On November 1, 2021 Kyowa Hakko Kirin reported that (Press release, Kyowa Hakko Kirin, NOV 1, 2021, View Source [SID1234593976])

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1. Consolidated Financial Results for the Nine Months Ended September 30, 2021
(1) Consolidated operating results
(2) Consolidated financial position

2. Dividends
3. Consolidated Earnings Forecasts for the Fiscal Year Ending December 31, 2021 (from January 1, 2021 to December 31, 2021)

1. Operating Results and Financial Statements
(1) Summary of Consolidated Financial Position Assets as of September 30, 2021, were ¥856.8 billion, an increase of ¥55.5 billion compared to the end of the previous fiscal year.

 Non-current assets increased by ¥3.9 billion to ¥362.7 billion, due mainly to an increase in intangible assets associated with in-licensing of development products, despite impairment of marketing rights, a decrease from sale of investment securities, etc.
 Current assets increased by ¥51.6 billion to ¥494.1 billion, due mainly to an increase in cash and cash equivalents from the proceeds from sale of assets held for sale (shares of Hitachi Chemical Diagnostics Systems Co., Ltd.) and proceeds from upfront payment received from Amgen Inc. based on an agreement for joint development and commercialization of KHK4083, as well as an increase in inventories, despite a decrease in assets held for sale.
 Liabilities as of September 30, 2021, were ¥143.5 billion, an increase of ¥40.6 billion compared to the end of the previous fiscal year, due mainly to an increase in contract liabilities accompanying the conclusion of an agreement with Amgen Inc.
 Equity as of September 30, 2021, was ¥713.3 billion, an increase of ¥14.9 billion compared to the end of the previous fiscal year, due mainly to an increase due to the recording of profit attributable to owners of parent as well as an increase in exchange differences on translation of foreign operations resulting from the impact of exchange rates, despite a decrease due to the payment of dividends, etc. The ratio of equity attributable to owners of parent to total assets as of the end of the third quarter was 83.2%, a decrease of 3.9 percentage points compared to the end of the previous fiscal year.

(2) Summary of Consolidated Business Performance
1) Overview of results The Group now applies the International Financial Reporting Standards ("IFRS") in line with its policy of expanding business globally, and adopts "core operating profit" as a level of profit that shows the recurring profitability from operating activities. Core operating profit is calculated by deducting "selling, general and administrative expenses" and "research and development expenses" from "gross profit," and adding "share of profit (loss) of investments accounted for using equity method" to the amountFor the nine months ended September 30, 2021 (January 1, 2021 to September 30, 2021), revenue was ¥254.0 billion (up 8.5% compared to the same period of the previous fiscal year), and core operating profit was ¥46.8 billion (down 7.6%). Profit attributable to owners of parent was ¥32.9 billion (down 12.2%).

 The increase in revenue was the result of steady growth of global strategic products in North America and EMEA and higher revenue year on year in Asia, mainly in China, despite lower revenue in Japan. The positive effect on revenue from foreign exchange was ¥4.6 billion.
 The decrease in core operating profit was the result of increases in selling, general and administrative expenses, and research and development expenses, despite an increase in gross profit due to an increase in overseas revenue. The positive effect on core operating profit from foreign exchange was ¥1.1 billion.
 Profit attributable to owners of parent decreased as a result of an increase in income tax expense in addition to a decrease in core operating profit, despite a decrease in other expenses.

On November 1, 2021 xFOREST Therapeutics Co., Ltd. (Headquarter: Kamigyoku, Kyoto, Japan, President and CEO: Shunichi Kashida, "xFOREST"), Axcelead Drug Discovery Partners Inc. (Headquarter: Fujisawa, Kanagawa, President: Yoshinori Ikeura, "Axcelead DDP"), and Kyowa Kirin Co., Ltd. (Headquarter: Chiyoda-ku, Tokyo, TSE:4151, President and CEO: Masashi Miyamoto, "Kyowa Kirin") reported that the three companies have entered into a joint research agreement to discover multiple drugs that target RNA structures (Press release, Kyowa Hakko Kirin, NOV 1, 2021, View Source [SID1234593975]).

