On March 29, 2021 Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, reported the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for relugolix for the treatment of advanced prostate cancer (Press release, Myovant Sciences, MAR 29, 2021, https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-announces-european-medicines-agency-validation [SID1234577282]). The validation of the application confirms the submission is sufficiently complete for the EMA to begin the formal review process.

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"We are delighted that the Marketing Authorization Application for relugolix has been accepted for review by the European Medicines Agency. This is an important milestone in bringing a potential oral treatment option to men with advanced prostate cancer in Europe," said David Marek, Chief Executive Officer of Myovant Sciences, Inc. "Following our recent FDA approval and launch in the U.S., we believe relugolix has the potential to transform the standard of care for men with advanced prostate cancer requiring androgen deprivation therapy. We look forward to making this potential treatment available to more men around the world."

Under the terms of the collaboration between Myovant and Pfizer to develop and commercialize relugolix, Pfizer has an exclusive option to commercialize relugolix in oncology outside of the U.S. and Canada, excluding certain Asian countries. If Pfizer exercises this option, Myovant will receive $50 million and be eligible to receive double-digit royalties on net sales from these markets. Pfizer’s decision to exercise this option is expected in the first half of calendar year 2021.

The MAA is supported by efficacy and safety data from the Phase 3 HERO study, a randomized, open-label, parallel-group, multinational clinical study evaluating the safety and efficacy of relugolix in over 1,000 men with androgen-sensitive advanced prostate cancer who required at least one year of continuous androgen deprivation therapy. Relugolix received U.S. Food and Drug Administration (FDA) approval in December 2020.

About Prostate Cancer
Prostate cancer is the second most prevalent form of cancer in men and the second leading cause of death due to cancer in men in the U.S. Cardiovascular mortality is the leading cause of death in men with prostate cancer and accounts for 34% of deaths in men with prostate cancer in the U.S. More than three million men diagnosed with prostate cancer are alive in the U.S., and approximately 250,000 men are estimated to be newly diagnosed in 2021.

Prostate cancer is considered advanced when it has spread or come back after initial treatment and may include biochemical recurrence (rising prostate-specific antigen in the absence of metastatic disease on imaging), locally advanced disease, or metastatic disease. Front-line medical therapy for advanced prostate cancer typically involves androgen deprivation therapy, which reduces testosterone to very low levels, commonly referred to as castrate levels (< 50 ng/dL). Luteinizing hormone-releasing hormone (LHRH) receptor agonists, such as leuprolide acetate, are depot injections and the current standard of care for androgen deprivation therapy. However, LHRH receptor agonists may be associated with mechanism-of-action limitations, including the potentially detrimental initial surge in testosterone levels that can exacerbate clinical symptoms, which is known as clinical or hormonal flare, and delayed testosterone recovery after the drug is discontinued. Approximately 300,000 men are treated with androgen deprivation therapy each year in the U.S.

On March 29, 2021 GenScript Biotech Corporation (HKEX: 1548.HK), a leading global biotechnology group, reported its 2020 Annual Results Conference (Press release, GenScript, MAR 29, 2021, View Source [SID1234577299]). Its management team announced the business updates and financial performance of the Group’s four business segments, sharing the achievements that bolster its confidence in future prospects.

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According to the full-year 2020 financial report, the Group earned a USD 390 million revenue, representing a 42.9% YoY growth, and a USD 260 million gross profit, for an increase of 41.9% YoY. The Group’s total R&D expenses reached USD 260 million, a 41.6% YoY increase, while R&D expenses of non-cell therapy business segments remained at about 10% of revenue.

