Legend Biotech Corporation Announces Proposed Public Offering

On July 25, 2022 Legend Biotech Corporation (NASDAQ: LEGN) ("Legend Biotech"), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, reported that it intends to offer and sell $250 million of American Depositary Shares ("ADSs"), each representing two ordinary shares, in an underwritten public offering (Press release, Legend Biotech, JUL 25, 2022, View Source [SID1234616936]). All ADSs to be sold in the proposed offering will be offered by Legend Biotech. Legend Biotech also intends to grant the underwriters a 30-day option to purchase up to an additional $37.5 million of ADSs sold in the public offering at the public offering price, less underwriting discounts and commissions. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed or the actual size or terms of the offering.

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Morgan Stanley, J.P. Morgan, Jefferies and Evercore ISI are serving as joint book-running managers for the offering. BMO Capital Markets is acting as a book-runner.

The ADSs are being offered by Legend Biotech pursuant to an effective shelf registration statement that was previously filed with the Securities and Exchange Commission ("SEC"). The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. A copy of the preliminary prospectus supplement can be obtained, when available, from Morgan Stanley & Co. LLC, 180 Varick Street, 2nd Floor, New York, NY 10014, Attention: Prospectus Department, or by telephone at (866) 718-1649; J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at 866-803-9204 or by email at [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at 877-821-7388 or by email at [email protected]; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, by telephone at 888-474-0200 or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy securities, and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that jurisdiction.

Ultragenyx to Host Conference Call for Second Quarter 2022 Financial Results and Corporate Update

On July 25, 2022 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel products for serious rare and ultra-rare genetic diseases, reported that it will host a conference call on Thursday, July 28, 2022, at 5:00pm ET to discuss its financial results and corporate update for the quarter ended June 30, 2022 (Press release, Ultragenyx Pharmaceutical, JUL 25, 2022, https://ir.ultragenyx.com/news-releases/news-release-details/ultragenyx-host-conference-call-second-quarter-2022-financial [SID1234616926]).

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The live and replayed webcast of the call will be available through the company’s website at View Source To participate in the live call, please register by clicking on the following link (registration link), and you will be provided with dial-in details. To avoid delays, we encourage participants to dial into the conference call fifteen minutes ahead of the scheduled start time. The replay of the call will be available for one year.

TechnoPhage announces signing of a PRR Grant Agreement with the Portuguese Government

On July 25, 2022 Technophage, together with partners LX Bio, VectorB2B and FFUL reported the signing of a new PRR Grant Agreement with the Portuguese Government, in the scope of the Mobilizing Agendas for Business Innovation in Portugal (Press release, TechnoPhage, JUL 25, 2022, View Source;utm_medium=rss&utm_campaign=technophage-announces-signing-of-a-prr-grant-agreement-with-the-portuguese-government [SID1234616925]).

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The Bio-Hub consortium aims to expand the development of biological medicines, conduct clinical trials of late phases, and implement registrations, marketing and distribution of these drugs globally. This strategy will increase the volume of exports of value-added products and increase highly qualified employment. The starting point will be the creation of a large-scale plant for the production of biological medicines with GMP-certified dedicated spaces that will reinforce the development of innovative medicines in the country, while supporting the needs of national start-ups.

"This new consortium will be life-changing for the companies and partners involved, constituting an exciting milestone for the whole team" commented Miguel Garcia, CEO of TechnoPhage.

The project will take place over a period of 36 months and aims to produce new knowledge in the R&D of biological medicines, a health market with a strong prospect of growth in the next decade.

Aurinia Pharmaceuticals to Release Second Quarter 2022 Financial and Operational Results on August 4, 2022

On July 25, 2022 Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) ("Aurinia" or the "Company") reported that it will release financial and operational results for the second quarter of 2022 on Thursday, August 4, 2022, before markets open (Press release, Aurinia Pharmaceuticals, JUL 25, 2022, View Source [SID1234616922]). Aurinia’s management team will host a conference call/webcast at 8:30 am ET that day to review these results and provide a general business update.