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Axcelead DDP and Kyowa Kirin originally started collaboration on the development of innovative small-molecule drugs based on a novel drug discovery technology platform in October 2020. Under the terms of the agreement among three companies announced here, xFOREST participates in the research being conducted by Axcelead DDP and Kyowa Kirin on the drug discovery targeting RNA structures.

xFOREST will provide its proprietary FOREST technologies, a suite of large-scale parallel analysis platforms, to promote systematic small-molecule drug discovery research targeting RNA structures. xFOREST obtains rights to receive milestone payments and royalties on sales from Kyowa Kirin according to the progress and success of its R&D. Kyowa Kirin has exclusive rights to develop and commercialize RNA-targeted small-molecules discovered from the collaboration.

Shunichi Kashida, Ph.D., President and CEO of xFOREST commented, "xFOREST Therapeutics has been promoting the development of its proprietary FOREST technologies, aiming to realize highly effective systematic RNA-targeted drug discovery. We appreciate that we will initiate the brandnew challenge to research for discovering the RNA-targeted drug with Kyowa Kirin and Axcelead DDP and we will push forward this research collaboration to deliver new drugs to patients as soon as possible."

Yoshinori Ikeura, Ph.D., President of Axcelead DDP commented, "Since Axcelead DDP and Kyowa Kirin started collaboration in 2020, we have been striving to develop fundamental technologies that will open up a new era of small-molecule drugs together. We feel the excitement at xFOREST’s participation in our collaboration, which is sure to help us construct a novel unparalleled platform for RNA-targeted small-molecule drug discovery. We are delighted that we utilize our expertise and technologies accumulated in the pharmaceutical industry for the development of novel technology."

Yoshifumi Torii, Ph.D., Executive Officer, Vice President, Head of R&D Division of Kyowa Kirin commented, "We are very delighted to initiate a collaboration with xFOREST and Axcelead DDP. We highly expect that xFOREST’s unique platform could further accelerate our efforts by integrating it with the Axcelead DDP’s extensive technology and experience of small-molecule drug discovery and our innovative drug discovery technology. We will work closely with both companies to research and develop novel drugs to answer unmet medical needs."

On November 1, 2021 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and PRISM BioLab Co., Ltd. (Headquarters: Kanagawa, President and CEO: Dai Takehara, "PRISM") reported that the CREB-binding protein (CBP) / β-catenin inhibitor E7386, a medium-molecular weight compound created through collaboration research between Eisai and PRISM, has achieved the clinical POC (Proof of Concept) (Press release, Eisai, NOV 1, 2021, View Source [SID1234593967]).

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Eisai is conducting a Phase I clinical study of E7386 monotherapy for solid tumors, and a Phase Ib clinical trial of E7386 plus lenvatinib mesylate (product name: LENVIMA, "lenvatinib"), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, for solid tumors including hepatocellular carcinoma. The achievement of the POC, which is defined in a collaborative research agreement between Eisai and PRISM, was confirmed based on data such as antitumor activity and changes of biomarkers in these clinical trials.

The E7386 targets, β-catenin, is considered to be one of the undruggable targets that are particularly difficult to develop into drug discovery. β-catenin, along with CBP, which is also the target of E7386, is located at the downstream of the Wnt signaling and regulates the Wnt signaling-dependent transcription activity. E7386 is a CBP / β-catenin inhibitor that inhibits CBP and β-catenin protein-protein interactions and regulates the Wnt signal-dependent gene expression. It is expected to suppress tumor growth dependent on the Wnt signaling. 1 E7386 is also expected to release the suppression of tumor-infiltrating T cells by the Wnt signaling activation, and to enhance the effect of immune checkpoint inhibitors1. The antitumor effect of E7386 alone and the combination of E7386 and anti-PD-1 antibody has been confirmed in a cancer-bearing mouse model. 1

Based on the POC achievement, Eisai has initiated a phase Ib/II clinical trial (Study 201) of E7386 in combination with anti-PD-1 therapy pembrolizumab for solid tumors in Japan.*

Dr. Takashi Owa, Senior Vice President, President of Oncology Business Group, at Eisai said, "With achieving the POC, we are confident with the prospect of offering E7386 to patients as a cancer treatment. E7386 may overcome lenvatinib and pembrolizumab treatment resistances through its combination therapy with lenvatinib or pembrolizumab. Eisai will accelerate clinical trials of E7386 in combination with lenvatinib or pembrolizumab, and do its utmost aiming to create new treatments for cancers with high unmet medical needs."

Dai Takehara, President and CEO of PRISM commented, "The approval of the clinical POC for the E7386 demonstrates that PRISM’s drug discovery platform is an effective option for novel drug targets which have been considered difficult. We are grateful to Eisai for advancing this development. We will continue to take on the challenge of targeting more novel targets, with the aim of providing new treatment to as many patients as possible."

