Recent Development Highlights and Pipeline Updates from Suozhi Bio, Qinhao Pharma, Vivavision Bio, Domain Therapeutics, Amberstone Biosciences, Anji Pharma, and QurAlis

ShanghaiJuly 27, 2022/PR Newswire/ -- Recent updates from Viva Biotech's investment incubation ecosystem:

Sorbonne Intelligence Biotech Collaborates with Tsinghua University's Institute of Immunology to Explore and Advance Novel Drug Development in the Autoimmune Field;

Genhouse Medicine's ERK1/2 Inhibitor GH55 Clinical Trial Application Accepted by CDE;

VIVAVISION's Self-Developed Dual-Target Innovative Glaucoma Drug VVN539 Completes First Patient Enrollment in U.S. Phase II Clinical Trial;

Domain Therapeutics Receives Multi-Million Dollar Milestone Payment from Merck for Clinical Development of Immuno-Oncology Drug M1069;

Amberstone Biosciences Announces the Establishment of Scientific Advisory Board;

Anji Pharmaceuticals Announces Latest Progress on Two Key Projects: ANJ908 and ANJ900

QurAlis Announces Appointment of Anne C. Whitaker as Chair of the Board

The core department of Viva Biotech's investment incubation and Equity-for-Service (EFS) business -- Viva Biotech Innovation Center -- is committed to becoming an open collaboration platform for the incubation and growth of global innovative biopharmaceutical enterprises.

Sorbonne Intelligence Biotech Collaborates with Tsinghua University's Institute of Immunology to Explore and Advance Novel Drug Development in the Autoimmune Field

Recently, Soochow Biologics, which is incubated and invested in by Viva Biotech, has reached a cooperation with the Institute of Immunology at Tsinghua University (referred to as "Tsinghua Immunology Institute"). Both parties will conduct validation and discussion on target selection and verification, pathogenesis, and other areas within the autoimmune field, helping Soochow Biologics build an innovative drug pipeline with global competitiveness. Starting from unmet clinical needs in autoimmune diseases, Soochow Biologics relies on its team's extensive experience in new drug development, combined with its complete AI-driven new drug discovery platform AIxMol™, to bring personalized precision treatment and deep disease remission solutions to patients with autoimmune diseases. The two parties held their first pipeline strategy seminar in Beijing on July 19th. This meeting was attended by three professors from Tsinghua University’s Institute of Immunology—Hu Xiaoyu, Liu Zhihua, and Zeng Wenwen—as well as members of the Soochow Biologics team.

Genhouse Medicine ERK1/2Inhibitor GH55Clinical Trial Application Approved by CDEAcceptance

On July 12, 2022, Keen Innovation Pharma, a research and development company invested in and incubated by Viva Biotech that is committed to developing the next generation of global anti-cancer small molecule drugs using a combination technology platform, announced that according to the latest disclosure by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration, the clinical trial application for GH55, a Class 1 new drug submitted by Keen Innovation Pharma, has recently been accepted. Meanwhile, the U.S. clinical trial application for GH55 is also being actively prepared.

The clinical trial application of GH55 further enhances Genhouse Pharma's strategic layout of its 1.0 pipeline in the RAS/MAPK signaling pathway. GH55 is a dual-mechanism ERK1/2 inhibitor that not only suppresses the kinase activity of ERK1/2 but also inhibits MEK-mediated activation of ERK1/2, preventing drug resistance caused by negative feedback regulation.

VIVAVISION's Self-Developed Dual-Target Innovative Glaucoma Drug VVN539Completed US Phase IIFirst Patient Enrolled in Phase Clinical Trial

On July 8, VIVAVISION, a company invested in and incubated by Viva Biotech that focuses on differentiated and globally innovative ophthalmic drugs, announced that its self-developed dual-target drug VVN539 for patients with open-angle glaucoma had completed the enrollment of its first patient in a U.S. Phase II clinical study at the Rochester Ophthalmological Group in New York State, USA. This also marksThe First in ChinaThe development of domestically innovated glaucoma drugs has entered a phase of rapid advancement.

This clinical study is a Phase II randomized, double-blind, vehicle-controlled trial evaluating the safety and efficacy of VVN539 eye drops with dose-response exploration. VVN539 is an ophthalmic drug independently developed by VIVAVISION, which owns global intellectual property rights. As a next-generation drug with a dual-target mechanism, it directly acts on the trabecular meshwork to increase aqueous humor outflow, achieving the desired effect of lowering intraocular pressure.

Domain TherapeuticsReceived Millions of Dollars in Milestone Payments from Merck for Immuno-Oncology Drug M1069Clinical Development

On June 28, Domain Therapeutics, a biopharmaceutical company invested in and incubated by Viva Biotech, which focuses on researching and developing G protein-coupled receptor (GPCR) targets in the field of immuno-oncology, announced that it had received a multimillion-dollar milestone payment from Merck. According to the revenue collaboration and license agreement signed between Domain Therapeutics and Merck in 2017 (which was undisclosed), this payment is part of the agreed milestone amount of 240 million euros (261 million US dollars).

M1069 is an orally available small molecule antagonist of the adenosine receptor co-developed by both companies. This highly efficient and successful collaboration leveraged Domain's expertise in GPCR medicinal chemistry, pharmacology, and drug development, enabling M1069 to be successfully integrated into Merck's oncology pipeline. M1069 is the first immuno-oncology candidate from Domain’s existing pipeline to reach the clinical development stage.

