[Translation] A double-blind, randomized, placebo-controlled, multicenter clinical study to evaluate the efficacy and safety of standard plus meldonium in the treatment of patients with chronic ischemic heart failure

主要目标：评估标准治疗加米屈肼相比较于标准治疗加安慰剂治疗慢性缺血性心衰病人 (NYHA II- III 级）的疗效次要目标：评估米屈肼治疗慢性缺血性心衰病人的安全性

[Translation]

Primary objective: To evaluate the efficacy of meldonium plus standard therapy compared with standard therapy plus placebo in patients with chronic ischemic heart failure (NYHA class II-III) Secondary objective: To evaluate the safety of meldonium in patients with chronic ischemic heart failure

Start Date14 Jul 2014

Sponsor / Collaborator

Jsc Grindeks

[+1]

CTR20131432 / Active, not recruitingPhase 1

米屈肼注射液人体药代动力学试验

[Translation] Pharmacokinetics of meldonium injection in humans

本次试验的目的是对米屈肼注射液进行人体药代动力学研究，研究米屈肼注射液在健康受试者中单次和多次给药的药代动力学研究，以了解米屈肼注射液在中国人体内的药代动力学规律，为临床研究给药方案提供依据。

[Translation]

The purpose of this trial is to conduct a human pharmacokinetic study on meldonium injection, to study the pharmacokinetics of meldonium injection after single and multiple doses in healthy subjects, so as to understand the pharmacokinetic laws of meldonium injection in Chinese people and provide a basis for the dosing regimen of clinical research.

Start Date04 Jun 2013

Sponsor / Collaborator

Jsc Grindeks

[+1]

100 Clinical Results associated with Meldonium hydrate

100 Translational Medicine associated with Meldonium hydrate

100 Patents (Medical) associated with Meldonium hydrate

832

Literatures (Medical) associated with Meldonium hydrate

01 Oct 2024·Fish & Shellfish Immunology

Involvement of mitochondrial fatty acid β-oxidation in the antiviral innate immune response in head kidney macrophages of large yellow croaker (Larimichthys crocea)

Article

Author: Zhao, Zengqi ; Liu, Qiangde ; Tang, Yuhang ; Chen, Zhiwei ; Li, Yueru ; Zhou, Yan ; Ai, Qinghui ; Wu, Caixia ; Pan, Shijie ; Wang, Haoran ; Mai, Kangsen ; Zhang, Jinze

As a vital pathway for cellular energy production, mitochondrial fatty acid β-oxidation (FAO) is essential in regulating immune responses to bacterial pathogens and maintaining intracellular homeostasis in vertebrates. However, the specific role of FAO in antiviral innate immune response in macrophages remains insufficiently understood. In this study, virus infection simulated by poly(I:C) inhibited FAO, as indicated by the reduced expression of FAO-related genes and proteins in the head kidney of large yellow croaker, with similar results observed in poly(I:C)-stimulated macrophages. Then, inhibition of FAO by supplementary mildronate in vivo and etomoxir treatment in vitro revealed varying increases in the mRNA expression of antiviral innate immune response genes after stimulated by poly(I:C) in the head kidney and macrophages. Notably, etomoxir significantly facilitated the transcriptional up-regulation of the IFNh promoter by IRF3. Moreover, inhibiting FAO by knockdown of cpt1b promoted antiviral innate immune response triggered by poly(I:C) in macrophages. Conversely, activating FAO through overexpression of cpt1b or cpt2 significantly reduced the mRNA levels of antiviral response genes in macrophages stimulated by poly(I:C). Unlike etomoxir, cpt1b overexpression inhibited the transcriptional up-regulation of the IFNh promoter by IRF3. Furthermore, in vivo dietary palm oil feeding and in vitro exposure to palmitic acid inhibited the antiviral innate immune response triggered by poly(I:C) in the head kidney and macrophages, respectively. These effects were partly associated with FAO activation, as evidenced by etomoxir. In summary, this study elucidates FAO's critical role in regulating antiviral innate immune response in head kidney macrophages. These findings not only deepen insights into the interaction between metabolic remodeling and host immune responses, but also offer valuable guidance for developing nutritional strategies to improve antiviral immunity in aquaculture.

