We are a global commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies and immunotherapies for the treatment of patients with cancer and immunological diseases. In addition to our Oncology/Immunology operations, we have built large-scale and profitable drug marketing and distribution capabilities through our Other Ventures operations, which primarily manufacture, market and distribute prescription drugs in China.
Founded in 2000, our Company was one of the first companies to establish an in-house drug discovery engine in China aimed at creating novel therapies for the global market, according to Frost & Sullivan. As these innovations have progressed, we have added extensive clinical and regulatory, manufacturing and commercial operations resulting in a fully integrated biopharmaceutical company of over 1,300 personnel as of the Latest Practicable Date. This allows us to retain complete operational control of our assets, in order to realize their full economic value in our two focus markets of China and the United States, which represented nearly 60% of the global pharmaceutical market in 2020.
Over the past fifteen years, our in-house discovery engine has created a broad pipeline of ten clinical stage drug candidates with a further seven oncology and immunology drug candidates in preclinical testing. Our success in discovery has also led to development collaborations with leading global pharmaceutical companies such as AstraZeneca and Eli Lilly.
In 2018, we became the first ever biotech company to bring a novel oncology drug, fruquintinib for third-line mCRC patients, from discovery through to unconditional approval and launch in China. Since then, we have built an oncology commercial team of about 520 persons in China to market fruquintinib as well as our other products as they are approved. Our commercial team launched our second in-house discovered oncology drug, surufatinib for advanced non-pancreatic NET, in early 2021. Our third in-house discovered drug, savolitinib for lung cancer, is now undergoing final regulatory review with a potential launch in China as early as mid-2021. A further seven oncology drug candidates are in an earlier stage of development in China, with one having transitioned into a Phase II registration-intent study in April 2021 and one targeted to transition into a Phase II registration-intent study in 2021.
In the United States, our three lead assets are also entering final regulatory review or have started registration-intent studies, and a further three oncology drug candidates are in an earlier stage of development. Supporting all international clinical and regulatory activities is a rapidly expanding organization of about 80 personnel based primarily in New Jersey as of the Latest Practicable Date. We are also now building our own U.S. commercial team in preparation for a potential surufatinib U.S. launch in late 2021 or early 2022. If approved, surufatinib will become only the second ever novel oncology drug discovered by a biotech company in China to be launched in the United States, according to Frost & Sullivan.
Our portfolio of in-house discovered drug candidates are being developed both as monotherapies and in novel drug combinations to treat a wide spectrum of diseases which we believe may address unmet medical needs and represent commercial opportunities globally.
Beyond our core markets of China and the United States, we intend to pursue opportunities for additional geographical partnerships to fully realize the value of our assets.
Our Other Ventures have provided us the know-how and infrastructure in operating and marketing pharmaceutical products in the complex and evolving healthcare system in China. Additionally, cash flow from our Other Ventures has provided an important source of funding for our Oncology/Immunology operations since our inception. See “Recent Developments – Business Updates – Recent Disposal” for details on the disposal of Hutchison Baiyunshan.
We started operations in 2000 as a wholly owned subsidiary of CK Hutchison. Our Shares have been admitted to trading on the AIM market of the London Stock Exchange since 2006, and our ADSs have been listed on Nasdaq since 2016.
Our operational achievements and capabilities to date include:
Broad pipeline of differentiated targeted therapies and immunotherapies built for the global market. We have a pipeline of differentiated drug candidates covering both novel and validated targets, including MET, VEGFR, FGFR, CSF-1R, PI3K , Syk, IDH, ERK and EGFR. The aim of our research is to develop drugs with high selectivity and superior safety profiles, a key benefit of which is that our drug candidates have the potential to be effectively paired with other oncology and immunology therapies at effective dosages with fewer side effects.
Commercially launching products while continuing to discover new assets. In China, we have launched two of our internally developed drugs, fruquintinib (Elunate in China) and surufatinib (Sulanda in China), to patients, and we have filed for marketing authorization for savolitinib. All three drugs are in late-stage development outside of China, with the most advanced being surufatinib. In addition, we have seven additional drug candidates in earlier stage clinical development and several advanced preclinical drug candidates.
Comprehensive global in-house discovery and development capabilities. We have a comprehensive drug discovery and development operation covering chemistry, biology, pharmacology, toxicology, chemistry and manufacturing controls for clinical and commercial supply, clinical and regulatory and other functions. It is led by a team of approximately 680 scientists and staff as of the Latest Practicable Date, who have created one of the broadest global clinical pipelines among our peer oncology and immunology focused biotechnology companies according to Frost & Sullivan. Currently, we are conducting and planning over 40 different clinical studies in oncology patients globally, including plans for over ten registration and registration-intent studies underway by the end of 2021.
