On March 29, 2022 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 reported 2021 annual results including its major achievements and progress (Press release, Innovent Biologics, MAR 29, 2022, View Source [SID1234611483]).

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Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated: "2021 is the 10th year since our company’s inception. Over the past decade, bearing the mission to develop and commercialize high-quality biopharmaceutical products that are affordable to ordinary people, Innovent has developed into a leading Chinese biopharmaceutical company with fully-integrated platform capability, strong execution with track record and a healthy financial position. For the past year, we are determined with the global innovation strategy and have made tremendous progress in all aspects including R&D, clinical development, CMC, commercialization and business collaboration. The company has rolled out development for a pipeline of 32 valuable assets in various clinic stages. We plan to expand commercial portfolio to over ten products in two years with continuous strong revenue growth, supported by our validated commercial platform capability and competitive cost advantage under large scale and high quality manufacturing facilities. Besides, we further fortified R&D structure and platform to expedite the development for over a dozens of clinical stage candidates with global potential and more preclinical projects with global innovation. For the year of 2022, as the inflection point for next decade of development, we will adhere to the company strategy of global innovation, strive to be a global premier biopharmaceutical company with steady growth prospects, and create sustainable value for patients, employees, shareholders and the society."

Business Highlight Overview

For the year of 2021, achieved RMB4,261million total revenue and RMB4,001million product revenue with an increase of 69.0% compared to the prior year.
For the year of 2021, commercial portfolio increased to six products with two innovative anti-cancer drugs approved.
Expanded strategic partnership with Eli Lilly in March 2022 added the seventh newly approved product and a ready-to-launch product at New Drug Application (NDA) stage.
TYVYT received three additional first-line indication approvals for major types of cancer and successfully included in the updated National Reimbursement Drug List (NRDL), also as the only PD-1 inhibitor globally with positive Phase 3 data in the first-line treatment for 5 major types of cancer.
6 molecules at NDA or late clinical stage.
7 molecules achieved positive Proof of Concept (PoC) data readout.
Acceleration of Global R&D and clinical development, to explore first-in-class (FIC) targets with full-functional global development platform and global talents.
About 10 strategic collaborations with global and regional partners in research, development and commercialization, unleashing the platform potential and explore synergic value of pipeline portfolio.
Commercial – Strong Track Record

Product revenue RMB4,001 million in 2021: an increase of 69.0% compared with the prior year.
Expansion of commercial portfolio into six approved products, including: TYVYT, BYVASDA, SULINNO, HALPRYZA, PEMAZYRE and NAILIKE by the end of 2021.
In March 2022, expansion of strategic collaboration with Eli Lilly, which showed further recognition by the global MNC: for Innovent to obtain sole commercialization right of the 7th approved product Cyramza (ramucirumab) and NDA-stage asset Retsevmo (selpercatinib), and the right of first negotiation for future potential commercialization of late-stage asset Pirtobrutinib (BTK inhibitor) in mainland China.
Broad coverage in commercial channels and networks with an experienced and professional sales and marketing team expanded to cover over 5,100 hospitals and 1,100 pharmacies across more than 320 cities, and a well-structured commercial team with nearly 3,000 people.
Pipeline – Expedited Speed to Launch

– TYVYT as leading brand in PD-(L)1 market:

Newly approved 3 additional indications got successfully included in the NRDL (non-squamous Non-Small Cell Lung Cancer [nsqNSCLC], sqNSCLC, hepatocellular carcinoma [HCC]).
The only PD-1 inhibitor with positive Phase 3 data in first-line treatments of five major types of cancer (1L nsqNSCLC, 1L sqNSCLC, 1L HCC, 1L esophageal squamous cell carcinoma [ESCC], 1L gastric cancer [GC]).
Multiple clinical datasets of TYVYT were published in world-renowned medical journals such as EClinicalMedicine, ESMO (Free ESMO Whitepaper) Open, BMJ etc.
– Six assets at late stage incl. NDA/pivotal trials:

Retsevmo (selpercatinib), NDA submitted
IBI-326 (BCMA CAR-T), planned NDA submission in 2022
IBI-306 (PCSK9), planned NDA submission in 2022
IBI-310 (CTLA-4), planned NDA submission in 2022
IBI-344 (ROS1/NTRK), ongoing pivotal Phase 2
IBI-376 (PI3Kδ), ongoing pivotal Phase 2[1]
– Seven innovative molecules achieved positive PoC data readout, plan to advance into the late stage in clinic:

