A Multicenter, Randomized, Parallel, Controlled, Prospective, Open-label Study of the Efficacy and Safety of Longidaze Lyophilisate for Solution for Injections and Rectal Suppositories 3,000 IU in the Combined Treatment of Patients With Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia

The goal of this clinical trial is to learn if Longidaze works to treat lower urinary tract symptoms in adult males with benign prostatic hyperplasia. It will also learn about the safety of Longidaze. The main question it aims to answer is:
* Does addition of Longidaze to tamsulosin lower the severity of symptoms assessed by International Prostate Symptom Score?
* What medical problems do participants have under the combined treatment by Longidaze and tamsulosin?
Researchers will compare combined therapy (Longidaze + tamsulosin) with monotherapy (tamsulosin only) to see if the combination works better.
Participants will:
* Take tamsulosin (0.4mg) every day for 130 days
* In combined therapy arm -- make intramuscular injections of Longidaze every 5 days (5 injections); then apply Longidaze rectal suppositories every 3 days (10 applications); then apply Longidaze rectal suppositories every 7 days (10 applications)
* Visit the clinic on day 1, 26±1, 60±1, 130±3 for checkups and tests

开始日期2023-03-20

申办/合作机构

NPO Petrovax Pharm Ltd.

NCT06385821 / Completed临床3期

Multicenter, Double-blind, Randomized, Parallel Group Study to Evaluate the Immunogenicity, Reactogenicity and Safety of the Grippol® Quadrivalent Vaccine in Children Aged 6 Months to 5 Years (Inclusive)

The goal of this clinical study is to prove the no less immunogenicity of the Grippol Quadrivalent vaccine compared to the Grippol plus vaccine in children aged 6 months to 5 years (inclusive) for three identical strains of the compared vaccines in terms of the "proportion of vaccinated with seroconversion in paired sera of the hemagglutination inhibition reaction obtained before and after vaccination".

开始日期2022-09-21

申办/合作机构

NPO Petrovax Pharm Ltd.

NCT05975879 / CompletedN/A

Multicenter, Prospective, Double-blind, Placebo-controlled, Randomized Study of the Feasibility of Using the Dietary Supplement "ARTNEO®", Capsules for Oral Administration in Patients With Stage II-III Primary Knee Osteoarthritis

The goal of this clinical study is to evaluate the effectiveness of the properties that support the functional state of the joints and the safety of the dietary supplement for food ARTNEO®, oral capsules, in patients with stage II-III primary osteoarthritis of the knee joint.
The main questions it aims to answer are:
1. To evaluate the effectiveness of the joint functional state-supporting properties of dietary supplement ARTNEO®, capsules for oral administration, in patients with stage II-III primary osteoarthritis of the knee joint;
2. To evaluate the safety of dietary supplement ARTNEO®, capsules for oral administration, in patients with stage II-III primary osteoarthritis of the knee joint.
Participants will be randomly distributed equally among two groups:
* Group 1 "ARTNEO" (106 people): patients take the study dietary supplement ARTNEO®, 1 capsule 1 time per day for 6 months;
* Group 2 "Placebo" (106 people): patients take placebo 1 capsule 1 time per day for 6 months.

开始日期2022-05-31

申办/合作机构

NPO Petrovax Pharm Ltd.

100 项与 NPO Petrovax Pharm Ltd. 相关的临床结果

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0 项与 NPO Petrovax Pharm Ltd. 相关的专利（医药）

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项与 NPO Petrovax Pharm Ltd. 相关的文献（医药）

Epidemiology and Vaccinal Prevention

Review of Grippol Family Vaccine Studies and Modern Adjuvant Development

作者: Volkova, N. V. ; Bykov, A. S. ; Karaulov, A. V.

Relevance. Vaccination remains the basis for the prevention of the most severe infectious diseases, including the prevention of influenza. The large number of vaccines have been developed and applied currently. The role of adjuvant vaccines is growing. Aims: To look back to the history of adjuvant vaccines and review the literature on clinical trials of influenza vaccines Grippol family. Conclusions: This review summarized principal data on adjuvanted vaccines containing Polyoxidonium as adjuvant which has been used for the production of Grippol family vaccines for more than 22 years. Grippol family vaccines show a high safety profile and good immunogenicity for vaccineers, including those with low responsiveness. In 2008 the vaccine Grippol® plus was approved in Russia. It contains a reduced antigen doses and adjuvant Polyoxidonium, but unlike the vaccine Grippol® is free from preservative thiomersal. There are no serious post-vaccination events, unexpected reactions, post-vaccinal complications to the vaccine were reported for Grippol regardless of the examined contingent. The Grippol® plus vaccine effectively induces the immune response. Adjuvanted lowdosed vaccines Grippol® and Grippol® plus are proved to be safe and effective and to have a good prophylactic efficacy being applied for mass immune prophylaxis. In 2018 new tetravalent influenza vaccine of Grippol family – Grippol® Quadrivalent was approved in Russia. Clinical studies (Phase I-II-III) have shown that the vaccine meet the immunogenicity criteria for inactivated influenza vaccines. Phase 3 clinical trials to expand the indications are continuing. The polymer adjuvant in the vaccine is shown to provide a high immunogenicity of low doses of subunit antigens; all Grippol family vaccines have a high safety profile; the dose reduction of viral antigens reduces the risk of adverse reactions for immunized. The adjuvant in the vaccine effectively stimulates an immune response and has no negative impact on the human health. The physicochemical properties of Polyoxidonium (INN: Azoximer bromide) let to consider Polyoxidonium as an universal adjuvant for different antigens.

