Innovent Provides Update on Phase Ib Study of Sintilimab in Combination with Chemotherapy for First-line Advanced or Metastatic Non-small Cell Lung Cancer

SUZHOU,China,May 31,2019 -- Innovent Biologics,Inc. (Innovent) (HKEX: 01801),a world-class biopharmaceutical company that develops and commercializes high quality medicines,today announced that the preliminary results of sintilimab,the anti-PD-1 antibody that co-developed with Eli Lilly and Company,in combination with chemotherapy for 1L advanced or metastatic non-small cell lung cancer (NSCLC) (NCT02937116,cohort D and cohort E) were presented at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) [Abstract #e20546].

As the top and most influential international oncology conference,ASCO Annual Meeting provides the most important platform for publishing and discussing cutting edge clinical studies. Under the theme "Caring for Every Patient,Learning from Every Patient",2019 ASCO Annual Meeting has attracted numerous top oncologists,scholars,staff from regulatory and patient organizations to share the latest updates and achievements in clinical oncology,with the ultimate goal to help deliver more promising medicines and treatment options to cancer patients.

It is worth noting that more and more Chinese companies choose to participate and disclose their programs in ASCO,showcasing the importance of emerging Chinese biotech industry. As a leading Chinese biotech company,Innovent will provide key result update of several clinical studies at the ASCO 2019 Annual Meeting. The results on the treatment of relapsed or refractory extranodal NK/T cell lymphoma (ORIENT-4) with sintilimab will be presented in an oral session,and key data from six other clinical studies will be presented by posters and other sessions.

Lung cancer is one of the malignant tumors with the highest morbidity and mortality,and non-small cell lung cancer (NSCLC) accounts for approximately 80%-85% of all lung cancer cases. Cohort D and E of NCT02937116,Phase Ib study in China,evaluating the efficacy and safety of sintilimab monotherapy orin combination with chemotherapy for patients with advanced NSCLC. Cohort D and E of NCT02937116 are designed to evaluate the efficacy and safety of sintilimab in combination with chemotherapy for 1L unresectable locally advanced or metastatic non-squamous (nsq-) and squamous (sq-) NSCLC patients. Patients with EGFR mutations or ALK rearrangements were excluded from these cohorts. Cohort D enrolled non-squamous NSCLC patients who received sintilimab in combination with pemetrexed platinum doublet. Cohort E enrolled squamous NSCLC patients who received sintilimab in combination with gemcitabine and cisplatin.

At data cutoff on 15 Jan 2019,21 and 20 patients had been enrolled in cohort D and E,respectively. Objective response rate (ORR) in nsq- and sq-NSCLC was 68.4% (95% CI,43.4 ~ 87.4) and 64.7% (95% CI,38.3 ~ 85.8) respectively based on data from 19 and 17 patients with at least one radiologic efficacy assessment. Median progression free survival (mPFS) was 11.4 months (95% CI,3.1 ~ NA) and 6.5 months (95% CI,5.3 ~ 8.0),respectively.

Cohort D

Cohort E

ORR (%,95%CI)

68.4（43.4~87.4）

64.7（38.3~85.8）

mPFS (months,95%CI)

11.4 (3.1 - NA)

6.5 (5.3 - 8.0)

mOS (months,95%CI)

18.9 (5.3 - 18.9) *

Not reached (10.3 - NA) *

12mon OS (%,95%CI)

68 (42 - 84)

64 (35 - 82)

Follow up (months),median (range)

11.4 (0.3 - 18.9)

10.3 (0.2 - 14.6)

*The data was immature at the time of data cut off.

The combination of sintilimab and chemotherapy showed clinical activity with an acceptable safety profile in 1L nsq- and sq-NSCLC.

Based on the results of the Phase Ib studies,Innovent and Eli Lilly have initiated two Phase III clinical trials evaluating sintilimab in combination with chemotherapy in 1L nsq- (NCT03607539) and sq-NSCLC (NCT03629925) in patients without EGFR mutations or ALK rearrangements to further investigate the efficacy of sintilimab in combination with chemotherapy for patients with advanced or metastatic NSCLC in China.

About Tyvyt® (sintilimab injection)

Tyvyt® (sintilimab injection) is an innovative drug jointly developed in China by Innovent and Eli Lilly and Company. Innovent is also conducting clinical studies of sintilimab injection in the United States. Tyvyt® (sintilimab injection) is a type of immunoglobulin G4 monoclonal antibody,which binds to PD-1 molecules on the surface of T-cells,blocks the PD-1/ PD-1 Ligand-1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Tyvyt® (sintilimab injection) is the only PD-1 antibody in China branded by both a local biopharmaceutical company and a global pharmaceutical company. Tyvyt® (sintilimab injection) has been granted marketing approval by the National Medical Products Administration (NMPA) for relapsed or refractory classical Hodgkin's lymphoma (r/r cHL) and has been included in the 2019 Guidelines of Chinese Society of Clinical Oncology (CSCO) for Lymphoid Malignancies. There are currently more than twenty clinical studies using sintilimab injection,including eight registration studies that evaluate the efficacy of sintilimab injection in other solid tumors.

About Innovent

Inspired by the spirit of "Start with Integrity,Succeed through Action," Innovent's mission is to develop and commercialize high quality biopharmaceutical products that are affordable to ordinary people. Established in 2011,Innovent is committed to developing,manufacturing and commercializing high quality innovative medicines for the treatment of oncology,autoimmunity and other major diseases. On October 31,2018,Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.

Since it was founded,Innovent has developed a fully-integrated platform which includes R&D,CMC (Chemistry,Manufacturing,and Controls),clinical development and commercialization capabilities. Leveraging the platform,the company has built up a robust pipeline of 20 innovative assets in the fields of oncology,ophthalmology,autoimmunity,and cardiovascular diseases. Fourteen assets have entered into clinical development,four have entered Phase 3 clinical trials,two monoclonal antibodies have their New Drug Application (NDA) under review and have been granted with priority review status,and one,Tyvyt® (sintilimab injection),is now approved for relapsed or refractory classical Hodgkin's lymphoma (r/r cHL).

Innovent has built an international team of advanced talents in high-end biological drug development and commercialization,including many overseas experts. The company has also entered into strategic collaborations with Eli Lilly and Company,Adimab,Incyte,Hanmi and other international pharmaceutical companies. Innovent strives to work with all relevant parties to help advance China's biopharmaceutical industry,improve drug availability to ordinary people and enhance the quality of the patients' lives. For more information,please visit: www.innoventbio.com.

About Eli Lilly and Company

Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs,and today we remain true to that mission in all our work. Across the globe,Lilly employees work to discover and bring life-changing medicines to those who need them,improve the understanding and management of disease,and give back to communities through philanthropy and volunteerism.

To learn more about Lilly,please visit us at www.lilly.com and http://newsroom.lilly.com/social-channels.

About Innovent Biologics' strategic collaboration with Eli Lilly and Company

Eli Lilly and Company (Lilly) and Innovent Biologics (Innovent) in March 2015 announced one of the largest biotech drug development collaborations in China to date between a multi-national and domestic company. Under the terms of the agreement,Lilly and Innovent will collaborate on the development and potential commercialization of at least three cancer treatments over the next decade. In October 2015,they announced an expansion of their drug development collaboration. The Innovent and Lilly partnership is one of the most comprehensive strategic collaborations between a Chinese company and a multinational partner in terms of the scope and breadth ranging from discovery to commercialization and involving up to six therapeutic antibodies for cancers.