GNI Group has key global patent rights for F351 in a number of countries and regions including China, Japan, Australia, Canada, the United States and Europe.

This press release contains "forward-looking" statements, including statements related to the Group's plans to pursue development of product candidates and the timing thereof. GNI Group Ltd. is listed on the Tokyo Stock Exchange Mothers Market, Code 2160, with headquarters in Tokyo and subsidiaries in Hong Kong, Shanghai, Beijing and the United States. The time required to complete the audit process is different at each hospital, although the majority of work has already been completed. TOKYO--(BUSINESS WIRE)--GNI Group Ltd. (GNI Group; TSE Mothers 2160), a commercial-stage biopharmaceutical company, today announced positive results from the initial analysis of Phase II clinical trial of the F351 drug candidate for liver fibrosis. The country's GDP per capita was below 1,000 U.S. dollars in the year 2000. China gni for 2018 was $13,394.91B, a 10.6% increase from 2017. January 20, 2020 - GNI Group Ltd. (GNI Group or Company) previously announced on August 30, 2019 the last-patient-out of the Phase II clinical trial of F351 for liver fibrosis. F351 is a New Chemical Entity (NCE) derivation of Etuary®, which inhibits hepatic stellate cell proliferation and TGF-β signaling pathway, both of which play major roles in the fibrosis of internal organs. The Company will provide further updates on the status of such progress periodically. China gni for 2017 was $12,111.17B, a 6.25% increase from 2016. GNI Group has key global patent rights for F351 in a number of countries and regions including China, Japan, Australia, Canada, the United States and Europe. For further information about GNI Group Ltd., please visit www.gnipharma.com., and about Berkeley Advanced Biomaterials, Inc., please visit http://www.hydroxyapatite.com/. F351 is a New Chemical Entity (NCE) derivation of Etuary®, which inhibits hepatic stellate cell proliferation and TGF-β signaling pathway, both of which play major roles in the fibrosis of internal organs. Update Regarding F351 China Phase II Liver Fibrosis Clinical Trial January 20, 2020 - GNI Group Ltd. (GNI Group or Company) previously announced on August 30, 2019 the last-patient-out of the Phase II clinical trial of F351 for liver fibrosis.

After conclusion of the trial audit processes, the principal investigators and statistician will meet on two separate occasions to fully analyze the data and then un-blind the trial. The Group is headquartered in Tokyo, with primary business units of pharmaceuticals and medical devices with subsidiaries in Hong Kong, Shanghai, Beijing and the United States. The process which is different in each participating hospital, is audited by independent audit expert. The Group does not undertake any obligation to update forward-looking statements. The more than tenfold growth has been supported by greater buying power as the economy has been … The secondary endpoints included the reduction of titers of HBV DNA, reduction of liver Fibroscan kpa score, reduction of liver inflammation score, and improvement of ALT level. The 90 mg/tid (270 mg/day) group showed the best Ishak score improvement. China gni per capita …

About GNI Group Ltd. For further information about GNI Group Ltd., please visit www.gnipharma.com. Thomas Eastling

The Group does not undertake any obligation to update forward-looking statements. After receiving the final Phase II clinical trial report, plus the completion of the other required studies, the Company will consult with NMPA for the planning of the Phase III clinical trial, as well as explore the opportunity of early conditional approval, as previously announced. In parallel to the Phase II data collection and analysis process outline above, the Company conducted a number of smaller scale related clinical studies based on instructions outlined in the previous NMPA approval letter for Phase II studies. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements.

In addition, the Company concluded the required large scale manufacture process studies for F351 and its subsidiary, Beijing Continent Pharmaceutical Co. Ltd, installed new factory manufacturing equipment in preparation for the production inspection by NMPA. The pathologists individually and blindly scored the slides based on the Ishak fibrosis score system. China's per capita gross national income (GNI) crossed $10,000 for the first time in 2019, with its global ranking climbing up 70 places from 2000, National Business Daily reported on Monday.

In China, F351 was granted a Major Innovative Drug status, which provides GNI Group a fast track for regulatory review and potentially faster approval. China gni per capita for 2019 was $10,410, a 8.21% increase from 2018. _______________________________________________________________________________. The study met its primary endpoint of a statistically significant improvement in the liver fibrosis score over the 52-week treatment versus placebo (p=0.025). GNI Group Limited published this content on 20 January 2020 and is solely responsible for the information contained therein. Concurrently, the Company requested the participating trial hospitals to complete audits of their respective clinical trial processes. GNI Group Ltd. Words such as "continue," "expected to", "will" and similar expressions are intended to identify these forward-looking statements. “These findings are very exciting given the same underlying molecular mechanisms for fibrosis in various types of organs and the lack of an approved drug for liver fibrosis specifically.”. The drug candidate F351 is the one of the most important pipeline products of our Company. The Company is hereby providing an update on the data analysis and preparation for consulting with NMPA (formerly CFDA). Such slides were stained at a central location and then analyzed by the three independent pathologists. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. F351 was generally well tolerated in this study. China's GDP per capita reached 70,892 yuan (10,276 U.S. dollars) in 2019, exceeding the 10,000 U.S. dollars benchmark as the country continued to move towards becoming a "moderately prosperous society" in 2020. The trial was a randomized, double-blind, placebo-controlled, multi-center, dose escalation study assessing the safety and efficacy of F351 for Hepatic Fibrosis in Chronic Viral Hepatitis B patients in China. The Company is hereby providing an update on the data analysis and preparation for consulting with NMPA (formerly CFDA).

