PharmaFocus Today – Page 5 – media

Chengda Bio and Kangle Guardian 15-valent HPV vaccine will start Phase II clinical trials

On the evening of March 19, Chengda Bio issued an announcement that the recombinant 15-valent human papillomavirus vaccine (Escherichia coli) (hereinafter referred to as “this vaccine” or “15-valent HPV vaccine”) jointly developed by the company and Beijing Kangle Guardian Biotechnology Co., Ltd. (hereinafter referred to as “Kangle Guardian”) has completed Phase I clinical trials and will start Phase II clinical trials. The 15-valent HPV vaccine jointly developed by Chengda Bio and Kangle Guardian is the highest-priced HPV vaccine that has been marketed or approved by IND worldwide so far. This vaccine covers all high-risk HPV types defined by IARC and can increase the protection rate of cervical cancer to more than 96%. This vaccine is used to prevent persistent infection caused by human papillomavirus (HPV) types 6, 11, 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68, and diseases such as CIN, VIN, VaIN, AIN, ...
- Source: drugdu
- 39
- March 21, 2025
Xinda launches “new engine”

Recently, Innovent Biologics received good news that its self-developed new ophthalmic drug, Tetuinumab N01 Injection (IBI311), was approved for marketing under the trade name: Symbimin. This is China’s first and the world’s second IGF-1R antibody drug for the treatment of thyroid eye disease (TED). This is also the first blockbuster new drug approved by Innovent Biologics this year. At the same time, the company’s other two highly anticipated potential blockbuster products – Masudopeptide and Piconazole are also expected to be approved for marketing this year, opening up a rapid growth channel in the non-tumor field. China’s first Thyroid eye disease (TED), also known as GRAVES eye disease, is an autoimmune disease closely related to thyroid disease. According to statistics, about 25%-50% of patients with diffuse goiter and hyperthyroidism will have varying degrees of GRAVES eye disease, which ranks first in the incidence of adult orbital diseases. In recent years, the ...
- Source: drugdu
- 37
- March 21, 2025
AIM Vaccine expects revenue of 1.25 billion to 1.3 billion yuan in 2024

AIM Vaccine (06660) issued an announcement that it is expected that the Group’s unaudited revenue will be between 1.25 billion and 1.3 billion yuan during the reporting period ending December 31, 2024, an increase of 60 million to 110 million yuan from 1.19 billion yuan in the previous year, an increase of 5% to 9%. At the same time, the unaudited net loss is expected to be between 250 million and 290 million yuan, a significant reduction from the net loss of 1.95 billion yuan in the previous year, with a reduction of 85% to 87%. The announcement pointed out that the main reason for the increase in revenue was the company’s sales growth of hepatitis B vaccines, while the reduction in comprehensive net losses was due to the reduction in the amount of large asset impairment losses and the increase in revenue this year. https://finance.eastmoney.com/a/202503173347407027.html
- Source: drugdu
- 52
- March 20, 2025
The holder of the drug marketing authorization for Angong Niuhuang Wan has been changed to Buchang Pharmaceutical

On March 18, Buchang Pharmaceutical announced that the company received the “Notice of Approval of Supplementary Drug Application” for Angong Niuhuang Wan approved and issued by the State Drug Administration, agreeing that the holder of the marketing authorization for Angong Niuhuang Wan has been changed from Liaoning Hancaotang to Buchang Pharmaceutical. This change will not have a significant impact on the company’s current production and operation, but it will help expand the company’s business, enrich its product line, and enhance its market competitiveness. The specific sales of drugs in the future may be affected by factors such as industry policies and changes in the market environment, and there is uncertainty. 21 Comments: In April 2023, Buchang Pharmaceutical announced that it plans to acquire the drug production technology of Angong Niuhuang Wan owned by Liaoning Hancaotang for 8.4 million yuan. In recent years, the sales volume and sales of Angong Niuhuang ...
- Source: drugdu
- 50
- March 20, 2025
Haimeng Zhisen Biotechnology and Sichuan Taiji Pharmaceutical were suspended from national centralized procurement for 18 months

According to the website of the National Healthcare Security Administration on the 17th, the National Joint Procurement Office for Drugs issued the “Announcement on Cancelling the Qualification of Sichuan Haimeng Zhisen Biopharmaceutical Co., Ltd. for Phloroglucinol Injection and Listing the Company and the Product Manufacturer Taiji Group Sichuan Taiji Pharmaceutical Co., Ltd. on the Violation List” on the 17th. The announcement shows that the phloroglucinol injection produced by Sichuan Haimeng Zhisen Biopharmaceutical Co., Ltd. on behalf of Taiji Group Sichuan Taiji Pharmaceutical Co., Ltd. is the selected drug in the tenth batch of national centralized drug procurement, which has not yet been implemented. According to the supervision and inspection notice issued by the Sichuan Provincial Drug Administration on March 17, 2025, the holder Sichuan Haimeng Zhisen Biopharmaceutical Co., Ltd. failed to effectively monitor the production process of the entrusted production enterprise, and the entrusted production enterprise Taiji Group Sichuan Taiji ...
- Source: drugdu
- 57
- March 20, 2025
the latest progress and clinical potential of EZH2 inhibitors

