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 Shanghai Fosun Pharmaceutical (Group) Co., Ltd ("Fosun Pharma" or "the Group"; Stock Code: 600196.SH, 02196.HK), a leading healthcare group in China, reported its annual results for the year of 2020 ("the Reporting Period"), together with its 2020 Corporate Social Responsibility (CSR) report (Press release, Fosun, MAR 29, 2021, View Source [SID1234577298]).

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Under the guidance of the 4IN (Innovation, Integration, Internationalization, and Intelligentization) strategy, Fosun Pharma practices innovation and transformation, integrated operation and steady development. Rooted in China with expanding global business, Fosun Pharma strategically operates businesses in the pharmaceutical and health industry, including pharmaceutical manufacturing, medical devices and medical diagnosis, and healthcare services. Through its associated company Sinopharm Co., Ltd., Fosun Pharma’s business extends to pharmaceutical distribution and retail.

During the Reporting Period, Fosun Pharma achieved steady growth as the revenue increased by 6.02% yoy, to RMB30,307 million; the net profit attributable to shareholders of the listed company amounted to RMB3,663 million, representing an increase of 10.27% yoy; the net profit attributable to shareholders of the listed company after deducting extraordinary gain or loss amounted to RMB2,718 million, representing an increase of 21.65% yoy. During the Reporting Period, the Group’s core business, the pharmaceutical manufacturing segment, realized revenue of RMB21,880 million. The medical devices and medical diagnosis segment realized revenue of RMB5,217 million. The healthcare services segment realized revenue of RMB3,172 million.

Continues to increase R&D investment with multiple innovative products launched

Took innovative R&D as its core driver and through in-house R&D, co-development, in-licensing and incubation, Fosun Pharma had established platforms for small molecule innovative drugs, antibody drugs and cell therapy, focusing on major therapeutic areas, including oncology, immunology, "4 hypes" (hypertension, hyperlipidemia, hyperglycemia, hyperuricemia) and their complications, as well as central nervous system. In the meantime Fosun Pharma keeps close track of cutting-edge technologies, such as Protac, RNA, oncolytic virus and gene therapy to enhance its innovation ability.

During the Reporting Period, Fosun Pharma continued to increase R&D investment. The annual R&D expenditure totaled RMB4,003 million, representing an increase of 15.59% yoy; of which, R&D expense was RMB2,795 million, representing an increase of 36.94% yoy. The R&D expenditure of pharmaceutical segment was RMB3,670 million, representing an increase of 17.21% yoy, accounting for 16.77% of the revenue from the segment. In particular, pharmaceutical R&D expense increased by RMB727 million or 41.76% yoy to RMB2,468 million, accounting for 11.28% of the revenue from the segment.

Fosun Pharma established in-house R&D platforms in China and the US since 2009, including Fochon and Henlius, and strived to improve its R&D competence through 24-hour ongoing R&D globally. In recent years, CMO office was established to manage global clinical registration, and an upgraded Global R&D Center has been set up in early 2020 to coordinate project approval and internal and external resources. It also prioritized strategic products, strengthened global clinical and registration capabilities, and improved R&D efficiency. In addition, Fosun Pharma cultivated a global Business Development team to search for the industry-leading products and technology platforms and realize the value. As of the end of the Reporting Period, there were nearly 2,300 R&D professionals (about 1,200 are with master’s degree or higher), representing approximately 7% of the total number of employees in the Group. The Group had 247 pipeline projects including innovative small molecule candidates, generic candidates, biosimilars and consistency evaluation of generic candidates, of which 56 were innovative candidates.

With over 10 years of investment, multiple products have been approved for marketing and realized increasing sales in the past two years, with innovative products being the major driver for sustainable growth. Among them, Rituximab Injection achieved rapid sales growth after obtaining approval for its additional production capacity (2,000L), with revenue amounting to RMB750 million for the year. The coverage of new patients was more than 50%. The new products, Avatrombopag Maleate Tablets and Trastuzumab Injection, which was launched to market in August 2020, accelerated market access and have been included in the National Drug Reimbursement List, with revenue reaching approximately RMB140 million respectively.

