1stOncology™: Cancer Intelligence Service – Page 12905 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Summary of Consolidated Financial Results [Japanese GAAP] For the Second Quarter of the Fiscal Year Ending March 31, 2020

On November 12, 2019 Nippon Kayaku reported that (Press release, Nippon Kayaku, NOV 12, 2019, View Source [SID1234550888])

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

1. Consolidated Business Results for the Second Quarter of the Fiscal Year Ending March 31, 2020 (April 1,201 September 30, 2019)

(Figures shown are rounded down to the nearest million yen.)

(1) Consolidated Operating Results

The provisional accounting treatment of the corporate combination that occurred during the third quarter of fiscal
year ended March 31, 2019 has been finalized and the amount of the impact from retrospective adjustments is
reflected in the figures for the first half of fiscal year ended March 31, 2019.

(2) Consolidated Financial Position

3. Consolidated Business Results Forecasts for the Fiscal Year Ending March 31, 2020 (April 1, 2019–March 31, 2020)

(1) Significant changes in subsidiaries during the first half (changes in designated subsidiaries that result in changes
in scope of consolidation): None
(2) Adoption of special accounting methods for presenting the quarterly consolidated financial statements: None
(3) Changes to accounting policies and estimates and restatements
[1] Changes to accounting policies associated with revision of accounting standards or similar items: None
[2] Changes other than [1]: None
[3] Changes to accounting estimates: None
[4] Restatements: None
(4) Number of shares issued (common stock)

[1] Number of shares issued at end of the fiscal period (including treasury stock)
As of September 30, 2019: 177,503,570 shares
As of March 31, 2019: 182,503,570 shares

[2] Number of treasury stock at end of the fiscal period
As of September 30, 2019: 4,359,265 shares

As of March 31, 2019: 9,358,749 shares
[3] Average number of shares during the fiscal period (cumulative)
First half of the fiscal year ending March 31, 2020: 173,144,521 shares
First half of the fiscal year ended March 31, 2019: 173,145,594 shares
* Quarterly summary financial statements are not subject to audit by a certified public accountant or audit firm.
* Analysis related to appropriate use of the business forecasts, and other notes

The information in this report constitutes forward-looking statements regarding future events and performance. This
information is based on the beliefs and assumptions of management in light of information currently available to it
at the time of announcement and subject to a number of uncertainties that may affect future results. Actual business results may differ substantially from the forecasts herein due to various factors. For matters pertaining to business forecasts, please refer to "(3) Analysis of Forward-looking Statements, including Consolidated Business Results Forecasts" on page 3 of the Supplementary Information.

Supplementary Information
Contents
1. Qualitative Information Concerning Results for the Second Quarter 2
(1) Analysis of Operating Results 2
(2) Analysis of Financial Position 3
(3) Analysis of Forward-looking Statements, including Consolidated Business Results Forecasts 3
2. Quarterly Consolidated Financial Statements and Notes to Quarterly Consolidated Financial
Statements

(1) Consolidated Balance Sheets 4
(2) Consolidated Statements of Income & Consolidated Statements of Comprehensive Income 6
(3) Consolidated Statements of Cash Flows 8
(4) Notes to Quarterly Consolidated Financial Statements 10
Notes Regarding Assumptions for the Going Concern 10
Notes in Case of Significant Change in Shareholders’ Equity 10
Segment Information and Other Items 10
Significant Subsequent Events

1. Qualitative Information Concerning Results for the Second Quarter
The figures in the provisional accounting for a business combination in the previous consolidated fiscal year have
been confirmed, and the content confirmed in the provisional accounting is reflected in the figures for the second
quarter of the previous consolidated fiscal year.

