San Diego, CA, USA – June 14, 2022 – HUYABIO International today announced that the first three patients had been dosed in an ongoing Phase 2 study of HUYABIO’s novel drug for pharmacological cardioversion of atrial fibrillation (AF).

Dr. Mireille Gillings, President, CEO & Executive Chair, said, “We are excited to proceed with dosing AF patients in our Phase 2 trial of HBI-3000. AF is a growing global problem and HUYABIO’s drug is well-positioned to provide a new pharmacological treatment for patients, many of whom would otherwise get electrically cardioverted which can be both stressful and painful.”

The study is evaluating pharmacological cardioversion of acute AF. Cardioversion aims to restore a normal heart rate and rhythm in AF patients and is often done by high energy electrical shock.  The Phase 2 trial HBI-3000-402 is a two-stage, serial cohort dose escalation and expansion study of a single intravenous infusion of HBI-3000 in patients with AF between 2 and 72 hours.

Denis Roy, MD, Montreal Heart Institute and Chief Investigator of the trial, said, “Demonstrating efficacy of HBI-3000 in this trial is an important step towards development of a new therapeutic option to AF patients.”

AF is a serious condition that affects more than 3.5 million patients in the US and 30 million worldwide. There is a significant need for safer and more effective pharmacological interventions to treat AF, as the current standard of care treatments have poor safety and efficacy profiles and the alternative, electrical cardioversion, requires fasting and sedation and can be anxiety provoking for patients.

About HBI-3000
HBI-3000 is a multi-ion channel blocker with in vitro inhibitory effects on INa-Peak, INa-Late, ICa, L and IKr being developed by HUYABIO International for the conversion of recent onset atrial fibrillation. The drug’s preclinical and clinical pharmacology supports the potential of HBI-3000 to restore sinus rhythm in Atrial Fibrillation. The drug has demonstrated a low risk for proarrhythmia in preclinical testing. Data from the first in human Phase 1 trial of the IV formulation were presented during a poster session at the American Heart Association 2019 annual meeting. www.huyabio.com.

About HUYABIO International
HUYABIO is the leader in accelerating the global development of novel biopharmaceutical product opportunities originating in China enabling faster, more cost-effective and lower-risk drug development in global markets. Through extensive collaboration with biopharmaceutical, academic and commercial organizations, it has built the largest China-sourced compound portfolio covering all therapeutic areas. With offices in the US, Japan, South Korea, Canada, Ireland and eight strategic locations across China, the company has become a partner of choice to accelerate product development and maximize value globally.

For more information, please visit www.huyabio.com.

Contact Details:
Yiota Merianos
Corporate Communications
+1.858.353.1217
ymerianos@huyabio.com

Phase 1 trial evaluated the pharmacokinetics and safety of HBI-3000 when dosed with the strong CYP2D6 inhibitor, paroxetine

San Diego, CA, USA – May 17, 2022 – HUYABIO International, the leader in accelerating global development of China’s pharmaceutical innovations, today announced the successful completion of a Phase 1 drug-drug interaction clinical trial of HBI-3000, a novel drug for cardioversion of atrial fibrillation (AF).

Dr. Mireille Gillings, President, CEO & Executive Chair, said, “I am pleased to announce this positive step in the development of HBI-3000 for potential use in patients suffering from AF, a serious condition that affects more than 30 million people worldwide. There is a pressing need for safer and more effective pharmacological interventions to treat this condition. The successful completion of this Phase 1 trial will enable progression of the ongoing Phase 2 trial investigating efficacy of HBI-3000 for the conversion of acute AF.”

Based on the preliminary safety and pharmacokinetic data, the US Food and Drug Association approved dose escalation in the HBI-3000-402 study which is evaluating pharmacological cardioversion of acute AF (NCT04680026). Cardioversion aims to restore a normal heart rate and rhythm in AF patients and is often done by high energy electrical shock.

