PharmaFocus Today – Page 6 – media

Wondfo Biologics’ subsidiary receives medical device registration certificate

On July 29, Wondfo Biotech(300482) announced that its wholly-owned subsidiary, Shenzhen Tianshen Medical EquipmentCo., Ltd. recently received medical device registration certificates issued by the State Food and Drug Administration and the Guangdong Provincial Food and Drug Administration . The approved products include multiple test kits, primarily used for the quantitative determination of relevant components in blood, and clinically used to assist in the diagnosis of various diseases. Specifically approved products include a tissue plasminogen activator-inhibitor 1 complex assay kit, a fibrinogen degradation product assay kit, and a plasmin-α2 plasmin inhibitor complex assay kit. These products, valid until 2030, cover the detection of thrombotic diseases and tumor markers, providing a richer testing menu for clinicians. The company stated that it will actively promote the sales of these products in the future, but it is currently unable to predict the specific impact of these products on the company’s performance. In the first ...
- Source: drugdu
- 44
- August 3, 2025
Fuyuan Pharmaceutical’s wholly-owned subsidiary, Bifonazole Solution, has been approved for registration

On July 30, Fuyuan PharmaceuticalDisclosure of the announcement regarding the receipt of the Drug Registration Certificate for Bifonazole Solution. Recently, the company’s wholly-owned subsidiary, Fuyuan Pharmaceutical Co., Ltd., received the Drug Registration Certificate (Certificate No.: 2025S02274) for Bifonazole Solution (Specification: 1% (10 ml: 0.1 g)) from the National Medical Products Administration, approving the production of the drug. This drug is used to treat the following fungal skin diseases: (1) Tinea pedis: Tinea pedis of the feet, body, and thighs. (2) Candidiasis: Interdigital erosions, intertrigo, and cutaneous candidiasis. (3) Vitiligo. Fuyuan Pharmaceutical received the application acceptance notice for its bifonazole solution on January 12, 2024, and recently received approval from the National Medical Products Administration (NMPA). According to relevant national policies and regulations, obtaining this Drug Registration Certificate is equivalent to passing the consistency evaluation, which will further enrich the company’s product line and help enhance the market competitiveness of its ...
- Source: drugdu
- 40
- August 3, 2025
Clinical Trial Application for LAE103 Approved by FDA

On July 31, Laekna Pharmaceuticals (02105) issued an announcement, announcing that its independently developed new drug LAE103 clinical trial (IND) application has been approved by the U.S. Food and Drug Administration (FDA). LAE103 is a monoclonal antibody targeting ActRIIB with the potential to treat sarcopenia and other muscle-related diseases. Source：https://finance.eastmoney.com/a/202507313472639341.html
- Source: drugdu
- 41
- August 3, 2025
FDA approves clinical trial application for CS231295 tablets

On July 31, Chipscreen Bio announced that its wholly-owned subsidiary, Chipscreen Biotech (USA), Inc., received FDA approval for a Phase I clinical trial of CS231295 for the treatment of advanced solid tumors. CS231295 is a brain-penetrating, selective inhibitor of Aurora B. Its superior blood-brain barrier penetration offers significant therapeutic advantages for primary and metastatic brain tumors. Currently, no other drug of this design has entered clinical trials globally. Brain tumors, due to the blood-brain barrier, make it difficult for most drugs to effectively enter the central nervous system, and have long been considered a “forbidden zone” in anti-tumor drug development. Chipscreen Biopharmaceuticals’ CS231295 has received FDA approval for clinical trials, demonstrating its differentiated innovation capabilities in brain tumor treatment. Source：https://www.yicai.com/news/102752034.html
- Source: drugdu
- 52
- August 2, 2025
Human Well Pharmaceutical’s subsidiary receives approval for drospirenone ethinylestradiol tablets

On July 31, Renmin Pharmaceutical(600079) issued an announcement that its controlling subsidiary Wuhan Jiulong Human Well Pharmaceutical Co., Ltd. recently received the “Drug Registration Certificate” for Drospirenone Ethinyl Estradiol Tablets approved and issued by the State Food and Drug Administration. The drug is a tablet, with each tablet containing 0.03 mg of ethinyl estradiol and 3 mg of drospirenone. It is registered as a Class 4 chemical drug, with the approval number being National Medicine Standard H20254968, and is valid until July 28, 2030. Jiulong Human Well submitted its marketing authorization application for drospirenone and ethinyl estradiol tablets, used for female contraception, to the National Medical Products Administration in March 2024 and received acceptance. Jiulong Human Well has invested approximately 8.5 million yuan in research and development. According to MinEnet data, national sales of drospirenone and ethinyl estradiol tablets in 2024 were approximately 320 million yuan. This approval qualifies the ...
- Source: drugdu
- 46
- August 2, 2025
Product “Vardenafil Hydrochloride Tablets” obtained registration certificate

