On December 20, 2021 Seagen Inc. (Nasdaq: SGEN) reported that management will present virtually at the 40th Annual J.P. Morgan Healthcare Conference on Monday, January 10, 2022 at 3:00 p.m. Eastern Time (Press release, Seagen, DEC 20, 2021, View Source [SID1234597446]). The presentation will be webcast live and available for replay from the investor section of Seagen’s website at investor.seagen.com.

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On December 20, 2021, Cytokinetics, Incorporated ("Cytokinetics") reported that entered into a License and Collaboration Agreement (the "License Agreement") with Ji Xing Pharmaceuticals Limited ("Ji Xing"), pursuant to which Cytokinetics granted to Ji Xing an exclusive license to develop and commercialize Cytokinetics’ proprietary small molecule cardiac sarcomere activator known as omecamtiv mecarbil (the "Product") in the greater China region, namely mainland China, Hong Kong, Macau, and Taiwan (Filing, 8-K, Cytokinetics, DEC 20, 2021, View Source [SID1234597464]).

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Under the terms of the License Agreement, Cytokinetics will receive from Ji Xing an upfront and near-term milestone payments of $50 million. Cytokinetics may be eligible to receive from Ji Xing additional milestone payments totaling up to $330 million for the achievement of certain commercial milestone events with respect to the Product. In addition, Ji Xing will pay to Cytokinetics tiered royalties from the mid-teens to the low twenties range on the net sales of the Product in the greater China region, subject to certain reductions for generic competition, patent expiration and payments for licenses to third-party patents.

Ji Xing will be responsible for the development and commercialization of the Product in its territory at its own cost and is required to use diligent efforts to develop and commercialize the Product in the greater China region. The development of the Product will be initially focused on heart failure with reduced ejection fraction (HFrEF), and Ji Xing will have the opportunity to participate in future Cytokinetics’ global clinical trials of the Product. Cytokinetics will supply the Product to Ji Xing either as a finished product or as an active pharmaceutical ingredient.

The License Agreement, unless terminated earlier, will continue on a market-by-market basis until expiration of the relevant royalty term. Ji Xing has the right to terminate the License Agreement for convenience. Each party may terminate the License Agreement for the other party’s uncured material breach, insolvency, or failure to perform due to extended force majeure events. Cytokinetics may also terminate the License Agreement if Ji Xing challenges Cytokinetics’ patents or undergoes certain change of control transactions. Product rights will revert to Cytokinetics upon termination, and, under certain circumstances, subject to a low single-digit royalty payments on the net sales of the Product in the greater China region.

The foregoing description of the material terms of the License Agreement does not purport to be complete and is qualified in its entirety by reference to the complete text of the License Agreement, a copy of which Cytokinetics intends to file, with confidential terms redacted, with the United States Securities and Exchange Commission (the "SEC") as an exhibit to Cytokinetics’ Annual Report on Form 10-K for the year ending December 31, 2021.

Common Stock Purchase Agreements

On December 20, 2021, in connection with the License Agreement Cytokinetics entered into Common Stock Purchase Agreements (each, a "CSPA") with each of RTW Master Fund, Ltd., RTW Innovation Master Fund, Ltd. and RTW Venture Fund Limited (collectively, the "RTW Investors").

The CSPAs provide for the sale and issuance to the RTW Investors of 511,182 shares of Cytokinetics common stock of (the "Shares") with an aggregate purchase price of $20.0 million at a price per share of $39.125. The closing will occur on December 20, 2021. The RTW Investors have agreed to certain trading and other restrictions with respect to the Shares, including a restriction on sales or other transfers of the Shares, subject to certain exceptions, for a period of one year from the closing date.

The foregoing description of the material terms of the CSPAs does not purport to be complete and is qualified in its entirety by reference to the complete text of the form of CSPA, a copy of which Cytokinetics intends to file, with confidential terms redacted, with the SEC as an exhibit to Cytokinetics’ Annual Report on Form 10-K for the year ending December 31, 2021.

On December 20, 2021 Shanghai Henlius Biotech, Inc. (2696.HK) reported that successfully held its Global R&D Day themed "H-evolution: From Biotech to Biopharma", and released its interim analysis results of Phase 3 clinical study (ASTRUM-005) in previously untreated patients with extensive-stage small cell lung cancer (ES-SCLC) of serplulimab (novel anti-PD-1 mAb) (Press release, Shanghai Henlius Biotech, DEC 20, 2021, View Source [SID1234597497]).