01 Oct 2024·Phytomedicine

Tetrastigma hemsleyanum polysaccharides alleviate imiquimod-induced psoriasis-like skin lesions in mice by modulating the JAK/STAT3 signaling pathway

Article

Author: Chen, Yuchi ; Zhou, Fangmei ; Mao, Zian ; Ding, Zhishan ; Ye, Yujian ; Zhu, Bingqi ; Lv, Yishan ; Yang, Liu ; Zhou, Mingyuan

BACKGROUNDThe pathogenesis of psoriasis involves the interaction between keratinocytes and immune cells, leading to immune imbalance. While most current clinical treatment regimens offer rapid symptom relief, they often come with significant side effects. Tetrastigma hemsleyanum polysaccharides (THP), which are naturally nontoxic, possess remarkable immunomodulatory and anti-inflammatory properties.METHODSIn this study, we utilized an imiquimod (IMQ)-induced psoriasis mouse model and a LPS/IL-6-stimulated HaCaT model. The potential and mechanism of action of THP in psoriasis treatment were assessed through methods including Psoriasis Area Severity Index (PASI) scoring, histopathology, flow cytometry, immunoblotting, and reverse transcription-polymerase chain reaction (RT-PCR).RESULTSPercutaneous administration of THP significantly alleviated symptoms and manifestations in IMQ-induced psoriatic mice, including improvements in psoriatic skin appearance (erythema, folds, scales), histopathological changes, decreased PASI scores, and spleen index. Additionally, THP suppressed abnormal proliferation of Th17 cells and excessive proliferation and inflammation of keratinocytes. Furthermore, THP exhibited the ability to regulate the JAK/STAT3 signaling pathway.CONCLUSIONFindings from in vivo and in vitro studies suggest that THP can inhibit abnormal cell proliferation and excessive inflammation in lesional skin, balance Th17 immune cells, and disrupt the interaction between keratinocytes and Th17 cells. This mechanism of action may involve the modulation of the JAK/STAT3 signaling pathway, offering potential implications for psoriasis treatment.

01 Sep 2024·Pediatric Neurology

Efficacy of Oral Trihexyphenidyl Plus Clonazepam Versus Trihexyphenidyl for the Treatment of Dystonia in Children With Dystonic Cerebral Palsy: An Open-Label Randomized Controlled Trial

Article

Author: Moirangthem, Vetoni ; Kumar Panda, Prateek ; Tomar, Apurva ; Sharawat, Indar Kumar ; Neyaz, Osama

BACKGROUNDTrihexyphenidyl and clonazepam are commonly used to treat dystonia in children with cerebral palsy (CP). However, there is a notable gap in the literature when it comes to studies that combine these first-line agents for the management of dystonia.METHODSThis open-label, randomized controlled trial aimed to compare the efficacy of adding oral clonazepam to trihexyphenidyl (THP + CLZ) versus using trihexyphenidyl alone (THP) in reducing the severity of dystonia, as measured by the Barry-Albright Dystonia (BAD) score. The study was conducted over a 12-week therapy period in children with dystonic CP aged two to 14 years.RESULTSEach group enrolled 51 participants. The THP + CLZ group showed significantly better improvement in dystonia severity at 12 weeks compared with the THP group alone (-4.5 ± 2.9 vs -3.4 ± 1.7, P = 0.02). Furthermore, the THP + CLZ group exhibited superior improvement in the severity of choreoathetosis, upper limb function, pain perception by the child, and quality of life, with P values of 0.02, 0.009, 0.01, and 0.01, respectively. The number of participants experiencing treatment-emergent adverse events was comparable in both groups (P = 0.67). Importantly, none of the participants in any of the groups reported any serious adverse events.CONCLUSIONA combination of oral THP + CLZ proves to be more efficacious than using THP alone for the treatment of dystonic CP in children aged two to 14 years in terms of reducing the severity of dystonia.

