Zai Lab: How To Go Further after Cancelling B?

On June 20, 2023, Zai Lab held the Investor Day. The company's management had in-depth exchanges with investors centering on Zai Lab development vision, future sustainable growth strategy, layout strategy of key disease areas, commercialization and business expansion strategy respectively.

On November 11, 2022, Zai Lab announced that its HKEX stock code suffix -B is cancelled officially, which is another "Cancel B" company in Hong Kong stock market 18A after Baekje, Innovent, TopAlliance, Henlius and CanSino Biologics. According to the regulations, in order to cancel B, 18A enterprises need to have an annual income of more than HKD 500 million and a market value of more than HKD 4 billion. Thus, cancelling B also marks that Zai Lab has grown from Biotech to Biopharma. After cancelling B, let's discuss the next step of Zai Lab combining with the Investor Day.

How about the achievements of 4 commercial products?

Zai Lab was founded in 2014, and has completed the listing in both America and Hong Kong during just eight years. At the same time, there are 4 commercial products. With its scientist team and technical strength, it has created its own unique business operation mode, that is, to introduce overseas drugs and lay out innovative product pipelines, which have greatly shortened the R&D cycle of innovative drugs. How about the commercialization achievements of 4 listed products?

In December, 2019, Zai Lab's PARP inhibitor, Niraparib (Zejula), was approved for marketing by National Medical Products Administration, using for the maintenance treatment in patients with platinum-sensitive recurrent ovarian cancer. Zai Lab obtained the exclusive license right of Niraparib in Greater China from Tesaro in 2016. Niraparib was approved for marketing in America by FDA in 2017, which is the only PARP inhibitor approved by FDA, EMA and NMPA.

In 2022, sales income of Zejula is USD 145 million, up 55.2% year-on-year, accounting for 67.51% of revenues.

In May, 2020, Optune, a tumor electric field therapy equipment for treating the glioblastoma, was approved for marketing in China. It is developed by Novocure, and Zai Lab obtained Optune's rights in Greater China in 2018. Optune is famous for its functions such as anti-mitosis and DNA repair, and it can act on many tumors like PD-1. But this therapy is still not commonly used until today. 

In 2022, sales income of Optune is USD 47.3 million, up 21.6% year-on-year, accounting for 21.99% of revenues. 

In March, 2021, Qinlock (Ripretinib) was approved in China for treating the adult patients with advanced GIST who have been treated with 3 or more kinase inhibitors including Imatinib. Qinlock, an inhibitor controlling the open and close of tyrosine kinase, can regulate the open and close of kinase and activation ring by the dual mechanisms of action to inhibit KIT and PDGFRα mutant kinases extensively. It can inhibit the primary and secondary mutations of KIT exons 9, 11, 13, 14, 17 and 18 in GIST, as well as the primary mutation of exon 17 D816V.

In the NVICTUS critical Phase III study, Qinlock has shown significant clinical benefits in progression-free survival and overall survival. And Qinlock also has a good safety. 

In 2022, sales income of Qinlock is USD 15 million, up 28.7% year-on-year, accounting for 6.97% of revenues. 

In December, 2021, the first-in-class Nuzyra (Omadacycline Tosilate) for treating the CABP and ABSSSI was approved for marketing by National Medical Products Administration. Nuzyra, an innovative tetracycline drug, is designed specially to overcome tetracycline resistance and improve broad-spectrum antibacterial activity, such as infections caused by gram-negative bacteria, gram-negative bacteria, atypical bacteria and many other pathogens. Its efficacy has been proved to be equivalent to that of Moxifloxacin for CABP and Linezolid for ABSSSI. What's important is that Nuzyra has a good safety and tolerability, especially in the gastrointestinal side effects which are easily caused by other tetracycline drugs.

In 2022, sales income of Nuzyra is USD 5.2 million, and in 2021, it is close to zero. It is worth noting that Qinlock and Nuzyra were officially included in National Medical Insurance Drug Catalogue (NHSA) in 2022, which was officially implemented on March 1, 2023.

Zai Lab said that they aim to achieve commercial profit by the end of 2023 and strive to achieve overall profitability at the company level by the end of 2025. 

How about the potential of pipelines under research?

According to the press release of Zai Lab, the company has established a differentiated product portfolio and R&D pipeline, including 22 kinds of innovative therapy, among which 13 therapies are in the late clinical development stage, and many products are expected to be approved for marketing in 2023.

Key products are as follows:

TF-ADC drug Tivdak (tisotumab vedotin)

Anti- FGFR2b monoclonal antibody Bemarituzumab 

The fourth generation EGFR targeted drug ZL-2313 (BLU-945)

Claudin18.2 monoclonal antibody ZL-1211

M1/M4 mAChR agonist KarXT

Main references:

1. "Work Hard, Keep Going ｜ Zai Lab Successfully Held the Investor Day in 2023", Zai Lab, 2023-06-21;

2. Phase 2 Fight Trial Continues To Show Improved Overall Survival With Bemarituzumab Plus Chemotherapy In Patients With FGFR2b+ Gastric And Gastroesophageal Cancers.

3. Yasir Y. Elamin et al, Poorer outcomes in EGFR L858R-driven NSCLC treated with osimertinib may be addressed with novel combination of BLU-945 and osimertinib. AACR 2023 abstract LB123/6.

4. "Zai Lab: with a Long and Hard Way To Go in Self-development, Is License-in Better?", bioSeedin, 2022-08-12.