Delivering Significant Progress with Drug Pipeline Development, Commercialization Readiness and Operation Excellence
HONG KONG, March 14, 2019 /PRNewswire/ — Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines, today announced its audited annual results for the year ended 31 December 2018.
"2018 was a landmark year for Innovent. In October, we successfully listed on the Main Board of the Hong Kong Stock Exchange with a satisfactory first day and aftermarket trading performance. With the approval and launch of Tyvyt® (sintilimab) Innovent enters a new era that highlights Innovent’s capabilities in the discovery and development of large molecule drugs. The achievement has propelled us to the commercial phase of the business cycle. The partnership with Incyte further strengthens our portfolio by broadening our emphasis from biologics into the new field of combining biologics and small molecules," said Michael Yu, Founder, Chief Executive Officer and Chairman of Innovent. "Recently, we have been awarded the Asia-Pacific ‘IPO of the Year’ for 2018 by a leading finance magazine, International Financing Review (IFR). Yet, in terms of Innovent’s journey, we are still in our infancy. As we look to 2019 and beyond, the biologics market continues to be very promising with massive growth opportunities. We will strive to focus on achieving successful commercialization of our Tyvyt® (sintilimab) product, further enhanceing our research and development capabilities and continue to rapidly advance the clinical programs for our pipeline products. We will continue to pursue our mission to build a world-class China-based biopharmaceutical company to develop and commercialize high quality drugs that are affordable to ordinary people."
Adjusted loss and total comprehensive expenses for the year was RMB1,481.7 million for the year ended 31 December 2018, representing an increase of RMB846.0 million from RMB635.7 million for the year ended 31 December 2017, primarily due to the increase in the research and development expenses and the selling, marketing and business development expenses.
Adjusted loss and total comprehensive expenses for the year represents the loss and total comprehensive expenses for the year excluding the effect of certain non-cash items and one-time events, namely the loss on fair value changes of preferred shares and share-based compensation expenses.
Total revenue and other income were RMB103.3 million for the year ended 31 December 2018, as compared to RMB82.9 million for the year ended 31 December 2017. For the year ended 31 December 2018, the revenue was generated from the research and development services provided to the customers and the other income consisted of government grants and bank interest.
Research and development expenses increased by RMB609.8 million to RMB1,221.7 million for the year ended 31 December 2018, compared to RMB611.9 million for the year ended 31 December 2017, primarily due to additional clinical trials of late stage drug candidates and upfront payment under the collaboration and license agreement with Incyte Biosciences International Sàrl (Incyte), a subsidiary of Incyte Corporation (Nasdaq: INCY).
Selling, marketing and business development expenses increased by RMB127.7 million to RMB136.0 million for the year ended 31 December 2018, from RMB8.3 million for the year ended 31 December 2017, primarily due to building of our sales and marketing capacity and activities in preparation for the commercialization of Tyvyt® (sintilimab) in 2019.
Loss and total comprehensive expenses by the IFRS standard was RMB5,873.0 million for the year ended 31 December 2018, compared to RMB716.1 million for the year ended 31 December 2017, primarily attributable to the losses of RMB4,338 million in fair value change of the Company’s preferred shares, which was a non-cash, onetime adjustment upon the listing as required under the International Financial Reporting Standard (the IFRS).
Since 31 October 2018 (the Listing Date) when the Company was successfully listed on The Stock Exchange of Hong Kong Limited (the Stock Exchange), we have delivered on our investors’ expectations by making significant progress with respect to our drug pipeline and business operations, including the following milestones and achievements:
Tyvyt® (sintilimab), our PD-1 monoclonal antibody co-developed with Eli Lilly and Company (Eli Lilly), received marketing approval from the National Medical Products Administration of the People’s Republic of China (China) for relapsed/refractory classical Hodgkin’s lymphoma (r/r cHL). Our manufacturing facilities have been certified as Good Manufacturing Practice (GMP) compliant and commercialisation activities have commenced, propelling us into the commercial phase of the business cycle and unleashing the full power of our integrated platform.
Key clinical results of Tyvyt® (sintilimab) in r/r cHL were published in The Lancet Haematology and featured as a cover story. Major media outlets and news channels including Xinhua News Agency, People’s Daily and China Central Television reported and lauded this publication.
IBI-305 (bevacizumab biosimilar) has met pre-defined primary endpoints in two randomised, head-to-head clinical trials comparing IBI-305 to branded bevacizumab: a phase III clinical trial in patients with advanced non-squamous non-small cell lung cancer and a pharmacokinetic study in healthy subjects.
New drug applications (NDAs) for IBI-305 (bevacizumab biosimilar) and IBI-303 (adalimumab biosimilar) were submitted to and accepted by the NMPA.
Collaboration and license agreement was reached with Incyte for three late-stage clinical drug candidates, including pemigatinib (FGFR1/2/3 inhibitor), itacitinib (JAK1 inhibitor) and parsaclisib (PI3Kδ inhibitor), increasing our pipeline to include 20 drug assets encompassing both biologics and small molecules.
