SAN FRANCISCO and SUZHOU, China, Aug. 25, 2021 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, announced its interim results for the six months ended June 30, 2021 and the corporate progress.

Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated: "With the clear strategy of global innovation and globalization, Innovent has been making a series of significant accomplishments in 2021. Our commercial portfolio was expanded from four to five with product revenue doubled from the first half of last year. We expect our commercial portfolio will own at least a total of ten products in next several years. We have built up a robust pipeline of 25 high value assets with broader global development footprint, which include our comprehensive and highly competitive pipeline in the immunology fields as well as high potential molecules in non-oncology areas. Moreover, our first BLA application of sintilimab in the U.S. marked a historic milestone for Innovent's globalization footprint. Our U.S. R&D center (the U.S. Lab) and the Scientific Advisory Board were established. This year we also entered into strategic collaborations with worldwide partners such as Ascentage Pharma, AnHeart and Synaffix. At the tenth year since its inception, we are very ambitious to transform Innovent to a premier global biopharmaceutical company, and will keep delivering value for our patients, employees, and shareholders along the journey."

BUSINESS HIGHLIGHTS

Five Commercial Products; Product Revenue Reached RMB1,854.6 Million

• Total product revenue reached RMB1,854.6 million during the first half of 2021, representing a 101.4% growth compared with the first half of 2020.
• As the leading brand in the PD-1 market, TYVYT has maintained continuous growth on the sales revenue and sales volume compared with both the first and the second half of 2020. Besides, revenue generated from the new products BYVASDA®, SULINNO®, HALPRAZA® and PEMAZYRE® also significantly contributed to the strong product revenue growth.
• With the approval of PEMAZYRE® in Taiwan market, Innovent expanded the commercial product portfolio from four to five, and from antibodies to small molecule.
• Innovent has built a comprehensive sales and marketing team of over 2,000 people who cover more than 4700 hospitals.

Robust Pipeline of 25 High Value Assets at Diverse Stages

Innovent has established a robust global pipeline of 25 high value assets across diversified clinical stages, within which 5 are commercialized, 6 are in phase 3 or pivotal trials, 14 in other clinical stages. The 25 assets cover major areas including monoclonal antibodies, bispecific antibodies, CAR-T and small molecules etc.

Approval of TVYTY® for Three Additional Major Indications

• In the first half of 2021, Tyvyt ® received approval for three major indications, including 1L non-squamous NSCLC, 1L squamous NSCLC, and 1L HCC. By end of this year, we anticipate to receive one more approval of Tyvyt for 2L squamous NSCLC.
• Tyvyt has also met primary endpoint in the Phase 3 registrational studies for 1L ESCC and 1L GC. This makes Tyvyt globally the only PD-1 inhibitor proven to be efficacious in the first-line treatment of five major types of cancer.

6 Assets in Phase 3 or Pivotal Stages

Besides 5 commercialized product portfolio, Innovent also have 6 assets that are in NDA stage or pivotal trails, which includes：

• IBI-348 (BCL/ABR)
• IBI-376 (PI3Kδ)
• IBI-326 (BCMA CAR-T)
• IBI-344 (ROS1/NTRK)
• IBI-310 (CTLA-4)
• IBI-306 (PCSK9)

Comprehensive and Differentiated Pipeline in Immunology

• IBI-188 (CD47): Phase 1b studies for MDS and AML ongoing
• IBI-110 (LAG-3): About to start Phase 1b/2 studies for multiple cancer types
• IBI-322 (PD-L1/CD47): Phase 1 study ongoing in China and US
• IBI-323 (PD-L1/LAG-3), IBI-321 (PD-1/TIGIT), IBI-319 (PD-1/4-1BB): started first-in-human Phase 1 studies

Non-oncology Pipeline Made Remarkable Progress

Non-oncology represents another important pillar of Innovent's long term growth in major therapeutic areas including autoimmune, metabolic, and ophthalmology. The non-oncology pipeline has made very exciting and significant progress this year. In particular:

• IBI-306 (PCSK9): Phase 3 study for HeFH subgroup has met primary endpoint; registrational trials for other subgroups ongoing
• IBI-362 (OXM3): Results of the Phase 1b study in overweight/obesity subjects showed a favorable safety profile and robust efficacy, including weight loss and multiple metabolic benefits. Results of the Phase 1b study in patients in Type 2 diabetes will be disclosed at 2021 IDF annual meeting. IBI362 shows the great potential to bring benefits to China's huge patient population of diabetics and obesity as new generation of GLP-1 based drug.

