Zai Lab Announces Closing of Hong Kong Secondary Listing

On September 28, 2020 Zai Lab Limited ("Zai Lab" or the "Company") (NASDAQ: ZLAB), an innovative commercial stage biopharmaceutical company, reported listing of its ordinary shares on the Main Board of The Stock Exchange of Hong Kong Limited (the "Hong Kong Stock Exchange") under the stock code "9688" and the closing of its previously-announced Hong Kong secondary listing (the "Hong Kong Secondary Listing") of 10,564,050 new ordinary shares (the "Offer Shares" or "Shares") which comprises an international offering (the "International Offering") and a Hong Kong public offering (the "Hong Kong Public Offering," and together with the International Offering, the "Offering") (Press release, Zai Laboratory, SEP 28, 2020, View Source [SID1234567666]). The final offer price for both the International Offering and the Hong Kong Public Offering (the "Offer Price") has been set at HK$562.00 per Share. Based on the ratio of one (1) ordinary shares per Nasdaq-listed American depositary share ("ADS"), the Offer Price translates to approximately US$72.52 per ADS. The Company had also granted the international underwriters an over-allotment option, exercisable from September 22, 2020 until 30 days thereafter, to require the Company to issue up to an additional 1,584,600 new Shares at the Offer Price.

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The gross proceeds to Zai Lab from this Offering, before deducting underwriting discounts and commissions and other offering expenses, were approximately HK$5.94 billion.

J.P. Morgan Securities (Far East) Limited (or its affiliates, as the case may be), Goldman Sachs (Asia) L.L.C. and Citigroup Global Markets Asia Limited (or its affiliate, as the case may be) are the joint sponsors, joint global coordinators, joint bookrunners and joint lead managers for the proposed Hong Kong Secondary Listing.

The International Offering was made only by means of a prospectus supplement dated September 22, 2020 and the accompanying prospectus included in an automatic shelf registration statement on Form F-3ASR filed with the U.S. Securities and Exchange Commission (the "SEC") on March 29, 2019 and was subsequently amended and became automatically effective upon filing with the SEC on January 21, 2020. The registration statement on Form F-3ASR and the prospectus supplement dated September 22, 2020 are available at the SEC website at: View Source Copies of the prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from: (i) J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at 1-866-803-9204 or by email at [email protected], (ii) Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282 or by telephone at 1-866-471-2526, or (iii) Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at 1-800-831-9146 or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer or an invitation to buy any securities, nor shall there be any offer or sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. This press release does not constitute a prospectus (including as defined under the laws of Hong Kong) and potential investors should read the prospectus of the Company for detailed information about the Company and the proposed offering, before deciding whether or not to invest in the Company. This press release has not been reviewed or approved by the Hong Kong Stock Exchange or the Securities and Futures Commission of Hong Kong.

The price of the Shares of the Company may be stabilized in accordance with the Securities and Futures (Price Stabilization) Rules. The details of the intended stabilization and how it will be regulated under the Securities and Futures Ordinance (Chapter 571 of the laws of Hong Kong) have been contained in the prospectus of the Company dated September 17, 2020.

Aqilion and Immunscape discontinue their joint feasibility study in oncology

On September 28, 2020 AQILION AB and Immunscape AB reported that it initiated a joint early project in oncology and autoimmune diseases in the spring of 2019 (Press release, Aqilion, SEP 28, 2020, View Source [SID1234567662]). The point of departure was to create a drug candidate that the parties would develop and test further in a joint feasibility study. The parties have now agreed to discontinue the project.

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"Collaborating with Immunscape has been highly rewarding and we continue to appreciate their expertise, from which we have gained great professional benefit. The feasibility study produced good technical results and new intangible assets, but external factors have led to declining interest in the continued commercial development of the project. We have therefore agreed to terminate our collaborative effort. It is extremely important for us to have the courage to start innovative projects, but also to have the courage to close those in which Aqilion cannot continue to create value, even if it is disappointing not to reach all the way to our goal," says Sarah Fredriksson, CEO of AQILION AB.

"We have appreciated the interactions with Aqilion and would like to thank them for their commitment to the project. Our collaboration with Aqilion has allowed us to advance our understanding of the drug targets in the project, which helps us to explore new uses of the compounds as potential treatments for certain cancers," says Lars Öhman, CEO of Immunscape AB.

EORTC abstracts selected at EBCC-12 Virtual Congress

On September 28, 2020 3 EORTC reported that abstracts were selected for the 12th European Breast Cancer Conference (EBCC-12) that will take place virtually on 2-3 October 2020 (Press release, EORTC, SEP 28, 2020, View Source [SID1234567660]).

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Plenary Session

Keynote Lecture, Best and Late Breaking Abstract Presentations

Clinical Utility of MammaPrint testing in Invasive Lobular Carcinoma: Results from the MINDACT phase III trial

Presentation number: ORAL-007
Date: 2 October 2020, 13:50-14:00
Speaker: Otto Metzger (USA)
Proffered Papers Session

Updated results of the MINDACT trial: 70-gene signature to guide de-escalation of chemotherapy in early breast cancer

Presentation number: ORAL-021
Date: 3 October 2020, 13:00-13:10
Speaker: Emiel Rutgers (The Netherlands)
Screen-detected breast cancers have different tumor biology and better prognosis compared to interval breast cancers

Presentation number: ORAL-011
Date: 3 October 2020, 12:50-13:00
Speaker: Josephine Lopez Cardozo (The Netherlands)
EBCC-12 is a breast cancer conference where the very latest practice-changing research is presented. It aims to provide a unique multidisciplinary setting for all professionals with a common interest in breast cancer to discuss, debate, inform and educate themselves about this evolving disease.