While improving its in-house research and development capabilities and promote the launching of products under development, Fosun Pharma actively seeks collaboration opportunities with the world’s leading pharmaceutical enterprises. By accessing the world’s leading technologies and high-value products, the Group enriched its product pipelines and enhanced its market expansion capabilities. In terms of in-licensing, on 16 March 2020, BioNTech and Fosun Pharma announced a strategic collaboration to work jointly on the development and commercialization of COVID-19 vaccine products in Chinese Mainland and Hong Kong SAR、Macau SAR and Taiwan Region based on BioNTech’s proprietary mRNA technology platform. The BNT162b2 COVID-19 mRNA vaccine has been granted Authorization for Emergency Use in Hong Kong in January 2021 and was used in the COVID-19 Vaccination Program of Hong Kong and Macau in March 2021. The phase II clinical trial in Mainland China was also in progress.

As for out-licensing, Fochon, a subsidiary of Fosun Pharma, entered into a licensing agreement with Eli Lilly in October 2020, authorizing Eli Lilly exclusive rights of a selective small-molecule BCL-2 inhibitor targeting hematological malignancies, to research, develop, manufacture, and commercialize in all countries and regions excluding Mainland China. Under the terms of the agreement, Eli Lilly will pay the Group an upfront payment up to $440 million. In addition, HLX02 (trastuzumab for injection) has been launched in the UK, Germany and Portugal through a strategic partnership with Accord.

Strengthening marketing system and global commercialization capability in shape

During the Reporting Period, Fosun Pharma continued to strengthen the construction and integration of its marketing system, formed a product line-based system matching the existing products and products to be launched, and adhered to the strategy of specialization, branding and digitalization. As of the end of the Reporting Period, Fosun Pharma had a commercial team of nearly 6,000staff, divided into multiple business units around the major product lines, covering more than 2,000 Class III hospitals and 10,000 Class I and Class II hospitals. There were around 1,500 sales professionals in the innovative drug commercialization team and around 1,000 in the OTC and online "new retail" channels. There were around 1,000 staff in the professional marketing team in Africa, Europe and the United States. Besides, Fosun Pharma’s clinical medicine, market access, brand promotion and other support systems to achieve efficient R&D realization of innovative products, and serve the implementation of more innovative drugs and comprehensive treatment programs in the future.

The medical devices segment has built a marketing network that combines global direct selling and distribution. The sales network of Breas mainly covers Europe, the United States, China, Japan and Australia, while Sisram Medical’s marketing network covers more than 90 countries and regions around the world, including 7 direct sales regions.

Values ESG management and take on corporate social responsibility

Fosun Pharma has always regarded sustainable development as an important benchmark of corporate operations, and has issued corporate social responsibility report for 13 consecutive years to show stakeholders the Group’s practices and achievements in the field of social responsibility. In 2020, in order to further improve its corporate governance structure, Fosun Pharma upgraded its internal ESG management structure, established the ESG Committee at the Board of Directors and its subordinate ESG working team, to carry out ongoing ESG management. Fosun Pharma strives for sustainable development in terms of health, environmental protection, occupational health and safety, staff development and business ethics. In the meantime, the MSCI ESG rating of Fosun Pharma has been upgraded from BB to BBB.

Looking forward, Wu Yifang, Chairman and CEO of Fosun Pharma, expressed that "China’s pharmaceutical and healthcare industry is still in the crucial phase of development and transformation in 2021. The opportunities and challenges coexist under the recovery time of post-COVID-19. As a large-scale pharmaceutical and medical enterprise with excellent products, Fosun Pharma takes the lead in internationalization and uses Internet technology to expand its business. Fosun Pharma will continue to accelerate its innovation and transformation, strengthen its integrated operation and expands its global market steadily. In the same time, Fosun Pharma will focus on the unmet demand in the therapeutic areas to take actions on mergers and acquisitions. As for the healthcare services, Fosun Pharma will continue to manage effective operation, and focus on disciplined clinical department construction and operation, leverage its development in specialty, so as to reinforce the leading position of private hospital management in China. Fosun Pharma will firmly follow the path of innovation transformation to provide patients with more affordable new treatment methods."

On March 29, 2021 Hansa Biopharma AB "Hansa" (Nasdaq Stockholm: HNSA), a pioneer in enzyme technology for rare immunological conditions, reported that they have entered into a preclinical research collaboration agreement with argenx BV to evaluate the therapeutic potential of combining the two companies’ IgG-modulating technologies (Press release, Hansa Biopharma, MAR 29, 2021, View Source [SID1234577297]).