“This Phase 1 study evaluated HBI-3000 pharmacokinetics in the presence of a strong CYP2D6 inhibitor, paroxetine,” said Jay Mason MD, University of Utah. “The data demonstrate lack of significant PK interaction between paroxetine and HBI-3000 and support dose escalation in the ongoing HBI-3000-402 Phase 2 study, without the need to prescreen for CYP2D6 genetic polymorphism or exclude concomitant medications that are CYP2D6 inhibitors.”

About HBI-3000
HBI-3000 is a multi-ion channel blocker with in vitro inhibitory effects on I_Na-Peak, I_Na-Late, I_{Ca, L} and I_Kr being developed by HUYABIO International for the conversion of recent onset atrial fibrillation. The drug’s preclinical and clinical pharmacology supports the potential of HBI-3000 to restore sinus rhythm in Atrial Fibrillation. The drug has demonstrated a low risk for proarrhythmia in preclinical testing. Data from the first in human Phase 1 trial of the IV formulation were presented during a poster session at the American Heart Association 2019 annual meeting. A copy is available via HUYABIO’s website at www.huyabio.com. Information on the ongoing Phase 2 acute Atrial Fibrillation trial, HBI-3000-402, can be found at https://clinicaltrials.gov/ct2/show/NCT04680026.

About HUYABIO International
HUYABIO is the leader in accelerating the global development of novel biopharmaceutical product opportunities originating in China enabling faster, more cost-effective and lower-risk drug development in global markets. Through extensive collaboration with biopharmaceutical, academic and commercial organizations, it has built the largest China-sourced compound portfolio covering all therapeutic areas. With offices in the US, Japan, South Korea, Canada, Ireland and eight strategic locations across China, the company has become a partner of choice to accelerate product development and maximize value globally. For more information, please visit www.huyabio.com.

Contact Details:
Yiota Merianos
Corporate Communications
+1.858.353.1217
ymerianos@huyabio.com

Clinical stage drug is the fifth asset in the growing pipeline of HUYABIO’s oncology products

San Diego, CA, USA – December 2, 2021 – HUYABIO International, the leader in accelerating global development of China’s pharmaceutical innovations, announced today it had licensed exclusive worldwide ex-China rights to the KRAS inhibitor, JMKX1899, from Shanghai Jemincare Pharmaceutical Co., Ltd. Jemincare will retain the relevant rights in the greater China area.

Mr. Hong Liang, President of Jemincare Pharmaceutical Group, said, “We are delighted to work with HUYABIO to explore global development of this unique KRAS inhibitor. This is our first new chemical entity program outlicensed to a global partner. HUYABIO has generated a lot of experience to bring innovative drugs from China to global market. We look forward to generating the clinical efficacy and safety data from global clinical trial since the candidate has huge potential to fill strong unmet needs.”

KRAS is one of the most mutated oncogenes in human cancers. The prevalent G12C mutation drives tumor growth and metastasis and has become an important validated target for therapy especially in lung and colorectal cancer. Targeting the GTP pocket of KRAS in the switch-II region, which has made KRAS druggable, enables the development of more potent and potentially effective inhibitors.

JMKX1899 is a KRAS inhibitor independently developed by Jemincare. Data from preclinical studies shows it has strong blood-brain-barrier crossing capability and has no risk of hERG inhibition and drug-drug-interaction. Jemincare filed the IND with the NMPA in October 2021. The parties will work closely to file the IND with the US FDA in 2021 to move towards clinical development.

Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO, said, “We are excited to have added the clinical stage KRAS inhibitor to our oncology pipeline especially to test in combination with our SHP2 inhibitor against a variety of solid tumors. We’re delighted to have an excellent partner Jemincare to co-develop combinations that can benefit patients worldwide.”

