On October 8, 2024, in San Francisco, USA and Suzhou, China, Innobiovent Bio Pharmaceuticals Group (Hong Kong Stock Exchange stock code: 01801), a biopharmaceutical company dedicated to the research, production, and sales of innovative drugs in the areas of tumors, autoimmunity, cardiovascular and metabolism, ophthalmology, and other major diseases, signed a cooperation agreement with Beijing Aosaikang Pharmaceuticals (Shenzhen Stock Exchange stock code: 002755), announcing the exclusive commercialization agreement on the third-generation representative skin growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) targeted drug, Uyvternalifanib tablets (Aoyixin).

Aosaikang Pharmaceuticals will act as the marketing authorization holder for the collaboration products, responsible for the commercial production and supply of the collaboration products, and will pay marketing promotion service fees to Innobiovent Bio according to the cooperation agreement. Innobiovent Bio will obtain the exclusive promotion and sales rights of the collaborative products in mainland China, and will pay the initial payment, registration milestone, and sales milestone payments to Aosaikang Pharmaceuticals as agreed in the cooperation agreement.

Uyvternalifanib is a third-generation EGFR-TKI that is orally active with significant activity, with independent intellectual property rights and a new molecular entity. Currently, the new drug application (NDA) for Uyvternalifanib tablets (Aoyixin) for two indications is under review and approval by the National Medical Products Administration (NMPA). The first indication is for adult patients with locally advanced or metastatic non-small cell lung cancer who have previously experienced disease progression after treatment with or after treatment with EGFR tyrosine kinase inhibitors (TKIs), confirmed to have EGFR T790M mutation positivity by testing, or a primary EGFR T790M mutation positivity. The second indication is for first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) exon 19 deletion (19DEL) or exon 21 substitution mutation (L858R).

In a multicenter, randomized, double-blind, positive-controlled Phase III clinical trial, Uyvternalifanib demonstrated efficacy in the first-line treatment of locally advanced or metastatic non-small cell lung cancer patients with EGFR-sensitive mutations compared to Gefitinib. The main study endpoint was achieved. The relevant data and analysis plan of this Phase III clinical study will be published in future academic conferences or journals. Previously, Uyvternalifanib presented the results of its Phase 2b clinical trial at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting in the form of a poster presentation.

Dr. Yu Dechao, founder, chairman, and CEO of Innovent Bio, said: "We are delighted to announce this strategic collaboration with Beijing Aosaikang Pharmaceutical. Aosaikang is a Chinese pharmaceutical company with excellent innovation capabilities. We hope our cooperation can bring new treatment options to Chinese cancer patients. Lung cancer is currently a highly prevalent type of cancer in China and even worldwide. Innovent Bio and our partners have built a broad and robust portfolio of innovative drug products in the field of lung cancer treatment, including Sintilimab injection (Tyvoss), Bevacizumab injection (Atuoyun), Cepatinib capsules (Ruituo), Fluzoparib tablets (Dabote), and Tepotinib (ROS1 inhibitor, under NDA review). Our collaboration with Aosaikang on Erlotinib tablets (Aoyixin) is expected to provide a novel targeted drug for a large number of EGFR-mutated lung cancer patients. This will further enhance Innovent Bio's leading position in the field of cancer treatment. Innovent Bio will also work together with industry colleagues to jointly promote the accessibility and affordability of innovative drugs in China, allowing more Chinese patients to benefit early."

Ma Jingfei, director and general manager of Beijing Aosaikang Pharmaceutical, stated: "We are pleased to announce a strategic partnership with Innovent Bio. Anti-tumor is one of the four major drug treatment areas that Aosaikang focuses on, with a tumor product line that includes chemotherapy drugs, small molecule targeted drugs, and biologics. Erlotinib tablets (Aoyixin) is Aosaikang's first innovative drug, targeting the highest incidence and mortality cancer domestically, focusing on the development of the highest mutation rate molecular target in lung cancer, aimed at providing effective drugs for a large number of EGFR-mutated lung cancer patients. Innovent Bio has a rich product pipeline in the field of lung cancer, which can synergize with Erlotinib tablets. Moreover, Innovent Bio has a professional and efficient marketing team and strong commercial capabilities. We believe this collaboration will help Erlotinib tablets (Aoyixin) fully demonstrate clinical value and benefit more patients."