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The preclinical research collaboration is set up to explore the potential of combining imlifidase, Hansa’s IgG antibody-cleaving enzyme, and efgartigimod, argenx’s FcRn antagonist, which are both in development for indications known to be driven by disease-causing IgGs. A combination of imlifidase and efgartigimod could potentially be used in both the acute and chronic setting of autoimmune diseases and transplantation.

Under the preclinical research collaboration agreement, both parties will contribute equally in terms of resource allocation and will share all intellectual property and data developed through the collaboration. Both parties will maintain exclusive rights to their respective technologies and products.

This is information that Hansa Biopharma AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out below, at 20:00 CET on March 29 2021.

About imlifidase

Imlifidase is an enzyme derived from the bacterium Streptococcus pyogenes, with the ability to specifically target and cleave all classes of immunoglobulin G (IgG) antibodies. Imlifidase has a rapid onset of action, cleaving IgG-antibodies and inhibiting their activity within two to six hours after administration. Imlifidase was granted conditional European Marketing Authorization from the European Medicine’s Agency (EMA) in August 2020 for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch test against an available deceased donor. Beyond kidney transplantation imlifidase is also being developed for potential treatment of acute episodes in relation to post-transplantation management and acute autoimmune diseases.

On March 29, 2021 Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, reported financial results for the fourth quarter and year ended December 31, 2020 and provided a clinical and corporate update (Press release, Milestone Pharmaceuticals, MAR 29, 2021, View Source [SID1234577296]).

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"We are keenly focused on executing on our etripamil development program for patients with PSVT following clear regulatory guidance in the second half of 2020 and commencement of the pivotal Phase 3 RAPID study," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "We believe that etripamil has the potential to overcome the limitations of the current standard of care for PSVT, which is invasive, anxiety-provoking and costly, and to serve as a meaningful new therapeutic option for patients."

Mr. Oliveto added, "Beyond PSVT, we are pleased to announce that the Phase 2 ReVeRA study of etripamil in patients with atrial fibrillation and rapid ventricular rate is now underway. We are committed to assessing the full potential of etripamil and helping patients with episodic cardiovascular conditions, and we look forward to providing updates on our progress in the coming months."

Recent Updates

Company Continues to Guide to Topline Data from Pivotal Phase 3 RAPID Trial in Late 2021/Early 2022. The pivotal Phase 3 RAPID trial, which is targeting a total of 180 adjudicated paroxysmal supraventricular tachycardia (PSVT) events, is expected to randomize approximately 500 patients 1:1 to receive either etripamil nasal spray or placebo. As previously announced, patients will be directed to administer a second dose of study drug if they do not experience symptom relief within 10 minutes of the first study drug administration to help maximize the potential treatment effect of etripamil. The primary efficacy analysis for both the RAPID trial and the already-completed NODE-301 trial will be time to conversion of SVT within 30 minutes following initial study drug administration, with a target p-value of less than 0.05 for each trial. The RAPID and NODE-301 trials could potentially serve to fulfill the efficacy requirement for a future New Drug Application (NDA) for etripamil in patients with PSVT.

While clinical site initiations and patient enrollment have been impacted by COVID-19 pandemic-related factors, the Company has initiated mitigation activities including increasing the number of clinical sites and continues to guide toward topline data in late 2021/early 2022.

First Patient Enrolled in ReVeRA Phase 2 Proof-of-Concept Trial Evaluating Etripamil in Patients with Atrial Fibrillation and Rapid Ventricular Rate (AFib-RVR). Milestone reported that the first patient has been enrolled in ReVeRA, its Phase 2 proof-of-concept study of etripamil nasal spray in patients experiencing AFib-RVR. The Phase 2 double blind, placebo controlled, proof-of-concept study is designed to assess the safety and efficacy of etripamil nasal spray to reduce ventricular rate in patients with AFib-RVR experiencing an episode of elevated heart rate requiring treatment. The trial, which will be conducted in Canada in collaboration with the Montreal Heart Institute and other research centers, is expected to enroll approximately 50 patients randomized 1:1 to receive either 70 mg of etripamil nasal spray or placebo. The primary endpoint will assess reduction in ventricular rate, with key secondary endpoints including the time to achieve the maximum reduction in rate and duration of the effect.