About Jemincare

Shanghai Jemincare Pharmaceutical Co., Ltd was established in 2018 as the R&D center of Jiangxi Jemincare Group Co., Ltd. Shanghai Jemincare now has developed into a strong team with around 500 scientists comprised by 3 innovation centers, Small Molecule Innovative Center, Biologics Innovation Center and Technology Innovation Center. JMKX1899 is developed by the Small Molecule Innovation Center which has 18 ongoing programs including 10 programs at IND or IND-enabling stage and 2 programs at phase 1 clinical trial.

Jiangxi Jemincare Group Co., Ltd. is a leading pharmaceutical company from China. Founded in 1999, Jemincare group has over 10,000 employees dedicated to the development, manufacturing and commercialization of therapeutics in its strategic fields including oncology, nephrology, cerebro-cardiovascular, anti-infection, analgesic, respiratory and Pediatrics.

About HUYABIO International

HUYABIO™ is the leader in accelerating the global development of novel biopharmaceutical product opportunities originating in China enabling faster, more cost-effective and lower-risk drug development in the global markets. Through extensive collaboration with biopharmaceutical, academic and commercial organizations, it has built the largest China-sourced compound portfolio covering all therapeutic areas. Hiyasta® the company’s first commercial product is marketed in Japan. With offices in the US, Japan, South Korea, Canada, Ireland and eight strategic locations across China, the Company has become a partner of choice to accelerate product development and maximize value globally. For more information, please visit www.huyabio.com.

Contact Details:

Yiota Merianos
Corporate Communications
+1.858.353.1217
ymerianos@huyabio.com

This is the second indication for Hiyasta® in Japan following adult T-cell leukemia/lymphoma (ATLL)

SAN DIEGO, November 30, 2021 /PRNewswire/ — HUYABIO International, the leader in accelerating global development of China’s pharmaceutical innovations, today announced the regulatory approval of HBI-8000, brand name Hiyasta®, monotherapy for the treatment of relapsed or refractory (R/R) PTCL by the Ministry of Health, Labour and Welfare in Japan.

“Relapsed and/or refractory PTCL carries a grim prognosis with limited treatment options. Data from the registration study of HBI-8000 has demonstrated clinically meaningful responses despite the advanced stage of disease and acceptable safety profile to address an important unmet medical need in this patient population”, said Dr. Kensei Tobinai, Visiting Scientist of the National Cancer Center Hospital in Japan and medical expert of HBI-8000 Phase 2 study.

The application of the supplemental indication for R/R PTCL is based on data from a Phase 2b study of 55 patients with aggressive PTCL in Japan and Korea. These patients all had advanced disease, refractory or relapsed relative to prior therapies. HBI-8000 40mg orally administered twice weekly resulted in a 46% Objective Response Rate, median Progression-Free Survival of 5.6 months and a median Overall Survival of 22.8 months.

Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO said, “This second regulatory approval for our lead oncology drug, Hiyasta, in Japan expands our drugs’ indications for patients with severe hematologic malignancies. We are looking forward to additional future indications for Hiyasta that will benefit even more patients.”

About Hiyasta®

HBI-8000 is an epigenetic immunomodulator with several approved indications including monotherapy for two subtypes of Non-Hodgkin’s Lymphoma in Japan and in combination therapy for metastatic breast cancer in China. This oral agent targets class I histone deacetylases causing cell cycle arrest and tumor cell death as the mechanism underlying its single agent activity against lymphoma. The drug also has demonstrated immunomodulatory impact and is being tested in a global pivotal trial in melanoma combined with the checkpoint inhibitor nivolumab.

About HUYABIO International
HUYABIO™ is the leader in accelerating the global development of novel biopharmaceutical product opportunities originating in China enabling faster, more cost-effective and lower-risk drug development in the global markets. Through extensive collaboration with biopharmaceutical, academic and commercial organizations, it has built the largest China-sourced compound portfolio covering all therapeutic areas. Hiyasta® is the company’s first commercial product marketed in Japan. With offices in the US, Japan, South Korea, Canada, Ireland and eight strategic locations across China, the Company has become a partner of choice to accelerate product development and maximize value globally. For more information, please visit www.huyabio.com. 

