Jiahe Biotech released its 2020 annual results today

 Achieve rapid and comprehensive development in new drug clinical trial application, clinical development, listing application, commercialization, business development, and finance.

Marketing application-Geptanolimab injection (Geptanolimab, GB226) has been given priority review for its indications for peripheral T-cell lymphoma, and a marketing application (NDA) has been submitted for its biosimilar drug (GB242) with infliximab

Clinical development – ​​The key clinical registration trials of 3 products (GB224, GB221, GB242) have been completed, GB491 (Lerociclib) cyclin-dependent kinase 4/6 inhibitor for the first-line second-line bridging of HR+/HER2- advanced breast cancer patients The trial has been approved, and the first human trial (FIH) clinical trial application of the GB261 (CD20/CD3) bispecific antibody was submitted in Australia in March 2021

 New drug clinical trial application-8 clinical trial applications have been approved, 2 are under review, and 3 bispecific antibodies have entered the IND-enabling stage

Commercialization-The commercialization team has been established steadily, and the key positions have been joined by outstanding managers; an investment agreement has been signed with the China (Shanghai) Pilot Free Trade Zone Lingang Special Administrative Bureau

Business development – ​​Introduce the HR+/HER2- breast cancer treatment drug GB491 (Lerociclib) from G1 Therapeutics and the license of GB492 (STING agonist) from ImmuneSensor.

Finance – In May 2020, it received US$160 million in Series B financing, and was listed on the main board of the Hong Kong Stock Exchange in October, successfully raising US$400 million

More progress will follow

GB261 (CD20/CD3)-The first patient in an Australian clinical trial will be enrolled in the third quarter of 2021, and preliminary POC data will be obtained in the first half of 2022

GB491 (Lerociclib) Cyclin-Dependent Kinase 4/6 Inhibitor (CDK4/6) – The first patient in the first-line second-line Phase III clinical trial of HR+/HER2-advanced breast cancer patients in the fourth quarter of 2021, the second quarter of 2023 Reach the second-tier interim analysis node

GB226 (Geptanolimab) – Approved for the marketing of indications for relapsed or refractory peripheral T-cell lymphoma in the third quarter of 2021

GB242 (Infliximab biosimilar) – Approved for marketing in the first half of 2022

March 24, 2021, Shanghai, China-Jiahe Biopharmaceuticals (Cayman) Holdings Co.

2020 is a year for Jiahe Biotech to accumulate vigorously and forge ahead.

Based in China, serving the world.

Accelerate the advancement of its new bi-specific/tri-specific candidate products into the clinical stage:

Jiahe Bio will continue to focus on the development of the early R&D product pipelines of the company's two R&D platforms in Shanghai and San Francisco.

At present, we have a variety of bispecific/trispecific antibody drug candidates, including CD20/CD3 (GB261), PD-L1/CD55 (GB262), EGFR/c-Met/c-Met (GB263T), Claudin 18.

Jiahe Biosciences has been deeply involved in the field of macromolecular drugs for more than ten years.

The company has submitted the first human trial (FIH) clinical trial application of the CD20/CD3 bispecific antibody (GB261) in Australia in March 2021 for the treatment of patients with B-cell non-Hodgkin's lymphoma (B-NHL) .

Accelerate the registration and approval of major candidate products

Geptanolimab injection (Geptanolimab, GB226) under Jiahe Biologics will be approved for marketing in the third quarter of 2021.

In addition, Jiahe Bio-GB491 (Lerociclib) Cyclin-dependent Kinase 4/6 Inhibitor (CDK4/6) obtained the implied license for clinical trials of the Center for Drug Evaluation (CDE) of the National Medical Products Administration in March 2021.

The GB492 (IMSA101) Stimulator of interferon genes (STING) agonist under Jiahe Biologics has been officially accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration.

The marketing application (NDA) of the infliximab biosimilar (GB242), a therapeutic drug in the field of autoimmunity, has also been accepted by the NMPA.

Regarding the product portfolio in the field of breast cancer, we plan to submit a marketing application for Coprelotamab (GB221) HER2+ breast cancer treatment to NMPA in the fourth quarter of 2021.

Strengthen and improve the management team and make comprehensive preparations for commercialization

Jiahe Biotech’s management team members have an average of more than 15 years of industry experience and a good practice record.

In January 2021, Dr.