News (Medical) associated with Meldonium hydrate

04 Jun 2024

·www.biospace.com

ASCO Data Highlights NeXT Personal® Ultra-sensitive MRD Performance in Early-stage Breast Cancer Recurrence Detection and Immunotherapy Monitoring

Personalis will host a webinar call on June 19th, 2024 at 1:00 p.m. Pacific Time / 4:00 p.m. Eastern Time to present ASCO highlights from the conference FREMONT, Calif.--(BUSINESS WIRE)-- Personalis, Inc. (Nasdaq: PSNL) announced today that data presented at the American Society for Clinical Oncology (ASCO) oral podium talks in Chicago, IL demonstrated that the Personalis NeXT Personal test had exceptional detection rates and performance for early-stage breast cancer and immunotherapy monitoring., Inc. (Nasdaq: PSNL) announced today that data presented at the American Society for Clinical Oncology (ASCO) oral podium talks in Chicago, IL demonstrated that the Personalis NeXT Personal test had exceptional detection rates and performance for early-stage breast cancer and immunotherapy monitoring. The NeXT Personal test is the first of a new class of ultra-sensitive liquid biopsy tests designed to detect the earliest traces of cancer recurrence and monitor a patient’s response to therapy. The test can detect circulating tumor DNA (ctDNA) down to an ultra-sensitive range (<100 parts per million of ctDNA) and the data presented as ASCO highlights the clinical importance of this approach. Earlier and more sensitive detection of recurrence in early-stage breast cancer Breast cancer is currently the most common cancer in the U.S., with an estimated 300,000 new cases and approximately 40,000 deaths forecasted for 2024 according to the U.S. National Cancer Institute (NCI). The current standard of care for relapse detection of breast cancer is primarily imaging such as mammography, which can have limited sensitivity. These studies are focused on addressing this challenge through advanced ctDNA analysis with NeXT Personal. Breast cancer results were presented in an oral presentation by Dr. Isaac Garcia-Murillas and come from a team at the Institute of Cancer Research, London and Royal Marsden NHS Foundation Trust in the UK led by Professor Nicholas Turner, renowned for his work on the use of ctDNA to guide breast cancer treatment. In this study, they found: NeXT Personal’s Ultra-sensitive range enabled earlier detection of recurrence, with a median ~15-month lead time over imaging detection 100% of patients that recurred were detected with NeXT Personal and 100% of patients that were ctDNA negative on longitudinal testing were cancer-free NeXT Personal enabled detection of very low traces of cancer, with ~39% of all detections falling in the ultra-sensitive range below 100 PPM (below 0.01% of ctDNA) NeXT Personal enabled substantially better sensitivity and lead times compared to other MRD assays on the same patient cohort Dr. Garcia-Murillas noted, “NeXT Personal demonstrated the best MRD performance we have seen in this study cohort. With the ultra-sensitive performance of NeXT Personal, we see strong opportunities to impact breast cancer care and management, especially for the escalation and de-escalation of treatment.” Additional breast cancer results presented at ASCO include a poster presentation by Dr. Adrienne Waks at the Dana Farber Cancer Institute using NeXT Personal to assess neoadjuvant therapy response in the DAPHNe HER2+ breast cancer trial. In this study, NeXT Personal demonstrated high baseline sensitivity (92%) for ctDNA for HER2+ breast cancer patients enabled by the ultra-sensitivity of the test with 27% of detections in the ultra-sensitive range. NeXT Personal was also able to demonstrate neoadjuvant THP treatment effectiveness by showing the treatment had cleared the tumor MRD. Strong performance in immunotherapy monitoring Several hundred thousand cancer patients are put on immunotherapy treatment annually. While over 40% of patients with cancer are eligible for immunotherapy, only ~12% of patients respond, underscoring the need for a blood test that monitors treatment response for patients, doctors, and payers. An oral presentation showed the importance of NeXT Personal’s use for immunotherapy monitoring. Dr. Rodrigo Toledo at the Vall d'Hebron Institute of Oncology (VHIO) presented data in an oral presentation that demonstrated that the baseline levels and the changes in levels of ctDNA detected by NeXT Personal are highly predictive of therapy response and clinical outcomes for late-stage cancer patients receiving immunotherapy. This