Contact details:
Bob Goodenow, PhD
President
+1.858.342.2430
bgoodenow@huyabio.com

Yiota Merianos
Corporate Communications
+1.858.353.1217
ymerianos@huyabio.com

Ex-China rights to the novel drug expands HUYABIO’s growing oncology pipeline

San Diego, CA, USA – November 9, 2021 – HUYABIO International, the leader in accelerating global development of China’s pharmaceutical innovations, announced today it had licensed exclusive worldwide ex-China rights to the Wee1 inhibitor from Shanghai Pharma, the second largest pharma group in China with annual sales of over $30 billion. This is the first program that Shanghai Pharma has outlicensed to a global partner.

“HUYABIO International has pioneered an innovative approach for partnering with Chinese research institutions and pharmaceutical companies. It identifies and licenses the most promising pre-clinical and clinical stage compounds in China, leverages and extends the research efforts of its Chinese partners, and provides a bridge into the international development process and global biopharma market. We are glad to collaborate with them on our SPH6162 as this collaboration is an important milestone of our global strategy due to our Licensed Molecules and Licensed Products”, said Min Zuo, CEO Shanghai Pharmaceuticals.

Wee1 regulates the G2 checkpoint and stimulates entry into mitosis in response to DNA damage. It is a nuclear kinase belonging to the Ser/Thr family of protein kinases and its cell size by inhibiting Cdk1. Wee1 over-expression has been observed in solid tumors including hepatocellular carcinoma, colon cancer, glioblastoma, non-small-cell lung cancer (NSCLS), neuroblastoma, and gastric cancers.

Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO, said, “We are delighted to partner with Shanghai Pharmaceuticals for a therapeutic mechanism that promises broad synergy across treatments for many tumor types. HUYABIO is the first global company with which Shanghai Pharma has signed a major outlicensing agreement and we look forward to co-development of this innovative program in China.”

About HUYABIO International

HUYABIO™ is the leader in accelerating the global development of novel biopharmaceutical product opportunities originating in China enabling faster, more cost-effective and lower-risk drug development in the global markets. Through extensive collaboration with biopharmaceutical, academic and commercial organizations, it has built the largest China-sourced compound portfolio covering all therapeutic areas. Hiyasta® the company’s first commercial product is marketed in Japan. With offices in the US, Japan, South Korea, Canada, Ireland and eight strategic locations across China, the Company has become a partner of choice to accelerate product development and maximize value globally. For more information, please visit www.huyabio.com.

About Shanghai Pharma

Shanghai Pharmaceuticals Holding Co. Ltd. (“SPH”) is a vertically-integrated and diversified Pharmaceutical Group. The company has dual listings on the stock exchanges in shanghai (601607) and Hong Kong (02607). The company is involved in research & development, manufacturing, distribution and retail. Shanghai Pharma is ranked 437 on the Global Fortune 500 List and is the 2^nd largest Chinese pharmaceutical company on the 2020 Forbes Global 2000 List. The company’s total R&D investment is more than 286 Million US Dollars last year. With over 50,000 employees, Shanghai Pharma is looking forward to its solid performance in the near future. For more information, please visit www.sphchina.com.

Contact details:
Bob Goodenow, PhD
President
+1.858.342.2430
bgoodenow@huyabio.com

Yiota Merianos
Corporate Communications
+1.858.353.1217
ymerianos@huyabio.com

First patient dosed in trial investigating cardioversion of recent-onset atrial fibrillation

San Diego, CA, USA – November 2, 2021 – HUYABIO International (HUYABIO), the leader in accelerating global development of China’s pharmaceutical innovations, today announced that the first patient has been dosed in a Phase 2 study of HUYABIO’s novel drug for cardioversion of atrial fibrillation (AF) at Wellington Regional Hospital in Wellington, New Zealand. Cardioversion aims to restore a normal heart rate and rhythm in AF patients and is often done by high energy electrical shock.