Julia Gaebler, Ph.D., appointed as Vice President, Commercial Strategy and Portfolio Planning. Today, Milestone announces the appointment of Julia Gaebler, Ph.D., as Vice President, Commercial Strategy and Portfolio Planning. Dr. Gaebler is a highly accomplished industry veteran with over 25 years of commercial strategy, market access, health services research, and corporate development experience. Dr. Gaebler joins Milestone from Health Advances, where she was Partner, and Head of Global Market Access, Pricing and Policy. Prior experience includes positions of increasing responsibility at Biogen, Amylin Pharmaceuticals, global and affiliate positions within Hoffman La Roche, and the RAND Corporation. She received her Ph.D. in Health Policy and Decision Sciences from Harvard University, M.A. in International Economics from Johns Hopkins University and B.A. in European Intellectual History from the University of Pennsylvania.
Fourth Quarter and Full Year 2020 Financial Results

As of December 31, 2020, Milestone had cash, cash equivalents, and short-term investments of $142.3 million compared to $119.8 million as of December 31, 2019, and 29.8 million common shares and 11.4 million pre-funded warrants outstanding.
Research and development expense for the fourth quarter of 2020 was $5.8 million compared with $14.1 million for the prior year period. For the full year ended December 31, 2020, research and development expense was $34.5 million compared with $42.0 million for the prior year. The COVID-19 pandemic contributed to delays in new clinical site initiation and patient enrollment, which translated into lower than expected research and development spending in the quarter and in the year ended December 31, 2020.
General and administrative expense for the fourth quarter of 2020 was $1.7 million compared with $2.3 million for the prior year period. For the full year ended December 31, 2020, general and administrative expense was $10.3 million compared with $7.0 million for the prior year. The increase of general and administrative expense in the year is mainly attributable to higher insurance costs, additional headcount and non-cash compensation cost related to share-based compensation expense.
Commercial expense for the fourth quarter of 2020 was $1.3 million compared with $2.5 million for the prior year period. For the full year ended December 31, 2020, commercial expense was $5.9 million compared with $8.9 million for the prior year. The decrease of commercial expense in the year ended December 31, 2020 reflects efforts in reducing operating expenses affecting primarily pre-commercialization activities as Milestone focused its efforts on an optimized clinical development pathway for etripamil.
For the fourth quarter of 2020, operating loss was $8.8 million compared to $18.9 million for the prior year period. For the full year ended December 31, 2020, Milestone’s operating loss was $50.0 million compared to $55.3 million for the prior year.
The Company believes its current cash, cash equivalents, and short-term investments will be sufficient to fund anticipated operating expenses and capital expenditure requirements through 2022. This guidance includes anticipated costs associated with the Phase 3 RAPID trial, which are expected to increase as study enrollment progresses.
About Paroxysmal Supraventricular Tachycardia

Paroxysmal supraventricular tachycardia (PSVT) is a rapid heart rate condition characterized by intermittent episodes of supraventricular tachycardia (SVT) that start and stop suddenly and without warning which affects approximately two million Americans. Episodes of SVT are often associated with symptoms including palpitations, sweating, chest pressure or pain, shortness of breath, sudden onset of fatigue, lightheadedness or dizziness, fainting, and anxiety. Certain calcium channel blockers have long been approved for the treatment of PSVT as well as other cardiac conditions. However, calcium channel blockers approved for the termination of SVT episodes must be administered intravenously under medical supervision, usually in an emergency department or other acute care setting.

About Atrial Fibrillation and Rapid Ventricular Rate

Atrial fibrillation (AFib) is a common arrhythmia marked by an irregular and often rapid heartbeat. AFib is estimated to affect five million patients in the United States, a prevalence projected by the Centers for Disease Control to increase to twelve million patients within the next 10 years. Atrial fibrillation and rapid ventricular rate (AFib-RVR) is a condition in which patients with AFib experience episodes of abnormally high heart rate, often with symptoms such as palpitations, shortness of breath, dizziness, and weakness. Oral calcium channel blockers and/or beta blockers are commonly used to manage heart rate in this condition. When episodes do occur, the corresponding symptoms often cause patients to seek care in the acute care setting such as the emergency department, where standard of care procedures include intravenous administration of calcium channel blockers or beta blockers under medical supervision. Milestone’s initial qualitative market research indicates approximately 40% of patients with AFib experience one or more symptomatic episodes of AFib-RVR per year that require treatment, suggesting a target addressable market for etripamil in patients with AFib of approximately two million patients.

