on September 15, 2023, Rongchang biology (688331) announced that the company will accept institutional research on September 14, 2023. CICC medicine, bodao fund, 3W, orbimed, fun time investment, pan Beijing assets, investment promotion self-management, temasek, pengyang fund, rich country fund, xingshi investment, guojun asset management, investment promotion fund, boyi investment and qianyi investment will participate.

The details are as follows:

Q: What is the construction of the company's R & D technology platform?

A: The company has built three core technology platforms with independent intellectual property rights, such as antibody and fusion protein platform, antibody drug conjugate (DC) platform and bifunctional antibody platform. Relying on the aforementioned core technology platform, the company has strong early discovery and molecular screening capabilities for innovative biopharmaceutical products to develop new molecules with new structures and new mechanisms.

Q: Under the current policy environment, the domestic sales strategy, sales situation and sales expectations of Tetasepp?

A: The commercialization of Tatsip is progressing smoothly after conditional approval in March 2021. China's B- cell-mediated autoimmune disease market is huge, the global autoimmune field market is vast, and the overseas market of products has huge growth space. Tatsip is expected to become a major competitor.

As of June 30, 2023, the company's autoimmune commercialization team has formed a sales force of more than 600 people with extensive experience in commercializing autoimmune therapeutics. As the world's first innovative dual-target biologic for the treatment of SLE, Tetashep was approved by NMP in March 2021 and went on sale, and in December of the same year, the product was included in the new version of the National Health Insurance Drug Catalog for the treatment of SLE. As of June 30, 2023, the Autoimmune Commercialization team has admitted more than 600 hospitals.

With the company's team's professional knowledge, industry contacts, and the substantial improvement in the accessibility of products after they are included in the medical insurance catalog, the company mainly promotes products through further marketing strategies for doctors, and further interacts with major opinion leaders in related treatment fields. And doctors directly interact to do a good job in product differentiation positioning and promotion.

Q: Is there any clinical progress related to taitacept?

A:(1) Systemic lupus erythematosus (SLE)

■ In March 2021, China, taitacept received conditional marketing approval from the National Medical Products Administration (NMP) for moderate to severe SLE with poor response to standard treatment. Based on the Phase IIb registered clinical trial completed by Tetacep in China, SLE Phase III confirmatory clinical trial was launched in China in July 2019, and positive clinical research results were achieved. The relevant clinical research results were presented at the 2022 Annual Meeting (CR) of the American College of Rheumatology. The supplementary application materials required for the full approval of this indication were submitted to the Drug Evaluation Center (CDE) of the State Food and Drug Administration at the end of 2022.

■ In April 2022, China, the application for clinical study (IND) of a new drug for the treatment of active systemic lupus erythematosus (cSLE) in children was implicitly approved by CDE for clinical trials. The company has conducted this clinical study in China and completed the first patient enrollment in the first half of 2023.

■ The US Food and Drug Administration (FD) approved the Phase II Investigational New Drug (IND) application for Tetatcept in August 2019. The Company held a Phase II end-of-clinical meeting with FD in January 2020, where FD reviewed the positive data obtained from our drug candidate in the China trial and discussed the design of the Phase III clinical trial. Based on this meeting, FD allowed us to conduct a phase III clinical study of taitacept for the treatment of SLE. In the first half of 2023, the international multi-center phase III clinical study is being promoted globally.

■ Lupus Nephritis (LN) In September 2022, the Phase II IND of Tetacept for the treatment of active lupus nephritis was approved by CDE. The company has conducted this clinical study in China in the first half of 2023 and has completed the first patient enrollment.

(2) Myasthenia Gravis (MG)

■ The Chinese company has completed a randomized, open-label phase II clinical trial in China and has achieved positive results. In November 2022, CDE was recognized as a breakthrough therapeutic drug for the treatment of systemic myasthenia gravis, and the Phase III clinical protocol for the treatment of MG was approved by CDE. In the first half of 2023, the company is conducting this clinical trial study in China and has completed the first patient enrollment.

■ In October 2022 in the United States, the company received FD orphan drug qualification for the treatment of myasthenia gravis. In January 2023, the FD approved the IND application of Tetatcept to advance its Phase III clinical trial study for the treatment of MG patients and granted it fast track accreditation.

(3) Primary Sjogren's syndrome (pSS)

■ In August 2022, China, the Phase III clinical protocol for the treatment of pSS was approved by CDE. In the first half of 2023, the company carried out the clinical trial in China and has completed the first patient group.

Prior to this, the company has completed a phase II clinical trial for the treatment of primary Sjogren's syndrome in China, and its research results were published online in the international authoritative journal RHEUMTOLOGY on July 17, 2023. This clinical trial is a randomized, double-blind, placebo-controlled phase II clinical trial designed to evaluate the efficacy and safety of taitocept in adult patients with pSS. A total of 42 subjects were included in the study and were randomly assigned according to 111 proportions to receive placebo, 160 mg of teatcept, and 240mg of teatcept subcutaneously once a week for 24 weeks. The mean change from baseline in the ESSDI score at 24 weeks was 0.6±4.55 [S.D.],-3.3±2.73, and -1.3±4.14 in the placebo, 160mg, and 240mg groups, respectively. By MMRM (mixed effects model), the change in ESSDI was significantly reduced in the treatment group compared to the placebo group. According to the placebo-adjusted least squares method, the change in ESSDI score from baseline at week 24 in the 160mg group was -4.3, with a P value of 0.002. There were no deaths or serious adverse events (SE) during the entire treatment period in the telatcept group.

The conclusion of the study indicates that the treatment of patients with pSS with taitcept shows a good clinical benefit. Compared with placebo, the Tetatcept treatment group can significantly improve the ESSDI score and MFI-20 of pSS patients at 12 weeks and 24 weeks, and reduce the level of immunoglobulin, safety and tolerance, no serious adverse events occurred, and no death events occurred in each group during the trial. In summary, Tetasep is expected to be a breakthrough drug for Sjogren's syndrome.

the main business of rongchang biological (688331): dedicated to the discovery, development and commercialization of innovative, distinctive first-in-class and best-in-class biological drugs, oriented to create clinical value of drugs, providing safe, effective and accessible clinical solutions for autoimmune diseases, tumor diseases, ophthalmic diseases and other major diseases, to meet a large number of unmet clinical needs.

Rongchang biological 2023 report showed that the company's main revenue was 0.422 billion yuan, up 20.56 percent from the same period last year. Net profit attributable to parent -0.703 billion yuan, down 43.8 percent from the same period last year; Deduct non-net profit -0.728 billion yuan, down 47.03 percent from the same period last year; In the second quarter of 2023, the company's single-quarter main revenue was 0.254 billion yuan, up 26.94 percent from the same period last year. Net profit -0.38 billion yuan, year-on-year decrease of 87.64; Single-quarter non-net profit -0.396 billion yuan, down 93.19 year-on-year; Debt ratio 26.34, investment income 1.1146 million yuan, financial expenses -11.2861 million yuan, gross profit margin 77.42.

The stock has been rated by 12 institutions in the last 90 days, with 9 buying ratings and 3 overweight ratings; the average institutional target price in the past 90 days is 83.58.

The following is detailed earnings forecast information:

Margin trading data show that the net outflow of financing of the stock in the past three months has 6.4951 million, and the financing balance has decreased; the net inflow of securities has 0.286 billion, and the balance of securities has increased.

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