Lukang Pharmaceutical(SH 600789, closing price: 10.5 yuan) issued an announcement on the evening of July 31st, stating that recently, Shandong Lu’an Pharmaceutical Co., Ltd.’s holding subsidiary Shandong Lu’an Pharmaceutical Group Saite Co., Ltd. received the “Drug Registration Certificate” for Vardenafil Hydrochloride Tablets issued by the State Food and Drug Administration. This drug is a generic drug approved in accordance with the new registration classification 4 and is deemed to have passed the generic drug quality and efficacy consistency evaluation. From January to December 2024, the operating income structure of Lu’an Pharmaceutical was as follows: human antibiotics accounted for 54.29%, veterinary antibiotics accounted for 39.72%, others accounted for 4.89%, and other businesses accounted for 1.1%. Source：https://finance.eastmoney.com/a/202507313472779816.html
- Source: drugdu
- 41
- August 2, 2025
Subsidiary obtains South Korean drug import license

Jincheng Pharmaceutical(300233.SZ) announced that its wholly-owned subsidiary, Beijing Jincheng Taier Pharmaceutical Co., Ltd., recently received a drug import license for Promestriene Cream from the Korean Ministry of Food and Drug Safety. This product, a strictly localized estrogen, is indicated for atrophic lesions of the vulva, vestibule, and vaginal ring, as well as the subjective symptoms associated with them. Promestriene Cream’s receipt of drug import approval from the Korean MFDS signifies that the product has secured market access in South Korea, positively impacting the company’s expansion into the Korean pharmaceutical market and boosting sales in overseas markets. Source：https://finance.eastmoney.com/a/202507313472756619.html
- Source: drugdu
- 44
- August 2, 2025
Obtained the summary report of the Phase I/II clinical study of BDB-001 injection (indication for ANCA-associated vasculitis)

On July 31, Shutaishen announced the recent completion of a Phase I/II clinical study of BDB-001 injection for ANCA-associated vasculitis (AAV). The study confirmed that BDB-001 injection demonstrated significant clinical advantages in achieving steroid reduction, particularly in complete remission rates. Based on the current data, the company will actively advance into a Phase III clinical trial to further validate its clinical benefits in treating AAV patients. BDB-001 has shown initial success in Phase I/II clinical trials, particularly in terms of hormone reduction and complete remission rates. However, it’s important to note that while Shutaishen has been simultaneously developing several innovative drugs in recent years, none of them are yet close to commercialization. This may put pressure on the company’s short-term performance. However, given the company’s stock price has experienced multiple rounds of speculation in the secondary market, investors should remain cautious. Source：https://www.phirda.com/artilce_39259.html?module=trackingCodeGenerator
- Source: drugdu
- 52
- August 2, 2025
Innovative drug amlodipine besylate oral solution lyophilized powder approved for marketing by the US FDA

On July 29, Changchun High-Tech announced that its controlled subsidiary, Beilinian, had received marketing approval from the U.S. Food and Drug Administration (FDA) for its lyophilized powder for oral solution of amlodipine besylate. This lyophilized powder is a modified version of Beilinian’s 505B2 innovative drug for children aged six and older and adults with hypertension and dysphagia. It can lower blood pressure in children and adults aged six and older, and reduce the risk of fatal and non-fatal cardiovascular events. This approval will enrich Beilinian’s product portfolio in the U.S. and enhance the company’s competitiveness in the pharmaceutical market. The FDA approval of this product is a positive attempt by Changchun High-Tech to export its improved innovative drugs overseas, demonstrating that the company has certain international registration and improved drug development capabilities. Source：https://www.yinsfinance.com/article/1393884.shtml
- Source: drugdu
- 54
- August 1, 2025
HB0043, the world’s first dual-antibody drug targeting IL-17A and IL-36R, has been approved for clinical trials

On July 31, Huahai Pharmaceutical announced that its subsidiaries, Huaotai and Huabo Bio, received approval from the National Medical Products Administration (NMPA) for the clinical trial approval of HB0043 for injection. HB0043 is a recombinant humanized IgG1 bispecific antibody targeting human interleukin-17A (IL-17A) and the human interleukin-36 receptor (IL-36R). It exhibits high binding and blocking activity and is being developed for the treatment of various autoimmune diseases. HB0043 is the world’s first bispecific drug targeting both IL-17A and IL-36R. Compared with monoclonal antibodies, HB0043 has a stronger inhibitory effect on cytokine-induced inflammation and fibrosis responses. Through dual blockade of IL-17A and IL-36R, it has demonstrated stronger efficacy than monoclonal antibodies in various animal disease models such as atopic dermatitis (AD), idiopathic pulmonary fibrosis (IPF), diabetic nephropathy (DN), and neutrophilic asthma. Source：https://www.nbd.com.cn/articles/2025-07-31/3997363.html
- Source: drugdu
- 62
- August 1, 2025

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