 Strong global pipeline progress three U.S. FDA1 Fast Track Designations; surufatinib U.S. NDA2 preparations underway; and initiation of global Phase III for fruquintinib Two further NDAs submitted in China savolitinib in MET3 Exon 14 skipping mutation NSCLC4, and surufatinib in pancreatic NET5 Expansion of commercial activities in oncology Chi-Med to be responsible for medical detailing and marketing for Elunate throughout Mainland China starting October 2020 Company to Host Results Call Webcast Today at 1 p.m. BST 8 a.m. EDT 8 p.m. HKT HONG KONG and SHANGHAI and FLORHAM PARK, N.J., July 30, 2020 GLOBE NEWSWIRE -- Hutchison China MediTech Limited Chi-Med NasdaqAIM: HCM, an innovation-driven, commercial-stage biopharmaceutical company, today announces its unaudited financial results for the six months ended June 30, 2020 and provides updates on key clinical and commercial developments.During the first half of 2020, we continued to build our fully integrated business in China, from research and development to manufacturing and commercialization and sales, with a focus on oncology, said Mr. Simon To, Chairman of Chi-Med. NDAs for surufatinib and savolitinib are currently under review by the China NMPA6 and we are now preparing for multiple potential launches employing our newly-established commercial organization in oncology, covering all provinces in Mainland China. We are also one of a few China-based biotech companies working to realize the global potential of our home-grown innovative drug candidates, he added. We currently have nine novel drug candidates in clinical trials, many with global potential, and an additional five drug candidates at the IND7-enabling stage.Over the past three years, we have significantly expanded our international development footprint and, in the first half of 2020, locked in global registration strategies for surufatinib and fruquintinib, while our global partnership with AstraZeneca8 is approaching the same for savolitinib. A deep pipeline of unpartnered earlier-stage oncology assets follows, with most notably, global development of our Syk9 and PI3Kδ10 assets progressing well and our IDH 1211 inhibitor expected to start Phase I in the United States this year.We believe that the anticipated launches of multiple innovative oncology drugs over the next twelve to eighteen months will address a broad range of unmet medical needs and benefit a large number of patients globally, propelling Chi-Med into a new phase of growth.FIRST HALF 2020 OPERATING HIGHLIGHTSSet out below are some of Chi-Meds operating highlights so far this year. For more details, please refer to Operations Review below.I. PREPARING TO LAUNCH MULTIPLE ONCOLOGY DRUGS IN CHINASavolitinib NDA submitted for potential first-in-class selective MET TKI12 in China: NDA accepted by NMPA in MET Exon 14 skipping mutation NSCLC: presented positive results at ASCO13 from a registration study in MET Exon 14 skipping mutation NSCLC demonstrating 49.2 ORR14, 93.4 DCR15 and 9.6 months DoR16 in efficacy evaluable patients, underpinning the NDA acceptance in May 2020 and subsequent grant of Priority Review status in July 2020.Surufatinib Two NDAs with first China launch in NET planned for late 2020: Progressed non-pancreatic NET NDA: Supported by the positive SANET-ep Phase III and submitted in late 2019, the NMPA NDA review process is on-track, and we continue to plan for launch in late 2020; Submitted Pancreatic NET NDA: Following positive interim analysis and early termination of SANET-p Phase III, an NDA for pancreatic NET has been submitted in China, which we anticipate may be accepted in the near term; Progressed to Phase II for Tuoyi combination: Initiated a Phase II in early 2020 in eight solid tumor indications for surufatinib plus Tuoyi, a China-approved PD-117 antibody from Junshi18. Data presented at AACR19, shows the combination is well tolerated with encouraging activity, ORR 64 and DCR 100 in efficacy evaluable patients at the RP2D20; and Initiated Tyvyt PD-1 combination: In July 2020, Innovent21 initiated a Phase I combining surufatinib with their China-approved PD-1 monoclonal antibody, Tyvyt.Fruquintinib Commercial progress on Elunate fruquintinib capsules: 174 overall increase in Elunate prescriptions22 during the first half of 2020: Inclusion in the 2020 National Reimbursement Drug List NRDL has led to a major increase in access. In-market sales, as provided by Lilly23, were 14.0 million24 H1-19: 11.4m during the first half of 2020; Chi-Med to commercialize Elunate in China beginning in October 2020: In July 2020, an agreement was reached with Lilly that Chi-Med will commence medical detailing and marketing activities for Elunate across all of China effective October 1, 2020; Phase