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Bio-Thera Solutions Submits Marketing Authorization Application (MAA) for BAT1706, a Proposed Biosimilar to Avastin®, to European Medicines Agency (EMA)

On November 25, 2020 Bio-Thera Solutions (SHA: 688177), a commercial-stage biopharmaceutical company, reported that it has submitted the MAA for BAT1706, a proposed biosimilar to Avastin (bevacizumab), to EMA (Press release, BioThera Solutions, NOV 25, 2020, View Source [SID1234571752]). Bio-Thera seeks a commercial license for all approved indications of bevacizumab in the European Union (EU) Member States, Iceland, Norway and Liechtenstein.

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"The submission of the MAA for BAT1706 marks a milestone for Bio-Thera as the first ex-China MAA or BLA submission," said Dr. Shengfeng Li, Founder and CEO of Bio-Thera Solutions. "Bio-Thera intends to bring its pipeline of biosimilars and innovative therapies to patients around the world and this submission is an important step for extending the global reach of BAT1706".

BAT1706 is a proposed bevacizumab biosimilar developed by the company. Bevacizumab is a humanized monoclonal antibody that targets vascular endothelial growth factor (VEGF). It can specifically bind to VEGF and block the binding of VEGF to its receptor, thereby reducing neovascularization, inducing the degradation of existing blood vessels, and thereby inhibiting tumor growth. Bevacizumab has been approved in Europe for the treatment of metastatic carcinoma of the colon or rectum, metastatic breast cancer, non–small cell lung cancer, advanced or metastatic renal cell cancer, epithelial ovarian, fallopian tube and primary peritoneal cancer, and cervical cancer.

A Biologics License Application seeking approval for BAT1706 for the treatment of metastatic carcinoma of the colon or rectum and non–small cell lung cancer is under review by the China National Medicinal Product Administration (NMPA). Bio-Thera intends to submit a BLA for BAT1706 to the U.S. Food and Drug Administration (FDA) before the end of 2020.

BAT1706 is Bio-Thera Solutions’ second proposed biosimilar submitted for regulatory approval. The company’s first biosimilar product, QLETLI (格乐立), a biosimilar to Humira (adalimumab), has received marketing authorization and is available in China. Bio-Thera Solutions is developing several additional proposed biosimilars, including golimumab, ustekinumab and secukinumab, and mepolizumab among others.

About BAT1706

BAT1706 is a monoclonal antibody that is in development as a potential biosimilar to Avastin. BAT1706 works by binding the vascular endothelial growth factor (VEGF) protein. In the EU, Avastin is indicated for the treatment of patients with metastatic colorectal cancer, non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, persistent, recurrent, or metastatic cervical cancer, and epithelial ovarian, fallopian tube, or primary peritoneal cancer. BAT1706 is an investigational compound and has not received regulatory approval in any country.

Novocure to Participate in the Evercore ISI 2020 Virtual HealthCONx Conference

On November 25, 2020 Novocure (NASDAQ: NVCR) reported that Novocure’s Executive Chairman William Doyle and Chief Science Officer Dr. Uri Weinberg will participate in the 3rd Annual Evercore ISI 2020 Virtual HealthCONx Conference on December 1 through December 2, 2020 (Press release, NovoCure, NOV 25, 2020, View Source [SID1234571751]). Mr. Doyle and Dr. Weinberg will take part in a fireside chat at 11:20am EST on December 2, 2020 and will also participate in one-on-one meetings with investors throughout the event.

A live audio webcast of the presentation can be accessed from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for replay for at least 14 days following the event.

Novocure’s corporate presentation is updated periodically, and the current presentation can be accessed from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations. Novocure has used, and intends to continue to use, its Investor Relations website as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

AnPac Bio Sets Record Test Volume in Q3, and Forecasts ~ 100% Revenue Growth in 2020

On November 25, 2020 AnPac Bio-Medical Science Co., Ltd. ("AnPac Bio," the "Company" or "we") (NASDAQ: ANPC), a biotechnology company with operations in China and the United States focused on early cancer screening and detection, reported that it experienced strong demand for its cancer screening tests and set a record in paid test volume in the third quarter (Press release, Anpac Bio, NOV 25, 2020, View Source [SID1234571750]). With a strong fourth quarter already underway, the Company forecasts a revenue growth of approximately 100% in 2020 over 2019, with a revenue range of US$3 million (~ RMB20 million) to US$3.3 million (~ RMB22 million). For 2019, the Company had a revenue of US$1.6 million (~ RMB10.9 million) (using a current US$ to RMB exchange ratio of ~ 6.6). We expect the strong momentum of YoY revenue growth due to market demand and customers accepting AnPac Bio’s novel cancer screening technology with multiple advantages (named cancer differentiation analysis (CDA) technology)) to continue into 2021. The Company plans to release its full year 2020 audited financial report in early March 2021.

With COVID-19 mainly contained in China and most businesses returning to normal operations since May, the demand for the Company’s cancer screening tests has remained strong. Further, its average selling price (ASP) in 2020 is expected to increase compared to 2019, contributing to a higher revenue growth forecast. In 2020, the Company has launched a number of new products including an immunology test in China and the COVID-19 antibody test in the US.

Dr. Chris Yu commented, "Our strong paid test volume in the third quarter demonstrated our novel, biophysics based CDA technology and its advantages in cost effectiveness, the ability to detect early a wide range of cancer types (over 20 cancer types), and relatively high sensitivity and specificity are increasingly being accepted and recognized by the market and customers. With our successful IPO on the NASDAQ earlier this year, we are now focusing on three areas: new product development, product commercialization including in the US, and revenue growth through sales, with an emphasis on execution and speed. Having successfully executed our phase one goal to become a volume leader in cancer screening among new generation cancer screening technologies, we are now turning our attention to enhance our ASP and gross margin. We have recorded an increase in ASP and launched two new products, which paved the way for further business growth. We are optimistic about our Company including commercialization in the US and growth in 2021."

Horizon Therapeutics plc to Participate in Upcoming Investor Conferences

On November 25, 2020 Horizon Therapeutics plc (Nasdaq: HZNP) reported that the Company will participate in the following conferences in December (Press release, Horizon Therapeutics, NOV 25, 2020, View Source [SID1234571749]):

2020 Evercore ISI HealthCONx Conference

Date: Wed., Dec. 2, 2020
Presentation Time: 9:15 a.m. ET
Piper Sandler 32nd Annual Virtual Healthcare Conference

Date: Wed., Dec. 2, 2020
Presentation Time: 1:30 p.m. ET
BMO 2020 Growth & ESG Conference

Date: Tues., Dec. 8, 2020
Presentation Time: 1:00 p.m. ET
The conference presentations will be webcast live and may be accessed by visiting Horizon’s website at View Source A replay of the webcasts will be available following each event.

Arrowhead Pharmaceuticals Announces Closing of Agreement with Takeda

On November 25, 2020 Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) reported that the collaboration and license agreement between Arrowhead and Takeda Pharmaceutical Company Limited announced on October 8, 2020, has now closed (Press release, Arrowhead Pharmaceuticals, NOV 25, 2020, View Source [SID1234571747]). Closing of the transaction was contingent on completion of review under antitrust laws, including the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976 in the U.S.