(1) Analysis of Operating Results
In the first half of this consolidated fiscal year (April 1 to September 30, 2019), the global economy as a whole saw
slow growth. This was mainly due to the deceleration of external demand in the manufacturing industry, while
consumer spending remained steady on the back of an improved employment and income environment in the U.S.
and Europe. The trend of deceleration in economic growth persisted in China, owing to the impact from trade
friction between the U.S. and China, among other factors. The Japanese economy showed signs of a gradual rebound despite weak exports. This resulted mainly from moderate growth in capital investment and a resurgence in
consumer spending.

Amid these conditions, the Nippon Kayaku Group worked to implement the key themes and resolve the midand long-term key issues outlined in "KAYAKU Next Stage," the mid-term business plan launched this fiscal year.
We worked to cut costs further to reinforce our profit structure, in addition to focusing on strengthening R&D,
optimal allocation of business resources into core businesses, and expanding our overseas business.

Sales for the first half of this consolidated fiscal year outperformed the same period last fiscal year in the functional
chemicals business, the pharmaceuticals business, and the safety systems business, resulting in total net sales of
85,608 million yen, an increase of 749 million yen (0.9%) year-on-year.

Operating income totaled 9,045 million yen, a decrease of 518 million yen (5.4%) year-on-year.
Ordinary income totaled 9,149 million yen, a decrease of 1,902 million yen (17.2%) year-on-year due to an
increase in exchange losses.
Profit attributable to owners of parent was 6,337 million yen, a decrease of 1,136 million yen (15.2%)
year-on-year.
Performance by business segment is as described below.

[Functional Chemicals Business]
Sales stood at 34,141 million yen, an increase of 27 million yen (0.1%) year-on-year.
The functional materials business recorded growth in sales over the same period of the previous fiscal year.
This growth was resulted from strong sales of epoxy resins for smartphones and 5G base stations, which more than
covered for the deceleration in demand from the semiconductor market.

The color materials business outperformed the first half of last fiscal year, boosted by strong sales of colorants
for inkjet printers for industrial applications and materials for thermal paper.

The catalyst business underperformed the same period of the previous fiscal year.

In the Polatechno Group, sales of components for X-ray analysis systems were strong, but sluggish sales of
dye-type polarizing films resulted in underperformance of the Polatechno Group as a whole, compared with the
same period of the previous fiscal year. Segment profit was 2,590 million yen, a decrease of 1,095 million yen (29.7%) year-on-year.

[Pharmaceuticals Business]
Sales stood at 23,225 million yen, an increase of 158 million yen (0.7%) year-on-year.
Pharmaceuticals in Japan recorded growth in sales for the antibody biosimilar, INFLIXIMAB BS for I.V.

Infusion, and for Trastuzumab BS for I.V. infusion. Sales for the pharmaceuticals business as a whole outperformed
the first half of last fiscal year. Growth in sales of the generic anti-cancer drugs OXALIPLATIN for I.V. Infusion
NK, TEMOZOLOMIDE Tab., and other generic anti-cancer drugs boosted performance, despite the year-on-year
underperformance of long-listed products as the switch to generic drugs continued.

Exports as a whole underperformed year-on-year due to a decline in exports of BLEOs and ETOPOSIDEs (anti-cancer drugs), despite year-on-year growth in high potency active pharmaceutical ingredients.

Sales of active pharmaceutical ingredients and contracted production for the Japanese domestic market, and
diagnostic agents underperformed the first half of last fiscal year.

Segment profit totaled 2,409 million yen, an increase of 743 million yen (44.6%) year-on-year

[Safety Systems Business]

Sales stood at 24,071 million yen, an increase of 590 million yen (2.5%) year-on-year.
Business in Japan outperformed the same period of the previous fiscal year due to firm sales of both airbag
inflators and micro gas generators for seatbelt pretensioners.

Nippon Kayaku Co., Ltd.

Summary of Consolidated Financial Results [Japanese GAAP]
For the Second Quarter of the Fiscal Year Ending March 31, 2020
This document is an English translation of the Japanese-language original.

All financial information has been prepared in accordance with generally accepted accounting principles in Japan.

