securities star news, on November 20, 2023, zejing pharmaceutical (688266) announced that the company would hold an analyst meeting on November 13, 2023, guotai Junan Securities, Huashang Fund, China Merchants Securities, CCB Fund, Guolian Securities, Wanjia Fund, Zheshang Fund, Jiupeng Asset, Qinchen Asset, Huaan Fund, Soochow Securities, Taikang Asset, Boshi Fund, Bank of China Fund, China Merchants Fund, Huitianfu Fund, Taiping Fund, China Shipping Fund, China Europe Fund, Haifutong Fund and PICC Asset participated.

The details are as follows:

Q: What is the current market coverage of Donafenib and the expectation of subsequent commercialization?

a: at present, donafenib has been included in the national health insurance catalogue, covering more than 1600 hospitals, more than 900 hospitals and more than 800 pharmacies. At the same time, Donafenib was included in the Health Commission's Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2022 Edition) (Evidence Level 1, recommend), Chinese Society of Clinical Oncology (CSCO) Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2022) (Level I Expert recommend and Type 1 Evidence), China Guidelines for Integrated Diagnosis and Treatment of Tumors (CC Guidelines), Guidelines for Clinical Application of New Antitumor Drugs (2022 Edition), China Guidelines for Transarterial Chemoembolization (TCE) Clinical Practice of Liver Cancer (2023 Edition), etc guidance/consensus in the field.

for the follow-up commercialization, the company will focus on the following aspects: first, to continuously promote the market access of donafenib; second, to strengthen academic research and market promotion; third, to continue to do a good job in the construction of marketing team, and further build a more efficient marketing system. Donafenib has been proved to be a new targeted therapy drug with definite curative effect, good safety and accessible to patients, and the market share is expected to be further expanded.

Q: What are the differentiation characteristics of recombinant human thrombin? Potential market expectations?

A: Thrombin is an important topical hemostatic drug. At present, there are two main sources of thrombin that have been listed and used in clinical in China, animal-derived and human-derived plasma extraction. Both animal-derived and human-derived thrombin have certain safety and immunogenicity risks.

the recombinant human thrombin independently developed by the company is obtained by the preparation process of complex recombinant protein, which has higher biological safety advantages and higher coagulation activity. it is the first recombinant human thrombin product in China to complete phase III clinical study and submit an application for marketing license, which is expected to fill the gap in the domestic market and meet the urgent clinical needs. According to Sullivan data, with the growth of the number of surgical stations in China, the market for surgical local hemostatic drugs has shown a relatively stable growth, from 6.31 billion yuan in 2016 to 7.07 billion yuan in 2020, with a compound annual growth rate of 2.9. The market for surgical topical hemostatic drugs is expected to continue to grow in the future.

Q: Is the current progress in the approval of recombinant human thrombin?

a: recombinant human thrombin has completed clinical on-site inspection, preparation registration inspection and two-in-one inspection of the production and registration of bulk drugs in the normal review and approval process of the drug administration. the company will actively communicate with the drug administration department to complete the registration review and approval process as soon as possible.

Q: What are the commercial considerations for the treatment of myelofibrosis with Jackitinib Hydrochloride Tablets?

A: According to the current plan, the company will, on the basis of the core backbone structure of the existing team, recruit new talents who are good at marketing, medicine and sales promotion in the field of blood diseases, and carry out the marketing and sales of Jackitinib tablets for the treatment of myelofibrosis indications. About 40 well-known hospitals have participated in the clinical trials of Jacktini, which has laid a good foundation for the future academic promotion of Jacktini.

Q: Clinical progress of Jackitinib Hydrochloride Tablets in severe alopecia areata, moderate to severe atopic dermatitis, and ankylosing spondylitis?

a: the phase iii clinical trial of jacotinib hydrochloride tablets for the treatment of severe alopecia areata is currently progressing smoothly and has been completed into the group. it is expected that the data will be read out after the follow-up observation period expires. Phase II data on the treatment of severe alopecia areata have been presented at an international academic conference, and the results show the safety and efficacy of the treatment of severe alopecia areata. The indications for the treatment of severe atopic dermatitis and ankylosing spondylitis by Jackitinib are currently in phase III clinical studies, and the enrollment is progressing smoothly. The company will step up its efforts to promote phase III clinical trials of these autoimmune diseases.

Q: Clinical progress, mechanism of action and application scenarios of recombinant human thyroid stimulating hormone.

answer: recombinant human thyroid stimulating hormone (rhTSH) for injection is a macromolecular drug independently developed by the company. at present, the phase III clinical study of postoperative auxiliary diagnosis of thyroid cancer patients has reached the main endpoint set by the plan. the company will submit a Pre-BL communication application to the drug evaluation center (CDE) of the state drug administration to promote the listing process of recombinant human thyroid stimulating hormone for injection.

