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Sep, 2021
14
Evergreen Therapeutics' COVID-19 Drug EG-009A has been cleared to proceed to phase II clinical trials in India
Evergreen Therapeutics Inc. (hereinafter referred to as "Evergreen Therapeutics" or "Evergreen") announced on September 14, 2021 that DCGI, the Indian regulatory authority, has officially approved the phase II clinical trial of EG-009A for COVID-19 in India.EG-009A is one of Evergreen's 13 R&D pipelines and will be used to treat Cytokine Release Syndrome (CRS) caused by COVID-19 infections. India is one of the major regions where the Delta variant of COVID-19 is prevalent, and the phase II clinical trial was approved to understand the efficacy of EG-009A in patients with moderate to severe COVID-19 caused by the Delta variant. It is understood that this is the world's first clinical trial with COVID-19 Delta variant as the main research target, so it has a great clinical significan
Aug, 2021
10
The U.S. FDA Has Granted Clearance to Evergreen's EG-007 for Phase III Pivotal Clinical Trial
On August 10, 2021, Shenzhen Evergreen Pharmaceutical Co., Ltd. announced that its innovative drug candidate EG-007 has been approved by the U.S. Food and Drug Administration (FDA) to conduct a phase III pivotal clinical trial in combination with targeted drugs and anti-PD-1 antibody drugs for the treatment of advanced endometrial cancer. The primary objective of this clinical trial is to improve the therapeutic effect/response rate to immunotherapy in patients with advanced endometrial cancer by combining EG-007. The results of this phase III clinical trial will serve as a pivotal trial to provide sufficient evidence for EG-007 to receive global regulatory marketing filing (NDA) approval.  FDA approved EG-007 for phase III clinical trials in patients with advanced endometrial ca
Jul, 2021
19
Dr. Charles Lee Joined Evergreen Therapeutics as Chief Medical Officer
On July 19, 2021, Shenzhen Evergreen Therapeutics announced the appointment of Dr. Charles Lee as the Company's Chief Medical Officer (CMO) with overall responsibility for the Company's global drug development efforts. Dr. Lee's joining will further improve the research team building, build a more efficient clinical trial medicine system, greatly promote the progress of clinical research projects, and accelerate the leap-forward development of the company. Dr. Lee graduated from the School of Medicine of Xi 'an Jiaotong University, received his master's degree in hospital management and his doctor's degree in public health from the University of Alabama at Birmingham, USA. He worked as a resident physician at the University of Chicago Medical Center for three years, and was licensed as a physician in the United States and certified as a clinical pathologist. Dr. Lee was a senior medical reviewer of the US Food and Drug Administration (FDA), and was the first person from mainland China who studied abroad to enter FDA clinical review as a doctor. He has experience in FDA drug review and has led the development of new drugs for a number of multinational pharmaceutical companies and achieved profitable business growth. In the past four years, he is responsible for an international CRO giant in Asia Pacific, clinical, laws and regulations, market access, such as consulting, seven countries/regions in the Asia-pacific region the leadership of the team, direct management and participate in every year hundreds of R&D strategy consulting projects and help international companies of drug approval and successfully listed in China, to help domestic companies to develop global research plans to enter the international market. Dr. Lee has extensive experience in the development of new drugs in oncology, immunotherapy, anti-inflammatory, gastrointestinal and gynecological diseases, and has extensive experience in Phase I to IV clinical trials worldwide
May, 2021
14
"First Hetao International Medical Forum" was held in Shenzhen, Where 30 FDA Experts Led the Way to Pharmaceutical Innovation
From May 14th to May 15th, 2021, the "First Hetao International Medical Forum" was held in Shenzhen; its theme was "Focusing on the Globalization of Medicine and Building a New Height in the Industry". This conference was jointly planned and prepared by Dr. Du Tao, the sitting president of the FDA Expert Association, and professional conference agencies. The agenda of the conference covered chemical and biological drug innovation, the application of AI technology in drug development, strategies in drug clinical trial, cell and gene therapy, companion diagnostic strategies in new drug development, drug registration regulations, innovation, entrepreneurship and investment, etc. The conference also helped to build up the pharmaceutical innovation industry chain in an all-around and
May, 2021
06
With the New Headquarter Set in Futian Shenzhen, Evergreen Therapeutics Ushered in a New Stage of Rapid Development