Benefitting from strong global momentum in the life science services & products segment and biologics CDMO segment, revenue of the Group’s non-cell therapy businesses increased by 45.9% to USD 315 million, reporting its fastest growth within the past five years, and a gross profit of USD 180 million, growing 46.6% year-on-year. The non-cell therapy business segments’ net profit was USD 22.1 million, a 42.6% YoY increase, and adjusted net profit approximately USD 44.4 million, a 105.6% YoY growth. This was also largely built on the success of answering global demands for COVID-19 related services, including the launch of cPass sVNT Kit – the world’s first reagent kit able to detect functional neutralizing antibodies quickly and effectively. Key highlights include:

The life science services and products business generated USD 250 million in revenue, a 44.4% YoY increase, maintaining its leading position as the world’s No. 1 gene synthesis supplier.
Revenue from GenScript Probio, the biologics CDMO business, reached USD 40.4 million, a 78% YoY growth. Among its business lines, revenue from CDMO services for gene and cell therapy increased by 148% YoY and from CDMO services for antibody drugs by 78.2%. And as a result of the Group’s long-standing commitment to high-quality standards and global business development, revenue increased by over 50% from Chinese customers, and over 150% from overseas customers.
Bestzyme, its industrial synthetic biology products business, boosted its revenue by 24%, maintaining a growth rate that exceeded the industry average and major competitors, and earning recognition as one of the top three industrial enzyme suppliers in China.
Legend Biotech, a Group subsidiary, continued to drive progress in its cell therapy business. It achieved a series of key milestones, including a successful Nasdaq IPO and the submission of Biologics License Application (BLA) to the US FDA for cilta-cel, an Anti-BCMA CAR T-Cell Therapy for treating Relapsed or Refractory Multiple Myeloma. Legend Biotech reached a USD 75.7 million gross profit, primarily attributable to its Janssen collaboration’s revenue recognition of upfront payment and milestone payment for developing and commercializing cilta-cel. Legend Biotech also spent USD 230 million in R&D, including USD 160 million on cilta-cel clinical trials in the United States and China and USD 68.2 million for other pipelines.

The Group’s capital expenditure amounted to USD 130 million to strengthen its competitiveness and profitability. The investments covered the construction of GMP facilities for the cell therapy business to support current clinical trials and future commercial needs; GMP facilities in Nanjing and Zhenjiang that will support the long-term development of the CDMO business; and its life science segment’s product upgrade and facility automation.

"Last year’s outbreak of a global pandemic presented both challenges and opportunities to the life science community. At GenScript Biotech, our people remained dedicated and strong, supporting the group to maintain the growth it has earned since listing, with all four business segments reporting outstanding performance," said Patrick Liu, Rotating CEO of GenScript Biotech. "To prove our unwavering commitment to the field, we will continue to invest in talents, innovation, R&D, infrastructure and other core competencies. As we hone our competitive edge for the future, we will also create more value for both our customers and shareholders. Guided by our mission to make people and nature healthier through biotechnology, we strive to advance the biotech community so that we can better serve society."

2020 Business Highlights

The Group’s high throughput gene synthesis production line achieved automation, adding 60% to production capacity, lowering costs and boosting efficiency while ensuring quality. Its protein, oligo and peptide services also established automated production lines, gaining a leading position in the market.
The company not only launched the only easily affordable EasyEdit sgRNA platform in China, but also formulated the first basic GMP quality management system for sgRNA service, contributing to promoting IND application and clinical trials for the gene and cell therapy community.
In May, GenScript partnered with Duke-NUS to launch the cPass sVNT Kit, the world’s first test that allows rapid and effective detection of neutralizing antibodies (Nabs), and obtained an exclusive agreement for its global commercialization. cPass is also the only serology test that received an Emergency Use Authorization by the US FDA. It has also acquired the CE (Conformite Europeenne) mark in Europe, HSA authorization in Singapore, ANVISA authorization in Brazil, ANMAT authorization in Argentina, and MOHAP authorization in the UAE as a medical device.
The bio-pharmaceutical CDMO business launched the GenScript ProBio brand. Its antibody GMP production center in Nanjing, China, went into production in November, increasing GMP production capacity to 2600L, able to meet the GMP production needs of Phase I/II clinical trials.
The GenScript Life Science Building, the integrated platform for innovative biologics R&D and production services, broke ground in Zhenjiang, Jiangsu Province, in June. Upon commission, it will cover over 30,000 m2 and serve as GenScript’s production and R&D platform for customized peptide services, and an oligo production platform with R&D and GMP production capability, helping GenScript maintain its competitive edge in the field.
Legend Biotech, cell therapy subsidiary, was successfully listed on Nasdaq in June and received USD 650 million in gross proceeds during Pre-IPO and IPO process, earning recognition from the international industry and capital market. Its product cilta-cel obtained the first "Breakthrough Therapy Designation" in China in August, and initiated rolling submission of BLA to the US FDA in December.
Legend Biotech further expanded its innovative product pipelines, and received IND approval from FDA for an investigational CAR-T therapy for the treatment of adults with relapsed or refractory T-cell lymphoma (RR TCL) in December, marking the company’s second successful IND application in the US.
Bestzyme launched the most heat-resistant glucose oxidase in China, becoming the main enzyme solution for antibiotic replacement and reduction, helping customers replace and reduce the use of the antibiotics in animal breeding. Furthermore, it obtained certifications for its products from the US FDA and Southeast Asian countries, and is actively exploring the overseas food enzyme market.
2021 Prospects

