GlobeNewswire Inc | Apr 29, 2021 07:30AM EDT

April 29, 2021

SHANGHAI, China, and REDWOOD CITY, Calif., April 29, 2021 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd.(Junshi Biosciences, HKEX: 1877; SSE: 688180) andCoherus BioSciences, Inc.(Coherus, Nasdaq: CHRS), today announced that a late-breaking abstract detailing clinical data of anti-PD-1 antibody, toripalimab, in first-line treatment for recurrent or metastatic nasopharyngeal carcinoma will be featured at ASCO 2021 in the plenary session on Sunday, June 6, 2021. The abstract has also been selected for ASCOs official press program.

Details regarding the plenary session and abstract publication are as follows:

JUPITER-02: Randomized, double-blind, phase 3 study ofTitle: toripalimab or placebo plus gemcitabine and cisplatin as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (NPC) Abstract #: LBA2 Presentation: Plenary Session, June 6, 2021, 1:00 p.m. ? 4:00 p.m. Eastern Daylight Time Publication: June 3, 2021, 5:00 p.m. Eastern Daylight Time

We are excited that results of JUPITER-02, a Phase 3 clinical trial evaluating toripalimab plus chemotherapy for the first-line treatment of recurrent or metastatic nasopharyngeal carcinoma, have been selected for presentation during ASCOs plenary session, which traditionally features high-impact studies, said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences. Treatment of nasopharyngeal carcinoma, a specific type of head-and-neck cancer, is challenging, as the diagnosis usually occurs when the cancer is in an advanced stage and treatment options are limited.

In addition to the JUPITER-02 late-breaking abstract, ASCO accepted for publication or presentation more than two dozen additional abstracts, primarily investigator-sponsored studies, that evaluate the utility of toripalimab in a variety of cancer types including lung cancer, melanoma, urothelial carcinoma, gastroesophageal cancer, and hepatobiliary malignancies.

About Toripalimab

More than thirty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally, including inChinaandthe United States. Pivotal clinical trials are ongoing or completed evaluating the safety and efficacy of toripalimab for a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.

In China, Toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved inChinaas TUOYI). OnDecember 17, 2018, Toripalimab was granted a conditional approval from theNational Medical Products Administration(NMPA) for the second-line treatment of unresectable or metastatic melanoma. InDecember 2020, Toripalimab was successfully included in the updated National Reimbursement Drug List. InFebruary 2021, the supplemental NDA for Toripalimab in combination with chemotherapy for the first-line treatment of patients with advanced, recurrent or metastatic nasopharyngeal carcinoma was accepted by the NMPA. In the same month, the NMPA granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy. In April, NMPA granted a conditional approval to toripalimab for the treatment of patients withlocally advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.

In the United States, a rolling submission of the first toripalimab Biologics License Application (BLA) is underway for the treatment of recurrent or metastatic nasopharyngeal carcinoma (NPC). The U.S. Food and Drug Administration (FDA) has granted toripalimab Breakthrough Therapy Designation for this indication. There are currently no PD-1 blocking antibodies indicated for use in NPC in the United States. Additionally, FDA has granted Fast Track status for the development of toripalimab for the treatment of mucosal melanoma and orphan drug designation for NPC, mucosal melanoma and soft tissue sarcoma. Earlier in 2021 Coherus in-licensed rights to develop and commercialize toripalimab in the United States and Canada. Coherus and Junshi Biosciences plan to file additional toripalimab BLAs with the FDA over the next three years for multiple rare cancers and highly prevalent cancers.