Global collaboration agreement was reached with Hutchison China MediTech Limited (Chi-Med) (LSE: HCM; Nasdaq: HCM), through its innovation platform subsidiary Hutchison MediPharma Limited (Hutchison MediPharma) to evaluate the safety and tolerability of our Tyvyt® (sintilimab) in combination with Hutchison MediPharma’s fruquintinib in patients with advanced solid tumors.
Number of clinical trials for registration has increased from six at the Listing Date to a total of nine at the date of this announcement.
Number of our drug and drug candidates that received the grants for the National Major New Drugs Innovation and Development Projects increased from two at the Listing Date to a total of four at the date of this announcement.
On 29 December 2018, our manufacturing facilities received GMP certification from the NMPA for manufacturing our Tyvyt® (sintilimab).
As of the date of this announcement, we have completed construction of our second stage production facilities and have completed installation of six 3,000L stainless steel bioreactors. These facilities are currently in validation phase. This expansion increased our total production capacity to 21,000L, and will provide us additional capacity to support commercial production as well as clinical trials. These facilities are scheduled to go into operation in the second half of 2019 and we expect them to provide us with sufficient manufacturing capacity to support our growth.
Using our platform and through collaborations with global strategic partners, we have built a pipeline of 20 drug assets over the last 7.5 years, led by IBI-308 (trade name: Tyvyt®; generic name: sintilimab), our anti-PD-1 monoclonal antibody co-developed with Eli Lilly, which has received marketing approval in China from the NMPA for r/r cHL and has commenced sales; and three biosimilar candidates that are in late-stage clinical development in China, including IBI-305 (bevacizumab biosimilar), IBI-301 (rituximab biosimilar) and IBI-303 (adalimumab biosimilar).
Out of our pipeline of 20 drug assets, two, IBI-305 (bevacizumab biosimilar) and IBI-303 (adalimumab biosimilar), are under NDA review by the NMPA; one, IBI-301 (rituximab biosimilar), has completed phase III clinical trial enrollment; one, IBI-306 (novel anti-PCSK9), has completed phase I single dose escalation; three, IBI-310 (anti-CTLA4), IBI-101 (novel anti- OX40) and IBI-188 (novel anti-CD47), have initiated phase I enrollment in China; three, IBI-101 (novel anti-OX40), IBI-188 (novel anti-CD47) and IBI-318 (novel anti-PD-1/undisclosed target bispecific), have received investigational new drug (the IND) approval in China; one, IBI- 307 (anti-RANKL), is initiating phase I clinical trials; three, IBI-110 (novel anti-LAG3), IBI-315 (novel anti-her2/anti-PD-1 bispecific), and IBI-322 (novel anti-CD47/anti-PD-L1 bispecific), have completed GLP toxicology studies and are under preparation for IND submission in China; three, IBI-375 (pemigatinib FGFR inhibitor), IBI-376 (parsaclisib PI3K inhibitor) and IBI-377 (itacitinib JAK1 inhibitor), were in-licensed from Incyte and are under preparation for IND submission in China.
In addition to developing our pipeline drug assets in China, we have obtained IND approvals from the United States of America (U.S.). Aside from the three drug candidates, which were licensed from Incyte and are currently under clinical development outside of China by Incyte, we have initiated patient enrollment in the U.S. for a multi-center phase Ib/II clinical trial for Tyvyt® (sintilimab) and a phase Ia clinical trial for IBI-188 (novel anti-CD47). We have also obtained the IND approval from the U.S. FDA for IBI-101 (novel anti-OX40) and can proceed with clinical development in the U.S. accordingly.
Innovent will continue the quest to build a world-class China-based biopharmaceutical company that develops and commercializes high quality drugs that are affordable to ordinary people. To accomplish this mission, we will strive to achieve successful commercialization of our Tyvyt® (sintilimab) and, upon requisite approval of our NDAs under review, also our IBI-305 (bevacizumab biosimilar) and IBI-303 (adalimumab biosimilar), to the benefit of both our shareholders and Chinese patients in need. In the meantime, we will continue to rapidly advance both ongoing and planned clinical programs for our pipeline products both in China and in the U.S. and will seek both expedited regulatory review of our upcoming NDAs and ultimately marketing approvals. Among other things, we expect to submit the NDA for IBI-301 (rituximab biosimilar) to the NMPA in the fourth quarter of 2019. We will also strengthen our fully-integrated platform, with a deliberate focus on the expansion of our manufacturing and commercialization capabilities, in order to suit and support the continued growth, maturation and fruition of our pipeline. Among other things, we expect that the validation of our second stage production facilities including the six 3,000L stainless steel bioreactors will be completed later this year.
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 III clinical trials, two monoclonal antibodies have their New Drug Application (NDA) under review 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.
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