Denis Roy, MD, Montreal Heart Institute and Chief Investigator of the trial, said, “This Phase 2 study will investigate the ability of HUYABIO’s candidate drug to safely pharmacologically convert patients with recent onset AF back into a normal rhythm. This follows a successful Phase 1 study in the United Kingdom, where this drug was well tolerated, with no dose limiting adverse events or arrhythmias observed.”

The Phase 2 trial, is a two-stage, serial cohort dose escalation and expansion study of a single intravenous infusion of HBI-3000 in patients with AF between 2 and 72 hours (NCT04680026) and aims to recruit 150 patients across North America and the Asia-Pacific region. Several public hospitals in New Zealand are now recruiting under approval by the country’s Medicines and Medical Devices Safety Authority, Medsafe and US sites will be initiating under a US IND. HUYABIO’s anti-arrhythmic is a multi-ion channel blocker with in vitro inhibitory effects on I_Na-Peak, I_Na-Late, I_{Ca, L} and I_Kr (as well as I_to and I_Kur) being developed for the cardioversion of recent onset AF. AF is a serious condition that affects more than 3.5 million patients in the US and 30 million worldwide. There is a significant need for safer and more effective pharmacological interventions to treat AF, as the current standard of care treatments have poor safety and efficacy profiles and the alternative, electrical cardioversion, requires fasting and sedation and can be anxiety provoking for patients.

“This is another encouraging milestone in HUYABIO’s development of a potentially new and improved treatment for patients with AF,” Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO, stated. “This new drug candidate will provide important treatment options for patients with high unmet medical need. The innovative two-stage design of our Phase 2 study will allow us an early look at potential efficacy and deliver placebo-controlled proof of concept data as well.”

About HUYABIO’s Anti-arrhythmic Program
HUYABIO’s HBI-3000 program consists of small molecule sulcardine derivatives which are multi-ion channel blockers with in vitro inhibitory effects on I_Na-Peak, I_Na-Late, I_{Ca, L} and I_Kr being developed by HUYABIO International for the conversion of atrial fibrillation (AF). The drug’s preclinical and clinical pharmacology supports the potential of the drug to restore sinus rhythm in AF. The drug has demonstrated a low risk for proarrhythmia in preclinical testing. Phase 1 data was presented during a poster session at the American Heart Association 2019 annual meeting. The poster is available via the HUYABIO website at www.huyabio.com.

About HUYABIO International
HUYABIO™ is the leader in accelerating the global development of novel biopharmaceutical product opportunities originating in China enabling faster, more cost-effective and lower-risk drug development in the global markets. Through extensive collaboration with biopharmaceutical, academic and commercial organizations, it has built the largest China-sourced compound portfolio covering all therapeutic areas. Hiyasta® the company’s first commercial product is marketed in Japan. With offices in the US, Japan, South Korea, Canada, Ireland and eight strategic locations across China, the Company has become a partner of choice to accelerate product development and maximize value globally. For more information, please visit www.huyabio.com.

Contact details:
Bob Goodenow, PhD
President
+1.858.342.2430
bgoodenow@huyabio.com

Yiota Merianos
Corporate Communications
+1.858.353.1217
ymerianos@huyabio.com

San Diego, CA, USA – October 28, 2021 – HUYABIO International (HUYABIO™), the leader in accelerating global development of China’s pharmaceutical innovations, announced today the FDA clearance of HBI-2376 as an Investigational New Drug, or IND, for a Phase 1 study. The authorization to proceed enables the first testing in patients for whom this novel SHP2 inhibitor might show clinical benefit. 