In July 2020, Mr.
Chen Wende joined the company as the chief operating officer.
Mr.
Chen Wende has more than 20 years of experience in the biopharmaceutical industry and is responsible for the commercial operation of Jiahe Biotech.

In preparation for the launch of new drugs, Jiahe Bio-Bio is steadily establishing a commercialization team and formulating business strategies to support the launch of GB226 in 2021 and the successful launch of other new products in the future.
At present, excellent management team members have been added to key positions.

In December 2020, the representative of the commercialization team, Jiahe Biotech, appeared at the 2020 China Cancer Prevention and Treatment Union Annual Meeting, introducing the company and the research results of GB226 r/r PTCL.
At the same time, the commercialization team has been working closely with experts and scholars in GB226 pharmacoeconomics research to prepare for product launch and participation in the National Medical Insurance Catalog (NRDL) negotiations.

In November 2020, Jiahe Bio-Bio completed the GB226 NDA registered production site inspection and GMP compliance inspection at its production base in Yuxi, Yunnan Province, and passed the inspection smoothly.
The commercial production company that cooperates with GB226 and more innovative drugs and the China (Shanghai) Pilot Free Trade Zone Lingang Special Zone Administration signed an investment agreement in February 2021 to build an area of ​​more than 43,000 square meters in the Shanghai Lingang Special Zone.
Commercial production facilities.

The adjusted net loss is based on the reporting period's losses minus (i) the fair value loss of preferred stocks, (ii) share-based payment expenses, (iii) net exchange losses and (iv) listing expenses.

Financial summary

• The total revenue during the reporting period was RMB 10.
3 million, which was mainly derived from the provision of research and manufacturing services to customers under service fee contracts.

• During the reporting period, R&D expenditure was RMB 696.
6 million, and the annual R&D expenditure as of December 31, 2019 was RMB 438.
8 million.
Related expenses are mainly attributable to (i) the increase in ongoing clinical trial expenses and (ii) the cost of employee salaries and related benefits.

• The total comprehensive loss during the reporting period was RMB 3.
0328 billion.
Among them, the total loss as of December 31, 2019 was 523 million yuan.
This is mainly because according to the Hong Kong Financial Reporting Standards ("HKFRS"),

• After the preference shares were converted into ordinary shares in the company's initial public offering (IPO), the Group caused a non-recurring loss of RMB 1,933,380,000 on the net fair value loss of the preference shares.

• Based on non-Hong Kong Financial Reporting Standards, the adjusted loss (1) during the reporting period was RMB 654.
6 million.

About Jiahe Bio

Jiahe Biopharmaceuticals (referred to as "Jiahe Bio", stock code: 6998.
HK) was established in 2007 and is an innovation-driven biopharmaceutical company; currently it has a strong product pipeline covering the world’s top three tumor targets (breast cancer) , Lung cancer, gastrointestinal tumors).

With a foothold in China and a global layout, Jiahe Biotech strives to build a biopharmaceutical innovation integrated company with a full value chain and a full industry chain.
Located in San Francisco, USA, a powerful bi-/multi-specific antibody R&D platform with global cutting-edge innovative technologies uses computer-aided technology for the development and optimization of significantly differentiated bi-target and multi-target monoclonal antibodies.
Located in the industry-leading CMC (chemistry, production and quality control) process technology research and development center in Shanghai, China, it has internationally advanced process development capabilities, preclinical and clinical drug production capabilities, strong and complete analysis and testing capabilities, and a complete quality system.
The commercial GMP production base located in Yuxi, Yunnan, China was built, verified and put into production in 2016.
It has leading high-expressing continuous perfusion culture technology (~20g/L), independent research and development of culture media, and high cost-effective commercial production capacity.
A technical team that highly meets GMP compliance can efficiently realize the production of drugs for phase III clinical and key clinical research of Jiahe product line, the verification of the marketing process and the commercial production of the final marketed products.

Jiahe Biological currently has more than 10 products under development in clinical trials or clinical application stages.
Among them, the new drug of gerolizumab injection (R&D code: GB226) has been granted priority review qualification by the National Center for Drug Evaluation (CDE), and has successfully passed the drug registration of the National Medical Products Administration (NMPA) Production site verification is planned to be commercialized in 2021.
As the world's first PD-1 product for the indication of peripheral T-cell lymphoma, it will bring safe and high-quality therapeutic benefits to patients.
The marketing application of infliximab for injection (R&D code: GB242) has also been accepted by CDE and is currently undergoing review.