* Study 201 is being conducted under a clinical trial collaboration and supply agreement between Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A.

On October 31, 2021 LianBio, a biotechnology company dedicated to bringing innovative medicines to patients in China and other major Asian markets, reported the pricing of its initial public offering of 20,312,500 American depositary shares ("ADSs") at a public offering price of $16.00 per ADS, for gross proceeds of approximately $325.0 million, before deducting underwriting discounts and commissions and offering expenses (Press release, LianBio, OCT 31, 2021, View Source [SID1234594003]). Each ADS represents one ordinary share of LianBio, and all of the ADSs are being offered by LianBio. In addition, LianBio has granted the underwriters a 30-day option to purchase up to 3,046,875 additional ADSs at the initial public offering price, less underwriting discounts and commissions.

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The ADSs are scheduled to begin trading on the Nasdaq Global Market on November 1, 2021 under the ticker symbol "LIAN," and the offering is expected to close on November 3, 2021, subject to customary closing conditions.

Goldman Sachs & Co. LLC, Jefferies LLC and BofA Securities, Inc. are acting as joint bookrunning managers for the offering. Raymond James is acting as lead manager for the offering.

A registration statement relating to these securities has been filed with the Securities and Exchange Commission and became effective on October 29, 2021. This offering is being made only by means of a prospectus. Copies of the final prospectus, when available, may be obtained from: Goldman Sachs & Co. LLC, Attn: Prospectus Department, 200 West Street, New York, New York 10282, Jefferies LLC, Attn: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022, by telephone at (877) 821-7388 or by email at [email protected], and BofA Securities, Inc., Attn: Prospectus Department, 200 North College Street, 3rd Floor, Charlotte, North Carolina, 28255-0001, or by email at [email protected].

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

On October 31, 2021 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for ATG-101, a bi-specific monoclonal antibody in development as a potential treatment for metastatic/advanced solid tumors and B-cell non-Hodgkin’s lymphoma (B-NHL) (Press release, Antengene, OCT 31, 2021, View Source [SID1234593972]). The IND approval enables Antengene to initiate a Phase 1 clinical trial to evaluate the safety and tolerability of ATG-101 in patients with advanced solid tumors and NHL.

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ATG-101 is the first in-house developed innovative molecule with global rights entering clinical stage. This is the second regulatory clearance of ATG-101, following Human Research Ethics Committee (HREC) approval and site initiation for a Phase 1, dose-escalating clinical trial in Australia. In addition, this also marks an important milestone for Antengene as the first IND approval in the U.S.

ATG-101 is a novel bispecific antibody that was designed to block the binding of immunosuppressive PD-L1/PD-1 and conditionally induce 4-1BB stimulation, thus activating anti-tumor immune effectors, with the potential for delivery of enhanced anti-tumor activity and an improved safety profile. ATG-101 demonstrated significant anti-tumor activity in animal models of tumors that progressed on anti-PD-1/L1 treatment, and showed a favorable safety profile in GLP toxicology studies.

"ATG-101 has been designed to provide a newer and more efficacious treatment option for patients with solid tumors and NHL who are resistant or refractory to anti-PD-1/PD-L1 therapies, a growing and increasingly important medical need." said Dr. Jay Mei, Chairman and CEO of Antengene. "Approval of our U.S. IND application for ATG-101 is an important milestone for Antengene. A Phase I dose-escalating clinical trial for ATG-101 is also underway in Australia and the Company plans to submit an IND application in China by year-end. These studies highlight global execution capabilities and further Antengene’s vision of Treating Patients Beyond Borders worldwide."

About ATG-101

ATG-101 is a novel PD-L1/4-1BB bi-specific antibody being developed for the treatment of metastatic/advanced solid tumors and B-cell non-Hodgkin’s lymphoma (B-NHL). ATG-101 was designed to activate anti-tumor immune effectors, by simultaneously blocking the binding of PD-L1/PD-1 and inducing 4-1BB stimulation. In PD-L1 over-expressing cancer cells, ATG-101 has shown potent PD-L1 crosslinking-dependent 4-1BB agonist activity, with the potential for delivery of enhanced therapeutic efficacy, whilst mitigating risk of hepatoxicity. ATG-101 is being evaluated in Phase I studies in both Australia and the United States for the treatment of patients with metastatic/advanced solid tumors and non-Hodgkin lymphoma.