On March 20, 2022 GenScript Biotech, the world’s leading biotech company, reported its annual results as of December 31, 2021 (Press release, GenScript, MAR 20, 2022, View Source [SID1234610393]).

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"2021 is a pivotal year for GenScript. Our continuous investments in innovation and optimization of current business portfolio over the past few years lead to encouraging results.", said Dr. Patrick Liu, Rotating CEO of GenScript. "In the life science segment, we are pushing forward our business through automation and industrial-scale production. In the emerging gene and cell therapy CDMO segment, GenScript ProBio achieved explosive revenue growth thanks to strategic investment, advanced platforms and high quality standards. Bestzyme reached breakeven, which is made possible by business optimization and product innovation. With continued investment in synthetic biology, Bestzyme will further unfold its potential in the future. In early 2022, our subsidiary Legend Biotech, an innovative cell therapy company, together with our partner J&J, successfully commercialized CarvyktiTM, which is a monumental event for the cell therapy industry and demonstrates innovation capabilities of China’s biopharmaceutical industry. Looking ahead, GenScript Group will continue investment in innovation capabilities to address challenges in the fields of gene and cell therapy and synthetic biology. We will stay committed to our mission to "make people and nature healthier through biotechnology" by accelerating innovation in the biotech industry, and continuously create value for our shareholders."

Results Analysis of the Four Business Segments

Life-science services and products

During the Reporting Period, revenue from life-science services and products was approximately US$315.8 million, representing an increase of 26.4% as compared with approximately US$249.8 million for the year ended December 31, 2020. During the Reporting Period, the gross profit was approximately US$183.3 million, representing an increase of 10.8% as compared with approximately US$165.4 million for the year ended December 31, 2020. During the Reporting Period, the operating profit of life-science services and products was approximately US$91.6 million, representing an increase of 6.5% from approximately US$86.0 million for the same period in 2020.

The growth of revenue and gross profit was mainly attributable to the (i) expanded capacity and productivity, (ii) successful commercial operation that focused on the novel products such as oligo synthesis and cPass services and kit, (iii) successful development of key accounts, and (iv) the improvement of online commercial platform and tools to attract new customers. The decrease in gross profit margin was primarily attributable to the (i) significant decrease of exchange rate of USD against RMB as compared to 2020 which caused an increase of converted cost as the majority of production cost occurred in Mainland China, (ii) increased freight and duty costs, and (iii) change of product portfolio strategy. The increase in operating profit was primarily attributable to the improved capacity utilization and operational efficiency, and was partially offset by increased investment in research and development.

Biologics development services

During the Reporting Period, revenue from biologics development services was approximately US$81.4 million, representing an increase of 101.5% as compared with approximately US$40.4 million for the year ended December 31, 2020. During the Reporting Period, the gross profit was approximately US$25.6 million, representing an increase of 158.6% as compared with approximately US$9.9 million for the year ended December 31, 2020. Total backlog for biologics development services increased by 108.4% from US$94.7 million as at December 31, 2020 to US$197.4 million as at December 31, 2021. The gross profit margin increased from 24.5% for the same period in 2020 to 31.4% this year. During the Reporting Period, the operating loss of biologics development services was approximately US$4.5 million, whilst the operating loss was approximately US$7.6 million for the same period in 2020.

The increase in revenue was primarily attributable to the (i) accumulated biologics development track records and expanded global customer base, (ii) expanded capacity and productivity of pre-clinical and clinical development, (iii) shorter delivery time for antibody and protein drug development, and (iv) significant increase in plasmid revenue from the boosting GCT market, including mRNA related applications. The increase in gross profit was primarily attributable to the (i) increased revenue, (ii) production cost reduction and quality improvement, and (iii) improved capacity utilization. The operating loss was primarily attributable to the (i) investment in selling and distribution, and (ii) investment in research and development activities.

Industrial synthetic biology products

During the Reporting Period, revenue from industrial synthetic biology products was approximately US$38.6 million, representing an increase of 33.6% as compared with approximately US$28.9 million for the year ended December 31, 2020. During the Reporting Period, the gross profit was approximately US$11.3 million, representing an increase of 31.4% as compared with US$8.6 million for the year ended December 31, 2020. During the Reporting Period, the industrial synthetic biology products segment has achieved operating break-even this Year, whilst the operating loss was approximately US$3.0 million for the same period in 2020.