The overseas business saw an increase in the automotive safety component installation rate; however, the
sluggish market in China caused air bag inflators, micro gas generators for seatbelt pretensioners, and squibs all to
underperform the same period of the previous fiscal year.

Segment profit was 3,431 million yen, a decrease of 271 million yen (7.3%) year-on-year.
[Other]Sales totaled 4,170 million yen, a decrease of 27 million yen (0.6%) compared to the same period of the previous Fiscal year.

The agrochemicals business outperformed the same period of the previous fiscal year in both domestic sales
and exports, resulting in year-on-year growth for the business as a whole.

Sales in real estate and other business decreased compared to the same period of the previous fiscal year.
Segment profit totaled 795 million yen, an increase of 137 million yen (20.9%) year-on-year.

(2) Analysis of Financial Position

[1] Status of Assets, Liabilities, and Net Assets

Total assets were 287,017 million yen, a decrease of 6,554 million yen from the end of the previous consolidated
fiscal year. The main decreases were in securities, a decrease of 4,752 million yen; notes and accounts receivable-trade, a decrease of 4,260 million yen; and investment securities, a decrease of 1,749 million yen. The
main increases were in cash and deposits, an increase of 3,432 million yen; and long-term loans receivable, an
increase of 632 million yen.

Liabilities were 58,923 million yen, a decline of 5,605 million yen compared to the end of the previous
consolidated fiscal year. The main decreases were in long-term loans payable, a decrease of 2,177 million yen;
accounts payable-other, a decrease of 1,885 million yen; income taxes payable, a decrease of 917 million yen; and
deferred tax liabilities, a decrease of 675 million yen. The main increase was in notes and accounts payable-trade, an
increase of 570 million yen.

Net assets were 228,093 million yen, a decrease of 949 million yen compared to the end of the previous
consolidated fiscal year. The main decreases were in translation adjustments, a decrease of 3,299 million yen; and
dividends paid, a decrease of 2,597 million yen. The main increase was in profit attributable to owners of parent, an
increase of 6,337 million yen.

[2] Cash Flows Status

Net cash provided by operating activities amounted to 15,746 million yen (versus a cash inflow of 14,465 million
yen during the first half of the previous fiscal year). The positive cash flow was primarily generated from profit
before income taxes of 8,840 million yen, depreciation and amortization of 5,983 million yen, and a decrease in
notes and accounts receivable-trade of 3,577 million yen. The above factors more than compensated for income tax
paid of 3,524 million yen and an increase in inventories of 1,118 million yen.

Net cash used in investing activities totaled 10,450 million yen (versus a cash outflow of 7,950 million yen
during the first half of the previous fiscal year). The net outflow was mainly due to expenditures of 8,702 million
yen for the purchase of property, plant and equipment.

Net cash used in financing activities amounted to 5,167 million yen (versus a cash outflow of 5,907 million yen
during the first half of the previous fiscal year). This was mainly due to expenditures for repayment of long-term
loans of 2,171 million yen and dividends paid of 2,590 million yen.

Reflecting the above cash flow performance, the balance of cash and cash equivalents at the end of the first
half was 51,297 million yen (versus 51,362 million yen during the first half of the previous fiscal year), a decrease
of 1,400 million yen from the end of the previous fiscal year.
(3) Analysis of Forward-looking Statements, including Consolidated Business Results Forecasts

The global economy will benefit from the anticipated firmness of the U.S. and European economies, and this will
affect the future business environment surrounding the Nippon Kayaku Group. However, there is concern over a
downswing in the global economic environment due to increased uncertainty over the future caused by trade friction and the political climate. The Chinese economy is expected to improve, due in part to various government policies which will underpin growth. Although a continued rebound in the Japanese economy is expected as employment and ncome environment continues to improve and also due to support from various government policies, we need to keep a cautious eye on the impact that a downswing in the global economy would have.

