On July 12, 2021 Biogen Inc. (Nasdaq: BIIB) and InnoCare Pharma Limited (HKEX: 09969) reported that they have entered into a license and collaboration agreement for orelabrutinib, an oral small molecule Bruton’s tyrosine kinase inhibitor (BTKi) for the potential treatment of multiple sclerosis (MS) (Press release, Biogen, JUL 12, 2021, View Source [SID1234584816]). Orelabrutinib is a covalent BTKi with high selectivity and the ability to cross the blood-brain barrier, and is currently being studied in a multi-country, placebo-controlled Phase 2 trial in relapsing-remitting MS.

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Orelabrutinib inhibits BTK, which is a key enzyme that is part of the signaling cascade of immune cells including B cells and myeloid cells. With the ability to cross the blood brain barrier, orelabrutinib has the potential to inhibit B cell and myeloid cell effector functions in the central nervous system (CNS), and may provide a clinically meaningful benefit on progression in all forms of MS. By addressing the progressive biology of the disease, orelabrutinib may offer people living with MS an additional treatment option and the possibility to slow disease progression.

"Given the complex and chronic nature of MS, we believe the unique characteristics of orelabrutinib, combining high selectivity and CNS penetrance, may translate to potential clinical advantages relative to other BTKi programs," said Alfred Sandrock, Jr., M.D., Ph.D., Head of Research and Development at Biogen. "For over 30 years, Biogen has led in MS research and today has a leading portfolio of MS products. We are focused on developing next-generation approaches that we hope will improve outcomes for those living with progressive and relapsing forms of MS."

"Biogen is a recognized leader in neuroscience and we believe this transaction will help advance the development of orelabrutinib in MS," said Jasmine Cui, Ph.D., Co-Founder, Chairwoman and Chief Executive Officer at InnoCare. "We are excited about the potential of orelabrutinib for the treatment of patients with all forms of MS given the potential efficacy and safety profile, plus a promising level of blood-brain barrier penetration. BTK inhibitors may have the potential to transform the treatment paradigm of autoimmune diseases, in particular MS."

Under the terms of the agreement, Biogen will have exclusive rights to orelabrutinib in the field of MS worldwide and certain autoimmune diseases outside of China (including Hong Kong, Macau and Taiwan), while InnoCare will retain exclusive worldwide rights to orelabrutinib in the field of oncology and certain autoimmune diseases in China (including Hong Kong, Macau and Taiwan). InnoCare will receive a $125 million upfront payment and is eligible to receive up to $812.5 million in potential development milestones and potential commercial payments should the collaboration achieve certain development, commercial milestones and sales thresholds. InnoCare is also eligible to receive tiered royalties in the low to high teens on potential future net sales of any product resulting from the collaboration. Closing of the collaboration is contingent on completion of review under antitrust laws, including the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 in the U.S., and other customary closing conditions.

About Orelabrutinib
Orelabrutinib is a small molecule Bruton’s tyrosine kinase inhibitor (BTKi) developed for the treatment of cancer and in development for the potential treatment of autoimmune diseases.

In the field of multiple sclerosis, orelabrutinib is a BTKi with high selectivity and ability to cross the blood-brain barrier and could achieve high-target occupancy in the central nervous system. It is currently being investigated in a global Phase 2 study in RRMS patients.

In the field of oncology, InnoCare received approval for orelabrutinib from the China National Medical Products Administration (NMPA) in two indications: the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL)/small lymphocytic lymphoma (R/R SLL), and the treatment of patients with relapsed/refractory mantle cell lymphoma (R/R MCL).

About Bruton’s Tyrosine Kinase Inhibitors
Bruton’s tyrosine kinase (BTK) is a tyrosine kinase that is encoded by the BTK gene in humans. BTK plays a crucial role in B-cell receptor signaling cascade in B cells leading to B cell proliferation, survival, differentiation and cytokine production. BTK also plays a key function in myeloid cell signaling. Central nervous system (CNS) penetrant BTK small molecule inhibitors work by inhibiting B cells and myeloid cells in the periphery and in the CNS. Among myeloid cells expressing BTK, microglia, which reside in the CNS, have been shown to express high level of BTK in multiple sclerosis.