III interim analysis in second-line gastric cancer: In June 2020, following the second and final interim analysis for futility of the FRUTIGA study in China the IDMC25 recommended to continue the study. FRUTIGA is expected to complete enrollment in late 2020 or early 2021; and Expanded Tyvyt PD-1 combination: Phase I dose escalation for the fruquintinib and Tyvyt combination completed in July 2020. A Phase Ib expansion study at the RP2D is underway in China targeting five solid tumor indications.Established in-house oncology commercial organization Team now in place for imminent launches: An in-house oncology commercial organization has now been established with over 320 staff, versus about 90 at the start of 2020, in order to support the potential launch of surufatinib in China and commercialization of Elunate.II. REALIZING THE GLOBAL POTENTIAL OF OUR LATE STAGE ONCOLOGY ASSETSSurufatinib U.S. NDA under preparation: Secured FDA Fast Track Designations: FDA granted Fast Track Designations for both pancreatic NET and non-pancreatic NET in April 2020; Positive U.S. NET bridging study: Presented results at ASCO from the U.S. Phase Ib NET study in June 2020, reporting 100 DCR in heavily pre-treated pancreatic-NET and non-pancreatic NET patients; Agreed U.S. NDA submission pathway: In May 2020, agreed with FDA that the two pivotal NET studies in China, along with existing data from the U.S. bridging study, could support an NDA submission. Now planning a U.S. NDA rolling submission from late 2020 into early 2021; U.S. commercial launch strategy: Work underway to establish U.S. launch readiness for late 2021; Progressed European regulatory discussions: Engaging extensively with European regulatory authorities, targeting MAA26 submission for NET during 2021; and BeiGene27 global PD-1 collaboration: Entered into a clinical collaboration in May 2020 to explore the combination of surufatinib with BeiGenes PD-1 antibody, tislelizumab, in the U.S..Fruquintinib global Phase III registration study in CRC28 underway: Secured FDA Fast Track Designation: Granted in June 2020 for patients with metastatic CRC; Initiated FRESCO-2 global Phase III registration study in CRC: Following study design endorsement by the FDA, EMA29 and PMDA30, we initiated the global Phase III registration study in metastatic CRC. Enrollment of over 500 patients in 130 sites in 10 countries targeted to complete in late 2021; and BeiGene and Innovent global PD-1 collaborations: Entered into a clinical collaboration with BeiGene in the U.S., Europe, China and Australia in May 2020 to explore the combination of fruquintinib and tislelizumab. Our work with Innovent has now established the RP2D for the fruquintinib and Tyvyt combination and a U.S. IND is planned for late 2020.Savolitinib AstraZeneca collaboration making progress in lung and kidney cancer: SAVANNAH interim analysis In late July 2020, AstraZeneca and Chi-Med conducted a first internal interim analysis for the SAVANNAH global Phase II study of the savolitinib plus Tagrisso combination in EGFR mutation positive TKI refractory NSCLC patients. Early interim efficacy and safety data is now under review. The enrollment of the SAVANNAH study continues apace in 13 countries; Encouraging efficacy in MET-driven PRCC31: In June 2020, we presented data at ASCO for SAVOIR, a Phase III study of savolitinib versus sunitinib. Savolitinib demonstrated encouraging efficacy compared to sunitinib with a 27 versus 7 ORR, a trend toward benefit in PFS32 and an improvement in OS33 with tolerability advantages; and Preliminary signal for savolitinibImfinzi PD-L134 combination in all PRCC: In February 2020, we presented data from the CALYPSO Phase II study at ASCO GU35 showing the combination was tolerable and associated with durable efficacy, with a 12.3 month median OS. III. INVESTING IN THE FUTURE EARLY PIPELINE Non-Hodgkins lymphoma NHL: Advanced Phase Ib expansion of both of our NHL assets, HMPL-523 Syk and HMPL-689 PI3Kδ in China. We expect these studies to inform our China registration study decisions in 2020. In the U.S. and Europe, we continued to expand development of HMPL-523 and HMPL-689, with over twenty Phase I sites now enrolling; HMPL-453 selective FGFR36 123 inhibitor: We initiated a Phase II study in advanced malignant mesothelioma in China in March 2020, with a second Phase II, in Cholangiocarcinoma, in planning; HMPL-306 IDH 12 dual inhibitor: In late July 2020, we dosed our first patient in a Phase I study in China with our ninth in-house discovered asset, HMPL-306; and Five additional novel drug candidates in oncology are currently progressing through IND-enabling studies and are anticipated to reach the clinic over the next twelve to eighteen months.IV. 