On December 1, 2021 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported Janssen Biotech, Inc. (Janssen) received U.S. Food and Drug Administration (FDA) approval of DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in combination with Kyprolis (carfilzomib) and dexamethasone (Kd) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy (Press release, Halozyme, DEC 1, 2021, View Source [SID1234596366]). This approval follows Janssen’s regulatory submission to the FDA in February 2021.

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"We are pleased that Janssen received U.S. FDA approval for the ninth indication for DARZALEX FASPRO in multiple myeloma, this time in combination with Kyprolis (carfilzomib) and dexamethasone," said Helen Torley, president and chief executive officer at Halozyme. "With its three-to-five-minute subcutaneous administration, DARZALEX FASPRO is now a treatment option for a broader range of patients suffering from multiple myeloma."

The FDA approval for DARZALEX FASPRO is based on data from Janssen’s PLEIADES Study, which met its primary endpoint of overall response rate. For more information about the PLEIADES study and its findings, please view Janssen’s press release issued today.

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

On December 1, 2021 Compass, Inc. (NYSE: COMP), a leading technology-enabled residential real estate brokerage, reported that it will participate in the following investor conferences (Press release, Compass Therapeutics, DEC 1, 2021, View Source [SID1234596365]). Robert Reffkin, Founder, Chairman, and Chief Executive Officer, and Kristen Ankerbrandt, Chief Financial Officer, will both present at:

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UBS Global Technology, Media and Telecommunications Conference on Tuesday, December 7, 2021 at 5:00 p.m. ET.
Barclays Global Technology, Media and Telecommunications Conference on Wednesday, December 8, 2021 at 12:40 p.m. ET.
Both live and replay versions of the presentations will be available under the Events & Presentations section of the Compass Investor Relations website, View Source

On December 1, 2021 Sapience Therapeutics, Inc., a biotechnology company focused on the discovery and development of peptide therapeutics to address difficult-to-treat cancers, reported that the company will present at the RBC Capital Markets Healthcare Private Company Conference, taking place virtually on December 15-16, 2021 (Press release, Sapience Therapeutics, DEC 1, 2021, View Source [SID1234596364]).

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Dr. Barry Kappel, CEO and President, will participate in a fireside chat on December 16, 2021 at 2:30 PM ET. In addition, company management will participate in one-on-one meetings with life science investors during the event.

On December 1, 2021 TOT BIOPHARM International Company Limited (TOT BIOPHARM, 1875.HK) reported its self-developed Pusintin (TAB008, bevacizumab injection) has been officially granted approval by the National Medical Products Administration ("NMPA") for marketing in mainland China (i.e., excluding Hong Kong, Macau and Taiwan regions) for the treatment of patients with advanced, metastatic or recurrent non-squamous non-small cell lung cancer and patients with metastatic colorectal cancer (Press release, Tot Biopharm, DEC 1, 2021, View Source [SID1234596363]). Pusintin is the first antibody drug of TOT BIOPHARM approved for marketing.

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Bevacizumab is a humanized monoclonal antibody targeting vascular endothelial growth factor (VEGF) which can specifically bind to VEGF and block the binding of VEGF to its receptor, thereby reducing angiogenesis and inducing degeneration of existing blood vessels, and inhibit tumor growth. As a broad-spectrum anti-tumor drug, bevacizumab injection has become a globally recommended standard therapy in the treatment guidelines for a variety of malignant tumors, which had abundant real-world evidence of its efficacy and safety since its entry into the market in 2004. Bevacizumab injection has currently been included in the National Medical Insurance Directory. According to the Frost & Sullivan Report, bevacizumab’s market share in China will increase to RMB 6.4 billion in 2023 and RMB 9.9 billion in 2030.

Pusintin is a biosimilar to bevacizumab injection sold under the trade name of Avastin in China. TOT BIOPHARM strictly followed the NMPA’s "Guidelines on Similarity Evaluation and Indication Extrapolation of Biosimilars" and has taken rigorous and comprehensive head-to-head comparisons between Pusintin and the reference bevacizumab. The results from pharmaceutical studies, non-clinical studies, and clinical studies proved that Pusintin has similar PK characteristics with the originator drug and presents clinically equivalent with highly similarity in safety and immunogenicity.

Bevacizumab has been approved for 8 indications globally, and 6 indications in China, including mCRC, NSCLC, glioblastoma multiforme (GBM), and for the treatment of hepatocellular carcinoma (HCC), ovarian cancer, and cervical cancer. According to the "Guidelines on Similarity Evaluation and Indication Extrapolation of Biosimilars", Pusintin will be eligible for application by way of extrapolation for use in all indications of Avastin approved in China.

TOT BIOPHARM has established large-scale commercial production base in Suzhou Industrial Park that meets international standards, covering an area of 50,000 square meters with a capacity of monoclonal antibodies reaches 20,000L until the first half of 2022. Pusintin adopts the self-developed Perfusion-batch mixed culture technology (PB-Hybrid Technology) for commercial production. This technology has been verified in the production of Phase III clinical drugs, which can simplify the process and shorten the production cycle, reduce production costs, and greatly improve the cost advantage of Pusintin.

Dr. Liu Jun, CEO of TOT BIOPHARM, said, "We are very pleased for the Pusintin ‘s marketing approval of NMPA, which can provide high-quality and affordable treatment options for more cancer patients. This is really a key milestone for TOT BIOPHARM. Meanwhile, it has once again verified the superiority of our one-stop innovative drug R&D and production platform. By virtue of our highly competitive commercial production platform and technology platform, we will constantly accelerate the implementation of innovative achievements and improve the availability of medicines, and let the achievements of national medicine benefit more patients."

On December 1, 2021 MEI Pharma, Inc. (Nasdaq: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported that it has priced the underwritten public offering of 17,500,000 shares of its common stock at $2.60 per share for total gross proceeds (before underwriting discount and commissions and estimated expenses) of $45,500,000 (Press release, MEI Pharma, DEC 1, 2021, View Source [SID1234596362]). In connection with the offering, the Company granted the underwriters a 30-day option to purchase up to an additional 2,625,000 shares of common stock offered in the public offering. The offering is expected to close on December 6, 2021, subject to the satisfaction of customary closing conditions.

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The Company plans to use the net proceeds of the offering, together with other available funds, to progress its clinical development programs, prepare for and support the commercial launch of zandelisib, subject to receiving FDA marketing approval, and for other general corporate purposes.

Jefferies, Stifel and Wells Fargo Securities are acting as joint book-running managers for the offering. LifeSci Capital and H.C. Wainwright & Co. are acting as co-managers for the offering.

The securities described above are being offered pursuant to a "shelf" registration statement previously filed and declared effective by the Securities and Exchange Commission (SEC). The offering is being made only by means of a prospectus supplement and accompanying base prospectus.

When available, copies of the final prospectus supplement and accompanying base prospectus relating to the offering may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022 or by email at [email protected]; Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at 415-364-2720 or by email at [email protected]; or Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 500 West 33rd Street, New York, New York 10001 at 833-690-2713 or email a request to [email protected]. An electronic copy of the preliminary prospectus supplement and accompanying base prospectus relating to the offering will also be available on the website of the SEC at www.sec.gov.

This release does not constitute an offer to sell, or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.