The increase in revenue and gross profit was primarily attributable to the (i) launch of innovative products, (ii) increased penetration into big industrial customers, and (iii) business development in overseas markets. The gross profit margin remained stable during the Reporting Period.

Cell therapy

During the Reporting Period, revenue from cell therapy was approximately US$89.8 million, representing an increase of 18.6% as compared with approximately US$75.7 million for the year ended December 31, 2020. During the Reporting Period, gross profit was approximately US$89.8 million, representing an increase of 18.6% as compared with approximately US$75.7 million for the year ended December 31, 2020. During the Reporting Period, the operating loss of cell therapy was approximately US$373.9 million, whilst the operating loss was approximately US$233.4 million for the same period in 2020.

The increase in both revenue and gross profit was primarily attributable to additional milestones achieved in 2020 and 2021, and thus further recognition of contract revenue from the collaboration with Janssen on developing cilta-cel. The operating loss was primarily attributable to the (i) investment in clinical trials, higher patients enrollment and more pipelines, (ii) cost for commercial preparation activities for the launch of cilta-cel, and (iii) expansion of administrative functions.

Revenue

In 2021, the Group recorded revenue of approximately US$511.1 million, representing an increase of 30.8% from approximately US$390.8 million in 2020. This was primarily attributable to (i) the continued increase of non-cell therapy products and services from major strategic customers and new competitive services and products, and (ii) the increase of contract revenue derived from Legend’s collaboration with Janssen with new milestones achieved.

Gross Profit

In 2021, the Group’s gross profit increased 18.6% to approximately US$303.5 million from approximately US$255.9 million in 2020. The increase in gross profit was primarily attributable to the (i) rapid growth of revenue, and (ii) operational efficiency improvement. The increase in gross profit was partially offset by unfavorable exchange rate fluctuation and increased shipping costs.

Selling and distribution expenses

The selling and distribution expenses increased by 56.6% to approximately US$168.0 million in 2021 from approximately US$107.3 million in 2020. This was mainly attributable to the (i) recruiting of more experienced personnel and improved incentive packages to enhance the business development capability, and (ii) increased marketing and advertising expenses, primarily attributable to the global expansion of our business, including Legend’s collaboration with Janssen.

Administrative expenses

The administrative expenses increased by 48.9% to approximately US$134.5 million in 2021 from approximately US$90.3 million in 2020. This was mainly caused by (i) reinforcing key administrative functions such as information technology, supply chain and legal to support the Group’s overall business expansion and ensure compliance with certain updated requirements, (ii) one-time consultation expenses and other costs related to the Investigation, and (iii) the CARVYKTI application and the Follow-on Public Offering of Legend.

Research and development expenses

The research and development expenses increased by 36.1% to approximately US$358.4 million in 2021 from approximately US$263.4 million in 2020. This was mainly due to the (i) increase in clinical trial expenses and preclinical study costs in the cell therapy segment, (ii) investment in new research and development projects to strengthen our competitiveness in the GCT market and related supply chain, (iii) investment in development projects that improved our production efficiency, and (iv) increase in compensation package including equity-settled share-based compensation expense for research and development personnel.

On March 19, 2022 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported full results from the pivotal SORAYA trial evaluating the efficacy and safety of mirvetuximab soravtansine (mirvetuximab) monotherapy in patients with folate receptor alpha (FRα)-high platinum-resistant ovarian cancer who have been previously treated with Avastin (bevacizumab) (Press release, ImmunoGen, MAR 19, 2022, View Source [SID1234610379]). The results are being presented by Dr. Ursula Matulonis in the late-breaking abstract plenary session on Saturday, March 19 at the Society of Gynecologic Oncology (SGO) 2022 Annual Meeting in Phoenix, AZ.

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"Patients with platinum-resistant ovarian cancer have limited treatment options, and these are associated with low response rates and significant toxicity," said Ursula Matulonis, MD, Chief of the Division of Gynecologic Oncology at the Dana-Farber Cancer Institute, Professor of Medicine at the Harvard Medical School, and SORAYA Co-Principal Investigator. "With an objective response rate of 32.4%, far exceeding that seen with current therapies, and a median duration of response approaching seven months, mirvetuximab continues to demonstrate impressive efficacy in patients with platinum-resistant disease who have already received bevacizumab. The anti-tumor activity and consistent safety and tolerability data from the SORAYA trial further underscore the potential of mirvetuximab, if approved, to become a practice-changing, biomarker-driven standard of care for these patients."

