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HUTCHMED Announces Full Exercise of the Over-allotment Option of the Global Offering

On July 12, 2021 HUTCHMED (China) Limited ("HUTCHMED" or the "Company") (Nasdaq/AIM: HCM, HKEX:13) reported the full exercise of the over-allotment option of the Global Offering (Press release, Hutchison China MediTech, JUL 12, 2021, View Source [SID1234584782]). The Joint Global Coordinators, on behalf of the International Underwriters, on July 12, 2021, fully exercised the Over-allotment Option, in respect of an aggregate of 15,600,000 offer shares (the "Over-allotment Shares"), representing approximately 15% of the total number of offer shares initially available under the Global Offering before any exercise of the Over-allotment Option to (among other things) facilitate the return to Hutchison Healthcare Holdings Limited (an indirect wholly owned subsidiary of CK Hutchison Holdings Limited) the borrowed shares under the Stock Borrowing Agreement which were used to cover over-allocations in the International Offering. The Company has been notified that following the return of such shares, the shareholding of CK Hutchison Holdings Limited in the Company will be 332,502,740 shares, representing 38.48% of the total number of voting rights of the Company as enlarged by the issuance of the Over-allotment Shares.

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The Over-allotment Shares will be allotted and issued by the Company at HK$40.10 per offer share (exclusive of brokerage of 1%, Securities and Futures Commission transaction levy of 0.0027% and Hong Kong Stock Exchange trading fee of 0.005%), being the offer price per offer share under the Global Offering.

Approval of Listing

Approval for the listing of and permission to deal in the Over-allotment Shares has already been granted by the Listing Committee of the Hong Kong Stock Exchange. Listing of and dealings in the Over-allotment Shares are expected to commence on the Main Board of the Hong Kong Stock Exchange at 9:00 a.m. on Thursday, July 15, 2021.

Total Number of Issued Shares upon the Full Exercise of the Over-Allotment Option

The Company’s total number of issued shares as of the date of this announcement and immediately after the completion of the full exercise of the Over-allotment Option (assuming there are no other changes to the total number of issued shares since the date of this announcement) is 848,515,660 shares and 864,115,660 shares, respectively.

AIM Admission

Application will be made to the London Stock Exchange for the 15,600,000 Over-allotment Shares to be admitted to the AIM market operated by the London Stock Exchange ("Admission"). It is expected that Admission will become effective at 8:00 a.m. UK time on July 16, 2021.

Following the above, the issued share capital of HUTCHMED will consist of 864,115,660 ordinary shares of US$0.10 each, with each share carrying one right to vote and with no shares held in treasury. This figure may be used by shareholders as the denominator for the calculations by which they could determine if they are required to notify their interest in, or a change to their interest in, HUTCHMED under the Financial Conduct Authority’s Disclosure Guidance and Transparency Rules. For illustrative purposes only, 864,115,660 shares would be equivalent to 864,115,660 depositary interests (each equating to one ordinary share) which are traded on AIM or, if the depositary interests were converted in their entirety, equivalent to 172,823,132 ADSs (each equating to five ordinary shares) which are traded on Nasdaq.

Use of Proceeds

The gross proceeds to the Company from the Over-allotment Option, before deducting underwriting fees and the offering expenses, are expected to be approximately HK$625 million. The Company intends to apply the additional net proceeds towards the same purposes as set out in the section headed "Use of Proceeds" in the prospectus.

The Company will make a further announcement after the end of the stabilization period in connection with the Global Offering pursuant to Section 9(2) of the Securities and Futures (Price Stabilizing) Rules (Chapter 571W of the Laws of Hong Kong).

Novo Nordisk A/S – Share repurchase programme

On July 12, 2021 Novo Nordisk reported that it initiated a share repurchase programme in accordance with Article 5 of Regulation No 596/2014 of the European Parliament and Council of 16 April 2014 (MAR) and the Commission Delegated Regulation (EU) 2016/1052 of 8 March 2016 (the "Safe Harbour Rules") (Press release, Novo Nordisk, JUL 12, 2021, View Source [SID1234584781]). This programme is part of the overall share repurchase programme of up to DKK 18 billion to be executed during a 12-month period beginning 3 February 2021.

Under the programme initiated 7 May 2021, Novo Nordisk will repurchase B shares for an amount up to DKK 3.3 billion in the period from 10 May 2021 to 3 August 2021.

Since the announcement as of 5 July 2021, the following transactions have been made:

The details for each transaction made under the share repurchase programme are published on novonordisk.com.

With the transactions stated above, Novo Nordisk owns a total of 15,794,444 B shares of DKK 0.20 as treasury shares, corresponding to 0.7% of the share capital. The total amount of A and B shares in the company is 2,310,000,000 including treasury shares.

Novo Nordisk expects to repurchase B shares for an amount up to DKK 18 billion during a 12- month period beginning 3 February 2021. As of 9 July 2021, Novo Nordisk has since 3 February 2021 repurchased a total of 16,955,946 B shares at an average share price of DKK 465.96 per B share equal to a transaction value of DKK 7,900,742,314.