includes the finding that patients who had a significant decrease in ctDNA levels from baseline to the third cycle of immunotherapy had overall survival that was more than two times longer than those who did not. They also demonstrated that NeXT Personal had an average lead time for detecting progression of 81 days over imaging. The VHIO data is a broad study that included patients across 18 different solid tumor types. “The changes in ctDNA levels elucidated by the NeXT Personal test can dramatically enhance our ability to understand if late-stage cancer patients are responding to their therapy. This is critical to optimally managing immunotherapy and other treatments for these very sick patients,” said Dr. Toledo. Additional results presented at ASCO include a poster presentation by Professor Andy Nixon at the Duke Cancer Institute in late-stage esophagogastric cancer that received immunotherapy in combination with chemotherapy as part of the KeyLargo trial. In this study, Dr. Nixon found that ctDNA levels were demonstrated to be highly prognostic for therapy response. In late-stage cancer patients, ctDNA levels can be very low with ~20% of samples falling in the ultra-sensitive range, underscoring the importance of an ultra-sensitive test like NeXT Personal. “With the addition of the ASCO data, we now have presented data across lung cancer, breast cancer, and patients on immunotherapy that consistently highlight the importance of an ultra-sensitive MRD platform like NeXT Personal to detect recurrence earlier, monitor therapy response, and more accurately predict clinical outcomes for cancer patients,” said Dr. Richard Chen, Chief Medical Officer and EVP of R&D at Personalis. “We also expect the strong performance in these studies will help drive clinical adoption and reimbursement of NeXT Personal.” Personalis will host a webinar call on June 19th, 2024 at 1:00 p.m. Pacific Time / 4:00 p.m. Eastern Time to present ASCO highlights from the conference. Webcast and Conference Call Information To receive the dial-in instructions, please email investors@personalis.com. About Personalis, Inc. At Personalis, we are transforming the active management of cancer through breakthrough personalized testing. We aim to drive a new paradigm for cancer management, guiding care from biopsy through the life of the patient. Our highly sensitive assays combine tumor-and-normal profiling with proprietary algorithms to deliver advanced insights even as cancer evolves over time. Our products are designed to detect minimal residual disease (MRD) and recurrence at the earliest time points, enable the selection of targeted therapies based on ultra-comprehensive genomic profiling, and enhance biomarker strategy for drug development. Personalis is based in Fremont, California. To learn more, visit and connect with us on LinkedIn and X (Twitter). Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements in this press release that are not historical are “forward-looking statements” within the meaning of U.S. securities laws, including statements relating to the attributes, advantages, sensitivity or clinical relevance of the NeXT Personal test. Such forward-looking statements involve known and unknown risks and uncertainties and other factors that may cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements, including the risks, uncertainties and other factors that relate to the ability of NeXT Personal to detect cancer recurrence early, monitor a patient’s response to therapy or more accurately predict clinical outcomes for cancer patients, or the clinical adoption or use of, or reimbursement for, the NeXT Personal test. These and other potential risks and uncertainties that could cause actual results to differ materially from the results predicted in these forward-looking statements are described under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Personalis’ Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission (SEC) on February 28, 2024, and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, filed with the SEC on May 8, 2024. All information provided in this release is as of the date of this press release, and any forward-looking statements contained herein are based on assumptions that we believe to be reasonable as of this date. Undue reliance should not be placed on the forward-looking statements in this press release, which are based on information available to us on the date hereof. Personalis undertakes no duty to update this information unless required by law.

