Event

Recently, many of Zaiding's products under research have shown very positive data results, and a number of product catalysts will further boost the development of enterprises in the second half of the year.

Brief comment

Data from KRAS inhibitor Adagrasib show good CNS permeability partner Mirati released Adagrasib positive data for second-line NSCLC, as well as early positive data for first-line NSCLC in conjunction with PD-1.

Adagrasib data show good central nervous system (CNS) permeability and can provide potential clinical benefits for patients with brain metastasis.

EGFR inhibitor CLN-081 is safe.

Zaiding partner Cullinan released the latest data of CLN-081 on ASCO, and the efficacy and safety are consistent with the previous positive data. CLN-081 has better safety advantages compared with other similar products and has the potential of best-in class.

Repotrectinib has the potential of the best drug of its kind.

On June 11, Repotrectinib was certified by CDE for two breakthrough treatments for ROS1-positive NSCLC. At present, Repotrectinib is the only product that has excellent clinical benefits in both initial and previous treatment of TKI in ROS1 and NTRK.

The phase II study of tumor electric field therapy (TTF) in the first-line treatment of gastric cancer has reached the main end point.

In early June, Zaiding announced the latest study of tumor electric field therapy. As the second phase of the first-line treatment of gastric cancer, the second phase of the study reached the main end point, and the secondary end point also showed a positive signal, which preliminarily verified the potential of TTF combined with standard therapy in the first-line treatment of gastric cancer.

The recent data of KRAS inhibitor Adagrasib is eye-catching, and it is well tolerated and effective in the late / metastatic NSCLC of KRAS G12C mutation.

Adagrasib's updated data were published in the New England Journal of Medicine and reported at the recent annual meeting of ASCO 2022. The KRAS G12C inhibitor Adagrasib has a lasting effect on patients with advanced non-small cell lung cancer with KRAS G12C mutations that have been previously treated.

Adagrasib is expected to become first-in-class KRAS G12C in China.

Adagrasib data show good CNS permeability. 27% of 42% of KRAS G12C mutation NSCLC patients have CNS metastasis, which is related to poor prognosis. In 33 patients with stable CNS metastasis, the ORR (IC ORR) of intracranial lesions was 33% (95% CI 18: 52) (RENO standard assessment), the median IC DOR was 11.2 months (95% CI 3.0~NE), the IC DCR was 85% (95% CI 68: 95), and the median IC PFS was 5.4 months (95% CI 3.3-11.6). Compared with Sotorasib for stabilizing 13% IC ORR data of patients with CNS metastasis, Adagrasib showed better CNS permeability. For patients with active, untreated CNS metastasis, three patients achieved complete remission and three patients achieved partial remission, with an objective response rate of 32% (6 to 19). Sotorasib did not disclose the relevant data.

Safety: among the 116patients who received Adagrasib treatment in clinical II phase, the incidence of treatment-related adverse events (TRAEs) of any grade was 97%, the incidence of grade 3-4 TRAEs was 43%, grade 5 TRAEs was 2 cases (2%), and treatment was discontinued in 8 cases (7%). The most common TRAEs were diarrhea (63%), nausea (62%), vomiting (47%), fatigue (41%), elevated glutamic pyruvic transaminase (ALT) / aspartate oxaloacetic transaminase (AST) (28%),

Serum creatinine increased (26%).

The treatment of NSCLC with PD-1 is effective. The clinical phase 2 (Ph2Krystal-7) of line 1 NSCLC treated with Adagrasib and PD-1 Pembrolizumab showed positive data, with 77% of ORR in patients with high expression of PD-L1 (PD-L1 TPS ≥ 50%) and 50% in patients with low expression of PD-L1 (PD-L1 TPS 1mer 49%) ORR was 50% (4 pm 8).

A number of product catalysts are expected in the second half of the year:

1. Epidon (tumor electric field therapy TTF)

Zaiding partner Novocure will release research data on III phase LUNAR (non-small cell lung cancer) by the end of 2022.

2. Efgartigimod (FcRn antagonist)

Efgartigimod is expected to go public this year, with the company expanding into the field of autoimmune diseases. On June 14, 2022, efgartigimod landed in Boao Le City, which is a new breakthrough of myasthenia gravis drugs in China in the past 30 years, breaking the domestic pattern of treatment in the field of this disease. At the same time, the company expects to submit an application for the listing of new drugs for myasthenia gravis indications to the State Drug Administration (NMPA) in mid-2022.

Zaiding partner Argenx expects to read out the main data of efgartigimod treatment of CIDP in the first quarter of 23 and subcutaneous treatment of PV/PF in the second half of 23.

3. Bemarituzumab（FGFR2b）

Bemarituzumab (anti-FGFR2b) is a modified monoclonal antibody against Fc, which aims to inhibit the binding and activation of fibroblast growth factor (FGF) and FGFR2b, thus inhibiting multiple downstream tumor-promoting signal transduction pathways and possibly delaying tumor progression. A registry study to evaluate bemarituzumab for first-line advanced gastric cancer / gastroesophageal junction cancer is expected to be launched in China in the fourth quarter of 2022.

4. Sulbactam-Durlobactam (SUL-DUR)

SUL-DUR is an innovative intravenous drug in the research stage, an innovative combination of sulbactam (intravenous β-lactam antibiotics) and durlobactam (a new broad-spectrum intravenous β-lactamase inhibitor, or BLI). Zaiding will submit an application in China in the fourth quarter for SUL-DUR 's new drug to be used as an antibiotic for Acinetobacter baumannii infection.

5. Repotrectinib（ROS1/TRK）

The company will discuss registration with Repotrectinib at a meeting in the fourth quarter of 22 prior to the filing of the listing application for NMPA. Zaiding partner Turning Point expects to update the results of BICR-analyzed TRIDENT-1, including intracranial activity, in detail at a medical conference in the second half of 22, and to provide clinical data updates for the cohort of NTRK-positive advanced solid tumors.

6. Odronextamab（CD20xCD3）

Zaiding partner Regeneron plans to publish the results of a key phase II study for the treatment of B-NHL in the second half of 22 and submit the BLA for the treatment of B-NHL to the FDA.

7. ZL-1102（IL17）

Zaiding self-developed product ZL-1102 will launch phase 2 global clinical trials of chronic plaque psoriasis (CPP) in the second half of this year.

Profit forecasts, valuations and investment advice

We estimate that from 2022 to 2024, the company's operating income will be 1.393 billion yuan, 1.906 billion yuan and 3.15 billion yuan respectively. In view of the growing maturity of the company's License-in model and the deepening of internal R & D and globalization, the "buy" rating is maintained.

Risk hint

Product sales fall short of expectations; product research and development fails or lags behind; fierce competition in the industry; risk of change of core technical personnel.