Building an Innovative Biopharmaceutical Company with Sustainable Growth and Comprehensive Capability

ROCKVILLE, Md. and SUZHOU, China, March 29, 2023 /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, ophthalmology and other major diseases, announces its 2022 annual results and major company business updates.

Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated: "2022 was the first year for Innovent's second decade in business. Despite challenges amid COVID and macro environments in the year, we are taking initiative to make profound improvements and strengthen our foundation for more sustainable growth, as we believe efficiency improvement, sustainable growth and technology innovation will be more emphasized in the biopharmaceutical industry. During the year, we built a more diversified commercial portfolio and further improved our commercial operational efficiency. Our strategical position in several key non-oncology areas brings us another important pillar of our future business growth. We further strengthened innovation with extended Innovent Academy technology and multiple international collaborations. Looking ahead, Innovent will strive to achieve our strategic goals of sustainable growth and global innovation, through further expansion of commercial portfolio, improvement of operational efficiency, and innovation through advanced R&D platform for the global market. We will uphold the vision of 'to become a global premier biopharmaceutical company' and create sustainable value for patients, employees, shareholders and the society."

Commercial – Continuous portfolio expansion and efficiency improvement achieved

• Expansion of commercial portfolio into eight approved products, including: TYVYT®, BYVASDA®, SULINNO®, HALPRYZA®, PEMAZYRE®, Olverembatinib, CYRAMZA® (new product) and Retsevmo® (new product).
• Product revenue RMB4,139 million in year 2022: an increase of 3.4% compared with the prior year with fast ramp-up of product volume and contribution of new products despite impact of COVID and price reduction of TYVYT® (sintilimab injection) during 2022.
• NRDL coverage further expanded, benefiting broader patient groups: In January 2023, two additional indications of TYVYT® (sintilimab injection), olverembatinib for the first listing, and multiple additional indications of BYVASDA® (bevacizumab injection), HALPRYZA® (rituximab injection), and SULINNO® (adalimumab injection) were included in the updated NRDL.
• Broad coverage in commercial channels and networks with an experienced and professional sales and marketing team: expansive coverage of over 5,000 hospitals and a well-structured commercial team of nearly 3,000 talents. The Company is also strategically establishing commercial presence in certain non-oncology therapeutic areas for more diversified and long-term growth.
• Improved efficiency in commercial operation with preliminary results observed:
  • The Company continuously develops a more sustainable and healthier commercial management model, which could further improve operational efficiency and expand the scale of business for long-term sustainable business growth.
  • In the past year, preliminary positive results were observed: the ratio of sales and marketing expenses to total product revenue (under IFRS measurement) decreased from 65.5% in 2021 to 62.6% in 2022, and from 68.5% in the first half of 2022 to 56.9% in the second half of 2022, in particular.

Pipeline – Expand the boundary of novel oncology therapies, and roll out non-oncology high-potential products

We have built a strong pipeline with over 30 innovative drug candidates, among which 8 products are approved, 3 assets are currently under NDA review by the NMPA, 5 assets are in Phase 3 or pivotal clinical trials, and approximately 20 assets in early Phase 1/2 clinical studies.

Oncology：Introduce novel modalities and therapies to expand the oncology pipeline

• Submitted NDAs of two product candidates for the treatment of hematological malignancies, and have pioneered the development of three drug candidates for treatment of lung cancer:
  • IBI326 (BCMA CAR-T): the NDA was accepted for the treatment of r/r MM
  • IBI376 (PI3Kδ): the NDA was accepted for the treatment of r/r FL
  • IBI344 (ROS1/TRK): Ongoing pivotal Phase 2 for ROS1 positive NSCLC
  • IBI351 (KRAS^G12C): Ongoing pivotal Phase 2 for KRAS^G12C mutated NSCLC
  • IBI126 (CEACAM5 ADC): Ongoing Phase 3 for CEACAM5 highly expressed NSCLC
• Received preliminary positive data for multiple global innovative molecules：
  • IBI110 (LAG3) : 1L sqNSCLC, 1L GC
  • IBI939(TIGIT): 1L NSCLC (PD-L1 TPS≥50%)
  • IBI188 (CD47): 1L MDS
• Established a fully-integrated and differentiated ADC proprietary technology platform:
  • IBI343 (CLDN18.2 ADC) : Phase 1 multi-regional clinical trial ongoing in Australia and China. IBI343 has potential best-in-class profiles with differentiated design for potential wide therapeutic window and high potency.
  • More than 10 differentiated ADC projects in IND-enabling stage.

Non-Oncology：Strategically positioned in three major chronic diseases to accelerate the development of high-potential assets