Under these conditions, the Nippon Kayaku Group aims to construct a solid financial structure which flexibly
adapts to changes in the business environment, as well as expand existing businesses in global growth markets,
accelerate the development of new businesses and new products, and enhance profits.

The business results forecasts for fiscal year ending March 31, 2020 have been revised from the forecasts
announced on May 10, 2019. See the Notice of Revision to the Business Results Forecasts posted on the corporate
website today for further details

Evotec SE reports first nine-month 2019 results and corporate updates

On November 12, 2019 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported financial results and corporate updates for the first nine months ended 30 September 2019 (Press release, Evotec, NOV 12, 2019, View Source;announcements/press-releases/p/evotec-se-reports-first-nine-month-2019-results-and-corporate-updates-5864 [SID1234550887]).

OPERATIONAL PERFORMANCE – DRIVING DRUG DISCOVERY AND DEVELOPMENT FAST FORWARD
Multiple new alliances in EVT Innovate and EVT Execute
Just – Evotec Biologics off to a very good start
Achievement of multiple important milestones (e.g. Bayer, Boehringer Ingelheim, Celgene, Indivumed)
Co-owned pipeline projects progressing very well, e.g. with positive Phase II POC results in chronic cough with Bayer
Extension of iPSC-based neurodegeneration partnership with Celgene into 2023; triggering additional $ 30 m payment
Joint venture created with Vifor Pharma focused on novel nephrology therapeutics (after period-end)
Expansion of BRIDGE roll-out with new BRIDGEs LAB10x and LAB555 (after period-end)
Continued company formations and equity participation e.g. in Aeovian, Eternygen, Facio, Immunitas; and spin-off formation Breakpoint Therapeutics GmbH focused on DNA damage response
Building a leading position in anti-infectives discovery and development (e.g. alliances with GARDP, GNA Now, Helmholtz, and the Bill & Melinda Gates Foundation)

INCREASE IN EBITDA GUIDANCE FOR FULL-YEAR 2019
Full-year 2019 guidance for revenue and unpartnered R&D costs confirmed; EBITDA guidance increased to approximately 15% (previously: >10%)

FINANCIAL PERFORMANCE
In the first nine months of 2019, Evotec’s Group revenues continued their strong performance and increased by 16% to € 321.4 m (9M 2018: € 278.1 m). This positive development is mainly due to the very strong performance in the base business across all business lines, solid milestone payments, and first revenue contributions by Just – Evotec Biologics (€ 10.4 m). Revenues from milestones upfronts and licences, which can vary significantly from quarter to quarter, decreased to € 22.3 m in comparison to the previous year (9M 2018: € 27.2 m) and included, amongst others, payments from Bayer, Boehringer Ingelheim, and Celgene.

The gross margin in the first nine months of 2019 amounted to 30.7% (9M 2018: 30.1%). This increase in margin compared to 2018 is based on very good capacity utilisation and favourable FX.

In the first nine months of 2019, Evotec focused its unpartnered R&D expenses of € 25.7 m primarily on initiatives in the fields of metabolic diseases, oncology, and platform projects. Its partnered R&D expenses of € 15.6 m on its infectious disease portfolio were shown under R&D while the expenses fully reimbursed by its partner Sanofi were recognised under other operating income. This split into unpartnered and partnered R&D expenses had not been applied in the first nine months of 2018, where total R&D expenses of € 16.0 m were recorded compared to total € 41.3 m in the reporting period.

The Group’s selling, general and administrative ("SG&A") expenses increased by 13% to € 46.2 m (9M 2018: € 40.8 m) in the first nine months of 2019. This increase is mainly due to overall company growth including staff increases, upgrading of systems, consultancy fees, plus expenses from acquired companies, equity and financing transactions.

Impairments of intangible assets and goodwill of € 11.9 m were recorded (9M 2018: impairment of intangible assets of € 4.2 m). This one-off impairment was mainly due to the termination of the SGM-1019 agreement by our partner Second Genome, the programme was fully impaired (€ 10.3 m). This impairment of intangible assets in addition triggered a goodwill impairment of € 1.6 m of the cash-generating unit Evotec (US) Innovate. All rights of the underlying asset were returned to Evotec.