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The study states that serplulimab combined with carboplatin-etoposide prolonged median overall survival (OS) in both the overall population and the Asian subgroup, the median OS in the serplulimab and placebo groups were 15.38 and 11.10 months, respectively, reducing risk of death by 38% (41% in the Asian subgroup), p <0.001. The 2-year OS rate (OSR) in the two treatment groups were 43.2% and 8.0%, respectively. Serplulimab also has a manageable safety profile. It is expected that serplulimab will become the first anti-PD-1 mAb in first-line SCLC treatment, providing a new treatment option for patients.

An urgent need for new drugs to break the enduring plight
According to GLOBOCAN 2020, lung cancer (LC) is the second commonly diagnosed and the first mortality cancer around the world, and the leading cause of cancer incidence and mortality in China. It is estimated that there are more than 810,000 new cases reported in 2020, accounting for 17.9% of new cancer cases in China, in which SCLC is the most malignant subtype of LC with 15%-20% among LC. The SCLC breaks down into limited stage small cell lung cancer (LS-SCLC) and ES-SCLC. Most patients are in extensive stage when diagnosed. Their clinical condition deteriorates rapidly and the overall prognosis is poor. In the past 20 years, etoposide combined carboplatin/cisplatin was still the standards of care for ES-SCLC, but almost all patients with extensive stage relapse within one year, with a median OS of only 10 to 11 months. The advent of immune checkpoint inhibitors brings hope to patients. At present, anti-PD-L1 mAb combined with chemotherapy has been recommended by the latest NCCN guidelines and CSCO guidelines as the first-line treatment for ES-SCLC. Data showed that the median OS was about 12-13 months in the anti-PD-L1 mAb groups and about 10 months in the chemotherapy groups. However, the application of immunotherapy in ES-SCLC still faces challenges. In recent years, a number of PD-1 mAbs have failed in the area. Therefore, more effective first-line treatment of PD-1 inhibitors is urgently needed.

Significantly improved patients’ OS, serplulimab vs. placebo groups: OS 15.38 months vs. 11.10 months, 2-year OSR 43.2% vs. 8.0%
ASTRUM-005 is the international multi-cetner clinical research and its principal investigator is Professor Ying Cheng, Director of Jilin Department of Medical Oncology Cancer Center, Jilin Province Lung Cancer Diagnosis and Treatment Center, and Jilin Cancer Hospital Malignant Tumor Clinical Research Integrated Diagnosis and Treatment Center. This study has set up about 128 sites in China, Poland, Russia, Turkey, Ukraine and Georgia, etc. 585 subjects were enrolled, among whom 31.5% were Caucasian. The enrolled patients are randomised 2:1 to receive intravenous infusion of either serplulimab or placebo in combination with chemotherapy every-3-week, until disease progression, death, intolerable toxicity, withdrawal of informed consent or other reasons specified in the protocol (whichever occurs first). The primary objective of this study is to compare the clinical efficacy of the two treatments as first-line therapies for ES-SCLC patients, and the secondary objectives are to evaluate the safety and tolerability. The primary endpoint is OS, and secondary endpoints include progression-free survival (PFS), PFS2, objective response rate (ORR), duration of response (DOR), safety, pharmacokinetic characteristic, and immunogenicity, etc.

By the cut-off date (Oct 22, 2021), 585 eligible subjects were enrolled in this study (serplulimab group: n=389; placebo group: n=196), with a median follow-up duration of 12.3 months. The median OS in the serplulimab and placebo groups were 15.38 and 11.10 months, respectively, with a hazard ratio (HR) of 0.62 (95% CI: 0.48, 0.80), p <0.001. The 2-year OS rate (OSR) in the two treatment groups were 43.2% and 8.0%, respectively. In Asian subgroup, the median OS in the serplulimab and placebo groups were 16.03 and 11.10 months, respectively, with a hazard ratio (HR) of 0.59 (95% CI: 0.44, 0.79), p <0.001. The results demonstrated that as first-line therapy, serplulimab in combination with carboplatin-etoposide significantly improved the OS in ES-SCLC patients with a manageable safety profile. On December 7, an interim analysis was conducted by the Independent Data Monitoring Committee (IDMC) for this study. IDMC suggested that the company can hence communicate with healthy authority.

Based on the promising data of this study, Henlius will proceed to file the regulatory applications for this indication as soon as possible. In the future, the company will continue putting the unmet clinical needs as the first priority, proactively promoting the combination immunotherapy of serplulimab and international regulatory registration, to benefit more patients around the world.

On December 20, 2021 I-Mab (the "Company") (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel biologics, reported strategic leadership changes and a new governance initiative designed to facilitate its global pipeline development and accelerate its ongoing transformation towards an integrated global biopharma company (Press release, I-Mab Biopharma, DEC 20, 2021, View Source [SID1234597530]). The announcement is an integral part of I-Mab’s strategic growth plans to position the Company for the next phase of development.

