Vernalis Research – a Fully Owned Subsidiary of HitGen Inc – and Hannibal Innovation Announce the Creation of Dania Therapeutics ApS

On October 31, 2021 Vernalis Research ("Vernalis"), a fully owned subsidiary of HitGen Inc., and Hannibal Innovation ApS ("Hannibal") reported the creation of Dania Therapeutics ApS ("Dania") to discover small molecules inhibitors against new undisclosed oncology targets (Press release, Vernalis, OCT 31, 2021, View Source;a-Fully-Owned-Subsidiary-of-HitGen-Inc—and-Hannibal-Innovation-Announce-the-Creation-of-Dania-Therapeutics-ApS [SID1234593971]).

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Dania’s new discovery program is based on the work from Professor Kristian Helin at University of Copenhagen. Prof. Helin and Dr. Karl Agger, from his laboratory, are the scientific founders of Dania.

Under the terms of the agreement, Vernalis will use its expertise in drug discovery to undertake all activities up to lead optimization and invest in Dania. Vernalis has the option to fund further discovery activities until the nomination of a preclinical candidate. The team at Hannibal will run operations for Dania throughout the initial stages of the collaboration.

Mike Wood – Managing Director at Vernalis – will join the Board of Dania. Hamed Brodersen and Karin Absalonsen from Hannibal will act as CEO and Chair of the Board of directors, respectively. Kim Andersen joins as COO of Dania.

"We are extremely pleased to work with Kristian Helin and Hannibal on such exciting targets. This innovative business model where Vernalis trades the usual cash and milestones payments for equity demonstrates Vernalis’ confidence in its expertise and its ability to collaborate with talented scientists and successful entrepreneurs," said Mike Wood – Managing Director at Vernalis, "and we have been impressed by the quality of the work from Kristian and the track record from the team at Hannibal in creating and nurturing successful biotech companies."

"We are very excited about the creation of Dania, and the collaboration with Hannibal and Vernalis in starting the company," said Kristian Helin. "We are looking forward to our continued collaboration and the development of new inhibitors to the oncology targets, identified in my lab at University of Copenhagen."

"Hannibal wants to be the go-to partner for scientists and research institutions that stand out in the industry because of the depth and quality of their scientific work. It is an honor for us to work with Kristian Helin in bringing new breakthroughs in science to underserved patients. We are also thrilled to work with Vernalis, which has an excellent track record in structure-based drug discovery, a strong management team and visionary owners. Hannibal’s business model is to establish strong partnerships with innovative approaches to business development. We look forward to shaping the industry together with Kristian and Vernalis," said Hamed Brodersen, CEO of Hannibal.

"I am delighted to see this new joint venture between Vernalis and Hannibal. The establishment of Dania demonstrates Vernalis’ strength in discovery research and innovative business thinking. Since the completion of acquisition at the end of 2020, Vernalis has already contributed to HitGen group’s topline. The research teams from Vernalis and HitGen Chengdu have also worked closely to progress the synergistic opportunities in our core technology platforms – DNA-encoded Libraries (DEL) and Fragment-Based Drug Discovery/Structure-Based Drug Design (FBDD/SBDD). I wish the new venture every success in its discovery research endeavor," said Dr. Jin Li, Chairman of the Board and Chief Executive Officer of HitGen.

Antengene Receives FDA Approval of IND for Phase 1 Trial of ATG-101 (PD-L1/4-1BB bispecific antibody) in Solid Tumors and Non-Hodgkin Lymphoma

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.

LianBio Announces Pricing of Initial Public Offering

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.

Posted Financial Results for 2Q/FY2021

On October 29, 2021 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, "the Company") reported the financial results for the first six months (April 1, 2021 – September 30, 2021) of the fiscal year 2021 (FY2021) ending March 31, 2022 (Press release, Astellas, OCT 29, 2021, View Source [SID1234592166]).

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1. Qualitative information on consolidated financial results for the first six months of FY2021
(1) Business performance
Consolidated financial results (core basis) in the first six months of FY2021 are shown in the table below. While revenue increased, core operating profit and core profit decreased.

Revenue
-Main products XTANDI for the treatment of prostate cancer, XOSPATA for the treatment of acute myeloid leukemia and PADCEV for the treatment of urothelial cancer showed steady growth as expected. In addition, the sales growth of EVRENZO for the treatment of renal anemia and Betanis / Myrbetriq / BETMIGA for the treatment of overactive bladder ("OAB") contributed to revenue as well.
-Moreover, other factor for the increase in sales in the first six months of FY2021 was the sales of pharmacologic stress agent Lexiscan returning to pre-pandemic level which decreased mainly in the first quarter of the previous fiscal year because of the impact of the spread of COVID-19.
-The sales growth of the products above offset the sales decrease mainly due to the termination of sales and distribution for Celecox for the treatment of inflammation and pain and Lipitor for the treatment of hypercholesterolemia, and the divestiture of Eligard for the treatment of prostate cancer.

As a result of the above, revenue in the first six months of FY2021 increased by 5.9% compared to those in the corresponding period of the previous fiscal year ("year-on-year") to ¥651.7 billion.

Core operating profit / Core profit
-Gross profit increased by 6.3% year-on-year to ¥526.9 billion. The cost-to-revenue ratio fell by 0.3 percentage points year-on-year to 19.1%, mainly due to changes in product mix
.-Selling, general and administrative expenses increased by 11.7% year-on-year to ¥270.5 billion. The total amount increased mainly due to the increase of copromotion fees associated with the growth of sales of XTANDI in the United States (increase of ¥10.2 billion year-on-year), investment in systems associated with globalization (increase of approximately ¥5.0 billion year-on-year), the increase in sales promotion expenses for new product launch readiness (increase of approximately ¥3.0 billion year-on-year), and the impact of the foreign exchange rates (increase of ¥8.4 billion year-on-year).

Excluding co-promotion fees of XTANDI in the United States, selling, general and administrative expenses increased by 10.0% year-on-year to ¥199.4 billion.-Research and development (R&D) expenses increased by 6.6% year-on-year to ¥119.1 billion. While there was a decrease in development expenses for fezolinetant, a selective neurokinin-3 receptor antagonist, for which patient enrollment in Phase III trials in the United States and Europe has been completed, the total amount increased mainly due to increases in development expenses for zolbetuximab, an anti-Claudin 18.2 monoclonal antibody and R&D investment for Rx+ business (related to iota).

-Amortisation of intangible assets increased by 7.2% year-on-year to ¥12.4 billion. 3

As a result of the above, core operating profit decreased by 3.8% year-on-year to ¥125.3 billion, and core profit decreased by 7.0% year-on-year to ¥98.8 billion.

Impact of exchange rate on financial results
The exchange rates for the yen in the first six months of FY2021 are shown in the table below. The resulting impacts were a ¥24.5 billion increase in revenue and a ¥11.5 billion increase in core operating profit compared with if the exchange rates of the first six months of FY2020 were applied.

Leidos Holdings, Inc. Declares Quarterly Cash Dividend

On October 29, 2021 Leidos Holdings, Inc. (NYSE:LDOS) reported that its Board of Directors has declared a quarterly cash dividend of $0.36 per outstanding share of common stock of Leidos Holdings, Inc (Press release, Leidos, OCT 29, 2021, View Source [SID1234592185]). The cash dividend is payable on December 30, 2021 to stockholders of record as of the close of business on December 15, 2021.

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