ASCOClinical ResultImmunotherapyClinical Study

23 Jun 2022

·www.prnewswire.com

Grindeks erweitert sein Angebot an generischen Medikamenten und seine Aktivitäten auf internationalen Märkten

RIGA, Lettland, 23. Juni 2022 /PRNewswire/ -- Grindeks, das führende pharmazeutische Unternehmen in den baltischen Staaten, gibt seine Ziele zur wesentlichen Ausweitung einer Reihe von generischen Expandsand-Aktivitäten auf internationalen Märkten bekannt. Grindeks Expands Range of Generic Medicines and Activities in International Markets Grindeks ist davon überzeugt, dass es ein großes Potenzial hat, den Zugang der Patienten und Patientinnen zu qualitativ hochwertigen und wirksamen Medikamenten für die Behandlung wichtiger Therapierichtungen - ZNS-Erkrankungen, Herz-Kreislauf-Erkrankungen, Diabetes und onkologische Erkrankungen - zu erweitern. Darüber hinaus hat Kalceks, ein Tochterunternehmen von Grindeks, eine überzeugende Ankündigung seiner Präsenz im globalen Wettbewerb im Krankenhaussegment gemacht. In den letzten Jahren ist die Grindeks Group schnell gewachsen und ist zuversichtlich, dass sie im Gegensatz zu den Führern des globalen Pharmamarktes in der Lage ist, schnell und flexibel auf die Bedürfnisse und Anforderungen der Patienten und Patientinnen zu reagieren. Das Unternehmen hat die Prozesse der Arzneimittelentwicklung, des Wissenstransfers und der kontinuierlichen Entwicklung der Infrastruktur erfüllt, um das Portfolio der generischen Produkte zu erweitern. Für das Jahr 2022 plant Grindeks, 18 Generika zur Registrierung anzumelden. Das Tochterunternehmen Kalceks wird 10 Arzneimittel für die Zulassung im Krankenhaussegment anmelden. Die Produktion von pharmazeutischen Wirkstoffen ist ebenfalls sehr wichtig für die Gruppe, da dies einer der Wettbewerbsvorteile von Grindeks ist, der seine Unabhängigkeit von den Rohstoffherstellern erhöht. Das Unternehmen stellt derzeit 25 pharmazeutische Wirkstoffe her, die sehr gefragt sind. 46 neue pharmazeutische Wirkstoffe befinden sich in der Entwicklung. Um die Verfügbarkeit der Medikamente von Grindeks und Kalceks für die Patienten und Patientinnen zu gewährleisten, hat die Gruppe ihre Aktivitäten in der ganzen Welt ausgebaut. Im vergangenen Jahr wurden Grindeks-Produkte in 103 Länder weltweit exportiert. Neben den bereits bestehenden Repräsentanzen und Tochtergesellschaften sollen in diesem Jahr Tochterunternehmen in den USA, der Schweiz und einer Reihe von Ländern der Europäischen Union eröffnet werden. Dr. chem. Juris Hmelnickis, Chairman des Board von Grindeks: „Es gibt keine unerreichbaren Ziele, wenn ein Unternehmen selbstbewusst arbeitet und die Bedürfnisse der Patienten und Patientinnen in den Vordergrund stellt. Grindeks Team hat seine Fähigkeit bewiesen, koordiniert auf ein gemeinsames Ziel hinzuarbeiten. Wir sind von der Erkenntnis geprägt, dass wir etwas besonders Wichtiges für die Gesundheit der Menschheit tun. Es ist ein Aufruf, Menschen zu helfen. Darüber hinaus verfügen wir über Mut, Wissen und Erfahrung. Die Ausweitung des Angebots an Generika und die Ausweitung der Geschäftstätigkeit von Grindeks wird den Patienten und Patientinnen große Vorteile bringen, da die Arzneimittel für sie leichter zugänglich werden." Informationen zur Grindeks Group Grindeks ist ein internationaler Pharmakonzern, der sich auf die Forschung, Entwicklung, Herstellung und den Vertrieb von Originalprodukten, Generika und Wirkstoffen konzentriert. Im Jahr 2021 hat die Gruppe ihre Produkte in 103 Länder exportiert. Die Grindeks Group besteht aus JSC Grindeks und ihren Tochtergesellschaften: JSC Kalceks in Lettland, JSC Tallinn Pharmaceutical Plant in Estland, HBM Pharma s.r.o. in der Slowakei, Grindeks Kalceks Lietuva, Grindeks Kalceks Eesti, Grindeks Kalceks USA und Namu Apsaimniekosanas projekti in Lettland. Die wichtigsten therapeutischen Gruppen von Grindeks sind Herz-Kreislauf-Medikamente, Medikamente für das zentrale Nervensystem, Krebsmedikamente und Diabetesmedikamente. Kalceks ist auf Medikamente für den Krankenhausbereich spezialisiert. Die Produktpalette umfasst die Originalprodukte Mildronate® (Meldonium) und Ftorafur® (tegafur), Generika sowie pharmazeutische Wirkstoffe. Foto - Logo - SOURCE Grindeks

03 Mar 2021

·www.globenewswire.com

In 2020 the “Grindeks” Group has achieved the historically sharpest increase in turnover and profit