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Dr. Andrew Zhu, an internationally renowned oncologist, joined I-Mab as President and board director to lead the Company’s global R&D organization, focusing on delivering the pipeline milestones and enhancing clinical development capability in the U.S. and China. With his rich experience in global drug development, Dr. Zhu has worked with numerous pharmaceutical companies, including Merck, Eli Lilly, Roche, and Bayer. He has led and participated in more than 50 global clinical trials. Dr. Zhu will be based in Shanghai and report directly to company Founder and Chairman Dr. Jingwu Zang.

"We’re excited to welcome Dr. Zhu to I-Mab. Dr. Zhu is an established and world-renowned expert in clinical oncology with an impressive track record in clinical research and clinical development of novel drugs. As I-Mab’s pipeline has reached a critical proof-of-concept and registrational stage, Dr. Zhu’s deep clinical research expertise and novel drug development experience at the world’s top academic institutions will be key to ensuring that we deliver the planned clinical milestones successfully and further enhance our competitive position in the global field of immuno-oncology," Dr. Zang commented.

"As a truly global biotech company with a rich and innovative pipeline, I-Mab has accomplished remarkable achievements within a short period of time. I am very excited to take on this role at I-Mab where I can effectively invest my passion and oncology expertise in leading the R&D team to the next level of clinical development capability and competitiveness and accelerating the delivery of I-Mab’s global innovative clinical compounds to patients in need around the world," said Dr. Zhu. Previously, Dr. Zhu served as a member of I-Mab’s Scientific Advisory Board.

To better prepare the transition towards the next phase of development, the Board has appointed Dr. Jingwu Zang, Founder and Chairman of I-Mab, as Acting Chief Executive Officer, effective January 1, 2022. Dr. Zang founded I-Mab Biopharma and has served as Chairman and CEO since 2016 (remaining as Chairman since October 2019). Under his vision and leadership, the Company has set an ambitious agenda to focus on innovation in immuno-oncology and has rapidly emerged as an innovative clinical stage biotech with globally competitive assets, such as lemzoparlimab (CD47 antibody), uliledlimab (CD73 antibody) and plonmarlimab (GM-CSF antibody), which are now among the global front-runners.

"Within a short period of time, I-Mab has evolved to become a significant global player in immuno-oncology field with a global reputation for its pursuit of first-in-class and best-in-class therapies. We trust that Dr. Zang will continue to help propel the Company to new levels and ensure a successful transition," said Mr. Wei Fu, Director and Chairman of the Nominating and Corporate Governance Committee of I-Mab.

With a well-positioned management team in place, the Company is progressing rapidly towards its staged transformational goal as governed by a newly established Commercialization Executive Council (CEC) to drive partnerships, corporate investment and potential merger & acquisition. The CEC provides a critical internal cross-functional governance body responsible for planning and overseeing the full spectrum of the Company’s commercialization activities. The key members of the CEC are composed of Mr. Jielun Zhu (Chief Strategy Officer), Mr. Yifei Zhu (Chief Commercial Officer), Dr. Weimin Tang (Chief Business Officer), Dr. Andrew Zhu (President) and Mr. John Long (Chief Financial Officer).

As part of this leadership change, Dr. Joan Shen, will step down as CEO on December 31, 2021 to pursue other interests.

"On behalf of the Board, I would like to express our gratitude to Joan for her impactful contributions to the Company over the past years. She was instrumental to the progress that we have made to advance our globally competitive pipeline, laying a solid foundation for I-Mab’s future," said Dr. Zang.

I-Mab Conference Call Information

I-Mab will also host an investor call on December 21, 2021, at 8:00 a.m. ET to introduce the new management members.

About Dr. Andrew Zhu

Dr. Andrew Zhu is an internationally renowned oncologist. He was Professor of Medicine at Harvard Medical School and served as Director of Liver Cancer Research at Massachusetts General Hospital (MGH) Cancer Center. In collaboration with his colleagues, Dr. Zhu established and led the multidisciplinary liver cancer clinic at the MGH and created one of the most productive clinical and translational research programs in hepatobiliary cancers in the U.S. Prior to joining I-Mab, Dr. Zhu was Director of Jiahui International Cancer Center of the Jiahui International Hospital in Shanghai, China and subsequently served as Chief Scientific Officer of Jiahui Health.