The traditional view is that cancer originates from the accumulation of somatic mutations, but many studies in recent years have found that epigenetic abnormalities are an important factor leading to tumorigenesis. At present, epigenetic changes can be used as biomarkers for cancer and can even be targeted by cancer treatment. As an important role in the epigenetic modification process, EZH2 has multiple targeted drugs approved for marketing and entered the late clinical stage, and has become a highly concerned anti-tumor target. Close connection between EZH2 gene and cancer The Zeste enhancer homolog 2 (EZH2) gene is one of the important members of the PcG family of epigenetic regulatory factors, and is also the catalytic subunit of Polycomb Repressive Complex 2 (PRC2). It plays a vital role in the H3 methylation pathway and plays an important role in the epigenetic modification process. Studies have found that EZH2 expression is elevated in ...
- Source: drugdu
- 45
- March 20, 2025
JSKN003 Receives Breakthrough Therapy Designation in China

CSPC Pharmaceutical Group announced that JSKN003 (an antibody-drug conjugate targeting HER2 dual epitopes) developed by its subsidiary Shanghai Jinman Biotechnology Co., Ltd. and Jiangsu Alphamab Biopharmaceuticals Co., Ltd. has been granted Breakthrough Therapy Designation by the China National Medical Products Administration. The proposed indication is monotherapy for the treatment of all patients with platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer (“the indication”). The annual incidence of ovarian cancer ranks third among female reproductive system tumors in China, and the mortality rate ranks first among female reproductive tract malignancies. About 70% of patients are in the advanced stage when they seek medical treatment. Tumor cell reduction surgery combined with postoperative platinum-containing chemotherapy is the current main treatment method, but almost all patients eventually develop platinum resistance. For patients with platinum resistance, non-platinum single-agent chemotherapy is the main treatment option recommended by domestic and international guidelines, but ...
- Source: drugdu
- 59
- March 19, 2025
Shapuaisi obtains drug registration certificate for tafluprost eye drops

On March 17, Shapuaisi (603168) issued an announcement that the company recently obtained the “Drug Registration Certificate” for tafluprost eye drops approved and issued by the State Drug Administration. The drug is an ophthalmic preparation with a specification of 0.0015% (0.3ml: 4.5μg) and is registered as Class 4 chemical drugs. The company’s cumulative R&D investment in the drug is approximately RMB 6.46 million. Obtaining a drug registration certificate will help enrich the company’s product categories and optimize product layout. However, the future production and sales of the drug will still face many uncertain factors such as changes in pharmaceutical industry policies, bidding and procurement, and market environment, so there is uncertainty about the impact on the company’s performance. https://finance.eastmoney.com/a/202503173347698684.html
- Source: drugdu
- 55
- March 19, 2025
Huiyu Pharmaceuticals Obtains Drug Registration Certificate for Melphalan Hydrochloride

On March 17, Huiyu Pharmaceuticals issued an announcement that the company recently received the “Drug Registration Certificate” for Melphalan Hydrochloride for Injection approved and issued by the State Drug Administration. The registration classification of this drug is Class 4 chemical drugs, the specification is 50mg, and the drug validity period is 18 months. The registration certificate number is 2025S00720, and the drug approval number is National Medicine Standard H20253620. Melphalan is suitable for high-dose pretreatment and palliative treatment of patients with multiple myeloma. According to Minnet data, the sales of melphalan hydrochloride for injection in terminal hospitals in urban public hospitals in China in the first half of 2024 were approximately 86 million yuan. The company is the second company deemed to have passed the consistency evaluation of generic drug quality and efficacy. It is expected that drugs that have passed the consistency evaluation will receive greater support in areas ...
- Source: drugdu
- 50
- March 19, 2025
Two drugs were included in the “Rare Disease Drug Development “Care Plan”

Recently, according to the official website of CDE, Hydroxocobalamin Injection of China Resources Double Crane and Fitusiran Injection of Genzyme Corporation were included in the pilot project of the “Patient-centered Rare Disease Drug R&D Pilot Work Plan (“Care Plan”)”. 1. Hydroxocobalamin Injection Variety name: Hydroxocobalamin injection Applicant: China Resources Double Crane Pharmaceutical Co., Ltd. Indications: This drug is suitable for the treatment of metabolic disorders in children with methylmalonic acidemia (MMA) with or without homocystinemia. Application stage: Phase A – R&D project establishment stage. Key points: During the R&D project establishment stage, detailed patient survey questionnaires will be collected to provide a basis for subsequent drug development, dosage forms, etc.; at the same time, the data on the natural history of MMA disease will be further enriched. 2. Fitusiran Injection Product name: Fitusiran injection Applicant: Genzyme Corporation Indications: This product is indicated as a routine preventive treatment for adult patients ...
- Source: drugdu
- 53
- March 19, 2025

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