Entered Strategic Collaboration with Worldwide Partners

Innovent has entered into a series of strategic collaborations with world-class partners in 2021, in particular:

• Entered into an exclusive license agreement with AnHeart Therapeutics for the co-development and commercialization of Taletrectinib (ROS1/NTRK inhibitor) in Greater China.
• Entered into a multifaceted strategic agreement with Ascentage Pharma including i) the joint commercialization of Olverembatinib (BCR-ABL inhibitor) in China; ii) the collaborative clinical development of APG-2575 (Bcl-2 inhibitor) with HALPRYZA® (rituximab biosimilar injection) and IBI188 (CD47); and iii) the equity investment in Ascentage Pharma.
• Entered into a license agreement with Synaffix to enable Innovent to rapidly progress one of its antibodies as a best-in-class ADC candidate

Accelerated Global R&D Footprint

• The BLA application of sintilimab was accepted by the U.S. FDA for the treatment of 1L nonsquamous NSCLC.
• The company owns a series of assets has global rights and potential, including CD47 cluster, LAG-3 cluster, TIGIT cluster etc.
• The company has established the U.S. R&D Center (the U.S. Lab）. the U.S. Lab will focus on the study of disease mechanism and the development of technology platform, with the aim to connect with the frontline global innovation and clinical practices, and accelerate translation of scientific discovery into medicines.
• The company has established the Scientific Advisory Board(SAB). The SAB members are world-class scientists with great expertise in oncology and life sciences, and will bring frontier innovation concepts and scientific advices on drug discovery and clinical development.
• The company is enhancing the global development organization and capability. Global development and registration team has expanded rapidly, which is capable to drive and execute the global development and registration strategy, monitor global CROs and vendors, provide support in global medical community and also meet the global requirement of regulatory, safety and quality standard.
• Innovent Academy will work as the robust drug discovery engine of the company. We have world-class capability in antibody engineering and immunology science. We have over 50 preclinical drug discovery projects ongoing, with the aim to generate global FIC and BIC blockbuster drug.

Significant Expansion in Production Capacity

• Innovent owns production capacity of 24,000L in use, containing six 3000 litter stainless steel bioreactors and six 1000 litter disposable bioreactors. In particular, the 3000 litter large scale bioreactors provided a highly market competitive cost advantage of Tyvyt.
• The company keeps expanding our manufacturing to support the commercial products and growing pipeline. We have started the construction of a new commercial facility in Suzhou site (the M2 site) which will house additional twelve 3,000 little production capacities. We anticipate to complete construction and receive GMP certificate for the M2 site later this year, and the production capacity will expand to 60,000L.

FINANCIAL HIGHLIGHTS（For the six months ended 30 June 2021）

• Total revenue was RMB1,941.8 million, representing an increase of 97.3% over the same period of last year. The growth was mainly driven by the strong product revenue growth.
• Product revenue increased by 101.4% to RMB1,854.6 million. This was mainly driven by the continued strong growth of TYVYT® coupled with revenue contribution from four new products.
• Gross profit margin of product sales was 87.3%, with an increase of 7.4% compared with 79.9% for the same period of last year. This was primarily due to the notable manufacturing efficiency improvement as the 6*3000L stainless steel bioreactor production lines were put in use since the fourth quarter of 2020.
• R&D expenses was increased by 29.0% to RMB1,042.1 million, which were mainly put into use of clinical trial development of more late-stage and prioritized pipeline assets in China and globally.
• Cash balance by the first half of 2021 was equivalent to US$1,728 million. This should be able to provide a strong and sufficient support to our drug discovery, potential collaboration, production infrastructure expansion and global operation.

About Innovent

Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture 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 cancer, autoimmune, metabolic 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 its inception, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 25 valuable assets in the fields of cancer, metabolic, autoimmune disease and other major therapeutic areas, with 5 products – TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection), HALPRYZA® (rituximab biosimilar injection) and Pemazyre® (pemigatinib oral inhibitor) – officially approved for marketing, 1 asset's NDA under NMPA review, sintilimab's Biologics License Application (BLA) acceptance in the U.S., 5 assets in Phase 3 or pivotal clinical trials, and an additional 14 molecules in clinical studies.

Innovent has built an international team with advanced talent in high-end biological drug development and commercialization, including many global experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Adimab, Incyte, MD Anderson Cancer Center, Hanmi and other international partners. Innovent strives to work with many collaborators to help advance China's biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives. For more information, please visit: .

Innovent Biologics, Inc. Forward-Looking Statements

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions.

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