IBI-188 (CD47): achieved preliminary PoC data readout in Phase 1b study for 1L MDS, promising efficacy data (ORR 83.3%) and a good safety profile. Plan to initiate Phase 3 study for 1L MDS in 2022.
IBI-362 (GLP-1/GCGR): showed robust efficacy in weight loss for Phase 1b in obesity, data published in EClinicalMedicine. Robust efficacy in blood glucose lowering effects in diabetics patients. Potentially the best GLP1-/GCGR dual agonist. Plan to initiate Phase 3 studies for obesity and type 2 diabetes in 2022.
IBI-326 (BCMA CAR-T): demonstrated impressive efficacy and safety in Phase 1/2 study, with improved in-vivo persistency and encouraging efficacy in patients with prior murine BCMA CAR-T treatment failure. Plan to submit NDA in 2022.
IBI-344 (ROS1/NTRK): ORR 90.5% in the crizotinib-naïve patient and ORR 43.8% in the crizotinib-treated patient group. Received NMPA BTD for ROS1+ NSCLC. Pivotal Phase 2 study ongoing.
IBI-310 (CTLA-4): achieved positive PoC in combination with sintilimab for CC and HCC. Plan to submit NDA for CC in 2022.
IBI-302 (VEGF/C): showed visual acuity improvement with edema reduction in Phase 1b study, ongoing Phase 2 study for nAMD.
IBI-112 (IL-23p19): observed significant efficacy signal in the Phase 2 study for psoriasis with long-acting potential. Plan to initiate Phase 3 study in 2022.
– Expedite the clinical development of multiple molecule clusters with global potentials, expected PoC data readout roll out in a well-schemed plan:

CD47 cluster: IBI-188 (CD47), IBI-322 (PD-L1/CD47), IBI-397 (SIRPα)
LAG-3 cluster: IBI-110 (LAG-3), IBI-323 (PD-L1/LAG-3)
TIGIT cluster: IBI-939 (TIGIT), IBI-321 (PD-1/TIGIT)
VEGF cluster: IBI-302 (VEGF/C), IBI-324 (VEGF/ANG-2), IBI-333 (VEGF-A/VEGF-C)
R&D: Infrastructure Set for Global Innovation

– Innovent US Lab established: primarily focused on disease mechanism study and technology-platform development, accelerating the translation of scientific discovery into the next-generation drug candidates.

– The Scientific Advisory Board (SAB) established: comprising three World-renowned scientists to provide insights of frontline global innovation in cancer biology and immunology and contribute scientific advice to our research and clinical pipelines.

– The CMC Advisory Board (CAB) established: comprising industry-leading experts to provide professional advice on production structure and process streamline, resources investment and strategic development.

– The global product development team expansion and infrastructure improvement: have built a full-functional global development team and expect to have 100+ employees in near term. Have established an effective global development platform and process which enables to cooperate seamlessly with China clinical development team of 1,000 people to carry out global development for our novel assets.

– Technology platform collaborations for global innovation:

The development of the proprietary ADC technologies with Synaffix.
The development of three new therapeutic immune-stimulating antibody conjugate (ISAC) candidates with Bolt Biotherapeutics.
The development of up to three enzyme specific inhibitors with Amagma Therapeutics.
The license-out of non-exclusive commercial right of fully-human BCMA CAR construct to SANA Biotechnology for certain in vivo gene therapy and ex vivo hypo-immune cell therapy application.
BD: Meaningful Collaboration to Succeed

– Established multiple co-development and co-commercialization collaboration to unlock assets potential:

Expanded strategic collaboration with Eli Lilly for the sole commercialization right of Cyramza (ramucirumab) and Retsevmo (selpercatinib), and right of first negotiation for future commercialization of pirtobrutinib (BTK inhibitor) in mainland China.
Taletrectinib (ROS1/NTRK) – a next-generation TKI designed to effectively target ROS1 and NTRK, co-development and co-commercialization with AnHeart in China.
NAILIKE (olverembatinib) – a novel third-generation BCR-ABL TKI, co-development and co-commercialization with Ascentage Pharma in China.
GFH925 (KRAS G12C inhibitor) – a novel, orally active, potent KRAS G12C inhibitor, co-development and co-commercialization with GenFleet Therapeutics in China and opt-in right for global development and commercialization.
Orismilast (PDE4 inhibitor) – a novel, orally active PDE4 inhibitor for broad target indications, granted sole development and sole commercialization right in China from UNION therapeutics A/S.
Manufacturing Facilities Upgradation

New Commercial Facility: successfully expanded the production capacity from 24,000L to 60,000L, which is one of the largest stainless steel production capacity in China.
Quality compliance to GMP and cost advantage further strengthen market competitiveness.
Financial Highlights (Non-IFRS measure)

Total revenue was RMB 4,261 million, including product revenue 4,001 million with an increase of 69.0% compared to the prior year.
Gross profit margin was 88.6%，an increase of 3.7% compared to the prior year.
R&D expenses were RMB2,116 million an increase of 23.2% compared to the prior year.
Loss for the year was RMB2,243 million.
Cash on hand and short-term financial assets at the end of 2021 was approximately USD1,415million, which enables strategical focus on the long-term development strategies.[2]
Note: [1] In January 2022, Incyte has withdrawn the application of parsaclisib in FL, MZL and MCL in the U.S. as a business decision and is not related to any changes in either the efficacy or safety of parsaclisib. We plan to have communication with China NMPA regarding the potential submission of PI3Kδ.

[2] The financial numbers mentioned above was based on non-IFRS measure which excluded certain non-cash items and non-recurring events. Detailed disclosure can be found at the Company’s annual result announcement.