To view the full two day programme, visit the EBCC-12 searchable programme.

EORTC Melanoma Group changing daily practice for cancer patients

On September 28, 2020 EORTC Melanoma group reported that it has presented and published new data that has shown improved outcomes for cancer patients. First of all, EORTC 1325/Keynote 054 study (adjuvant pembrolizumab vs. placebo after complete resection of high-risk stage III melanoma) which was presented at ASCO (Free ASCO Whitepaper) 2020, showed new recurrence free survival (RFS) data with median 3-year follow-up, confirming that the positive effect of pembrolizumab is durable with longer follow-up (Press release, EORTC, SEP 28, 2020, View Source [SID1234567658]).

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In addition, EORTC 1325 study presented, at the ESMO (Free ESMO Whitepaper) virtual Congress, the reduced risk of Distant Metastasis Free Survival (DMFS) or death with adjuvant immunotherapy.

EORTC MG has, also, published a number of papers, Alexander van Akkooi, group chair, highlights the importance of these papers:

Evaluating the potential of relapse-free survival as a surrogate for overall survival in the adjuvant therapy of melanoma with checkpoint inhibitors (EJC)
This is an important paper, as it shows that RFS is a surrogate for OS in case of adjuvant immunotherapy for melanoma. This is an important methodological study, since RFS is not always a proxy for durable and meaningful benefit in OS.
Prognosis of Patients With Stage III Melanoma According to American Joint Committee on Cancer Version 8: A Reassessment on the Basis of 3 Independent Stage III Melanoma Cohorts (JCO)
This paper shows that the new AJCC 8th edition staging prognosis seems to be too positive, which does not seem realistic. In this independent European cohort ofall substages of melanoma, the prognosis seems slightly worse compared to AJCC, which is important information when counselling patients about their risks and the need for adjuvant treatment or participation into trials.
Adjuvant therapy with pegylated interferon-alfa2b vs observation in stage II B/C patients with ulcerated primary: Results of the European Organisation for Research and Treatment of Cancer 18081 randomised trial (EJC)
Although one might think that this prospective randomized trial with an ‘old’ therapy would not be worth reporting, it still confirms that patients with non-metastatic, but thick and ulcerated primary melanomas can benefit from PEG-IFN treatment. Might not be very relevant anymore in Europe, but certainly important findings for developing countries.
The EORTC-DeCOG nomogram adequately predicts outcomes of patients with sentinel node-positive melanoma without the need for completion lymph node dissection (EJC)
This study is relevant as it gives a prognostic risk assessment of melanoma patients with a positive Sentinel Node, without the need to perform extensive surgery (CLND). The latter clearly benefits patients’ Quality of life. This study was conducted by an early career investigator, who defended her PhD thesis in recent months.

Apollomics, Inc. Receives China Investigational New Drug Approval for APL-106 to Initiate a Phase 3 Bridging Study in Acute Myeloid Leukemia

On September 27, 2020 Apollomics, Inc., an innovative biopharmaceutical company committed to the discovery and development of mono- and combination- oncology therapies, reported APL-106 (uproleselan) has received Investigational New Drug (IND) approval from the China National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) (Press release, Apollomics, SEP 28, 2020, View Source [SID1234567657]). This approval enables the initiation of a Phase 1 pharmacokinetic (PK) and tolerability study and includes acceptance of a Phase 3 bridging study of APL-106 in combination with chemotherapy in relapsed/refractory acute myeloid leukemia (AML).

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"Our team has worked diligently since licensing APL-106 earlier this year, and receiving China IND approval for our Phase 3 bridging study is a major milestone for Apollomics," said Guo-Liang Yu, PhD, Co-Founder, Chairman and Chief Executive Officer. "AML is one of the most common leukemias in adults, and there is a strong demand for an effective breakthrough treatment for relapsed/refractory AML. We are pleased that the CDE recognized the need to improve treatment outcomes in this patient population and accepted our Phase 3 bridging study while the Global Phase 3 trial sponsored by GlycoMimetics, our partner, is ongoing. We look forward to initiating our clinical trials in China as we strive to offer a new and effective treatment option for AML patients."

A comprehensive Phase 3 development program in AML is currently ongoing with uproleselan in the United States by GlycoMimetics. Uproleselan has received Fast Track designation from the U.S. Food and Drug Administration (FDA) as well as Breakthrough Therapy Designation for the treatment of adult AML patients with relapsed or refractory disease. Uproleselan has also been granted Orphan Drug Designation in AML from the FDA and European Union.

About Uproleselan (APL-106)

Discovered and developed by GlycoMimetics, uproleselan (APL-106) is a late clinical stage, first-in-class, targeted inhibitor of E-selectin. Uproleselan (yoo’ pro le’ sel an) 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 within the bone marrow microenvironment. Apollomics licensed APL-106 from Glycomimetics in January 2020. Under the terms of the agreement, Apollomics has the rights and responsibility to develop and commercialize APL-106 in Mainland China, Hong Kong, Macau and Taiwan, also known as Greater China.

About Acute Myeloid Leukemia (AML)

Acute Myeloid Leukemia (AML) is a cancer of the blood and bone marrow. It is an aggressive disease that causes the bone marrow to produce immature cells that are unable to carry out their normal function and develop into leukemic white blood cells called myeloblasts. In the U.S., there are approximately 20,000 new cases of AML each year and a 5-year survival rate of 28.7%.1 The annual incidence of new cases of AML in China is 21,600, and relapsed/refractory AML has an extremely poor prognosis.2