Shu Taishen (300204.SZ): Pharmaceutical production license change
Gelonghui, May 28, 丨 Shu Taishen (300204.SZ) announced that the company recently obtained a pharmaceutical production license issued by the Beijing Drug Administration and agreed to the “Pharmaceutical Production License” change application. The company reduced the commissioned production address, production workshop, production line and production scope: No. 18, Kechuang Avenue, Jiangbei New District, Nanjing (Nanjing Haina Pharmaceutical Co., Ltd.): oral emulsion (oral liquid workshop: oral emulsion production line), commissioned product type: Ximetyl silicone emulsion (under research). Other relevant content remains unchanged.
Shu Taishen (300204.SZ): Net loss of 3.7694 million yuan in the first quarter
Gelonghui, April 24 | Shu Taishen (300204.SZ) released its report for the first quarter of 2024. Operating income for the reporting period was 94.9834 million yuan, an increase of 46.09% over the previous year; net profit attributable to shareholders of listed companies - 37.694 million yuan; net profit attributable to shareholders of listed companies after deducting non-recurring profit and loss - 4,4392 million yuan; basic earnings per share - 0.01 yuan.
Shu Taishen (300204.SZ): The company holds Shu Weixin's production approval. Currently, this product is a reserve project
Gelonghui, April 17 | Shu Taishen (300204.SZ) said at an investor relations event that the company holds Shu Weixin's production approval. Currently, this product is the company's reserve project, and the production plan will be adjusted in due course according to market conditions.
Shu Taishen (300204.SZ): STSP-0902 eye drops (used to treat neurotrophic keratitis) declared a new drug clinical trial application accepted
Gelonghui, April 12 | Shu Taishen (300204.SZ) announced that recently, Shu Taishen (Beijing) Biopharmaceutical Co., Ltd. received the “Notice of Acceptance”, an administrative license document from the State Drug Administration. The State Drug Administration agreed to accept the clinical trial application submitted by Shu Taishen for STSP-0902 eye drops for the treatment of neurotrophic keratitis. STSP-0902 is a recombinant human nerve growth factor fC fusion protein independently developed by Shu Taishen that targets specific sites. Preclinical experimental data shows that STSP-0902 can activate TrkA receptors
Shu Taishen (300204.SZ): End clinical trials of some ongoing research projects
Gelonghui, March 25, 丨 Shu Taishen (300204.SZ) announced that based on the current COVID-19 situation and in conjunction with the annual audit work, the company sorted out the company's R&D projects. After careful judgment, it was decided to terminate the research work of BDB-001 injection, STSA-1002 injection, STSA-1005 injection, STSA-1002 and STSA-1005 combined medication projects in the direction of COVID-19 indications. The above projects did not affect continued research on other indications after the end of research work in the direction of COVID-19 indications; they have already been carried out
Shu Taishen (300204.SZ): 2023 net loss of 399 million yuan
On March 25, Ge Longhui | Shu Taishen (300204.SZ) announced the 2023 annual report. During the reporting period, the company achieved operating income of 364 million yuan, a year-on-year decrease of 33.66%; operating profit - 366 million yuan, net profit attributable to shareholders of listed companies - 399 million yuan; net profit attributable to shareholders of listed companies after deducting non-recurring profit and loss - 406 million yuan; and basic earnings per share.
Shu Taishen (300204.SZ): BDB-001 injection (indications for moderate to severe suppurative hidradenitis) obtained phase II clinical study summary report
Gelonghui, March 22丨Shu Taishen (300204.SZ) announced that recently, Shu Taishen (Beijing) Biopharmaceutical Co., Ltd. (hereinafter referred to as “Shu Taishen” or the “Company”) received a multi-center, open, phase II clinical study exploring the efficacy and safety of BDB-001 injections in the treatment of patients with moderate to severe suppurative hidradenitis. BDB-001 injection showed a certain efficacy trend in HS patients, improving efficacy indicators such as HiSCR. BDB-001 injection has weaker immunogen in patients with moderate to severe suppurative hidradenitis according to the dosage plan
The actual controller of Shu Taishen (300204.SZ) received a warning letter from the Beijing Securities Regulatory Bureau
Shu Taishen (300204.SZ) announced that the actual controller of the company received supervision from the China Securities Regulatory Commission in Beijing...