The cPass sVNT Kit is currently seeking regulatory approval in China, and has already signed a cooperation agreement to promote its commercial application in the market. With expanding commercial channels and approvals in more countries, the product is expected to achieve considerable sales.
GenScript ProBio’s second GMP plasmid plant is under construction in Zhenjiang, China, which is expected to go into production in the second half of 2021 and double its current plasmid and virus production capacity. Its third GMP facility for clinical study and commercialization of GCT projects is also in the planning stages.
Legend Biotech is expected to submit a Marketing Authorization Application (MAA) for cilta-cel to the EMA in the first half of 2021, and submit a BLA to the National Medical Products Administration (NMPA) of China and receive BLA approval from the US FDA in the second half of 2021.
Legend Biotech is also promoting several investigator-initiated clinical studies, including studies on allogenic therapies for diffuse large B cell lymphoma (DLBCL), acute myelogenous leukemia (AML), gastric cancer, pancreatic cancer, and non-Hodgkin’s lymphoma (NHL).

On March 29, 2021 Hutchison China MediTech Limited ("HUTCHMED") (Nasdaq/AIM: HCM) reported that on March 26, 2021, it granted conditional awards ("LTIP Awards") under the Long Term Incentive Plan adopted by HUTCHMED in 2015 ("LTIP") and share options under the Share Option Scheme adopted by HUTCHMED in 2015 as refreshed in April 2020 (the "Share Option Scheme") (Press release, Hutchison China MediTech, MAR 29, 2021, View Source [SID1234577245]).

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1. Performance-related LTIP Award for the HUTCHMED Financial Year 2021 ("Performance LTIP") – award based on a maximum cash amount, which amount is determined by the achievement of performance targets for the financial year ending 31 December 2021. The performance targets will be determined by the Remuneration Committee of HUTCHMED based on the strategic objectives of HUTCHMED.

The Shares, to be purchased by the Trustee following determination of the cash amount based on actual achievement of performance targets, will then be held by the Trustee until the underlying LTIP Awards are vested. Vesting will occur two business days after the date of announcement of the annual results of HUTCHMED for the financial year ending December 31, 2023. Vesting will also depend upon the continued employment of the award holder with the HUTCHMED group and will otherwise be at the discretion of the Board of Directors of HUTCHMED.

HUTCHMED has granted the following LTIP Awards for the Performance LTIP to the following PDMRs:

Award Holder Maximum amount for the Performance LTIP
Mr Christian Hogg (Executive Director and Chief Executive Officer) US$1,616,538
Mr Johnny Cheng (Executive Director and Chief Financial Officer) US$657,211
Dr Weiguo Su (Executive Director and Chief Scientific Officer) US$1,622,123
An additional 585 employees of HUTCHMED and its subsidiaries have simultaneously been granted LTIP Awards under the Performance LTIP.