“We are pleased to see that our partner HUYABIO is initiating clinical testing of our SHP2 inhibitor in the US, which will complement Genhouse’s clinical development program in China. We are expecting IND approval in November in China. We believe our SHP2 inhibitor will bring clinical benefit to cancer patients worldwide,” said Dr. Kuifeng Wang, CEO of Genhouse.

The HUYABIO-sponsored Phase 1 trial is an open-label dose escalation study using the Company’s SHP2 inhibitor to measure the safety and tolerability in patients with solid tumors harboring KRAS or EGFR mutations. Anti-tumor effects of the monotherapy, determined according to RECIST 1.1, included among the secondary endpoints of the study. Up to 6 sites in the US will be involved in the study that will enroll 42 patients.

Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO said, “We are excited to have FDA clearance to begin clinical testing of HBI-2376 because of the enormous potential of the drug against a number of different tumors. This represents another important milestone for HUYABIO in building a strong oncology pipeline with products that address significant unmet need and provide potential benefit to patients afflicted with debilitating malignancies.”

About HBI-2376

HBI-2376 is an oral small molecule inhibitor of SHP2 targeting multiple tumor types whose cellular growth is dependent on the activity of receptor tyrosine kinases in the mitogen-activated protein kinase, or MAPK, pathway. Extensive biochemical characterization has shown that HBI-2376 is a highly potent and selective inhibitor of SHP2 phosphatase with the potential for activity as a single agent or in combination with various other targeted agents, including checkpoint inhibitors.

About HUYABIO International

HUYABIO is the leader in accelerating the global development of novel biopharmaceutical product opportunities originating in China enabling faster, more cost-effective and lower-risk drug development in the global markets. Through extensive collaboration with biopharmaceutical, academic and commercial organizations, it has built the largest China-sourced compound portfolio covering all therapeutic areas. With offices in the US, Japan, South Korea, Canada, Ireland and eight strategic locations across China, the Company has become a partner of choice to accelerate product development and maximize value globally. For more information, please visit www.huyabio.com.

Contact Details:

Bob Goodenow, PhD
President
+1.858.342.2430
bgoodenow@huyabio.com

Yiota Merianos
Corporate Communications
+1.858.353.1217
ymerianos@huyabio.com

SAN DIEGO, CA, USA – October 19, 2021 – HUYABIO International (HUYABIO™), the leader in accelerating global development of China’s pharmaceutical innovations, today announced the product launch in Japan for Hiyasta^® tablets to treat relapsed and/or refractory (R/R) adult T-cell leukemia/lymphoma (ATLL).

Japanese patients with relapsed and/or refractory R/R ATLL have very poor prognosis. The effectiveness of available treatments, such as chemotherapy, diminishes with each relapse. Results from the HBI-8000 study in these patients have demonstrated clinically meaningful tumor response despite the advanced stage of disease. The treatment was safe and side effects could be managed with routine care. “In my opinion, this treatment is expected to address an important unmet medical need,” said Dr. Kensei Tobinai, Visiting Scientist of the National Cancer Center Hospital in Japan and medical expert of the HBI-8000 Phase 2 study.

HUYABIO recently announced the approval of Hiyasta^® by the Japanese Minister of Health, Labor and Welfare based on the results of a clinical trial conducted in Japan in patients with R/R ATLL. Meiji Seika Pharmaceuticals, HUYABIO’s partner, will market the product in Japan. HUYABIO retains worldwide rights to the drug ex-Asia. Development of HBI-8000 is ongoing globally. 

Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO said, “This first product launch for our lead oncology drug, HBI-8000, is a major milestone for HUYABIO as we transition into a revenue generating Company. It demonstrates our global reach and ability to develop and commercialize products licensed from China for debilitating diseases and make a major public health contribution.”

About HBI-8000
HBI-8000 is an epigenetic immunomodulator approved for the treatment of lymphoma and metastatic breast cancer in China. This oral agent targets class I histone deacetylases (HDAC) and suppresses the expression of the viral oncogene HTLV-I bZIP factor, nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) and the inflammasome in ATLL cells. Furthermore, HBI-8000 may induce latent viral antigen expression making ATLL cells more sensitive to immune cytotoxicity targeting.