About EGFR mutations in NSCLC

Lung cancer is the most deadly malignant tumor globally, ranking second in global malignant tumor incidence rates. It is also the malignant tumor with the highest incidence and mortality rates in China. Non-small cell lung cancer (NSCLC) accounts for approximately 80% to 85% of all lung cancers, with about 70% of NSCLC patients being diagnosed with locally advanced or metastatic disease unsuitable for surgical resection. EGFR is the most common driver gene in NSCLC, with 30% to 50% of Asian NSCLC patients having EGFR gene mutations. EGFR-TKIs are the recommended first-line standard treatment for this type of patient, with the third-generation EGFR-TKIs having a wide range of applicable populations.

About the pharmaceutical of Eli Neipian

Eli Neipian is a third-generation EGFR-TKI that is orally active, with independent intellectual property rights and a completely new molecular entity.

Currently, the new drug applications (NDA) for two indications of Eli Neipian (Afinitor) are under review and approval by the National Medical Products Administration (NMPA), specifically for 1) the treatment of locally advanced or metastatic NSCLC adult patients with EGFR T790M mutation-positive after progression on or after EGFR-tyrosine kinase inhibitor (TKI) therapy, or having primary EGFR T790M mutation-positive; 2) the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) adult patients with exon 19 deletion (19DEL) or exon 21 substitution mutation (L858R) of the epidermal growth factor receptor (EGFR).

In a multicenter, randomized, double-blind, positive-controlled Phase III clinical trial, Eli Neipian has achieved its primary endpoint in the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) patients with EGFR-sensitive mutations compared to gefitinib. The relevant data and analysis plan of this Phase III clinical study will be published in future academic conferences or journals.

Previously, in 2022, the clinical results of phase 2b clinical study of erlotinib were presented in the form of a poster at the American Society of Clinical Oncology (ASCO) annual meeting. The study explored the efficacy and safety of erlotinib in the treatment of locally advanced or metastatic NSCLC with EGFR T790M+ progression after previous EGFR-TKI treatment. The study results showed an objective response rate (ORR) assessed by an independent review committee (IRC) of 68.8%, disease control rate (DCR) of 92.4%, duration of response (DoR) of 11.1 months, and progression-free survival (PFS) of 11.0 months. For patients with brain metastases (CNS), the intracranial ORR was 56.1%, and CNS PFS was 10.6 months, indicating a good efficacy of erlotinib in CNS patients.

In October 2024, Innovent Bio and Beijing Aosaikang Pharmaceutical reached an exclusive commercial cooperation agreement for erlotinib tablets in China.

"Starting with trust and ending with action", developing high-quality biopharmaceuticals that the general public can afford is the ideal and goal of Innovent Biologics. Innovent Biologics was established in 2011 and is committed to the development, production, and sales of innovative drugs to treat major diseases such as tumors, metabolic diseases, and autoimmune diseases. On October 31, 2018, Innovent Biologics went public on the Main Board of the Hong Kong Stock Exchange with stock code: 01801. Since its establishment, the company has stood out among many biopharmaceutical companies with its innovative achievements and international operating model. It has established a product chain including 23 new drug varieties, covering multiple disease areas such as tumors, metabolic diseases, and autoimmune diseases, of which 6 varieties have been selected for the national "Major New Drug Creation" special project, and 3 products (Sintilimab Injection, brand name: Tyvyt, English trademark: TYVYT; Bevacizumab Injection, brand name: Duligotong, English trademark: BYVASDA; Camrelizumab Injection, brand name: Sulinno, English trademark: SULINNO) have been approved.