On May 6, 2021, Evergreen Therapeutics has set its new headquarter in the Radio and Television Financial Center in Futian, Shenzhen. The new site overlooks the top of Lianhua Mountain in the north and is backed by the Shenzhen-Hong Kong Science and Technology Innovation Cooperation Zone ("Hetao"). The location will be more beneficial to Evergreen's internationalization and financing activities. In December 2020, the Greater Bay Area Center for Drug Evaluation of National Medical Products Administration was established in Shenzhen's "Hetao". Shenzhen will once again usher in opportunities for the development of biomedical innovation. For this, Dr. Du Tao, Chairman of Evergreen Therapeutics said, “The Greater Bay Area Center of National Medical Products Administration has been e
Mar, 2021
15
Evergreen Therapeutics, Inc. Raised RMB 100 million in Series A Financing to Develop Covid-19 Drugs
On March 15, a fast-growing bio-innovative pharmaceutical company, Evergreen Therapeutics, announced the completion of RMB 100 million Series A financing. This round of financing was led by Shenzhen Tiantu Capital, Shenzhen Share Capital, and other investment institutions followed. The funds raised will be used to support Evergreen's new drug research and development, including phase II clinical trial of coronavirus pneumonia injection drug EG-009A and the development of other clinical phases and preclinical projects.  "Evergreen Therapeutical, Inc. received three US FDA clinical approvals in just over a year. Its success is a result of Evergreen’s professional and excellent team, and is also inseparable from the trust and support of investors." Dr. Du Tao, Chairman of Evergr
Dec, 2020
10
Evergreen Therapeutics, Inc. Officially Launched Phase I Clinical Trials of a Moderate/Severe Oral Treatment for COVID-19
EG-009, one of the nine R&D pipelines of Evergreen Therapeutics, Inc., will be used to treat the Cytokine Release Syndrome (CRS) triggered by the COVID-19. The total number of COVID-19 cases worldwide now stands at nearly 70 million, with more than 1.5 million deaths. CRS is a complex inflammatory response and is the leading cause of death for moderate to severe COVID-19. CRS can cause acute respiratory distress syndrome and multiple organ failure. In addition, many COVID-19 patients will have a secondary cytokine storm after being discharged from hospital. EG-009 can inhibit the activity of a variety of cytokines, so as to achieve the treatment of moderate/severe COVID-19 and reduce the mortality of patients. At present, EG-009A injection, another COVID-19 treatment drug, is being pl
Oct, 2020
27
Third IND of Evergreen Therapeutics Inc. Was Successfully cleared by the FDA within One Month
On October 27, 2020 (Beijing time), Evergreen Therapeutical, Inc. announced that the US FDA had approved its application for the phase II clinical trial of COVID-19 EG-009A in advance on October 26, Eastern Time. The IND application was made under the FDA's CTAP* program specific to the Novel Coronavirus Pneumonia. The entire IND review took only 29 natural days.  EG-009A is one of the nine R&D pipelines of Evergreen. It is mainly used for the treatment of Cytokine Release Syndrome (CRS) in moderate to severe patients with the new COVID-19. This approval marks Evergreen's position as the only global innovator to have both oral and injectable agents for COVID-19, and its full coverage of the cytokine storm caused by the COVID-19 virus. On September 23, 2020, Evergreen rece
Oct, 2020
13
Another Good News from Evergreen Therapeutics Inc.: New Oral Drug EG-001 for Idiopathic Interstitial Pneumonia Has Been Cleared by the FDA for Phase I clinical Trial
Evergreen Therapeutics Inc. announced on October 13, 2020, Beijing time, that the US FDA has officially approved its phase I Clinical Application (IND) for the treatment of idiopathic interstitial pneumonia (idiopathic interstitial pneumonia). EG-001 is one of Evergreen's nine R&D pipelines, used to control Idiopathic Interstitial Pneumonias (IIP). IIP is a kind of rare disease with unknown etiology and similar clinical features. Histologically, IIP can be classified into 6 subclasses, characterized by various degrees of pulmonary inflammation and pulmonary fibrosis. The clinical manifestations of IIP are progressive dyspnea and pulmonary imaging abnormalities. None of the countries in the world have approved drugs to treat IIP. In the face of such an incurable disease, heavy use
Oct, 2020
05
Dr. Florence Houn Joined the Detailed Interpretation of "FDA Guidelines for Conducting Clinical Trials in Public Health Emergencies for COVID-19"
On October 5, 2020, Dr. Florence Houn, former Director of Division III of the Office of New Drugs at the FDA, joined several senior FDA clinical, CMC, device, statistical, and registered experts in a detailed interpretation of the FDA's July 2020 "FDA Guidelines for Conducting Clinical trials in Public Health Emergencies for COVID-19." Dr. Florence Houn is a distinguished former FDA leader. She served as the Office Director of CDER, CBER, and CDRH for nearly 15 years. She also served as an executive officer for several large multinational pharmaceutical companies and worked for many years at the NIH/ Johns Hopkins/Columbia University School of Medicine.  Dr. Florence Houn is currently serving as a senior consultant for developments of COVID-19 drugs for Evergreen Therape
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