Shu Taishen (300204.SZ): Expected net loss of 344 million yuan to 420 million yuan in 2023
Gelonghui, January 29丨Shu Taishen (300204.SZ) announced that it is expected to have a net loss of 420.6026 million yuan to 344.1294 million yuan in 2023, after deducting non-net loss of 429.0679 million yuan to 35,10555 million yuan, and operating income of 32,779.43 million yuan to 40,06.375 million yuan. During the reporting period, the company's production and operation activities were normal. The company actively carried out various marketing and market exploration work, and focused on expanding the layout of new products. Affected by factors such as the external environment and industry policies, the company's main business revenue declined during the reporting period; the company base
Shu Taishen (300204.SZ): The Shenzhen Stock Exchange terminated the review of the company's fixed stock increase
Zhitong Finance App News, Shu Taishen (300204.SZ) announced that on January 10, 2024, the company and sponsor Guojin Securities Co., Ltd. submitted the “Application of Shu Taishen (Beijing) Biopharmaceutical Co., Ltd. to withdraw the 2022 application documents for issuing shares to specific targets and listing on GEM” and “Guojin Securities Co., Ltd.'s application to withdraw the application documents for the 2022 issuance of shares to specific targets and listing on GEM” to the Shenzhen Stock Exchange. The Shenzhen Stock Exchange decided to terminate the company's application to the Special Committee
Shu Taishen (300204.SZ): Termination of issuance of shares to specific targets and withdrawal of application documents
Gelonghui, January 8, 丨 Shu Taishen (300204.SZ) announced that the company held the 22nd meeting of the 5th board of directors and the 22nd meeting of the 5th board of supervisors on January 8, 2024. The meetings separately reviewed and passed the “Proposal on Termination of Issuance of Shares to Specific Targets and Withdrawal of Application Documents”, agreeing that the company will stop issuing shares to specific targets. Since the announcement of the company's 2022 share issuance plan to specific targets, the company and relevant intermediaries have actively promoted related work, and are now comprehensively considering current capital market conditions, policy changes, company development plans and market financing
Sultaishen (300204.SZ): STSA-1001 injection for treating cancer pain obtained a clinical trial notice for a new drug
Gelonghui, January 3 | Shu Taishen (300204.SZ) announced that recently, Shu Taishen (Beijing) Biopharmaceutical Co., Ltd. received the “Drug Clinical Trial Approval Notice” (Notice No.: 2024LP00023) for STSA-1001 injection to treat cancer pain from the State Drug Administration, agreeing to carry out clinical trials on cancer pain with this product. STSA-1001 injection is a recombinant anti-NGF wholly human IgG1 monoclonal antibody injection. The antibody can effectively block the binding of NGF to its receptors, thereby effectively inhibiting NGF signals in pain diseases
Shutaishen (300204.SZ): BDB-001 injection (an indication for ANCA-associated vasculitis) included as a breakthrough treatment variety
Gelonghui, December 19丨Shutaishen (300204.SZ) announced that, according to public information issued by the Drug Evaluation Center of the State Drug Administration (“CDE”), Shutaishen (Beijing) Biopharmaceutical Co., Ltd. and its wholly-owned subsidiary Beijing Defengrui Biotechnology Co., Ltd. (“Defengrui”) applied for a breakthrough treatment in the BDB-001 injection project for anti-neutrophil cytoplasmic antibodies (ANCA) associated vasculitis (AAV) recently completed a public announcement and has been included in the list of breakthrough treatment varieties.
Shu Taishen (300204.SZ): Xiangtang Group plans to reduce its shares by no more than 1%
On December 15, Gelonghui (300204.SZ) announced that Xiangtang Group Co., Ltd., a shareholder holding 5% or more of Shu Taishen shares (8.68% of the company's total share capital), plans to reduce its holdings of the company's shares by no more than 4.7777 million shares (about 1% of the company's total share capital) through centralized bidding within 3 months of 15 trading days from the date of disclosure of the announcement.
Shu Taishen (300204.SZ): STSA-1002 injection (acute respiratory distress syndrome indication) phase IBii clinical trial completed administration to the first subject
Gelonghui, December 11, Shu Taishen (300204.SZ) announced that in March 2023, the company received the “Drug Clinical Trial Approval Notice” (CXSL2200630) for STSA-1002 injections for acute respiratory distress syndrome (ARDS) indications issued by the State Drug Administration, agreeing to carry out clinical trials of this product for acute respiratory distress syndrome (ARDS). Recently, STSA-1002 injection completed the administration of the first subject in the acute respiratory distress syndrome (ARDS) phase IB/II clinical trial. STSA
Shutaishen (300204.SZ): Injectable STSP-0601 obtained a summary report on the phase II clinical study of patients with hemophilia A or B without inhibitors for on-demand treatment of bleeding
Gelonghui, December 11|Shutaishen (300204.SZ) announced that recently, Shutaishen (Beijing) Biopharmaceutical Co., Ltd. obtained a phase II clinical study summary report on the indications of injectable STSP-0601 in “on-demand treatment of hemorrhage in patients with hemophilia A or B without inhibitors”. Results of studies on the safety, pharmacokinetics, and pharmacodynamics of multiple doses: STSP-0601 has good safety and tolerability for multiple intravenous administration of drugs in patients with hemophilia A or B without inhibitors. The blood concentration gradually increases with the number of doses, and the increase in blood concentration is dose-dependent
Shu Taishen (300204.SZ) passed the national high-tech enterprise certification again
Gelonghui November 30丨Shu Taishen (300204.SZ) announced that the company recently received the “High-tech Enterprise Certificate” jointly issued by the Beijing Municipal Science and Technology Commission, the Beijing Municipal Finance Bureau, and the Beijing Municipal Taxation Bureau of the State Administration of Taxation, and the Beijing Municipal Taxation Bureau. The company has passed the re-certification of the high-tech enterprise.
Shu Taishen (300204.SZ): Currently, there is no layout related to influenza prevention or treatment in the company's products
On November 28, Gelonghui, Shu Taishen (300204.SZ) stated on the investor interactive platform that there is currently no layout related to influenza prevention or treatment in the company's products.
Shu Taishen (300204.SZ): Marketed products include innovative biopharmaceuticals and specialty chemicals, covering many treatment fields such as the nervous system and intestinal system
Gelonghui November 28丨Shu Taishen (300204.SZ) stated on the investor interactive platform that the company's main business is the R&D, production and marketing of innovative drugs with independent intellectual property rights, especially biopharmaceuticals, and falls into the “C27 pharmaceutical manufacturing industry” category in the industry classification of listed companies in the China Securities Regulatory Commission. The company's listed products include innovative biopharmaceuticals and specialty chemicals, covering many treatment fields such as the nervous system and intestinal system, and have formed a certain level of product influence in related application fields.
Shu Taishen (300204.SZ): The production registration for the 3,350 dispersion of polyethylene glycol was accepted
Shu Taishen (300204.SZ) issued an announcement. Recently, the company received information from the State Drug Administration about “gathering...
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