"Starting from trust, reaching through actions", developing affordable high-quality biopharmaceuticals for lbx pharmacy chain joint stock is the mission and goal of Innovent Bio. Innovent Bio was established in 2011, dedicated to the research and development, production, and sale of innovative drugs in major disease areas such as oncology, autoimmunity, metabolism, and ophthalmology, benefiting more lives through our work. The company has had 11 products approved for marketing, including Sintilimab Injection (Tyvyt), Bevacizumab Injection (AiRuiShu), Camrelizumab Injection (ShuLixin), Rituximab Injection (Tyvorka), Pemigatinib Tablets (Tyvodin), Alectinib Tablets (Nailik), Lenvatinib Injection (XiRanzhe), Selpercatinib Capsules (Ruituo), Igilumab Injection (Fukesu), Toripalimab Injection (Xinbile) and Fluzoparib Tablets (Dabote). Currently, there are 5 varieties under review by the NMPA, 3 new drug molecules entering phase III or pivotal clinical studies, and another 18 new drug varieties entering clinical research.

The company has reached more than 30 strategic cooperation agreements with international partners such as Eli Lilly, Roche, Sanofi, Adimab, Incyte and MD Anderson Cancer Center. While seeking self-development through independent research and development of innovative drugs, Innovent adheres to the development concept of economic construction centering on the people. Over the years, it has always had a scientific and kind heart, stuck to the principle of "patient-centered," concerned about the patients and their families, and actively fulfilled its social responsibilities. The company has launched and participated in a number of drug public welfare assistance projects, enabling more and more patients to benefit from the progress of life sciences and buy and afford high-quality biological drugs. Up to now, Innovent's patient assistance project has benefited more than 170,000 ordinary patients, and the total value of drug donations is 3.4 billion yuan. Innovent hopes to work together with everyone to improve the development level of China's biopharmaceutical industry, to meet the accessibility of the people's medication and the pursuit of a better life and health.

For more details, please visit the company's website: or the company's LinkedIn account.

About Beijing Aosaikang Pharmaceutical

Beijing Aosaikang Pharmaceutical was established in 2003 and is an innovative and research-driven pharmaceutical manufacturing company. The company independently developed China's first domestically produced proton pump inhibitor (PPI) injection. After more than twenty years of development, the pharmaceutical treatment field has covered four major areas: digestion, anti-tumor, anti-infection, and chronic diseases. The company has a high brand influence in the China pharmaceutical sub-market.

Beijing Aosaikang Pharmaceutical focuses on the research and development of small molecule targeted innovative drugs and tumor immunotherapy innovative drugs through independent research and development as well as introduction and cooperation. Currently, there are a total of 48 main research projects, including 11 key ongoing chemical and biological innovative drug projects. Among them, the innovative anti-tumor drug Laitenib tablets are in the application for market approval stage, ASKC109 (Malt Iron Capsules), ASKB589 (Claudin18.2 monoclonal antibody) are in the phase III clinical research stage, and several other innovative drugs are in early clinical and preclinical research stages.

Beijing Aosaikang Pharmaceutical upholds the corporate mission of 'For Health and Health Actions', aiming at clinical urgent needs and unmet clinical demands, sticking to the original intention, moving towards the new, accelerating the transformation of innovative achievements into real productivity, developing and bringing more domestically produced high-quality new drugs and good medicines to the market, to improve the accessibility, advancement, and sustainability of patient medication, and contribute to the high-quality development of the biomedical industry with the power of Beijing Aosaikang Pharmaceutical.

For more information, please visit the company's website:

Innovent Bio Forward Statement

This press release may contain certain forward-looking statements. These statements inherently involve risks and uncertainties. When using words such as "expect," "believe," "anticipate," "intend," "plan," and other similar expressions, it is the company's intention to identify forward-looking statements. The company has no obligation to continually update these forward-looking statements.

These forward-looking statements are based on management's current views, assumptions, expectations, estimates, forecasts, and understandings of future events, which are inherently subject to risks, uncertainties, and other factors, some of which are beyond the company's control, and may be difficult to predict. Therefore, actual results may differ materially from those included in the forward-looking statements due to future changes and developments in our business, competitive environment, politics, economy, laws, and social circumstances.