In 2020 the “Grindeks” Group has achieved the historically sharpest increase in turnover and profit In 2020 the “Grindeks” Group has achieved the historically sharpest increase in turnover and profit. The consolidated, preliminary financial data of the Group show that in 2020 the turnover of the “Grindeks” Group reached 187.0 million euro, which is 45.6 million euro or 32% more than in 2019. In 2020 the Group’s profit amounted to 19.0 million euro, which is 5.6 million euro or 42% more than in 2019. In 2020 the “Grindeks” Group has strengthened its positions in the global pharmacy market and exported its products to 93 countries for the total amount of 176.1 million euro. The Group offers its products in the pharmacy market under two brands – “Grindeks” and “Kalceks”. Ph. D. Juris Hmelnickis, the Chairman of the Board of JSC “Grindeks” describes the last year as a year of significant changes and achievements: “In 2020 we began introducing new Business strategy until 2025 and made very important steps to change the business organization, work culture and the “Grindeks” brand. It all happened under the complex global situation, which was affected by Covid-19 pandemics. The well-coordinated team work of the Group and the ability to adapt to unexpected situations helped achieving the so far highest turnover and profit indicators. Our goals for 2021 are also ambitious and the current accomplishments give confidence in the future opportunities for “Grindeks” Group.” In 2021 the “Grindeks” Group plans to increase the turnover by 19%. Global expansion in new markets and strengthening positions in the existing markets The sales volume of the Group's final dosage forms in 2020 was 173.6 million euro and has increased compared to 2019 by 41.5 million euro or by 31%. The sales volume in Russia, other CIS countries and Georgia in 2020 amounted to 87.7 million euro, which is 9.8 million euro or 13% more than in 2019. Compared to 2019, in 2020 significant increase of sales volume was achieved – in Uzbekistan by 39%, in Azerbaijan by 22%, in Kirgizstan by 16% and in Kazakhstan by 15%. In 2020 the sales volume of the Group's final dosage forms in the European Union countries, in Great Britain and Norway amounted to 76.9 million euro, which is 26.1 million euro or 52% more than in 2019. In 2020 the sales volume, compared to 2019, in Belgium increased 751 times, in Spain 81 times, in Denmark and Netherlands 5 times, in Finland 3 times, in Latvia by 37%, in Great Britain by 29%, In Estonia by 20%, while in Germany – by 10%. The high sales performance in Belgium and Spain were achieved due to the intense work and business development in the European Union countries of the company “Kalceks”, the subsidiary of “Grindeks”. In 2020 the sales volume of the active pharmaceutical ingredients amounted to 12.5 million euro, which is 3.9 million euro or 46% more than in 2019. The highest volume of the active pharmaceutical ingredients produced by “Grindeks” was exported to EU countries, the USA, Japan and Canada. The strategic goal of the Group is expanding operation in the European Union countries, USA, Japan, South Korea, Australia and New Zealand. Covid-19 obstacles provide new opportunities Similar as other companies, the “Grindeks” Group also rearranged its economic activities in 2020 due to the impact of the spread of Covid-19 virus. In order to overcome the operating obstacles caused by Covid-19, the Group defined three priorities: health protection and safety of the personnel, ensuring health needs of the patients and continued economic activity. Covid-19 pandemics has changed the needs of the patients, therefore, the production process was rearranged to meet the growing demand and allow producing more. The ability to operate under extraordinary situation and quickly respond to growing demand encouraged activity in new markets – Spain, Belgium, Italy, Denmark, Great Britain and other countries. Health care solutions for contemporary requirements and dynamic lifestyle Business strategy 2025 envisages significant expansion of the “Grindeks” product range by adding advanced medicines for treating cardiovascular, central nervous system, oncological diseases and diabetes, as well as “Kalceks” medicines for hospital use. 51 new “Grindeks” and 35 new “Kalceks” medicines are under development. “Grindeks” constantly produces 25 active pharmaceutical ingredients and has accumulated knowledge in the field of active pharmaceutical ingredients business for many years. It is the unique feature and competitive advantage of the Group. Development of this segment increases the independence of the Group from raw material manufacturers, which in the future will result in a benefit of Latvian and even European Union level in patients’ access to medicines. 21 new active pharmaceuticals are under development. Development of the subsidiary “Kalceks” In 2020 JSC “Kalceks”, which is the subsidiary of “Grindeks”, specializing in medicines for hospital use, achieved sharp increase in sales volumes by increasing the number of export countries and introducing new products. In 2020 “Kalceks” products were sold in the amount of 40.7 million euro, which is 24.0 million euro or 2.4 times more than in 2019. In 2020 “Kalceks” medicines were exported to 62 countries and the main sales markets were Spain, Belgium, Israel, Czech Republic and France. Expanding the production infrastructure “Grindeks” has started to develop a project for construction of a new pharmaceuticals production plant in Latvia. The new production plant will be constructed in several stages and will include complex processes of production of active pharmaceutical ingredients and diverse technological equipment. It will be the biggest pharmaceutical production plant in the Baltic region with automated and energy efficient technical solutions. Pharmaceutical forms those are not currently manufactured in Latvia by “Grindeks” will be introduced in production: ampoules, vials, lyophilized vials, eye drops and antibiotics. 800-1000 new jobs will be created in the new plant, which will be located in Asotes Street 2a, Riga. If the construction project will be successfully approved, the construction of the new production plant is due to begin in 2022. Kirovs Lipmans, the Chairman of the Board of JSC “Grindeks” highly rates the performance of “Grindeks” Group in 2020: “Although the situation last year was not simple and easy, “Grindeks” Group has increased its competitiveness in the global pharmaceutical arena by offering effective medicines and useful health care solutions. Business strategy 2025 is being implemented and shows excellent results. I would like to thank the employees and cooperation partners for the achievements!” About “Grindeks” Group “Grindeks” is an international pharmaceutical Group, and its main activities are research, development, production and sale of original products, generic medicines and active pharmaceutical ingredients. The “Grindeks” Group consists of JSC “Grindeks” and its companies: JSC “Kalceks” in Latvia, JSC “Tallinn Pharmaceutical Plant” in Estonia, “HBM Pharma” s.r.o. in Slovakia, LLC “Grindeks Rus” in Russia and LLC “Namu Apsaimniekosanas projekti” in Latvia. Representative offices have been opened in 11 countries. The main therapeutic groups of “Grindeks” are cardiovascular, central nervous system, anti-cancer and diabetes medicines. “Kalceks” specializes in medicines for the hospital segment. The product range consists of the original products Mildronate® (meldonium) and Ftorafur® (tegafur), generics as well as active pharmaceutical ingredients. In 2020 the Group exported its products to 93 countries. Major “Grindeks” markets are the European Union countries, Russia and other CIS countries, Israel, Canada and the USA. Contacts: Laila Klavina, Head of Communications Department of JSC „Grindeks” Phone.: 67083370, 29256012 E-mail: laila.klavina@grindeks.lv