Dr. Zhu has an excellent track record in clinical development of innovative oncology drugs. He has led early-stage development of numerous targeted therapy and immuno-oncology drugs for liver cancer and several pivotal studies that led to regulatory approval by the FDA, including the development of pembrolizumab (KEYNOTE-224) and ramucirumab (REACH-2) for advanced liver cancer, and the successful development of the first IDH-1 inhibitor (Ivosidenib) for cholangiocarcinoma. Dr. Zhu also served on the Steering Committee of several phase III trials in the development of combination immunotherapies for liver cancer, including atezolizumab combined with bevacizumab. He has also served on the committee for the establishment of many global HCC Clinical Trial Design and Practice Guidelines, including the NCCN Guidelines for Hepatobiliary Cancers, AASLD Guidelines for the Treatment of Hepatocellular Carcinoma, and ASCO (Free ASCO Whitepaper) Guidelines on Systemic Therapy for Advanced Hepatocellular Carcinoma.

Dr. Zhu received his medical degree from Peking University Health Science Center and his Ph.D. from Columbia University. Following his postdoctoral research training at Harvard Medical School. he completed his clinical training in internal medicine at Yale New Heaven Hospital, Yale School of Medicine, and a fellowship in Hematology-Oncology at Memorial Sloan-Kettering Cancer Center. Dr. Zhu has published more than 300 scientific papers and reviews in top international journals such as New England Journal of Medicine, Lancet, JAMA, Nature Medicine, Lancet Oncology, Journal of Clinical Oncology and Cancer Discovery.

On December 20, 2021 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported it has entered into an agreement with Gilead Sciences, Inc. (Headquarters: Foster City, California, "Gilead") for the commercialization and distribution of filgotinib (generic name, product name: Jyseleca ), an oral, JAK1 preferential inhibitor for indications of rheumatoid arthritis (RA), ulcerative colitis, and Crohn’s disease in Asia (South Korea, Taiwan, Hong Kong and Singapore) (Press release, Eisai, DEC 20, 2021, View Source [SID1234597411]). In December 2019, Eisai signed a partnership agreement with Gilead Sciences K.K. (Headquarters: Tokyo), a Japanese subsidiary of Gilead, for the distribution and co-promotion of filgotinib in Japan.

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Under the terms of the new agreement, Eisai will obtain an exclusive marketing right for filgotinib in South Korea, Taiwan, Hong Kong and Singapore from Gilead. Gilead has received approval for the treatment of RA in Taiwan and has applied for approval of filgotinib for the treatment of RA in South Korea. Following approvals, Eisai will take over the manufacturing and marketing licenses for filgotinib from Gilead in South Korea and Taiwan. In Hong Kong and Singapore, Eisai will apply for approval for filgotinib. With this agreement, Eisai will pay Gilead a contractual up-front payment, as well as regulatory milestones and sales milestones.

Filgotinib is a once-daily, oral, JAK1 preferential inhibitor. In Japan, filgotinib has been approved for the treatment of rheumatoid arthritis (including prevention of structural joint damage) in patients who have had an inadequate response to conventional therapies. In April 2021, Gilead Sciences K.K. applied for an additional indication of filgotinib as a treatment for patients with moderate to severe active ulcerative colitis.

Eisai will leverage its strong business foundation throughout Asia, provide new treatment options for patients with rheumatoid arthritis and inflammatory bowel disease, and contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients their families, and healthcare providers.

1. About filgotinib

Filgotinib is a once-daily, oral, JAK1 preferential inhibitor. In Japan, filgotinib has been approved for the treatment of RA (including prevention of structural joint damage) in patients who have had an inadequate response to conventional therapies. In April 2021, Gilead Sciences K.K. applied for an additional indication of filgotinib as a treatment for patients with moderate to severe active ulcerative colitis.

In addition, filgotinib has been approved in the European Union and Great Britain for the treatment of adults with moderate to severe active rheumatoid arthritis who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs). Filgotinib has also been approved in the European Union for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent. Applications have been submitted to the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of adults with moderately to severely active ulcerative colitis and are currently under review.

2. About the market for biological products South Korea, Taiwan, Hong Kong and Singapore

The market of biological products in 2020 in South Korea, Taiwan, Hong Kong and Singapore is approximately US $ 400 million, accounting for approximately more than 80% of the total market for biological products in Asia (Hong Kong, India, Indonesia, South Korea, Malaysia, Philippines, Singapore, Taiwan, Thailand and Vietnam).1 Many of biological products are adapted in the treatments for rheumatoid arthritis and inflammatory bowel disease.

1 Copyright © 2021 IQVIA. Internal analysis based on IQVIA Analytics Link 2020. Unauthorized reproduction prohibited.