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荣昌生物(688331):业绩符合预期 适应症持续拓展

Rongchang Biology (688331): Performance meets expectations, indications continue to expand

西南證券 ·  Nov 1, 2023 00:00

Event: The company released its report for the third quarter of 2023. Revenue for the third quarter of 2023 reached 350 million yuan (+58.3%), and revenue reached 770 million yuan (+35.1%) from the beginning of the year to the end of the reporting period. The results were in line with expectations.

The volume of core products was significant, with revenue reaching 770 million yuan in the first three quarters. Tetacept and verdicitumab were released significantly in 2023, and the volume was clearly exchanged for price after inclusion in medical insurance. Revenue for the first three quarters of 2023 reached 770 million yuan (+35.1%). We believe that the accessibility of the company's two core products was greatly improved after the inclusion of health insurance, and are currently being rapidly scaled up.

The core varieties are progressing smoothly clinically and are gradually entering the harvest period. The domestic phase III clinical trial plan for the treatment of immunoglobulin A nephropathy (IgAN) was approved by the CDE in September 2022, and clinical research was carried out domestically in the first half of 2023, and the first patient was enrolled. Phase III clinical trials of titacept for Sjogren's syndrome (PSs) indications were approved by the CDE and FDA in August and November 2022, respectively.

The CDE approved a phase II/III study application for verdicitumab combined with PD-1 and chemotherapy or PD-1 and hercetine for first-line HER2 expression locally advanced or metastatic gastric cancer. Many of the core varieties have entered clinical phase III and gradually entered the harvest period.

The pipeline continues to advance to explore the “ADC+PD-1” combination therapy. The company began a phase III clinical trial of RC28 to treat WAMD and DME in January 2023. The phase I/IIa clinical study of RC88 (MSLN ADC) combined with treprilizumab for the treatment of advanced solid tumors was approved by the Drug Review Center of the State Drug Administration. The phase Ib/II clinical study of RC108 (c-Met ADC) combined with vometinib or vormetinib and treprilizumab was approved by CDE for NSCLC patients who failed to treat EGFR TKI with MET.

We believe that the company's early pipeline is progressing rapidly and continuing to explore the combination therapy of ADC and PD-1.

Profit forecast: As the company's R&D investment increases and innovative varieties continue to be launched, the company's performance growth momentum is sufficient. The company's revenue for 2023-2025 is estimated to be $1.35 billion, 21.13, and $2.99 billion, respectively.

Risk warning: R&D progress falls short of expectations, commercialization of core varieties falls short of expectations, policy risks.

The translation is provided by third-party software.


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