SORAYA is a single-arm study of mirvetuximab in patients with platinum-resistant ovarian cancer whose tumors express high levels of FRα and who have been treated with one to three prior regimens – at least one of which included bevacizumab. The primary endpoint for the study is confirmed objective response rate (ORR) as assessed by investigator and the key secondary endpoint is duration of response (DOR). ORR was also assessed by blinded independent central review (BICR). The study is designed to rule out a 12% ORR, based on expected outcomes of 4% to 13% with available single agent chemotherapy. Data previously generated in a post-hoc pooled analysis of seventy patients from prior studies of mirvetuximab in platinum-resistant disease formed the basis for the design of SORAYA, with an investigator-assessed ORR of 31.4%, median DOR of 7.8 months, and median progression-free survival (PFS) of 4.4 months.

Key Findings from SORAYA

SORAYA enrolled 106 patients with a median of three prior lines of therapy; 51% had three prior lines of therapy and 48% had one to two prior lines of therapy. All patients received prior bevacizumab; 48% of patients received a prior PARP inhibitor (PARPi).

Confirmed ORR by investigator was 32.4% (95% confidence interval [CI]: 23.6%, 42.2%), including five complete responses (CRs). ORR by BICR was 31.6% (95% CI: 22.4%, 41.9%), including five CRs. Response rates were consistent regardless of number of prior lines of therapies or prior PARPi.
1-2 prior lines of therapy: ORR by investigator was 35.3% (95% CI: 22.4%, 49.9%).
3 prior lines of therapy: ORR by investigator was 30.2% (95% CI: 18.3%, 44.3%).
Prior PARPi exposure: ORR by investigator was 38.0% (95% CI: 24.7%, 52.8%).
Without prior PARPi exposure: ORR by investigator was 27.5% (95% CI: 15.9%, 41.7%).
The median DOR was 6.9 months (95% CI: 5.6, 8.1) by investigator as of the March 3, 2022 data cut-off.
The median PFS was 4.3 months (95% CI: 3.7, 5.1) by investigator and 5.5 months (95% CI: 3.8, 6.9) by BICR.
Mirvetuximab was well-tolerated, consistent with the known safety profile seen in more than 700 patients treated in the broader mirvetuximab program. Treatment-related adverse events led to dose reductions in 19% of patients, dose delays in 32% of patients, and discontinuations in 7% of patients. The most common treatment-related adverse events were low-grade and generally reversible, including blurred vision (41% all grade; 6% grade 3), keratopathy (36% all grade; 8% grade 3+), and nausea (29% all grade; 0% grade 3).
"We are thrilled with the SORAYA results, which are remarkably consistent with data previously generated with mirvetuximab in a heavily-pretreated population of platinum-resistant ovarian cancer patients that included prior exposure to bevacizumab. Based on the impressive anti-tumor activity, durability of response, and safety profile observed in SORAYA, we believe mirvetuximab has the potential to displace single-agent chemotherapy as the standard of care for FRα-high platinum-resistant ovarian cancer," said Anna Berkenblit, MD, Senior Vice President and Chief Medical Officer of ImmunoGen. "We are very grateful for all of the patients and physicians who committed their time and effort to this study, and with these positive results, we expect to submit the BLA for mirvetuximab this month to support potential accelerated approval in the US this year. The strength and consistency of the SORAYA data give us confidence in a positive outcome in the ongoing confirmatory MIRASOL trial, intended to support the potential full approval of mirvetuximab, with top-line data anticipated in the third quarter."

Oral Presentation Details

Title: Efficacy and Safety of Mirvetuximab Soravtansine in Patients with Platinum-Resistant Ovarian Cancer with High Folate Receptor Alpha Expression: Results from the SORAYA Study
Session: Scientific Plenary IV: Late-Breaking Abstracts
Session Date: Saturday, March 19, 2022
Session Time: 4:15 pm to 5:45 pm MST/7:15 pm to 8:45 pm EDT

Other Presentations

Trial in progress posters from ImmunoGen’s MIRASOL and PICCOLO trials of mirvetuximab in ovarian cancer and a Phase 2 investigator-sponsored combination trial of mirvetuximab with carboplatin as a neoadjuvant therapy for patients with newly diagnosed ovarian cancer will also be presented. Final data from the mirvetuximab plus bevacizumab platinum-agnostic combination, which were originally shared at ASCO (Free ASCO Whitepaper) 2021, will also be featured in a seminal presentation.