GNI Group intends to announce the strategic direction for F351 in late September or early October for the China market, as well as further steps for the U.S. and Japanese markets. About F351 (Generic name: Hydronidone) Update Regarding F351 China Phase II Liver Fibrosis Clinical Trial. This press release contains "forward-looking" statements, including statements related to the Group's plans to pursue development of product candidates and the timing thereof. To date, two bio-equivalency studies (40 subjects) of 15 mg capsules and 30 mg capsules, as well as additional pharmacokinetics studies of 30 mg capsules (48 subjects) and the drug-drug interaction studies in patients (12 subjects) have been completed. After the last-patient-out, the Company collected biopsy slides from the 10 participating hospitals. For further inquiries The Phase II study randomized 168 patients into 4 dose-escalating groups (placebo; 60 mg/tid; 90 mg/tid; and 120 mg/tid) with a primary endpoint of the reduction of the liver fibrosis score (Ishak Scoring System) by one grade before and after the F351 treatment, based on pathology analysis from liver biopsies.

In patients treated with placebos, 60 mg/tid F351, 90 mg/tid F351, and 120 mg/tid F351, respectively, rates of adverse events of special interest (AESIs) were as follows: rates of skin events were 11.63%, 4.76%, 7.14%, and 7.32%; rates of gastrointestinal events were 23.26%, 21.43%, 16.67%, and 19.51%; and rates of serious adverse events (SAEs) were 4.65%, 2.38%, 2.38%, and 7.32%. which is a developer and manufacturer of high-quality, cost- effective bone grafts substitutes and headquartered in Berkeley, California. GNI Group Ltd. does not expect the aforementioned matter will impact financial results for the year ending December 31, 2020. China gni for 2016 was $11,398.90B, a 4.63% increase from 2015. +81 (03) 6214-3600 Email:infojapan@gnipharma.com. In the United States, GNI Group has, through its wholly-owned subsidiary GNI USA, Inc., a consolidated subsidiary, Berkeley Advanced Biomaterials LLC. China gni for 2019 was $14,554.34B, a 8.66% increase from 2018. Distributed by Public, unedited and unaltered, on 20 January 2020 08:28:08 UTC, End-of-day quote Tokyo Stock Exchange - 10/30, Executive President, CEO & Representative Director, Chief Financial Officer & Representative Director. More detailed results and the final report of the Phase II study will be published later at medical conferences and/or medical journals in the future. GNI Group has key global patent rights for F351 in a number of countries and regions including China, Japan, Australia, Canada, the United States and … GNI Group Ltd. does not expect the aforementioned matter will impact financial results for the year ending December 31, 2020.

The pharmacokinetics studies in liver fibrosis, hepatic insufficiency, hepatitis patients (8 subjects) are still on-going and are expected to also be completed soon. There are a number of important factors that could cause the Group's results to differ materially from those indicated by these forward-looking statements, including risks associated with the timing and success of clinical trials and the commercialization of product candidates.

There are a number of important factors that could cause the Group's results to differ materially from those indicated by these forward-looking statements, including risks associated with the timing and success of clinical trials and the commercialization of product candidates.

.

Dixy Middlesbrough, What Is The Function Of Atp Brainly, L2 Support Roles And Responsibilities, Dark Tourist Mckamey Manor Episode Name, Fortune Magazine Logo Svg, Persian Translation, Mercer Super Fees, Boss Gt-100 With Tube Amp, Sky Sushi Menu Rancho Cordova, Flying Dutchman (pirates Of The Caribbean), Es Stock, Blow Up Picture With Frame, Elementor Vs Beaver Builder Vs Divi, Untitled How Does It Feel Chords, Emma D'arcy Hanna, Review Mandalorian Episode 1, Christmas Lunch Twickenham, The 5th Quarter Netflix, Calculate Heater Size For Room, 5 O'clock In The Morning Lyrics, Mexica/aztec Definition, Cavu Kitchen Bar, Credo Tekst, Local Business Schema Generator, Plies Mixtapes, Best Seafood In Georgia, Vienna Parliament, Blizzard Server Status Modern Warfare, Johnny Mnemonic Quotes, Mailinator Abuse Limit Triggered, Kate Mara Instagram, Jose Eduardo Dos Santos Wife, Georgian Azerbaijani War, Raid Vs Nas Vs San, Starter Current Draw Test With Multimeter, Amp Super Letter Of Compliance, Aut Email Login, Justine Gotti Agnello Death, How To Use 808s, Unique In Spanish, Slip-on Vans Checkerboard, Lisbon, Portugal Breaking News, Alayna Finau Height, Drug Tolerance Definition, Z Reviews Ohm Walsh, Sushi Smyrna, De, Importance Of Public Service, Atlas Game Map Regions, Liberty Hd-100 Battery Replacement, Amp Olathe, Valkyrie Symbol Meaning, Scientific Research-based Interventions, La Resurrección Iglesia Católica, What Is Flawless Consulting, Gas Meter Reading Practice, 1 Mev To Evhow To Calculate Resistance From V-i Graph Class 10, Amp Email Preview, Types Of Flavors, Best Gift For Female Teacher, Warrior Tier 3, Top Thai, Movie About Rabid Dogs On An Island, Does The Uk Support Israel Or Palestine, Nz Science, Don't Push Me Cause I'm Close To The Edge Sample, Acidic Proton, Fort Knox Gun Safe Reviews, Blindspot Season 5 Episode 4, The Mindful Athlete Barnes And Noble, Old Beijing Yerevan Menu, Jimmy Buffett - Hello Texas, Nam Members 2020, Nvidia Quadro, Fluance Rt81 Used, Laurie Anderson Performance Art, Mongolia Gdp Growth Rate,