GlycoMimetics Announces Initiation of Clinical Trial Evaluating Uproleselan in Combination With Venetoclax and Azacitidine

On July 12, 2021 GlycoMimetics, Inc. (Nasdaq: GLYC) reported that clinicians at University of California (UC) Davis Comprehensive Cancer Center initiated dosing of the first patient in a clinical study of uproleselan combined with venetoclax and azacitidine for the treatment of older or unfit patients with treatment-naïve acute myeloid leukemia (AML). Brian A. Jonas, MD, PhD, FACP, UC Davis Division of Hematology/Oncology, is the clinical trial’s principal investigator (Press release, GlycoMimetics, JUL 12, 2021, View Source [SID1234584780]).

According to Eric Feldman, MD, GlycoMimetics’ Chief Medical Officer, "While the field has seen strong uptake on venetoclax paired with a hypomethylating agent (HMA) in the frontline unfit AML setting, the depth and durability of responses, particularly in patients with adverse risk biology, has been somewhat less than optimal. In this setting, there remains a significant unmet need, and we know that environment-mediated drug resistance (EMDR), driven by E-selectin, contributes to HMA/venetoclax resistance. If the study shows that E-selectin antagonism with uproleselan improves minimal residual disease (MRD) negative response rates, this would be an important step forward that underscores the foundational opportunities for uproleselan across the broad spectrum of patients treated for AML."

The UC Davis Comprehensive Cancer Center study is an investigator-sponsored trial (IST) for which GlycoMimetics is providing uproleselan. Designed to evaluate the safety and efficacy of the triple combination, the study is non-randomized, open label and multi-center. The goal of the two-part trial is first to determine a recommended Phase 2 dose, and then to explore efficacy in a dose expansion cohort. Up to 31 patients will be enrolled, and a preliminary/interim readout is expected in 2022.

At the 2020 annual meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper), a preclinical study of uproleselan in combination with venetoclax and the HMA azacitidine demonstrated the triple combination’s potential in overcoming some of the limitations related to depth and durability of response with venetoclax/HMA alone. An oral presentation highlighted how antagonizing E-selectin with uproleselan can overcome microenvironment-mediated resistance to venetoclax/HMA therapy. In the study, the addition of uproleselan both prolonged survival of the murine model, and also promoted normal hematopeoic stem cell pro-survival signaling.

About Uproleselan

Discovered and developed by GlycoMimetics, uproleselan is an investigational, first-in-class, targeted antagonist of E-selectin. Uproleselan (yoo’ pro le’ sel an), currently in a comprehensive Phase 3 development program in AML, has received Breakthrough Therapy designation from the U.S. FDA and the Chinese Health authority for the treatment of adult AML patients with relapsed or refractory disease. Uproleselan is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance.

Monopar Appoints Octávio Costa, MD, as Chief Medical Officer

On July 12, 2021 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, reported the appointment of Octávio Costa, MD, as Chief Medical Officer (Press release, Monopar Therapeutics, JUL 12, 2021, View Source [SID1234584778]). In this role, Dr. Costa will oversee global clinical development and regulatory affairs, and will provide strategic direction for Monopar’s pipeline.

Dr. Costa joins Monopar with over 30 years of experience overseeing clinical development, clinical operations, development strategy and global medical affairs. He has extensive Phase 1 through 4 clinical development expertise as well as regulatory experience. Dr. Costa’s previous roles include positions of increasing responsibility in clinical development at Merck, Celgene, Novartis and most recently as Chief Medical Officer at Rafael Pharmaceuticals. He has played an important role in the development and life-cycle management of significant products, including the blockbuster product REVLIMID (lenalidomide). Dr. Costa earned his Doctor of Medicine from The Medical College of Sorocaba, São Paulo.

"We are excited to welcome Octávio, especially as our lead program enters late-stage clinical studies," said Chandler Robinson, MD, Chief Executive Officer of Monopar. "Octávio’s track record of navigating all stages of clinical development will aid Monopar in executing our growing clinical development pipeline."

"I am thrilled to be joining this accomplished management team, as Monopar’s Chief Medical Officer," said Dr. Costa. "My industry knowledge and expertise in moving cancer therapies through all stages of clinical testing is well suited to help accelerate Monopar’s pipeline of innovative mid- and late-stage clinical programs and early drug development candidates."

Halozyme Announces Janssen Receives U.S. FDA Approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in Combination with Pomalidomide and Dexamethasone for Patients with Multiple Myeloma After First or Subsequent Relapse

On July 12, 2021 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported that Janssen Biotech, Inc. (Janssen) received U.S. Food and Drug Administration (FDA) approval of DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in combination with pomalidomide and dexamethasone (Pd) for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor (Press release, Halozyme, JUL 12, 2021, View Source [SID1234584777]). The approval marks Janssen’s sixth indication for DARZALEX FASPRO in the treatment of multiple myeloma. Findings from the Phase 3 APOLLO study were recently published in The Lancet Oncology.

"We are delighted that Janssen received this FDA approval for DARZALEX FASPRO, making it the first and only FDA-approved subcutaneous anti-CD38 monoclonal antibody therapy available in this combination," said Helen Torley, president and chief executive officer at Halozyme. "This introduces a new delivery option for multiple myeloma patients in the U.S. being treated with this regimen."

DARZALEX FASPRO is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE drug delivery technology.

This FDA approval for DARZALEX FASPRO in combination with Pd for patients with multiple myeloma after first or subsequent relapse is supported by data from the Phase 3 APOLLO study, which met its primary endpoint of improved progression-free survival (PFS). For more information related the Phase 3 APOLLO study findings, please view Janssen’s press release.