Additional information can be found at www.sgo.org.

INVESTOR EVENT INFORMATION

ImmunoGen will hold an investor event to discuss the SORAYA oral presentation, featuring a roundtable with key opinion leaders, on Sunday, March 20 at 7:30 am MST/10:30 am EDT in the Moly Meeting Room at the Westin Phoenix Downtown. To access the live event by phone, dial (877) 621-5803; the conference ID is 1986619. The event may also be accessed via webstream on the Investors and Media section of the Company’s website, www.immunogen.com. Following the call, a replay will be available at the same location.

ABOUT MIRVETUXIMAB SORAVTANSINE

Mirvetuximab soravtansine (IMGN853) is a first-in-class ADC comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin-targeting agent, to kill the targeted cancer cells.

On March 18, 2022 Nymox Pharmaceutical Corporation (NASDAQ: NYMX) reported it has entered into definitive agreements with institutional and accredited investors for the purchase and sale of 3,030,304 common shares at a purchase price of $1.65 per share in a registered direct offering for gross proceeds of approximately $5 million before deducting placement agent fees and expenses (Press release, Nymox, MAR 18, 2022, View Source [SID1234610339]). The Company has also agreed to issue to the investors, in a concurrent private placement, unregistered warrants to purchase up to an aggregate of 3,030,304 common shares. The warrants are exercisable immediately at an exercise price of $2.00 per share and will expire five (5) years from the date of an effective registration statement covering the shares underlying the warrants. The closing of the offering is expected to occur on or about March 22, 2022, subject to the satisfaction of customary closing conditions.

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Nymox intends to use the proceeds for general corporate purposes, including working capital.

A.G.P./Alliance Global Partners is acting as sole placement agent for the offering.

This offering of the common shares (but not the warrants or the common shares underlying the warrants) is being made pursuant to an effective shelf registration statement on Form F-3 (File No. 333-261571) previously filed with the U.S. Securities and Exchange Commission (the "SEC"). A prospectus supplement describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the prospectus supplement may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected]. Interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that Nymox has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about Nymox and such offering.

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the common shares underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and the underlying common shares may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On March 18 2022 Today marks a major milestone for EUROAPI, a leading European company dedicated to the development, production and marketing of active pharmaceutical ingredients* (API), as Sanofi’s Board of Directors reported, on March 17th, to submit to its shareholders the distribution of circa 58% of the share capital of EUROAPI. In addition to the previously proposed €3.33 cash dividend per Sanofi share, this additional extraordinary dividend, exclusively in kind, is subject to shareholders approval
at Sanofi’s May 3, 2022 Ordinary and Extraordinary Shareholders’ Meeting. If approved, the distribution will take place shortly after the listing of EUROAPI’s shares on the regulated market of Euronext Paris, subject to the approval of the French Autorité des Marchés Financiers (AMF) on EUROAPI’s French prospectus, which will be made available to the public ahead of Sanofi’s Shareholders’ Meeting. Through this transaction, Sanofi is giving its shareholders the opportunity to take part in the success of a leading player in the API market with strong ambitions to become a global champion on a growing and dynamic market, and due to be listed on the regulated market of Euronext Paris.

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In connection with the proposed spin-off, French Tech Souveraineté has agreed to purchase
12% in EUROAPI shares from Sanofi for up to €150 million, with the acquisition price to be determined based upon the thirty day volume weighted average trading price ("VWAP") of EUROAPI’s shares on Euronext Paris, starting on the first day of trading. As a result, French Tech Souveraineté will become a long-term reference shareholder of EUROAPI and will be represented by two non-executive members on EUROAPI’s Board of Directors, including Benjamin Paternot and another member to be determined. French Tech Souveraineté’s investment is subject to approval of the spin-off by Sanofi’s shareholders and other customary conditions.

Post transaction, Sanofi confirms that it will hold circa 30% of the share capital and voting rights of EUROAPI and will remain a long-term strategic partner, supporting EUROAPI’s growth ambitions as an independent company over the coming years. In addition to its highly diversified customer base of approximately 530 customers, EUROAPI benefits from a strong and long-term customer relationship with Sanofi, which represented nearly half of EUROAPI’s revenues in 2021.

