On April 20, 2021 Zai Lab Limited ("Zai Lab" or the "Company") (NASDAQ:ZLAB, HKEX: 9688), an innovative commercial stage biopharmaceutical company, reported the pricing of its underwritten public offering of 4,776,000 American depositary shares ("ADSs"), each representing one ordinary share of the Company, at a price of US$150.00 per ADS, and 224,000 ordinary shares, at a price of HK$1164.20 per ordinary share, which will be settled in Hong Kong dollars, based upon each ADS representing one ordinary share and an exchange rate of HK$7.7613 to US$1.00, the spot rate of exchange at the time of pricing (Press release, Zai Laboratory, APR 20, 2021, View Source,(%E2%80%9CADSs%E2%80%9D)%2C%20each [SID1234578770]).

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The gross proceeds to Zai Lab from the offering, before deducting underwriting discounts and commissions and other offering expenses, are expected to be approximately US$750 million. Subject to customary closing conditions, the underwriters expect to deliver the ADSs against payment to the purchasers on or about April 23, 2021, on a "T+2" basis, and to deliver the ordinary shares against payment therefor through the facilities of the Central Clearing and Settlement System on or about April 28, 2021, on a "T+5" basis. In addition, Zai Lab has granted the underwriters a 30-day option to purchase up to an additional 716,400 ADSs at the public offering price, less underwriting discounts and commissions, which purchase will be settled only in ADSs.

J.P. Morgan Securities LLC, Goldman Sachs & Co. LLC, Jefferies LLC, Citigroup Global Markets Inc., SVB Leerink LLC and Guggenheim Securities, LLC are acting as joint book-running managers for the ADS offering. J.P. Morgan Securities plc, Goldman Sachs (Asia) L.L.C., Jefferies Hong Kong Limited, Citigroup Global Markets Limited and Guggenheim Securities, LLC are acting as joint book-running managers in respect of any ordinary shares issued to investors electing to receive ordinary shares in lieu of ADSs.

The ADSs and ordinary shares are offered pursuant to a shelf registration statement on Form S-3ASR, which became automatically effective upon filing with the U.S. Securities and Exchange Commission ("SEC") on April 19, 2021.

The offering is being made only by means of a prospectus supplement and an accompanying prospectus included in Form-S-3ASR. The registration statement on Form S-3ASR and the prospectus supplement are available at the SEC’s website at: View Source Copies of the prospectus supplement and the accompanying prospectus may be obtained from: (i) J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, via telephone at 1-866-803-9204 or via email at [email protected], (ii) Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, facsimile: 212-902-9316 or by emailing [email protected], (iii) Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York 10022, or by telephone at 1-877-821-7388 or via email at [email protected], (iv) Citigroup Capital Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by telephone at 1-800-831-9146 and (v) SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525 ex. 6105 or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy ADSs, ordinary shares or any other securities, nor shall there be any sale of ADSs or ordinary shares 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 April 20, 2021 GloriousMed Biomedical Group Co., Ltd ("GloriousMed") and Minomic International Ltd ("Minomic") of Australia reported that officially executed the agreement, which formally launched the commercialization of MiCheck Prostate, a prostate cancer early diagnosis product, in mainland China (Press release, Minomic, APR 20, 2021, View Source [SID1234578242]). Finalizing this agreement completes an important step in commercializing MiCheck Prostate in one of the world’s largest healthcare markets. Under the agreement GloriousMed will make an initial investment in Minomic to fund a validation study of MiCheck Prostate using samples sourced from Chinese patients. The agreement also includes an option for GloriousMed to make a further investment of up to US$2.5 Million in Minomic.

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GloriousMed is a leading provider of total solutions for precision tumor management in China, and a market leader in precision urological tumor testing, committed to creating an integrated ecological loop for precision treatment of vertical tumor types. Minomic is an Australian medical diagnostic company specializing in the development of diagnostic technologies for solid tumors, including prostate, bladder and pancreatic cancers. MiCheck Prostate, a blood test developed by Minomic over six years, is a rapid, non-invasive, highly specific test with higher sensitivity and specificity than existing PSA screening technologies. The product helps urologists decide whether to subject patients to a puncture biopsy by assessing the risk of aggressive prostate cancer, effectively avoiding unnecessary biopsies.

With the aging of the population, the incidence of prostate cancer in China is increasing. GloriousMed is actively expanding its multi-omics technology platform and introducing the most cutting-edge international technologies and products to promote the development of precise diagnosis and treatment of prostate cancer in China and further assist in the early diagnosis and treatment of prostate cancer. Through the application of MiCheck Prostate in mainland China, it is expected to increase the early diagnosis rate of prostate cancer patients in China and improve their survival quality.

Dr Brad Walsh CEO Minomic, Mrs Jin Ge CEO GloriousMed, Prof Xue Wei, Shanghai Jiaotong University School of Medicine

Minomic’s CEO, Dr Brad Walsh, noted "being able to test MiCheck Prostate on a Chinese population has been an aim of the company for some time. We recognize that to be successful in the China market we must work with a partner with significant local expertise and experience to execute this and are very pleased to partner with one of the leading urology companies in China. Our thanks to the GloriousMed team for making this possible. We are very excited to be working with them as they continue to build their franchise in the urological testing space".