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Interested participants can dial 877-407-9170 (Toll-free U.S. & Canada). The audio webcast can also be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia’s website.

Anti-PD-1 monoclonal antibody Puyouheng™ (HX-008, Pucotenlimab injection) Co-developed by LEPU BIOPHARMA and HANX BIOPHARMACEUTICALS was approved for marketing in China by NMPA

On July 25, 2022 HanX Biopharmaceuticals reported that Anti-PD-1 monoclonal antibody – PuyouhengTM (HX-008, pucotenlimab injection), was conditionally approved by the National Medical Products Administration (NMPA) for marketing in China to treat patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) advanced solid tumors, specifically (Press release, HanX Biopharmaceuticals, JUL 25, 2022, View Source [SID1234616920]):

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Patients with advanced colorectal cancers have progressed following previous treatment with a fluoropyrimidine, oxaliplatin and irinotecan;
Patients with other advanced solid tumors that have progressed following at least previous first-line therapy with no satisfactory alternative treatment options.
The approval is based on a multi-center, open-label, phase II clinical study with a primary study endpoint of the objective response rate (ORR) assessed by the Independent Review Committee (IRC) according to the RECIST1.1. As of December 4, 2021, a total of 100 patients with histologically confirmed advanced solid tumors that are identified as having MSI-H/dMMR by the central Laboratory were enrolled in the study. They were given 200 mg of pucotenlimab by intravenous drip every 3 weeks (Q3W). The median follow-up duration for the ITT population was 22.5 months. And the ORR for the ITT population was 49.0% (95% CI: 38.86%, 59.20%), with 9 cases of complete response (CR) and 40 cases of partial response (PR). In the subgroup of patients with colorectal cancers who had failed previous triplet therapy (a fluoropyrimidine, oxaliplatin, and irinotecan), the ORR was 50.0% (95% CI: 31.30%, 68.70%). The results of the study showed that pucotenlimab monotherapy was safe and effective in patients with unresectable or metastatic MSI-H/dMMR advanced solid tumors who have failed previous standard therapy. The expected clinical endpoints were achieved, indicating that patients can benefit significantly from the therapy. The results of the clinical study were first published at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting.

"We are thrilled to see the approval of pucotenlimab, which validates our years of collaboration with Lepu Biopharma", said Dr. Faming Zhang, Chairman of Hanx Biopharmaceuticals, Inc., "I’m very glad to see the first indication of pucotenlimab was approved in China. The clinical research data of pucotenlimab for MSI-H/ dMMR solid tumors is outstanding and the approval brings new hope to better meet the demands of clinical treatment. Pucotenlimab is the first product launched by Lepu Biopharma as well as a significant milestone in the company’s evolution towards Biopharma", commended by Dr. Sui Ziye, CEO of Lepu Biopharma.

About Puyouheng (HX-008, pucotenlimab injection)

Puyouheng (pucotenlimab injection) is a humanized IgG4 monoclonal antibody against human PD-1 discovered by HanX Biopharmaceuticals, It can bind to PD-1 with high affinity to restore the ability of immune cells to kill cancer cells by blocking the binding of PD-1 to its ligands PD-L1 and PD-L2. Puyouheng (pucotenlimab injection) adopts an innovative molecular design to prolong its half-life, showing strong clinical anti-tumor activity and good safety. The innovative use of antibody engineering technology to introduce triple mutations in the Fc region improves the binding affinity of FcRn, thereby prolonging the drug’s half-life significantly, showing its promising clinical efficacy and drug compliance in patients [5]. Compared with all rival anti-PD-1 antibodies that have been marketed or entered phase III clinical trials, the mean half-life of Puyouheng (pucotenlimab injection) is 21.8 days (single dosing) and 38.2 days (steady-state). In addition, the prolonged half-life does not cause additional adverse events, indicating the excellent clinical efficacy of the drug.