In line with its "Play to Win" strategy aiming at simplifying its operations, Sanofi announced in February 2020 its ambition to create a new world leader in APIs to secure significant manufacturing and supply capacities that are critical for patients in Europe and beyond, in a context of increasing shortage of medicines essential to patient care. In 2021, Sanofi announced several critical steps in this journey with the unveiling of the creation of EUROAPI and the appointment of Karl Rotthier as its CEO in January, the appointment of Viviane Monges as Chair of the Supervisory Board in July and the finalization of the carve-out in December 2021.

Despite volatile market conditions, Sanofi has decided to move forward with the listing process of EUROAPI. As an independent stand-alone company, EUROAPI will be able to fully unlock its growth potential, offering the best alignment of strategy, value creation and financial objectives for all of Sanofi’s shareholders.

With a diversified technology portfolio, EUROAPI is positioned as the world’s leading manufacturer of small molecule API (including complex chemical synthesis molecules, biochemical molecules from fermentation and highly potent molecules). It was the world’s second largest manufacturer of APIs (including both small and large molecules such as peptides and oligonucleotides) in 2021 and number seven in the global CDMO (Contract Development and Manufacturing Organization) market in 20201.

EUROAPI develops, manufactures, markets and distributes APIs and intermediates used in the formulation of medicines for human and veterinary use, both from originators and generics, through its API Solutions business and CDMO activities.

Drawing on more than 150 years of experience in the growing API market, EUROAPI has a network of six production sites, all of which are located in Europe, and delivers around 200 APIs to approximately 530 customers in over 80 countries. The company will be able to rely on the expertise of around 3,350 employees and expects to achieve consolidated sales of around EUR 1 billion in the year ending December 31, 2022.

Further details regarding the specifics of the distribution, including the parity, and the timetable of the spin-off will be set forth in EUROAPI’s French prospectus.

Following the AMF’s approval of EUROAPI’s French prospectus, Sanofi and EUROAPI’s management teams will host a dedicated Capital Markets Day on April 1, 2022 at 1:30 pm CET to present EUROAPI’s business in greater detail (event registration details are available here).

*About Active Pharmaceutical Ingredients (APIs)
Active Pharmaceutical Ingredients (APIs) are the chemical or biological substances in a medicine that have a therapeutic effect. They are the essential molecules used in the composition and manufacture of any medicine.

On March 18, 2022 Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for cancer, reported its financial results for the full year ended December 31, 2021 and provided corporate updates on key events and achievements since the start of 2021 (Press release, Antengene, MAR 18, 2022, View Source [SID1234610343]).

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"The last 15 months have been a time of significant achievements for Antengene," said Dr. Jay Mei, Antengene’s Founder, Chairman and CEO. "The company was founded to develop innovative cancer medicines to treat patients beyond borders, worldwide. We have delivered on our vision this year and significantly de-risked the Company. We accomplished this by securing our first regulatory approvals for our lead first-in-class/only-in-class product, XPOVIO (selinexor), across China and 3 Asia-Pacific countries, and making the transition to a commercial organization, and by significantly advancing our portfolio with potential first-in class/best-in-class clinical programs in China, Australia and the US."

Dr. Mei continued, "We also delivered on our mission of building a research-driven biopharmaceutical company that is developing transformational, best-in-class/first-in-class medicines for cancer, focusing on resistant or relapsing diseases with high unmet medical needs. Today, we have 8 programs in 18 clinical studies, including 5 registrational trials, utilizing our internal capabilities and platform and clinical development partnerships. We have built a team of over 350 employees across China, the US and APAC regions, and have built core capabilities in drug discovery, development, manufacturing and commercialization."

"Looking ahead," said Dr. Mei, "2022 is the fifth anniversary of Antengene’s founding and we believe it will be a landmark year for the Company. We expect to have regulatory approvals for selinexor in all 6 markets in Greater China and Asia Pacific markets where we have submitted new drug applications (NDAs). We are optimistic about the first launch of selinexor in Q2:22 in China, based on strong participation in the Named Patient Program (NPP) as well as the inclusion of selinexor in several important practice treatment guidelines. In addition, we expect to report data on at least 5 clinical programs and file 2 new investigational new drug (INDs), from in-house development programs."