About Junshi BiosciencesFounded inDecember 2012, Junshi Biosciences is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R & D pipeline comprising 28 innovative drug candidates and 2 biosimilars, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA antibody for solid tumors was the first in the world to be approved for clinical trials by the FDA and NMPA and its anti-PCSK9 monoclonal antibody was the first inChinato be approved for clinical trials by the NMPA. In early 2020, Junshi Biosciences joined forces with theInstitute of Microbiology Chinese Academy of Science and Eli Lillyto co-develop JS016 (etesevimab), Chinas first neutralizing fully human monoclonal antibody against SARS-CoV-2. JS016 administered with bamlanivimab has received Emergency Use Authorization (EUA) byUS FDAinFeb 2021for the treatment of recently diagnosed, mild to moderate COVID-19 in patients who are at high risk of progressing to severe COVID-19 and/or hospitalization. The JS016 program is a part of our continuous innovation for disease control and prevention of the global pandemic. Junshi Biosciences has over 2,000 employees inthe United States(San FranciscoandMaryland) andChina(Shanghai,Suzhou,BeijingandGuangzhou). For more information, please visit: http://junshipharma.com.

AboutCoherus BioSciencesCoherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients lives and to deliver significant savings to the health care system.

InFebruary 2021, Coherus and Junshi Biosciences announced a collaboration in which Coherus would in-license toripalimab, an anti-PD-1 antibody, inthe United StatesandCanada. Coherus strategy is to build a leading immuno-oncology franchise funded with cash generated by its commercial biosimilar business. Coherus markets UDENYCA (pegfilgrastim-cbqv) inthe United Statesand through 2023 expects to launch biosimilars of Humira, Avastin and Lucentis, if approved.

For additional information, please visitwww.coherus.com.

UDENYCA is a trademark ofCoherus BioSciences, Inc.Avastin and Lucentis are registered trademarks ofGenentech, Inc.Humira is a registered trademark of AbbVie Inc.

Forward-Looking Statements

Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Coherus ability to generate cash flow from its UDENYCA business; Coherus and Junshi Biosciences ability to co-develop toripalimab, and Coherus ability to commercialize toripalimab, or any other drug candidates developed as part of its collaboration with Junshi Biosciences in the licensed territory; Coherus ability to expand a late-stage pipeline into the rapidly growing checkpoint inhibitor market; any market size expectation for checkpoint inhibitor therapeutic agents inthe United States; the potential for toripalimab to gain approval inthe United Statesfor nasopharyngeal carcinoma or any indication; toripalimabs possibility to be the first marketed Chinese anti-PD-1 antibody in the overseas market; Coherus and Junshi Biosciences plans to file additional toripalimab BLAs with the FDA over the next three years for any clinical indication; Coherus plans to invest the cash generated by its biosimilar commercial business to build a focused immuno-oncology franchise; Coherus ability to prepare for projected launches through 2023 of biosimilars of Humira, Avastin and Lucentis, if approved.

Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risk that the parties are unable to obtain clearance under the Hart-Scott Rodino Antitrust Improvements Act, from theCommittee on Foreign Investmentinthe United States, or any other statute or regulatory agency having jurisdiction with respect to the proposed transactions, the risks and uncertainties inherent in the clinical drug development process; the risks and uncertainties of the regulatory approval process, including the timing of Coherus regulatory filings; the risk that Coherus is unable to complete commercial transactions and other matters that could affect the availability or commercial potential of Coherus drug candidates; and the risks and uncertainties of possible patent litigation. All forward-looking statements contained in this press release speak only as of the date on which they were made. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus business in general, see Coherus Annual Report on Form 10-K for the year endedDecember 31, 2020, filed with theSecurities and Exchange CommissiononFebruary 25, 2021, and its future periodic reports to be filed with theSecurities and Exchange Commission. Our results for the year endedDecember 31, 2020are not necessarily indicative of our operating results for any future periods.

Junshi Biosciences Contact Information

IR Team:Junshi Biosciencesinfo@junshipharma.com+ 86 021-2250 0300

Solebury TroutBob Aibai@soleburytrout.com+ 1 646-389-6658

PR Team:Junshi BiosciencesZhi Lizhi_li@junshipharma.com+ 86 021-6105 8800

Coherus BioSciences Contact Information:

IR ContactMcDavid StilwellCoherus BioSciences, Inc.mstilwell@coherus.com

Media ContactDenise Powelldenise@redhousecomms.com