Amberstone BiosciencesAnnouncement of the Establishment of the Scientific Advisory Committee

Amberstone Biosciences, an emerging biotechnology company invested in and incubated by VivaVision, focuses on developing next-generation cancer immunotherapies. Recently, it announced the establishment of a Scientific Advisory Board, consisting of top scientists in the fields of drug delivery, oncology, immunology, and drug development. The Scientific Advisory Board will work closely with Amberstone to advance the company’s product pipeline based on tumor microenvironment-specific activation therapy (T-MATE). Members of Amberstone's Scientific Advisory Board include Dr. Robert Langer, a professor at the Massachusetts Institute of Technology (MIT), co-founder and board member of Moderna, and known as the "Father of Tissue Engineering and Drug Delivery," as well as Philip Tagari, Vice President of Research and Development at Amgen.Well-knownScientist.

Anji Pharmaceuticals Announces Two Key Projects: ANJ908and ANJ900Latest Developments

Recently, Anji Pharmaceuticals, invested in and incubated by Viva Biotech, shared the latest progress of its key projects ANJ908 and ANJ900 at two important scientific conferences – Digestive Disease Week (DDW) and the 82nd Scientific Sessions of the American Diabetes Association (ADA):

- Anji has completed patient enrollment for the Phase 2 study of ANJ908 (pradigastat) for the treatment of chronic constipation;

- Currently recruiting patients with normal renal function or mild to moderate chronic kidney disease (CKD stages 1-3B) who have type 2 diabetes (T2D) for the global Phase 3 study of ANJ900 (a novel delayed-release formulation of metformin); the global program for ANJ900 is expected to expand to include T2D patients with concurrent CKD stage 3B/4 in the fourth quarter of 2022, with studies being conducted in the United States, China, and other regions worldwide.

QurAlisAnnouncement of the Appointment of Anne C. WhitakerChairman of the Board

On June 21, 2022, QurAlis Corporation, a biotechnology company invested in and incubated by Viva Biotech that focuses on precision treatments for amyotrophic lateral sclerosis (ALS) and other neurological diseases, announced the appointment of Anne Clem Whitaker as Chair of the Board. As a seasoned industry expert, Ms. Whitaker has held senior positions in several large pharmaceutical enterprises and biotech companies, bringing extensive commercialization experience and exceptional leadership skills. Her addition will further advance the company’s research and development efforts in ALS and other severe neurodegenerative diseases.

About SuoZhi Bio

Sorcerer Bio is an innovative pharmaceutical company driven by demand and based on AI-powered new drug discovery technology. We focus on developing innovative drugs for treating immune and neurodegenerative diseases. Meanwhile, according to the needs of research and development, we create an end-to-end AI new drug discovery paradigm through introduction, cooperation, and technological innovation, helping achieve efficient and high-precision differentiated new drug innovation. We aim to build a structure-based, AI and data-driven efficient new drug discovery paradigm.

About Genovo Biopharma

Genhouse Bio is a biotechnology company focused on the development of globally leading small-molecule anti-cancer drugs. The company’s management team has years of experience in enterprise management, new drug research and development, and clinical medical research, and is committed to overcoming "undruggable" targets while emphasizing original innovation. Genhouse Bio is dedicated to building a distinctive R&D system for innovative drugs, including a structure-based SAR (Structure-Activity Relationship) research platform, an early drug screening platform based on target studies, and a preclinical evaluation platform covering efficacy, metabolism, and safety research, forming a product pipeline centered on targeted anti-cancer therapies.

About VIVAVISION

VIVAVISION is a clinical-stage biotechnology company focused on the field of ophthalmic treatments, possessing a world-class innovative ophthalmic drug research and development team and technology platform. Relying on independent research and development, it has established a product pipeline with global competitiveness, including First-in-Class and Best-in-Class products. In addition to VVN001 and VVN539, which are currently in the clinical stage, the Phase I clinical trial in China for VVN461, used to treat non-infectious uveitis, is also about to commence. For more information, please visit:www.vivavisionbio.com

About Domain Therapeutics

Domain Therapeutics is a biopharmaceutical company operating in both France and Canada, dedicated to the discovery and development of innovative drug candidates targeting G protein-coupled receptors (GPCRs). GPCRs are among the most important categories of drug targets currently. The company focuses on developing high-value drug candidates to address GPCR-mediated immunosuppression in immuno-oncology. For more information, please visit:www.domaintherapeutics.com

About Amberstone Biosciences

Amberstone Biosciences, founded in 2018, is an emerging biopharmaceutical company focused on developing novel tumor microenvironment-activated immunotherapies for the treatment of solid cancers. For more information, please visitwww.amberstonebio.com

About Anji Pharmaceuticals

Anji Pharmaceuticals is a clinical-stage biopharmaceutical company dedicated to providing innovative therapies to patients to significantly improve their quality of life. Anji's business model focuses on its product pipeline, utilizing a "hub-and-spoke" approach to fully leverage its core competencies in clinical development, rapidly and flexibly creating clinical value. Anji's innovative drugs currently in late-stage clinical development include: Metformin Hydrochloride Delayed-Release Tablets (ANJ900 – Global Phase 3 Clinical Trial), for effectively managing blood glucose levels in Type 2 diabetes patients with moderate to severe chronic kidney disease; and Pradigastat (ANJ908 – Global Phase 2 Clinical Trial), for the treatment of chronic constipation. For more information, please visitwww.anjipharma.com

About QurAlis

QurAlis Pioneers the Development of Next-Generation Precision Medicines for Amyotrophic Lateral Sclerosis (ALS) and Other Neurodegenerative Diseases. Based on in-depth research into disease-causing genes, QurAlis leverages biomarker discovery and its proprietary R&D platform to provide precision treatments for neurodegenerative diseases. Founded by world-class neurobiology experts from Harvard University and Harvard Medical School, the company has established a robust pipeline that includes multiple programs such as nucleic acids and small molecules, aiming to develop innovative therapies targeting major subtypes of ALS. For more information, please visitwww.quralis.com