa considering the existing competition.”