项与 NPO Petrovax Pharm Ltd. 相关的新闻（医药）

2023-12-09

·生物制药小编

“一哥”恒瑞携手的俄罗斯药企，揭露出一段苏联往事

近日（12月6日），根据俄罗斯《生意人报》的消息，中国江苏恒瑞医药股份有限公司与俄罗斯制药企业Petrovax就多种抗癌药物的购销及后续国产化问题达成协议，《生意人报》指出，此次出口到俄罗斯的主要是恒瑞的PD-1单抗卡瑞利珠单抗。就在2022年俄乌冲突爆发之后，辉瑞、诺华、赛诺菲、默沙东等多家国际制药公司暂停了对俄投资，也暂停开展新的临床试验。包括中国在内的亚洲制药企业目前正在积极进军俄罗斯市场，以取代国际厂商。对此，俄罗斯制药企业Petrovax总裁齐费罗夫认为，3-4年后，中国公司将能够成为新分子领域的绝对领军者。那么这家接下了恒瑞协议的俄罗斯药企究竟是何方神圣？合作方Petrovax的过往历史一些人曾经调侃，俄罗斯的研究需要找苏联考古。而事实确实有些接近，Petrovax的发展和苏联时代的研究密不可分。在苏联20世纪70年代和80年代进行的研究中，苏联的研究人员旨在通过天然和合成的聚合化合物azoximer bromide来增强对感染的免疫反应。当时因为发表刊物几乎都在俄语期刊上，因此受限于国际环境，研究也没有得到国际认可。而后来，由于戈尔巴乔夫上台，削减了免疫学研究所的预算，使得研究也就此停摆，其实那时对先导化合物azoximer bromide的研究进展已经相当顺利，开展了一系列临床前和临床研究。而在苏联解体到1996年之间的混乱时期，虽然研究已经停摆，但是仍然有一群科学家很好地守护了知识产权，最后，负责开发azoximer bromide的团队在Arkady Nekrasov教授的领导下成立了第一家俄罗斯本土商业制药公司Petrovax NPO。后来，成功商业化的azoximer bromide（商品名：Polyoxidonium）作为一种免疫调节剂而在多种领域得到应用，就包括成人继发性免疫缺陷疾病，包括急性和复发性感染、过敏、败血症、手术后并发症和治疗诱导的免疫缺陷。而病毒感染之类的问题也用得上，因此也可以看到新冠疫情时俄罗斯仍然有采用azoximer bromide治疗新冠的用途。而从机理上来看azoximer bromide显然是很好的免疫佐剂，因此这一团队又在这基础上衍生出了流感疫苗Grippol家族，开发了多价形式的流感疫苗包括Grippol， Grippol plus， pandemic MonoGrippol plus和Grippol Quadrivalent。而后Polyoxidonium和Grippol均出口到了欧盟市场。有趣的是，除了自身产品的License-out，在2010后的这家公司代理产品也日趋增多，这家公司还引进了辉瑞的Prevenar 13肺炎疫苗和勃林格殷格翰的溶栓药物Metalyse和替奈普酶，在新冠疫情时，还和我国的康希诺就新冠疫苗达成了合作。这家公司后期的发展也更加多元化，保健品，医美，膳食补充剂等领域均有涉足，例如保健品就有俄罗斯版本的脑白金（Velson）。总结总的来说，Petrovax公司和其幕后苏联科学家保护药物知识产权的举动值得尊敬，而Petrovax在此次合作上，此前已有代理其他国家产品的经验，公司规模和体量不小，可以期待这家公司在俄罗斯本土进行卡瑞利珠单抗的临床注册更为顺利，惠及俄罗斯患者，打开广阔市场。参考来源：https://www.epidemvac.ru/jour/article/view/794https://petrovax.com/medication/catalog/velson/https://en.wikipedia.org/wiki/Azoximer_bromide

疫苗引进/卖出并购临床研究

100 项与 NPO Petrovax Pharm Ltd. 相关的药物交易

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药物(靶点)	适应症	全球最高研发状态

Quadrivalent adjuvanted subunit inactivated influenza vaccine(Petrovax Pharm)	流感病毒感染更多	批准上市
阿佐西姆牛透明质酸酶 ( Hyaluronic acid )	增生更多	批准上市
干扰素α-2b生物类似药(Petrovax Pharma) ( IFNAR )	丙型肝炎更多	无进展
Azoximer bromide	新型冠状病毒感染更多	无进展