About HUYABIO International
HUYABIO is the leader in accelerating the global development of novel biopharmaceutical product opportunities originating in China enabling faster, more cost-effective and lower-risk drug development in the global markets. Through extensive collaboration with biopharmaceutical, academic and commercial organizations, it has built the largest China-sourced compound portfolio covering all therapeutic areas. With offices in the US, Japan, South Korea, Canada, Ireland and eight strategic locations across China, the Company has become a partner of choice to accelerate product development and maximize value globally. For more information please visit www.huyabio.com.

Contact details:
Bob Goodenow, PhD President	Yiota Merianos Corporate Communications
+1.858.342.2430	+1.858.353.1217
bgoodenow@huyabio.com	ymerianos@huyabio.com

San Diego, CA, USA – September 21, 2021 – HUYABIO International (HUYABIO™), the leader in accelerating global development of China’s pharmaceutical innovations, announced today the first patient treated in a pivotal trial designed to measure the safety and efficacy of HBI-8000 combined with Bristol Myers Squibb’s anti-PD-1, antibody Opdivo® (nivolumab), in patients with unresectable or metastatic melanoma. The multicenter, randomized, double blinded, placebo-controlled Phase 3 trial entitled, “Study Comparing the Investigational Drug HBI-8000 Combined with Opdivo vs. Opdivo in Patients with Advanced Melanoma,” will have a primary outcome of objective response rate and progression-free survival. Secondary outcomes include safety and overall survival. Opdivo® is a trademark of Bristol-Myers Squibb Company.

Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO said, “The initiation of the Phase 3 trial represents another significant milestone for HBI-8000 following the recent approval for the drug as monotherapy for the treatment of ATLL in Japan. The Company has taken another important step in expanding the clinical indications for our lead oncology asset in solid tumors. The results from our Phase 2 trial of HBI-8000 combined with Opdivo in solid tumors pointed to the important immunomodulatory activity for our drug. We are pleased to begin this global study in collaboration with Bristol Myers Squibb.”

The pivotal multi-national trial will enroll 480 patients from the United States, Europe, Australia, New Zealand and Japan. In the US Phase 2 trial, the combination of HBI-8000 with Opdivo was well tolerated with a favorable safety profile in checkpoint naïve melanoma patients who achieved a promising clinical response.

“Australia has one of the highest rates of melanoma in the world, especially relevant to the Sunshine Coast and Queensland”, said Principal Investigator Dr. Hong Shue, who treated the first patient and is from Sunshine Coast Haematology and Oncology Clinic and University of the Sunshine Coast Clinical Trials Unit. “We are really excited to participate in this HUYABIO International sponsored Phase 3 registrational clinical trial. This trial potentially offers a practice-changing, effective combination treatment of HBI-8000 with Opdivo to our patients on the Sunshine Coast. This study, if positive, may provide an additional treatment option and significant change in the metastatic melanoma treatment paradigm.”

About HBI-8000

HBI-8000 is an epigenetic immunomodulator approved for the treatment of lymphoma and metastatic breast cancer in China. This oral agent targets class I histone deacetylases causing cell cycle arrest and tumor cell death as the mechanism underlying its single agent activity against lymphoma. The drug also has immunomodulatory impact by increasing the efficacy of checkpoint inhibitors in preclinical animal models. The Company recently reported results from its ongoing Phase 2 study for the Opdivo combination demonstrating an overall objective response rate of approximately 70% with a disease control rate over 90% in a cohort of checkpoint naïve patients with melanoma.

