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Disitamab Vedotin has become the first ADC drug created and developed by a China biopharma to receive marketing approval

On June 9, 2021 RemeGen reported that National Medical Products Administration(NMPA), China’s first independently developed antibody-drug conjugate (ADC)- Disitamab vedotin (trade name: Aidexi, research code: RC48) was approved to market for the treatment of locally advanced or metastatic gastric cancer (including gastroesophageal junction adenocarcinoma) with HER2 over-expression in patients who have received at least two types of systemic chemotherapy (Press release, RemeGen, JUN 9, 2021, View Source [SID1234594764]).

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The approval of Disitamab vedotin has broken the situation that there is no original domestic new drug in the field of ADC drugs, and filled the gap in the global post-line treatment of patients with HER2 over-expression of gastric cancer. It is a milestone in the history of independent innovation of biological medicine in China.

Prior to this, the world’s first dual-target treatment for systemic lupus erythematosus (SLE) biological medicine Telitacicept was approved by the NMPA on March 9. In less than 6 months, two world-class novel drugs have been approved, RemeGen shows its strength in research and development, and aims to become a leader in the China bio-pharmaceutical industry.

WuXi XDC and LegoChem Biosciences Signed Memorandum of Understanding for the Development and Manufacturing of Antibody-drug Conjugates

On June 9, 2021 WuXi XDC ("XDC"), a global CDMO company dedicated to end-to-end bioconjugates services, and LegoChem Biosciences (141080KS, "LCB"), reported that a Memorandum of Understanding (MOU) was signed to form a strategic partnership in development and manufacturing of antibody-drug conjugates (ADCs) (Press release, LegoChem Biosciences, JUN 9, 2021, View Source [SID1234583858]).

Under the partnership, LCB will have access to XDC’ integrated services in mAb, linker, payload, analytical and formulation development as well as ADC drug substance and drug product development and manufacturing. XDC will provide a full range of development and manufacturing services in one centralized region, which is within 2 hours’ driving distance.

Dr. Yong-Zu Kim, CEO and President of LCB, commented, "We’re excited to collaborate with WuXi XDC. This partnership will allow us to leverage XDC’s world-class expertise in both innovative conjugation technologies and the comprehensive capabilities for the ADC development and manufacturing. We’re looking forward to making more ADC products accessible to the patients."

"We’re glad to partner with LegoChem Biosciences to proceed its leading ADC products into clinical development, eventually to the commercialization." Dr. Jimmy Li, CEO of WuXi XDC, commented, "With more ADC programs now advancing towards clinical trials and commercial production, we have witnessed increasing outsourced demand for ADCs in recent years. As one of a few CDMO companies who have the end-to-end capability and entire supply chain, we’re committed to providing innovative technical solutions, reliable and sustainable manufacturing supply chain for global partners to benefit patients worldwide."

CARsgen Therapeutics to Raise $400 Million in Hong Kong IPO

On June 9, 2021 Shanghai CARsgen Therapeutics reported that it is staging an IPO on the Hong Kong Exchange that could raise $400 million to support development of the company’s CAR-T portfolio (Press release, Carsgen Therapeutics, JUN 9, 2021, View Source [SID1234583806]). The shares are scheduled to begin trading on June 18. Lilly Asia Ventures and New China Life are among nine cornerstone investors that will acquire $230 million of the shares. CARsgen is advancing 11 candidates for solid tumors and hematological malignancies including six clinical stage molecules. The company’s lead drug is a BCMA CAR-T for multiple myeloma currently in a pivotal Phase II/III trial.

Vernalis, a fully owned subsidiary of HitGen Inc., and Servier achieve two milestones in their oncology drug discovery collaboration

On June 9, 2021 Vernalis, a fully owned subsidiary of HitGen Inc., and Servier reported the achievement of one research and one pre-clinical milestone in their oncology drug discovery collaboration, triggering undisclosed milestone payments to Vernalis (Press release, Vernalis, JUN 9, 2021, View Source;utm_medium=rss&utm_campaign=vernalis-and-servier-achieve-two-milestones-in-their-oncology-drug-discovery-collaboration [SID1234583798]).

Vernalis and Servier’s partnership has been running successfully since 2007. The collaboration takes advantage of Vernalis’ proprietary fragment and structure-based drug discovery platform, and of Servier’s expertise in medicinal chemistry, cancer biology and pharmacology to bring innovation in oncology one step further.

The collaboration focuses on complicated molecular targets, some of which, like Mcl-1, were considered as undruggable until recently. Previously, has been announced the discovery of the first generation of Mcl-1 inhibitors which have entered clinical trials (published in Nature, 538: 477; ACS Omega, 4: 8892; J. Med. Chem., 63: 13762). The pre-clinical milestone announced today corresponds to a second generation, selective Mcl-1 inhibitor entering pre-clinical development. The research milestone relates to success in early drug discovery against another challenging, promising but undisclosed target.

"These milestones further validate our fragment and structure-based drug discovery platform as well as the strength and success of our relationship with Servier. We look forward to working together to develop exciting new cancer treatment opportunities to add to the already disclosed success in targeting Bcl-2 and Mcl-1", commented James Murray, Research Director at Vernalis.

"These research and clinical milestones are the result of highly interactive joint efforts between chemists, biochemists and biologists from both companies and hopefully will lead to new treatments for cancer patients," Olivier Geneste, Head of Apoptosis and Targeted Therapies Research Program in Oncology at Servier commented. "They illustrate well the innovative freedom that Servier has kept through its important investment in R&D."

Under the current agreement, Vernalis receives fees for work undertaken as well as research and development milestones and potentially royalties on sales.

Aclaris Announces Pricing of Public Offering of Common Stock

On June 9, 2021 Aclaris Therapeutics, Inc. (Nasdaq:ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, reported the pricing of its underwritten public offering of 7,042,254 shares of its common stock at a price to the public of $17.75 per share (Press release, Aclaris Therapeutics, JUN 9, 2021, View Source [SID1234583796]). In addition, Aclaris has granted to the underwriters a 30-day option to purchase up to 1,056,338 additional shares of common stock at the public offering price, less the underwriting discount. The gross proceeds from the offering to Aclaris are expected to be approximately $125.0 million, before deducting underwriting discounts and commissions and offering expenses, but excluding any exercise of the underwriters’ option. The offering is expected to close on or about June 14, 2021, subject to customary closing conditions.

Jefferies LLC, SVB Leerink LLC and Piper Sandler & Co. are acting as joint book-running managers for the offering.

A shelf registration statement relating to this offering was filed with the Securities and Exchange Commission (SEC) and was effective on May 20, 2021. 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 and accompanying prospectus relating to the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov. A final prospectus supplement and accompanying prospectus will be filed with the SEC. When available, copies of the final prospectus supplement and the accompanying prospectus may also be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022; Email: [email protected]; Telephone: (877) 821-7388; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110; Email: [email protected]; Telephone: 1-800-808-7525, ext. 6105; or Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402; Email [email protected]; Telephone: (800) 747-3924.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered 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.