2. Share Option Scheme

HUTCHMED granted share options under its Share Option Scheme to 147 employees to subscribe for a total of 8,279,900 Ordinary Shares represented by 1,655,980 American Depositary Shares ("ADSs") (each equating to five Ordinary Shares) subject to the acceptance of the grantee. Details of such share options granted prescribed are as follows:

Date of grant : March 26, 2021
Exercise price of share options granted : US$27.94 per ADS
Number of share options granted : 8,279,900 represented by 1,655,980 ADSs (five share options shall entitle the holder thereof to subscribe for one ADS)
Closing market price of ADSs on the date of grant : US$27.66 per ADS
Validity period of the share options : From March 26, 2021 to March 25, 2031
Among the share options granted, a total of 1,391,800 share options represented by 278,360 ADSs were granted to Mr Christian Hogg, Dr Weiguo Su and Mr Johnny Cheng (Executive Directors of the Company), being persons discharging managerial responsibility under the EU Market Abuse Regulation as follows:-

Grantee Number of share options granted
Mr Christian Hogg (Executive Director and Chief Executive Officer) 868,900 Ordinary Shares represented by 173,780 ADSs
Mr Johnny Cheng (Executive Director and Chief Financial Officer) 240,500 Ordinary Shares represented by 48,100 ADSs
Dr Weiguo Su (Executive Director and Chief Scientific Officer) 282,400 Ordinary Shares represented by 56,480 ADSs

(a) Mr Christian Hogg
1 Details of the person discharging managerial responsibilities/person closely associated
a) Name Mr Christian Hogg
2 Reason for the notification
a) Position/status Executive Director and Chief Executive Officer
b) Initial notification/Amendment Initial notification
3 Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor
a) Name Hutchison China MediTech Limited
b) LEI 2138006X34YDQ6OBYE79
4 Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted
a) Description of the financial instrument, type of instrument
Identification code
Option over American Depositary Share (each equating to five Ordinary Shares of US$0.10)

Option over American Depositary Share with ADS ISIN: US44842L1035

b) Nature of the transaction
Grant of options in respect of 868,900 Ordinary Shares represented by 173,780 ADSs under the Share Option Scheme.

The share options granted are exercisable subject to a vesting schedule of 25% on each of the first, second, third and fourth anniversaries of the effective date of grant.

c) Price(s) and volume(s)
Price(s) Volume(s)
Nil 173,780
d) Aggregated information
— Aggregated volume
— Price N/A
e) Date of the transaction 2021-03-26
f) Place of the transaction Outside a trading venue

(b) Mr Johnny Cheng
1 Details of the person discharging managerial responsibilities/person closely associated
a) Name Mr Johnny Cheng
2 Reason for the notification
a) Position/status Executive Director and Chief Financial Officer
b) Initial notification/Amendment Initial notification
3 Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor
a) Name Hutchison China MediTech Limited
b) LEI 2138006X34YDQ6OBYE79
4 Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted
a)
Description of the financial instrument, type of instrument

Identification code

Option over American Depositary Share (each equating to five Ordinary Shares of US$0.10)

Option over American Depositary Share with ADS ISIN: US44842L1035

b) Nature of the transaction
Grant of options in respect of 240,500 Ordinary Shares represented by 48,100 ADSs under the Share Option Scheme.

The share options granted are exercisable subject to a vesting schedule of 25% on each of the first, second, third and fourth anniversaries of the effective date of grant.

c) Price(s) and volume(s)
Price(s) Volume(s)
Nil 48,100
d) Aggregated information
— Aggregated volume
— Price N/A
e) Date of the transaction 2021-03-26
f) Place of the transaction Outside a trading venue

(c) Dr Weiguo Su
1 Details of the person discharging managerial responsibilities/person closely associated
a) Name Dr Weiguo Su
2 Reason for the notification
a) Position/status Executive Director and Chief Scientific Officer
b) Initial notification/Amendment Initial notification
3 Details of the issuer, emission allowance market participant, auction platform, auctioneer or auction monitor
a) Name Hutchison China MediTech Limited
b) LEI 2138006X34YDQ6OBYE79
4 Details of the transaction(s): section to be repeated for (i) each type of instrument; (ii) each type of transaction; (iii) each date; and (iv) each place where transactions have been conducted
a)
Description of the financial instrument, type of instrument

Identification code

Option over American Depositary Share (each equating to five Ordinary Shares of US$0.10)

Option over American Depositary Share with ADS ISIN: US44842L1035

b) Nature of the transaction
Grant of options in respect of 282,400 Ordinary Shares represented by 56,480 ADSs under the Share Option Scheme.