The strong increase in the adjusted Group EBITDA to € 93.2 m (9M 2018: € 68.7 m), resulted mainly from the very strong performance in the base business, solid milestones and licence contributions, a positive EBITDA contribution by Just – Evotec Biologics and effects from the first-time application of the new accounting standard IFRS 16 (+€ 10.1 m).

In the first nine months of 2019, Evotec’s operating result was € 46.4 m (9M 2018: € 59.5 m). A year on year comparison is not meaningful, as 2018 was significantly positively affected by a one-off impact from the bargain purchase ID Lyon in 2018 (€ 15.4 m). The Company’s net result for the first nine months of 2019 amounted to € 29.7 m (9M 2018: € 52.3 m) and also cannot be compared like for like as it was affected by the one-off effect of the impairments on intangible assets and goodwill.

Evotec ended the third quarter of 2019 with a strong liquidity position of € 282.6 m (31 December 2018: € 149.5 m), which was composed of cash and cash equivalents (€ 249.6 m) and investments (€ 33.0 m). In the first nine months of 2019, liquidity was primarily affected by the completion of the repayment of the remainder of the € 140 m debt bridge facility drawn down in context of the acquisition of Aptuit in August 2017 as well as the repayment of flexible bank loan agreements, the successful issue of a promissory note (Schuldschein) worth € 250 m, gross, at very attractive interest rates of below 1.5%, as well as the draw-down of another tranche of the European Investment Bank R&D loan and the acquisition of Just – Evotec Biologics.

OPERATIONAL PERFORMANCE
Overall, the EVT Execute segment continued its strong progress in existing alliances and signed new or extended established partnerships. The strong performance was highlighted through the signing of a strategic multi-year drug discovery collaboration across multiple therapeutic areas with Takeda. Evotec will use its leading integrated drug discovery platform to deliver clinical candidates for Takeda to pursue into clinical development. Evotec is eligible to receive pre-clinical, clinical, and commercial milestones that can total in excess of $ 170 m per programme as well as tiered royalties on future sales.

The Just – Evotec Biologics integration into the Evotec Group is fully on track. In the first three months since the acquisition, Just – Evotec Biologics signed new agreements e.g. with Teva and Biocon Biologics.

EVT Innovate continued to deliver strong progress within its collaborations, signed important new contracts and extensions plus achieved major advances in Evotec’s co-owned pipeline. Bayer achieved positive Phase II POC results with its P2X3 antagonist in chronic cough showing good efficacy and safety.

Evotec’s academic BRIDGE portfolio has been expanded through LAB555 (after period-end), the first BRIDGE built in Israel. The partnership aims to expedite drug discovery and development by providing efficient translation of early stage Hebrew University research.

Evotec continues to invest in promising companies with operational synergies. Evotec was participating in Aeovian’s series A financing after successfully delivering Aeovian’s first candidate drug, and formed its second spin-off Breakpoint Therapeutics, a virtual company focusing on the development of Evotec’s DNA damage response portfolio. Furthermore, Evotec invested in the NewCo Immunitas Therapeutics, a Boston-based monoclonal antibody company.

Furthermore, Evotec expanded its position, being at the forefront of women’s health and anti-infective drug discovery. Evotec entered an alliance with Celmatix, a partnership to develop pre-clinical programmes in prevalent but underserved conditions affecting women’s reproductive health, including polycystic ovary syndrome, endometriosis, and infertility.

In the field of anti-infectives, Evotec closed additional collaborations, e.g. kicking off "GNA Now", a new initiative for the development of novel antibacterial agents. The increasing recognition of antibiotic resistance as growing threat to public healthcare systems enabled Evotec to receive grants for projects to further accelerate drug discovery efforts in this area of high medical need.