On July 12, 2021 48Hour Discovery Inc and RayzeBio reported the companies have entered a strategic research collaboration to discover and develop novel peptide-based radiopharmaceuticals for the treatment of cancer (Press release, 48Hour Discovery, JUL 12, 2021, View Source [SID1234586901]).

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"We are excited to work with a cutting edge biotechnology company like RayzeBio" said Ratmir Derda, CEO of 48Hour Discovery "For this collaboration project, 48Hour Discovery will identify potent ligands for a series of targets selected by RayzeBio. This project will help us further validate the potential of our billion-scale molecular libraries and cloud-based discovery pipeline. We are looking forward to accelerating the preclinical programs of RayzeBio and providing peptide drug candidates that will advance the radiopharmaceutical field."

"48Hour Discovery has a promising proprietary platform for novel peptide discovery," said Ken Song, M.D., CEO of RayzeBio. "We are intrigued by the potential to quickly discover novel binders."

Under the terms of the agreement, 48HD will receive undisclosed payments. RayzeBio has exclusive rights to develop and commercialize peptides discovered under the collaboration, and an option to further expand the collaboration to include additional targets.

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.

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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.

On July 12, 2021 ProfoundBio reported the closing of a $55+ million Series A financing round led by Lilly Asia Venture and co-led by LYFE Capital, with participation from Sequoia Capital China and Oriza (Press release, ProfoundBio, JUL 12, 2021, View Source [SID1234584798]). All investors from the Series Pre-A financing, K2VC, Gaorong Capital, and Chang’an Capital, also participated in this round of financing.

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ProfoundBio will use the proceeds to accelerate development and implementation of novel technology platforms for ADCs and IO therapeutics and to advance a portfolio of differentiated therapeutics into clinical development.

"We made significant progress with our lead programs and novel technology platforms since the completion of Series Pre-A financing. The additional funding will allow us to further strengthen and expand our integrated R&D capability, grow and broaden our innovative product pipeline, and prepare for multiple IND submissions in 2022 and beyond," said Baiteng Zhao, PhD, co-founder, CEO, and Chair of the Board of ProfoundBio. "We are really excited about the enthusiastic participation of the new investors and the continued support from our shareholders. I am confident that by working together, we can bring more innovative targeted therapeutics to patients with cancer sooner."

"We believe emerging modalities, such as ADCs, will bring hope to patients with solid tumor to address the significant unmet medical needs," said Dr. Fei Chen, Managing Partner of LAV. "ProfoundBio’s founding team are industry veterans with rich experience, deep knowhow and a FDA drug approval track record established during their tenure at the global leader of ADC drug development. It is a great pleasure to partner with ProfoundBio at this critical moment, and we are committed to support the company to realize the potential of ADC and create new targeted drugs for patients around the world."

According to LYFE Capital, "The antibody-drug conjugate modality has demonstrated great potential in oncology treatment. The ProfoundBio team has extensive R&D and clinical translation experience in ADC drug development. The company quickly established a strong R&D and translational platform and built up a differentiated ADC drug pipeline. We believe that the ProfoundBio team will leverage their rich experiences and efficient R&D platform to develop more differentiated ADC drug pipeline to address large unmet clinical needs in oncology."

"Congratulations to ProfoundBio on completing Series A funding!" said Lynn Yang, Partner of Sequoia Capital China. "Healthcare has been a key sector of investment since Sequoia Capital China’s establishment. We are impressed by ProfoundBio’s long-term commitment to ADC development, where the company has gained extensive experience and achieved remarkable progress. We hope ProfoundBio will continue creating value for society by helping more patients in their recovery."

"Antibody-drug conjugate (ADC) has become another important sector after monoclonal antibodies," said Yunfei Chen, Investment Director of Oriza. "ProfoundBio’s management team comes from SeaGen, a global leader in the ADC industry, which makes them well experienced in ADC development. ProfoundBio focuses on clinical unmet needs instead of overcrowded targets and mainly develops ADC drugs with innovative targets. We expect ProfoundBio to become a leading ADC enterprise. Oriza is pleased to help ProfoundBio grow rapidly and benefit more patients as soon as possible with greater success."

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).