Fast expanding and productive international organization. Our U.S. and European teams of approximately 80 mainly clinical and regulatory staff as of the Latest Practicable Date have significantly broadened our international operations, particularly in the United States, Europe, Japan and Australia. Our international clinical team has established a productive track record since it was established in 2018, including the initiation and completion of a rolling U.S. NDA filing for surufatinib, a large global randomized controlled study for fruquintinib, and ongoing U.S. and European Phase I/II trials for our drug candidates HMPL-689, HMPL-523 and HMPL-306. We are now also building a commercial team in the United States, having completed the recruitment of a senior leadership team based in New Jersey, to support the potential upcoming launch of surufatinib in the United States.
Long-standing drug marketing and distribution experience to support the realization of in-house oncology innovations in China. Our 20-year track record and deep institutional knowledge of the drug marketing and distribution process developed through our Other Ventures are being leveraged to bring our in-house oncology innovations to patients. We have built and continue to expand our in-house oncology drug sales team of about 520 persons (compared to 90 at the end of 2019) to support the commercialization of recently launched Elunate and Sulanda and our other innovative drugs, if approved, throughout China. Our oncology drug sales team has the capability to cover over 2,500 oncology hospitals and over 20,000 oncology physicians in China, a network that we estimate represents over 90% of oncology drug sales in China.
Oncology Commercial Operations
Surufatinib – Sulanda in China
We received approval from the NMPA for Sulanda as a treatment for patients with advanced non-pancreatic NET in December 2020 and commercially launched it in mid-January 2021, within three weeks of approval. By the end of January 2021, Sulanda prescriptions had been written in 30 provinces in China. Further commercialization activities are underway. Most notably, we are working to improve patient access to Sulanda. We have implemented a broad-scale, need-based patient access program which could materially reduce patients’ out-of-pocket costs, while aiming to have Sulanda be included on the 2022 NRDL. According to Frost & Sullivan, there were potentially over 300,000 patients living with NET in China in 2019.
Fruquintinib – Elunate in China
At the end of 2018, our collaboration partner Eli Lilly commenced commercial sales of Elunate targeting the more than 80,000 mCRC third-line patients in China each year. In January 2020, Elunate was included on China’s NRDL and is therefore now available in public hospitals throughout China, paving the way to significantly broaden access for advanced CRC patients and rapidly build penetration in China over the coming years. In October 2020, we took over the development and execution of all on-the-ground medical detailing, promotion and local and regional marketing responsibilities in China through an amendment to our collaboration terms with Eli Lilly. Since taking on these commercial responsibilities, we have deployed our oncology drug sales to market Elunate. We are now quickly expanding hospital pharmacy listings, one of the most important factors affecting broad-scale adoption of Elunate in China. We increased hospital listings to approximately 380, an approximately 95% increase since our assumption of responsibility.
Driven in part by the inclusion of Elunate on the 2020 NRDL and our assumption of responsibility for detailing, promoting and marketing the drug in China in October 2020, total in-market sales of Elunate by Eli Lilly, as provided to us by Eli Lilly, increased by 91.5% to US$33.7 million for the year ended December 31, 2020 compared to US$17.6 million for the year ended December 31, 2019. Total in-market sales of Elunate also increased significantly for the three months ended March 31, 2021 compared to the three months ended March 31, 2020, which was prior to our assumption of commercial responsibilities as discussed below under “– Recent Developments – Summary of First Quarter 2021 Highlights”. We recognize revenue for royalties and manufacturing costs and, since October 1, 2020, additional service payments in association with our expanded role in the commercialization of Elunate paid to us by Eli Lilly.
Subject to meeting pre-agreed sales targets, Eli Lilly will pay us an estimated total of 70% to 80% of Elunate sales in the form of royalties, manufacturing costs and service payments.
Savolitinib – to be marketed by AstraZeneca, if approved, in China
We have submitted an NDA to the NMPA for the treatment of patients with MET exon 14 skipping alteration NSCLC. The NDA was accepted in May 2020, priority review status was granted in July 2020 and review is underway. If the NDA is approved, we will be responsible for manufacturing and all other marketing authorization holder responsibilities, and our commercial collaboration partner AstraZeneca is expected to launch savolitinib in China through the same large-scale oncology commercial organization that markets Tagrisso, Imfinzi and Iressa, among others. In return for these commercial rights, AstraZeneca will pay us a 30% royalty on all sales, various development and commercial milestones and manufacturing fees.
Source: HUTCHMED (00013) Prospectus (IPO Date : 18/06/2021) |