After period-end, Evotec and Vifor Pharma launched a joint venture focused on the discovery and development of novel nephrology therapeutics. Both companies will hold a 50% share, with Vifor Pharma benefiting from access to an external R&D capability for the development of a Nephrology pipeline, while Evotec will gain access to a commercial partner for assets developed through the Joint Venture. The initial funding of € 25 m for pre-clinical development will be covered by Vifor Pharma, while Evotec contributes its PanHunter bioinformatics platform and high-quality data sets from thousands of human kidney disease patients to the Joint Venture.

INCREASE IN EBITDA GUIDANCE FOR FULL-YEAR 2019
Full-year 2019 guidance for revenue and unpartnered R&D costs confirmed; EBITDA guidance increased to approximately 15% (previously: >10%).

Webcast/Conference Call
The Company is going to hold a conference call to discuss the results as well as to provide an update on its performance. The conference call will be held in English.

Conference call details

Date: Tuesday, 12 November 2019

Time: 02.00 pm CET (08.00 am EST, 01.00 pm GMT)

NEC and VAXIMM Announce Collaboration to Advance Personalized Neoantigen Cancer Vaccines

On November 12, 2019 NEC Corporation (NEC; TSE: 6701), a leader in IT and network technologies, and VAXIMM AG, a Swiss/German biotech company focused on developing oral T-cell immunotherapies, reported that the companies have signed a strategic clinical trial collaboration agreement and an equity investment agreement to develop novel personalized neoantigen cancer vaccines (Press release, NEC, NOV 12, 2019, View Source [SID1234550868]).

Under the terms of the collaboration agreement, which is non-exclusive to both parties, NEC will provide funding for a Phase I clinical trial. NEC and VAXIMM will co-develop personalized cancer vaccines using NEC’s cutting-edge artificial intelligence (AI) technology, which is utilized in its Neoantigen Prediction System, and VAXIMM’s proprietary T-cell immunotherapy technology. The vaccines are planned to be evaluated in a Phase I clinical trial in various solid tumors. VAXIMM will be responsible for conducting the clinical trial, which is expected to be initiated in 2020.

NEC has the option for development and commercialization rights to the program worldwide, except for China and other Asian territories outside of Japan.

Osamu Fujikawa, Senior Vice President, NEC Corporation, said: "Cancer is consistently one of the most serious healthcare challenges, with millions of new cases diagnosed worldwide annually. NEC’s core technology is well positioned for the development of personalized medicine, and we are strongly committed to delivering effective treatments for cancer patients. We are delighted to be working with VAXIMM in order to develop an optimal immunotherapy for each individual patient."

Heinz Lubenau, PhD, Chief Operating Officer and Co-Founder of VAXIMM, said: "We are excited to enter this alliance with NEC and to have their strong support of VAXIMM. NEC’s novel AI technology will enable not only the identification but also the prioritization of neoantigens from each patient, facilitating the optimal potential treatment for each individual. Once the list of neoantigens is available, we will be able to apply our technology to quickly produce a personalized vaccine. Individualized therapy is at the cutting edge of cancer treatment today, and, with this collaboration, we are able to further contribute to this approach."

About NEC’s Neoantigen Prediction System
NEC’s neoantigen prediction utilizes its proprietary AI which is combined with NEC OncoImmunity AS’s bioinformatics pipelines – making it the leading neoantigen prediction system in the field. NEC comprehensively evaluates candidate neoantigens, which allows it to effectively prioritize numerous candidate neoantigens identified in a single patient.