About Etripamil

Etripamil, Milestone’s lead investigational product, is a novel calcium channel blocker designed to be a rapid-response therapy for episodic cardiovascular conditions. As a nasal spray that is self-administered by the patient, etripamil has the potential to shift the current treatment experience for many patients from the emergency department to the at-home setting. Milestone is conducting a comprehensive development program for etripamil, with Phase 3 trials ongoing in paroxysmal supraventricular tachycardia (PSVT) and now a Phase 2 proof-of-concept trial underway in patients with atrial fibrillation and rapid ventricular rate (AFib-RVR).

On March 29, 2021 Ascletis Pharma Inc. (HKEX: 1672) reported that the board of directors (the "Board") of the Company has resolved to deploy more resources and investment in the R&D of cancer lipid metabolism and oral checkpoint inhibitors, our pipeline of which is shown below (Press release, Ascletis, MAR 29, 2021, View Source [SID1234577295]):

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The Board believes that the Company has made significant efforts and progress over the last few years through in-licensing and in-house R&D in the areas of cancer lipid metabolism and oral PD-L1 small molecule inhibitors, which has laid a solid foundation for the future development in our oncology pipeline.

The positive results were demonstrated from the investigator sponsored Phase II trial of ASC40(TVB-2640) in combination with bevacizumab in patients with first relapse of high-grade astrocytoma, which was completed in the United States (ClinicalTrials.gov Identifier: NCT03032484). The Company plans to initiate a pivotal randomized, double-blind, placebo-controlled Phase II trial of ASC40 (TVB-2640) in combination with bevacizumab in China for the same patient population (first relapse of high-grade astrocytoma) as in the United States.

The data from the investigator sponsored Phase II trial were presented at European Society for Medical Oncology 2020 and have shown that the overall response rate (ORR) for ASC40 (TVB-2640) plus bevacizumab was 65% including the complete response (CR) of 20% and partial response (PR) of 45%. Furthermore, the data indicate that the progression-free survival at six months (PFS6) observed for ASC40 (TVB-2640) plus bevacizumab was 47%, representing a statistically significant improvement in PFS6 over historical bevacizumab monotherapy (BELOB16%, P=0.01). ASC40 (TVB-2640) in combination with bevacizumab was safe and well tolerated in such patient population.

Lipid metabolism has been reported to play a critical role in various cancers. Fatty acid synthase (FASN) is one of the most important proteins which regulate lipid metabolism. Many solid and hematopoietic tumors overexpress FASN, including glioblastoma (GBM, Grade IV astrocytoma), non-small cell lung, breast, ovarian, prostate, colon, pancreatic cancers, and non-Hodgkin lymphoma.

In addition to FASN inhibitors in combination of bevacizumab, an anti-angiogenesis drug, in-house data and external research papers indicate that FASN inhibitors have potential to treat multiple tumors in combination with signal transduction inhibitors and immunotherapies. Therefore, the Company is considering additional clinical trials for (1) ASC40 in combination with chemotherapies for high-grade astrocytoma immediately followed by the surgery and radiation therapy; (2) ASC40 in combination with other therapies for various solid tumors. As a next generation oral FASN inhibitor, ASC60 has potential to be combined with other therapies for various solid tumors.

In addition to cancer lipid metabolism drug candidates targeting FASN, the Company’s oral PD-L1 small molecule inhibitors discovered in-house have shown favorable anti-tumor activities in animal model compared to a marketed anti-PD-L1 antibody. The Company believes that oral PD-L1 small molecule inhibitors are next generation checkpoint inhibitors as cancer immune therapies and have potential to be combined with oral FASN small molecule inhibitors.

"We are excited about our oncology pipeline since it has strong competitive edges in the crowded oncology space," said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis. "The recent breakthrough from the Phase II trial in patients with first relapse of high-grade astrocytoma indicates that oral FASN inhibitors can play a significant role in the treatment of multiple solid tumors. Furthermore, we are now seeking collaborations with other pharmaceutical companies to develop various combination regimens with FASN inhibitors."