At the same time, the company is carrying out a phase III clinical study of recombinant human thyroid stimulating hormone for injection for the treatment of postoperative radioactive iodine in patients with differentiated thyroid cancer, and the progress is smooth. The effect of TSH activation of thyroid cells is to increase the uptake of radioactive iodine, which can be detected by scanning or radioactive iodine to kill thyroid cancer cells. TSH activation can also cause thyroid cells to release thyroglobulin (Tg), a tumor marker for thyroid cancer in blood samples, which facilitates the detection of thyroid cancer. Due to the rapid development of thyroid cancer epidemiology in China and the demand for future monitoring and adjuvant therapy, recombinant human thyroid stimulating hormone for injection is expected to become an auxiliary diagnosis and adjuvant therapy drug for well-differentiated thyroid cancer, filling the gap in the domestic market, helping to promote the establishment and optimization of industry treatment standards, and meeting the clinical needs of thyroid cancer treatment and diagnosis in China.

Q: Please describe the mechanism and characteristics of the company's trispecific antibody ZG006.

A: ZG006 is a trispecific antibody against CD3 and two different DLL3 epitopes. The anti-DLL3 end of ZG006 binds to different DLL3 epitopes on the surface of tumor cells, and the anti-CD3 end binds to T cells. ZG006 connects tumor cells and T cells, and pulls T cells closer to tumor cells, so as to use T cells to kill tumor cells. DLL3 is a highly expressed target in small cell lung cancer and has been proven effective by international pharmaceutical companies.

ZG006 has high affinity activity for tumor target DLL3, and is the first trispecific antibody drug in the world to carry out clinical use of similar molecular structure. ZG006 has received clinical approval from China and the United States and is currently conducting Phase I clinical studies in China.

Q: Please introduce the mechanism and characteristics of the company's bispecific antibody ZG005.

a: ZG005 has the function of double-targeting blocking PD-1 and TIGIT, which can promote the activation and proliferation of t cells by effectively blocking the signaling pathway PD-L1 PD-1 and its ligand. It can also effectively block the signaling pathways of TIGIT and its ligand PVR, etc., prompting PVR to bind CD226 to generate costimulatory activation signals, thus promoting the activation and proliferation of T cells and NK cells, it also produces a synergistic enhancement of the immune system's ability to kill tumor cells when both targets are blocked. According to public inquiries, ZG005 is one of the first drugs with the same target to enter clinical research in the world, and no drugs with the same mechanism have been approved for marketing worldwide.

The company has completed the Phase I dose climbing study of ZG005, and the clinical results show that ZG005 has a good safety. At this year's SCO meeting, the company disclosed some results of ZG005's Phase Ia clinic, showing good anti-tumor effect within an evaluable period of time. For patients who have been treated with anti-PD-1 or anti-PD-L1 and other tumor immune drugs or multi-line anti-tumor drugs, DCR reached more than 60%, and objective responses were also seen in specific tumors. The Company is currently conducting a follow-up extended clinical study of ZG005.

Q: Please ask the company for follow-up research and development strategies and plans?

Answer: The company's R & D strategy is to continue to promote innovation, continuously optimize the pipeline, continue to focus on improving R & D efficiency and quality, and focus on the R & D of varieties with differentiated competitive advantages; at the same time, the company will also focus more on key projects and actively promote The commercialization of products in the later stages of research and development.

Zejing Pharmaceutical (688266) main business: research and development, production and sales of new chemical and biological drugs.

the third quarter report of ze Jing pharmaceutical in 2023 shows that the company's main revenue is 0.282 billion yuan, up 42.55 year on year. Net profit attributable to parent -0.202 billion yuan, up 44.44 year on year; Deduct non-net profit -0.243 billion yuan, up 38.21 year on year; In the third quarter of 2023, the company's main revenue in a single quarter was 62.1767 million yuan, down 32.78 year on year. Net profit attributable to mother in a single quarter -87.8607 million yuan, up 24.74 year-on-year; Single-quarter non-net profit -0.113 billion yuan, up 13.15 year-on-year; Debt ratio 38.81, investment income 1.5288 million yuan, financial expenses -9.4991 million yuan, gross profit margin 92.4.

the stock has been rated by 14 institutions in the last 90 days, with 13 buying ratings and 1 overweight rating; the average institutional target price in the past 90 days is 64.23.

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 is 22.5577 million, and the financing balance is reduced; the net outflow of securities is 0.284 billion, and the balance of securities is reduced.

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