Chi-Med to Attend Upcoming Investor and Industry Conferences

On November 11, 2019 Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) reported that Christian Hogg, Chief Executive Officer, will present at the following conferences (Press release, Hutchison China MediTech, NOV 11, 2019, https://www.chi-med.com/chi-med-to-attend-upcoming-investor-and-industry-conferences/ [SID1234552848]):

Deutsche Bank Depositary Receipts Virtual Investor Conference (dbVIC) webcast on Wednesday, November 13, 2019 at 8:30 am (EST) / 1:30 pm (GMT) / 9:30 pm (China Time);
BioCentury & Bayhelix China Healthcare Summit on Wednesday, November 20, 2019 at 1:30 pm (China Time) in Shanghai; and
Presentation at Piper Jaffray Annual Healthcare Conference on Tuesday, December 3, 2019 at 8:50 am (EST), and investor meetings on Tuesday, December 3, 2019 in New York.

In addition, members of the management team will attend the following investor conferences:

Presentation at Jefferies University Specialist Speakers Summit on China Disruption & Innovation on Friday, November 15, 2019 in Hong Kong;
Investor meetings at Jefferies London Healthcare Conference on Wednesday, November 20, 2019 and Thursday, November 21, 2019 in London;
Investor meetings at Morgan Stanley Annual Asia Pacific Summit on Thursday, November 21, 2019 in Singapore; and
Presentation at Goldman Sachs Asia Pacific Healthcare Forum on Monday, November 25, 2019 at 11:30 am (Hong Kong Time), and investor meetings on Monday, November 25, 2019 and Tuesday, November 26, 2019 in Hong Kong.

Chi-Med Announces NDA Acceptance in China for Surufatinib in Non-Pancreatic Neuroendocrine Tumors

On November 11, 2019 Hutchison China MediTech Limited ("Chi-Med") (AIM/Nasdaq: HCM) reported that its New Drug Application ("NDA") for surufatinib for the treatment of patients with advanced non-pancreatic neuroendocrine tumors ("NET") has been accepted for review by the China National Medical Products Administration (Press release, Hutchison China MediTech, NOV 11, 2019, View Source [SID1234551038]).

The NDA is supported by data from the successful SANET-ep study, a Phase III study of surufatinib in advanced neuroendocrine tumors – extra-pancreatic patients in China for whom there is no effective therapy. The positive results of this trial were highlighted in an oral presentation at the 2019 European Society for Medical Oncology Congress on September 29, 2019.

Christian Hogg, Chief Executive Officer of Chi-Med commented, "This NDA filing puts us on track for the potential approval and launch of surufatinib in China, an important development for NET patients with limited treatment options. In order to maximize patient access to surufatinib upon regulatory approval, we are now building our own dedicated commercial oncology organization and expect to be ready to cover all relevant hospitals and clinics in China at the time of launch."

"We believe surufatinib has robust efficacy, tolerability and combinability with a dual angio-immuno kinase inhibition profile, which may make it an attractive treatment in China," Mr. Hogg added.

Chi-Med currently retains all worldwide rights to surufatinib. Surufatinib is under investigation in multiple solid tumors in China, the U.S. and Europe, both as a monotherapy and in combination with immunotherapies.

Surufatinib is Chi-Med’s second in-house discovered novel oncology drug to reach NDA submission in China, following the launch of fruquintinib last year for colorectal cancer under the brand name Elunate.

About Neuroendocrine Tumors (NET)

Neuroendocrine tumors form in cells that interact with the nervous system or in glands that produce hormones. They can originate in various parts of the body, most often in the gut or the lungs and can be benign or malignant. Neuroendocrine tumors are typically classified as pancreatic neuroendocrine tumors or other neuroendocrine tumors. Approved targeted therapies include Sutent and Afinitor for pancreatic neuroendocrine tumors, or well-differentiated, non-functional gastrointestinal or lung neuroendocrine tumors.

According to Frost and Sullivan, there were 19,000 newly diagnosed cases of neuroendocrine tumors in the U.S. in 2018. Importantly, neuroendocrine tumors are associated with a relatively long duration of survival compared to other tumors. As a result, there were approximately 141,000 estimated patients living with neuroendocrine tumors in the U.S. in 2018 of which over 90%, or approximately 132,000, were non-pancreatic neuroendocrine tumor patients.