In conclusion, Dr. Mei said "Looking forward, we believe our strong cash, bank balances and cash management products of RMB 2.370 billion, and revenue growth will continue to fund advancement of our programs and continue to deliver additional value for investors. Since cancer are diseases that knows no borders, we are devoted and passionate in advancing our programs to treat cancer patients beyond borders, worldwide. Antengene is optimistic about this year and the future based on the excellent work of our team and collaborators, all around the world, and we look forward to updating you on our progress as the year unfolds."

Overview of Antengene’s Products and Clinical Pipeline:

XPOVIO (selinexor) Commercial Approvals, Bridging Studies and Inclusion in Practice Treatment Guidelines: Antengene is strategically investing in XPOVIO (selinexor) and positioning the product for a successful commercial launch across the Asia-Pacific region based on solid registrational data and a growing body of studies to support product adoption and label expansions. In addition, Antengene has implemented a well-supported Named Patient Program, and built a highly experienced, well respected commercial team to position for market launch and revenue growth.

XPOVIO (selinexor) Approvals: We secured approvals for XPOVIO (selinexor), a first-in-class, oral selective inhibitor of nuclear export (SINE), in mainland China, Australia, South Korea and Singapore for hematological cancer indications including relapsed/refractory multiple myeloma (R/R MM), refractory diffuse large B-cell lymphoma (R/R DLBCL) for use as monotherapy and as part of established multi-drug regimen.
Further Selinexor Approvals in 2022: We expect further approvals in Hong Kong and Taiwan markets in 2022.
Named Patient Program: We provided selinexor to patients in mainland China and Hong Kong under the Named Patient Program which generated revenue of RMB28.5 million in 2021. This program provided Antengene with the opportunity to connect with key opinion leaders on selinexor, which will pave the way for an effective commercial launch of selinexor in China, planned to begin in Q2:22.
Selinexor Inclusion in Practice Treatment Guidelines: Use of selinexor was included in the Chinese Society of Clinical Oncology (CSCO) 2021 Diagnosis and Treatment Guidelines (CSCO Guidelines). This follows prior inclusion of multiple selinexor regimen into practice guidelines by major oncology networks, National Comprehensive Cancer Network (NCCN) in the U.S. and the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) in the EU.
Pivotal Selinexor Studies Presented at Major Medical Meetings: Positive results of the pivotal MARCH bridging study were reported at international medical meetings including the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Meeting in 2021. Results from the MARCH trial have confirmed the efficacy and manageable safety profile to be consistent with that observed in the STORM trial which supported selinexor’s accelerated approval by the U.S. Food and Drug Administration (FDA).
Pivotal Bridging Studies, BENCH and SEARCH are registrational trials in China: The BENCH study, which evaluates selinexor in combination with bortezomib and dexamethasone, for patients with R/R MM, will serve as the confirmatory trial to support selinexor’s conditional approval. The SEARCH study evaluates selinexor as monotherapy in patients with R/R DLBCL who have received at least 2 but no more than 5 prior treatment regimens. We expect to file sNDA for SEARCH and complete patient enrollment for the BENCH study in 2022.
Well-Prepared for Commercialization across China and Asia-Pacific Countries: Antengene has carefully invested in a commercial team of 170 with a proven track record of commercial success in China and APAC for a successful launch of XPOVIO (selinexor).
Business Development: focused on partnerships to facilitate clinical collaborations, in-license novel programs or enable access to novel platform/drug development technologies to complement and enrich our in-house capabilities.

ATG-037 (CD73 small molecule inhibitor): In May 2021, we entered into an exclusive, worldwide license agreement with Calithera Biosciences, Inc. for the development and commercialization of CB-708 (ATG-037), Calithera Biosciences, Inc.’s small molecule inhibitor of CD73. The Phase 1 STAMINA trial has secured HREC approval in Australia and is planned to begin enrollment in H1:22.
LegoChem Deal for New ADCs: In October 2021, we entered into a Research Collaboration and License Option Agreement with LegoChem Biosciences, Inc. ("LCB", KOSDAQ: 141080) for new antibody-drug conjugates (ADCs). Under this agreement, the two parties will jointly generate and evaluate ADC candidates using Antengene’s antibodies and LCB’s next generation ADC technology platform.
Bristol Myers Squibb Clinical Collaboration for ATG-017 (ERK1/2 inhibitor) and Opdivo (nivolumab): In December 2021, we entered into a clinical trial collaboration with Bristol Myers Squibb to evaluate the safety, pharmacokinetics and preliminary efficacy of ATG-017 in an open-label, Phase 1/2 combination trial with Bristol Myers Squibb’s anti-PD-1 checkpoint inhibitor, Opdivo (nivolumab) for patients with advanced solid tumors.
Clinical Program Poised to Deliver Multiple Data Readouts in 2022 and 2023 (originated in-house/through partners): The Antengene pipeline has been developed with a special focus on key mechanisms linked to relapsing/resistant disease including metabolic changes, genetic alterations, the tumor microenvironment and immune suppression/down-regulation. With a robust R&D portfolio, Antengene is well-positioned to evaluate proprietary combinations, further differentiating its programs.