GloriousMed’ CEO, Mrs. Jin Ge, said "We are very pleased to reach this cooperation with Minomic. In the past five years, GloriousMed has devoted itself to the integration of urological tumor diagnosis and treatment. In both independent research and global introduction, we hope to establish the entire urological tumor treatment pathway and diagnostic sequence. With five years of hard work, GloriousMed has become a leader in precision treatment of urological tumors in China, and we also hope to build a more professional product system. MiCheck Prostate is a very competitive product that can bring real value to Chinese prostate cancer patients. GloriousMed has already started to communicate with many clinical experts in China and is ready for future clinical trials to achieve the translation of MiCheck in China as soon as possible.

Prostate cancer has now leaped to the top of malignant tumors of the male genitourinary system in China, said Professor Xue Wei of Renji Hospital, Shanghai Jiaotong University School of Medicine. Due to untimely screening and diagnosis, about half of the newly diagnosed prostate cancer patients in China are at advanced stages. It is evident that early screening, early diagnosis and early treatment of prostate cancer will be the key factor to improve the survival time and quality of life of patients. As we know, PSA test is one of the main tools for prostate cancer screening and diagnosis, but there are certain problems in the specificity of PSA test, leading some patients with elevated PSA to undergo unnecessary prostate puncture biopsy. Minomic has spent 6 years developing a rapid, non-invasive, highly specific blood test: MiCheck Prostate, which has higher sensitivity and specificity than existing PSA screening technologies. The introduction of this technology into China by GloriousMed is expected to improve the current situation of early diagnosis and treatment of prostate cancer in China, help clinicians accurately select patients who do need to undergo puncture biopsy, effectively avoid unnecessary biopsies and reduce patient trauma."

On April 20, 2021 Amgen reported that The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to bemarituzumab for first-line treatment of patients with fibroblast growth factor receptor 2b (FGFR2b) overexpressing and human epidermal growth factor receptor 2 (HER2)-negative metastatic and locally advanced gastric and gastroesophageal (GEJ) cancer (Press release, EVERSANA, APR 20, 2021, View Source [SID1234578243]).

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The designation was supported by the Phase II FIGHT trial, in which bemarituzumab treatment plus chemotherapy demonstrated clinically significant and substantial improvements in progression-free survival and overall survival in the patient population with at least 10% of tumor cells overexpressing FGFR2b.

"The FIGHT trial is the first study to evaluate targeting the overexpression of FGFR2b in cancer. Bemarituzumab demonstrated clinically meaningful outcomes in key endpoints for patients with advanced gastric or gastroesophageal cancer as a frontline therapy," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "Amgen looks forward to further investigating the role of FGFR2b and will continue to work with regulatory agencies on next steps to bring this potential first-in-class, frontline therapy to patients."

The designation makes bemarituzumab the second asset in Amgen’s oncology portfolio to receive Breakthrough Therapy Designation in the past six months – following sotorasib.

On April 20, 2021 Cerus Corporation (Nasdaq: CERS) reported that its first quarter 2021 financial results will be released on Tuesday, May 4, 2021, after the close of the stock market (Press release, Cerus, APR 20, 2021, View Source [SID1234578259]). The Company will host a conference call and webcast at 4:30 P.M. ET that afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook.

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To listen to the live webcast and view the presentation slides, please visit the Investor Relations page of the Cerus website at View Source Alternatively, you may access the live conference call by dialing (866) 235-9006 (U.S.) or (631) 291-4549 (international).

A replay will be available on Cerus’ website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering conference ID number 8668508. The replay will be available approximately three hours after the call through May 18, 2021.

On April 20, 2021 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported a regulatory update for omburtamab, which is an investigational, monoclonal antibody that targets B7-H3 and has been radiolabeled before intraventricular central nervous system ("CNS") administration (Press release, Y-mAbs Therapeutics, APR 20, 2021, View Source [SID1234578244]). B7-H3 is an immune checkpoint molecule that is widely expressed in tumor cells of several cancer types.

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Y-mAbs recently concluded a Type B meeting with the U.S. Food and Drug Administration ("FDA") regarding omburtamab and received requests from the FDA for additional data concerning the granularity of data from our identified historical control groups. In order to agree on a statistical analysis plan ("SAP"), this additional granularity data is being collected and we anticipate submitting it to the FDA by the end of April. An additional Type B meeting has been scheduled for June 1, 2021 to discuss the SAP based on review of the additional data. We continue to be in close dialog with the FDA and maintain our aim of resubmitting the Biologics License Application ("BLA") for omburtamab late in the second quarter or in the third quarter of 2021.

"We believe omburtamab is on track to potentially become the first FDA approved targeted therapy for pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma, addressing an important unmet medical need, where no standard therapy is currently available," said Thomas Gad, founder, Chairman and President of Y-mAbs.

Dr. Claus Moller, the Company’s Chief Executive Officer, continued, "We believe omburtamab can potentially address a significant unmet medical need for children with CNS/leptomeningeal metastasis from neuroblastoma, and we continue to work closely with the FDA to resubmit the omburtamab BLA. In addition, we are targeting submission of a Marketing Authorization Application to the European Medicines Agency on April 30, 2021."

Researchers at Memorial Sloan Kettering Cancer Center ("MSK") developed omburtamab, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interest related to the compound and Y-mAbs.