In China, there were approximately 67,600 newly diagnosed neuroendocrine tumor patients in 2018 and, considering the current incidence to prevalence ratio in China, potentially as many as 300,000 patients living with the disease in the country1. It is estimated that approximately 80% of the patients living with neuroendocrine tumors in China are non-pancreatic neuroendocrine tumor patients.

About SANET-ep

SANET-ep is a randomized, double-blind, placebo-controlled, multi-center, Phase III study comparing surufatinib orally daily with placebo in patients with low- or intermediate-grade advanced extra-pancreatic neuroendocrine tumors for whom there is no effective therapy. In June 2019, a 198 patient interim analysis was conducted, leading the Independent Data Monitoring

Committee (IDMC) to determine that the study met the pre-defined primary endpoint of progression-free survival ("PFS") and should be stopped early. 84% of the patients in the study had disease with pathological grade 2. 41% of patients had disease originating outside of the gastrointestinal (GI) tract and the lung or with unknown origin.

Surufatinib reduced the risk of progression or death by 67%. Median PFS per investigator assessment was 9.2 months for patients treated with surufatinib, as compared to 3.8 months for patients in the placebo group (hazard ratio [HR] 0.334; 95% confidence interval [CI] 0.223-0.499; p<0.0001). The efficacy of surufatinib was seen across all subgroups, and supported by statistically significant improvement as measured by secondary efficacy endpoints including objective response rate (ORR), disease control rate (DCR), time to response (TTR), duration of response (DoR), safety, and tolerability. Efficacy was also supported by Blinded Independent Image Review Committee (BIIRC) assessment. Overall survival (OS) data was not mature, with only 18.7% OS events at data cut-off. The safety profile was consistent with observations in prior clinical studies. Additional details may be found at clinicaltrials.gov, using identifier NCT02588170.

About Surufatinib

Surufatinib (previously known as HMPL-012 or sulfatinib) is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with vascular endothelial growth factor receptors ("VEGFR") and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Its unique dual mechanism of action may be very suitable for possible combinations with other immunotherapies. Surufatinib is in several late-stage and proof-of-concept clinical trials in China and proof-of-concept clinical trials in the U.S.

According to Frost & Sullivan, the market for VEGF/VEGFR inhibitors in China has grown from US$500 million in 2015 to over US$1.5 billion in 2019 and is expected to reach US$5 billion by 2026.

Chi-Med currently retains all rights to surufatinib worldwide.

Pancreatic neuroendocrine tumors in China: In 2016, we initiated the SANET-p study, which is a pivotal Phase III study in patients with low- or intermediate-grade, advanced pancreatic neuroendocrine tumors in China. The primary endpoint is PFS. We expect an interim analysis in the first half of 2020 and enrollment to complete in 2020 (clinicaltrials.gov identifier: NCT02589821).

Neuroendocrine tumors in the U.S. and Europe: The encouraging data from the Phase II and Phase III studies of surufatinib in neuroendocrine tumors in China (clinicaltrials.gov identifier: NCT02267967), and the ongoing Phase Ib study in the U.S. (clinicaltrials.gov identifier: NCT02549937), have led us to decide to proceed with planning a registration study in neuroendocrine tumors patients.

Biliary tract cancer in China: In March 2019, we initiated a Phase IIb/III study comparing surufatinib with capecitabine in patients with advanced biliary tract cancer whose disease progressed on first-line chemotherapy. The primary endpoint is OS (clinicaltrials.gov identifier NCT03873532).

Immunotherapy combinations: In November 2018 and September 2019, we entered into collaboration agreements to evaluate the safety, tolerability and efficacy of surufatinib in combination with anti-programmed cell death protein 1 (PD-1) monoclonal antibodies. This included global collaborations to evaluate the combination of surufatinib with Tuoyi, approved in China by Shanghai Junshi Biosciences Co. Ltd, and with Tyvyt, approved in China by Innovent Biologics, Inc.