Mid to Late-Stage Programs: (Antengene has certain Asia-Pacific rights): Antengene is exploring two members of the novel XPO1 family plus a novel mTOR cell growth inhibitor.

Selinexor (ATG-010, first-in-class XPO1 inhibitor): Antengene has developed a robust program to maximize the clinical utility for selinexor and the XPO1 class. The drug is being evaluated for new cancer indications, including maintenance treatment of endometrial cancer, and in combination with standard therapy for MM and DLBCL. The objective of these programs is to potentially improve response rates, maintain disease control, and expand the clinical utility of the drug.

Phase 2 MF-035 Myelofibrosis Trial designed to evaluate the safety and efficacy of selinexor in the treatment of patients with myelofibrosis in China (Global study).
Phase 2/3 XPORT-DLBCL-030 Trial designed to evaluate selinexor in combination with rituximab, gemcitabine, dexamethasone and platinum (SR-GDP) for patients with rr-DLBCL in China (Global study).
Phase 1b MATCH Trial designed to evaluate selinexor in combination with ATG-008 (onatasertib) for the treatment of R/R DLBCL (sponsored by Antengene).
Phase 1/2 SWATCH Trial designed to evaluate selinexor in combination with lenalidomide plus rituximab ("S-R2") for the treatment of relapsed/refractory indolent non-Hodgkin lymphoma ("rriNHL") (sponsored by Antengene).
Selinexor Data Presentations:

Phase 1b TOUCH Results: At the 2021 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (ASH 2021), we published positive results from the open-label Phase 1b TOUCH trial of selinexor plus gemcitabine-oxaliplatin ("GemOx") for the treatment of Chinese patients with relapsed/refractory (R/R) T and NK-Cell lymphoma. The combination demonstrated an Overall Response Rate (ORR) of 46.2%, a Complete Response Rate (CRR) of 26.9% and a Duration of Response (DOR) of 3.1 months. ORR for peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS) and extranodal NK/T-cell lymphoma (ENKTL) subgroups reached 53.8% and 57.1%, CRR of 30.8% and 28.6%, and median Progression-Free Survival (PFS) of 4.4 months and 4.7 months, respectively (sponsored by Antengene).
Eltanexor (ATG-016, second generation XPO1 inhibitor): An expansive program to evaluate ATG-016 monotherapy in:

Phase 1/2 HATCH Trial in patients with high-risk myelodysplastic syndrome (MDS). Enrollment in China is underway (sponsored by Antengene).
Phase 1/2 REACH in patients with solid tumors. Enrollment in China is underway (sponsored by Antengene).
Phase 2 segment of the Solid Tumor/Hematologic Cancer trial. Enrollment in patients with high-risk MDS in China is underway (Global Study).
Eltanexor Data Presentations:

Phase 1/2 MDS Results: At the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (ASH 2021), Karyopharm published Phase 1/2 data with eltanexor in patients with MDS showing that single agent eltanexor was active in patients with high-risk, refractory disease. Of the 15 patients evaluable for efficacy, Karyopharm reported that 47% of patients achieved a bone marrow complete response and 33% had stable disease (SD) for a total disease control rate (DCR) of 80%.
Onatasertib (ATG-008, dual mTORC1/2 inhibitor) targets multiple key mTOR cell growth pathways. Data from the TORCH-2 Phase 1/2 solid-tumor dose-finding study in combination with PD-1 antibody was reviewed at Antengene’s 2021 R&D Day in November 2021. This promising signal warrants further exploration and Antengene will move rapidly to expand the study whilst exploring a potential accelerated regulatory path (sponsored by Antengene).