Generic Drug

100 Deals associated with Meldonium hydrate

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KEGG	Wiki	ATC	Drug Bank
-	Meldonium hydrate	C01EB22	DB13723

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Alcoholism	-	-	-
Myocardial Ischemia	-	-	-

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Heart Failure	Phase 2	CN	Nanjing Huaxin Biopharmaceutical Co.	03 Apr 2014
Cerebrovascular Disorders	Phase 2	CN	Jiangsu Yangtze River Pharmaceutical Group Co., Ltd.	10 Jan 2014
Myocardial Ischemia	Phase 2	CN	Shandong Chengchuang Pharmaceutical R&D Co., Ltd.	07 May 2008
Alcoholism	Phase 1	CN	Yangtze River Pharmaceutical Group Beijing Haiyan Pharmaceutical Co., Ltd.	10 Jan 2014
Malnutrition	Phase 1	CN	Yangtze River Pharmaceutical Group Beijing Haiyan Pharmaceutical Co., Ltd.	10 Jan 2014
Retinal Vascular Disorder	Phase 1	CN	Yangtze River Pharmaceutical Group Beijing Haiyan Pharmaceutical Co., Ltd.	10 Jan 2014
Chronic heart failure	Phase 1	CN	Nanjing HUAXIN Biopharm. Co., Ltd.	12 Sep 2010
Chronic heart failure	Phase 1	CN	Jsc Grindeks	12 Sep 2010
Heart Failure	Preclinical	CN	Nanjing Huaxin Biopharmaceutical Co.	03 Apr 2014

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