The share options granted are exercisable subject to a vesting schedule of 25% on each of the first, second, third and fourth anniversaries of the effective date of grant

c) Price(s) and volume(s)
Price(s) Volume(s)
Nil 56,480
d) Aggregated information
— Aggregated volume
— Price N/A
e) Date of the transaction 2021-03-26
f) Place of the transaction Outside a trading venue

On March 29, 2021 Checkmate Pharmaceuticals, Inc. (NASDAQ: CMPI) ("Checkmate"), a clinical stage biopharmaceutical company focused on developing its proprietary technology to harness the power of the immune system to combat cancer, reported full year 2020 financial results and provided an update on recent progress (Press release, Checkmate Pharmaceuticals, MAR 29, 2021, View Source [SID1234577267]).

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"We made strong progress in 2020, laying the groundwork to broaden and accelerate our CMP-001 clinical program in melanoma and other solid tumor indications," said Barry Labinger, President and Chief Executive Officer of Checkmate.

Recent Progress

In December 2020, Checkmate announced a clinical collaboration with Bristol Myers Squibb to evaluate vidutolimod (formerly CMP-001) in combination with nivolumab. The companies will collaborate on two melanoma clinical trials.
In January 2021, Checkmate appointed Robert F. Dolski as Chief Financial Officer. Mr. Dolski brings more than 20 years of diversified management experience as a life sciences financial executive.
Vidutolimod (formerly CMP-001) Anticipated 2021 Milestones

Advance lead melanoma indication toward potential registration, supported by two Phase 2 trials. These trials will study vidutolimod in combination with nivolumab for the treatment of anti-PD-1 refractory melanoma and first-line metastatic or unresectable melanoma. We initiated patient dosing in the first-line melanoma trial in March 2021. Trial sites have been activated and patient screening is underway in the refractory melanoma study.
Expand into new indications, such as head and neck cancer, which is expected to be supported by a Phase 2 proof-of-concept trial. This trial will study vidutolimod in combination with pembrolizumab for the treatment of first-line head and neck cancer. Trial sites have been activated and patient screening is underway. Initial data from this trial are expected before the end of 2021.
Full Year 2020 Financial Results

Cash, cash equivalents and investments: Cash, cash equivalents and investments were $125.9 million as of December 31, 2020.
Research and development expenses (R&D): R&D Expenses for the full year 2020 were $26.7 million, compared to $24.3M for the prior year. The increase was primarily attributable to increased headcount and consulting costs in connection with preparing for the initiation of planned additional clinical trials of CMP-001. These increases were partially offset by a decrease in contract manufacturing costs.
General and administration expenses (G&A): G&A expenses for the full year 2020 were $10.2 million, compared to $4.6 million for the prior year. The increase was primarily attributable to increases in personnel and other operating expenses incurred in connection with Checkmate beginning to operate as a publicly traded company.
Net loss: Net loss for the full year 2020 was $36.9 million, compared to $28.3 million for the prior year.

On March 29, 2021 Onconova Therapeutics, Inc. (NASDAQ: ONTX) ("Onconova"), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, reported that Steven Fruchtman, M.D., President and Chief Executive Officer, will present a Company overview and hold one-on-one meetings during the Spring 2021 Oncology Investor Conference, sponsored by the National Foundation for Cancer Research (Press release, Onconova, MAR 29, 2021, View Source [SID1234577283]).

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Event: Spring 2021 Oncology Investor Conference
Date: The virtual conference will take place March 29 to April 2, 2021
Onconova Presentation: Thursday, April 1, 2021 at 11:50 a.m. Eastern time
Conference Registration Link: View Source

A webcast of Dr. Fruchtman’s presentation will be available on the Company’s website at View Source beginning Friday, April 2nd.