Early-Stage Clinical Programs (Antengene has global rights)

ATG-017 (ERK1/2 inhibitor) has potential synergy with checkpoint inhibitors and KRAS inhibitors. The Phase 1 ERASER dose escalation for the treatment of advanced solid tumors and hematologic malignancies is well advanced in Australia (sponsored by Antengene). Antengene will also be collaborating clinically with Bristol Myers Squibb in the ERASER study to evaluate ATG-017 in combination with Opdivo (nivolumab) in advanced solid tumors.
ATG-101 (PD-L1/4-1BB bispecific antibody) designed to block the binding of immunosuppressive PD-1/PD-L1 and activate immune effectors via 4-1BB co-stimulation. In preclinical studies, ATG-101 demonstrated significant anti-tumor activity in animal models of resistant tumors as well as those that progressed on anti-PD-1/L1 treatment. Furthermore, ATG-101 has also showed an excellent safety profile in GLP toxicology studies. The Phase 1 PROBE multicenter, dose-escalation clinical trial, in patients metastatic/advanced solid tumors and B-cell non-Hodgkin’s lymphoma (B-NHL), is ongoing in the US and Australia and the Investigative New Drug (IND) application has been approved in China.
ATG-037 (CD73 small molecule inhibitor) has the potential to reverse immunosuppression in the tumor microenvironment. Enrollment in the Phase 1 STAMINA trial, in patients with locally advanced or metastatic solid tumors, is planned to begin in Australia in H1: 22 (sponsored by Antengene).
Planning 2 INDs per Year (Antengene has global rights): Antengene has developed a vibrant, productive R&D team.

2022 IND Candidates: Antengene plans to submit an IND application for ATG-018 (ATR inhibitor) in H1:22. In addition, preclinical studies are also underway to support IND/CTA applications of ATG-022 (Claudin 18.2 antibody-drug conjugate) in 2022.
2023 Potential IND/CTA Filings: ATG-031 (CD24 antibody) and ATG-027 (B7H3/PD-L1 bispecific antibody)
Early Stage, IND Track Programs: ATG-032 (LILRB antibody) and ATG-041 (Axl-Mer inhibitor)
Corporate Updates: Corporate milestones related to development of critical research and development and manufacturing infrastructure to support biological and small molecule programs highlight Antengene’s transition to a fully-integrated biopharmaceutical company are exemplified by opening and development of two major manufacturing and R&D centers. These resources help Antengene stand out in the industry.

Antengene’s selection as a constituent stock in highlights the Company’s significant progress since its November, 2020 IPO.

Manufacturing Center in Shaoxing: In May 2021, the Company hosted an inauguration ceremony for our manufacturing center at the Binhai Life Science and Healthcare Industrial Zone in Shaoxing. Completion of the manufacturing center prepares for future production of oral medicines and provides Antengene with integrated capabilities in discovery, development, manufacturing, and commercialization. Antengene plans to initiate the manufacturing of selinexor at this site.
Agreement with Hangzhou Qiantang New Area Administrative Committee: In May 2021, we entered into a framework agreement with the Hangzhou Qiantang New Area Administrative Committee to build a drug discovery and manufacturing center for antibody biologics.
Selection in Major Stock Indexes: Antengene was selected as a constituent stock in three major, well-respected family market indexes, the Hang Seng Index Family, the FTSE Russell Index Family, and the MSCI Global Small Cap Indexes.
Financial Results

Cash, bank balances and cash management products: Cash, bank balances and cash management products at December 31, 2021 were RMB2,370.5 million as compared to RMB3,109.8 million at December 31, 2020.

Research and development costs: Research and development costs for the year ended December 31, 2021 were RMB405.0 million as compared to RMB347.7 million for the comparable period in 2020.

The increase relates to increased drug development expenses and expansion of R&D personnel.

Selling and distribution expenses: Selling and distribution expenses for 2021 were RMB67.9 million compared to RMB0.5 million for 2020.

The increase is primarily attributable to increased employee head count and professional fees related to preparations for the planned launch of our lead product, XPOVIO (selinexor) in 2022.

Administrative expenses: Administrative expenses for 2021 were RMB169.5 million compared to RMB154.2 million for 2020.

The increase is attributable to increased professional fees and headcount related to costs of operating as a public company and in support of commercial operations.