About HUYABIO International

HUYABIO is the leader in accelerating the global development of novel biopharmaceutical product opportunities originating in China enabling faster, more cost-effective and lower-risk drug development in the global markets. Through extensive collaboration with biopharmaceutical, academic and commercial organizations, it has built the largest China-sourced compound portfolio covering all therapeutic areas. With offices in the US, Japan, South Korea, Canada, Ireland and eight strategic locations across China, the Company has become a partner of choice to accelerate product development and maximize value globally. For more information, please visit www.huyabio.com.

Contact details:

Bob Goodenow, PhD President

+1.858.342.2430

bgoodenow@huyabio.com

Yiota Merianos

Corporate Communications

+1.858.353.1217

ymerianos@huyabio.com

US and China simultaneous filings by HUYABIO-Genhouse will initiate coordinated global clinical testing

San Diego, CA, USA – August 31, 2021 – HUYABIO International (HUYABIO™), the leader in accelerating global development of China’s pharmaceutical innovations, announced today the filing of an investigational new drug application (IND) with the FDA for HBI-2376 along with Genhouse who has filed an IND with the Chinese Center for Drug Excellence CDE.

“HBI-2376 (GH21) is a SHP2 allosteric inhibitor with very high selectivity. Both in vitro and in vivo studies have shown that HBI-2376 is effective against multiple SHP2 point mutations and has a very good PK and safety profile,” said Dr. Keifung Wang, CEO of Genhouse. “Therefore, GH21 is a very promising small molecule drug candidate that Genhouse along with HUYABIO will coordinate the global clinical development to make it available for cancer patients as soon as possible.”

The companies entered into a licensing agreement granting HUYABIO worldwide rights outside China to HBI-2376 prior to filing the regulatory submissions.

Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO, said, “This submission represents a first filing of simultaneous INDs, to coordinate the development of our SHP2 inhibitor in both the US and China. We believe the drug’s global testing will accelerate its commercialization as an important new agent. It will add synergy to current immuno-oncology products which to date, have transformed cancer care. The potential here is to transform current immuno-oncology therapy to an even higher level and so improve public health.”

About HBI-2376; SHP2 Inhibitor

HBI-2376 is an oral small molecule inhibitor of SHP2 for multiple tumor types whose cellular growth is dependent on the activity of receptor tyrosine kinases in the mitogen-activated protein kinase or MAPK pathway. Extensive biochemical characterization has shown that HBI-2376 is a highly potent and selective inhibitor of SHP2 phosphatase. Furthermore, preclinical investigations showed significant efficacy for HBI-2376 as a single agent or in combination with other small molecule inhibitors or checkpoint inhibitors in multiple tumor models.

About HUYABIO International

HUYABIO is the leader in accelerating the global development of novel biopharmaceutical product opportunities originating in China enabling faster, more cost-effective and lower-risk drug development in the global markets. Through extensive collaboration with biopharmaceutical, academic and commercial organizations, it has built the largest China-sourced compound portfolio covering all therapeutic areas. With offices in the US, Japan, South Korea, Canada, Ireland and eight strategic locations across China, the Company has become a partner of choice to accelerate product development and maximize value globally. For more information, please visit www.huyabio.com.

About Genhouse

Genhouse Bio is a clinical-stage biotech company focusing on the development of global next-generation anti-cancer therapeutics, headquartered in the Suzhou Industry Park. The senior management team of Genhouse has multiple years of experience in new drug development, clinical research and corporate management. Genhouse has a clear focus on original innovation and overcoming those “undruggable” targets. Genhouse has established integrated in-house drug development platforms. With these platforms, Genhouse has started to build a highly innovative anti-cancer pipeline and out-licensed the ex-China rights of its SHP2 inhibitor GH21 to HUYABIO, an international biotech company. Genhouse will continue to advance more innovative pipeline programs into global development.

Contact Details:

Bob Goodenow, PhD
President
+1.858.342.2430
bgoodenow@huyabio.com

Yiota Merianos
Corporate Communications
+1.858.353.1217
ymerianos@huyabio.com