• Cardiovascular and metabolism ("CVM") field -- high-potential innovative assets for multiple high-prevalence chronic diseases:
  • IBI306 (PCSK9): the NDA was accepted for the treatment of hypercholesteremia
  • IBI362 (GLP-1R/GCGR): Phase 2 study results in obesity and type 2 diabetes shows its best-in-class potential in weight loss, blood glucose lowering with favorable safety and multiple metabolic benefits. Phase 3 registrational studies for both indications have been initiated during late 2022 to early 2023.
  • IBI128 (XOI) : Phase 2 study (by LG Chem) data readout demonstrated its potential as best-in-class XOI for the treatment of hyperuricemia in gout patients, with overall superior efficacy and good safety profile. The Company plans to start a Phase 3 clinical study in 2023 in China.
  • IBI311 (IGF-1R) : Phase 2 study for the treatment of thyroid associated ophthalmopathy ("TAO") is ongoing and a Phase 3 registrational study will start in 2023.
• Autoimmune field -- capture differentiated clinical value and fulfill substantial unmet medical needs:
  • IBI112 (IL-23p19) : the Phase 2 data for IBI-112 (IL-23p19) demonstrated its potential long-lasting efficacy advantage and convenient extended dosing intervals for psoriasis. The Phase 3 registrational clinical study started in early 2023.
  • IBI353(PDE4): the multi-regional Phase 2b clinical study (led by UNION) of IBI353 in psoriasis reached positive topline results. Phase 2 clinical study in China will start in 2023.
  • Additional innovative autoimmune molecules such as IBI355 (CD40L) and IBI356 (OX40L) will enter first-in-human clinical studies in 2023 to explore other unmet medical needs in various types of autoimmune diseases.
• Ophthalmology field -- multiple differentiated bispecific antibodies:
  • IBI302(VEGF/C): Phase 2 studies of IBI302 for the treatment of nAMD are ongoing to explore potential effect in anti-macular atrophy.
  • IBI324 (VEGF-A/ANG-2) and IBI333 (VEGF-C/VEGF-A) are in the Phase 1 stage. The potential differentiation versus existing therapy brought by their innovative mechanisms and molecule designs as bispecific antibodies will be explored.

R&D: Global innovation continues as core long-term strategy

• We continue to build Innovent Academy as an engine of innovation power:
  • In 2022, Innovent Academy has successfully delivered six high quality novel molecules into IND enabling stage.
  • Further enhance the R&D platform by leveraging the Company's profound know-how in immunology, cancer biology and antibody engineering, with a focus on global innovation and cutting-edge technology extension.
  • Innovent Academy has built a fully integrated and differentiated ADC proprietary technology platform, which will gradually deliver next-generation ADC candidates into the clinical development stage to further enrich our long-term pipeline.
• Deploy scientific and efficient approaches to early stage innovative pipeline development
  • Exploring the early-to-mid stage pipeline with global potential in ongoing PoC studies, with several molecules in the IO and ophthalmology fields.
  • Further explore the early clinical development of novel molecules with global potential, such as PD-1/IL-2, ADC clusters, etc, in multi-regional clinical trials.

BD: Strategic collaborations deepen overall strength of innovation

• Entered into strategic collaboration with Sanofi to benefit more patients in China and Sanofi's initial equity investment of EUR300 million in Innovent. Both companies are committed to accelerating the development and commercialization of clinical Phase 3 stage SAR408701 (tusamitamab ravtansine; anti-CEACAM5 ADC) and clinical Phase 2 stage SAR444245 (non-alpha IL-2) in China.
• Expanded oncology strategic partnership with Lilly: Innovent obtained the sole commercialization right of Cyramza® (ramucirumab) and Retsevmo® (selpercatinib) in mainland China, and the right of first negotiation for potential future commercialization of pirtobrutinib (BTK inhibitor) in mainland China. 
• Launched antibody drug benefiting emerging markets: BYVASDA® (Indonesian trademark: Bevagen®) was approved by the Indonesian Food and Drug Administration (BPOM) and is the first Chinese antibody drug commercialized and expected to be locally manufactured in Southeast Asia markets.

CMC：High-quality and scalable manufacturing capabilities

• 60,000L GMP certified production capacity which is currently the largest stainless steel bioreactor production capacity in China with more capacity construction in plan.
• Quality compliance to GMP and cost advantage further strengthen market competitiveness.

Financial Highlights for the Year 2022

• Total revenue was RMB4,556.4 million, an increase of 6.7% compared to the prior year.
• R&D expenses were RMB2,871.2 million, an increase of RMB548.7 million from the prior year.
• The ratio of selling and marketing expenses to produce revenue was 62.6%, a decrease of 2.9% compared to the prior year.
• Loss for the year was RMB2,179.3 million, mainly due to continuous investment in R&D to support our long-term strategic goal of global innovation.
• Cash and short-term financial assets was RMB9,166.0million, or approximately USD1.3 billion, which enables us to focus on the long-term sustainable development.^[1]

Note:

[1] The financial numbers mentioned above was based on IFRS measure. Detailed disclosure can be found at the Company's annual results announcement.

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 in the fields of oncology, metabolism, autoimmunity, ophthalmology 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 36 valuable assets in the fields of cancer, metabolic disorder, autoimmune disease and other major therapeutic areas, with 8 approved products on the market. These include:  TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection), HALPRYZA® (rituximab biosimilar injection) , Pemazyre® (pemigatinib oral inhibitor), olverembatinib (BCR-ABL TKI) , Cyramza® (ramucirumab) and Retsevmo® (selpercatinib). An additional 3 assets are under NMPA NDA review, 5 assets are in Phase 3 or pivotal clinical trials, and 20 more molecules are 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, Sanofi, Adimab, Incyte, MD Anderson Cancer Center 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: www.innoventbio.com and www.linkedin.com/company/innovent-biologics/.

Note:

TYVYT® (sintilimab injection) is not an approved product in the United States.

BYVASDA® (bevacizumab biosimilar injection), SULINNO®, and HALPRYZA® (rituximab biosimilar injection) are not approved products in the United States.

TYVYT® (sintilimab injection, Innovent)

BYVASDA® (bevacizumab biosimilar injection, Innovent)

HALPRYZA® (rituximab biosimilar injection, Innovent)

SULINNO® (adalimumab biosimilar injection, Innovent)

Pemazyre® (pemigatinib oral inhibitor, Incyte Corporation). Pemazyre® was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan.

CYRAMZA® (ramucirumab, Eli Lilly). CYRAMZA® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China.

Retsevmo® (Selpercatinib, Eli Lilly). Retsevmo® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China.

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 Biologics ("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.

Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialise or turn out to be incorrect.

Source: Innovent Biologics Related Stocks: HongKong:1801 OTC:IVBIY