event 1

on September 25, 2023, junshi biology overseas partner Coherus announced on the official website that FDA has completed the on-site review of junshi biology's three clinical centers in China. currently, trepril monoclonal antibody (tuoyi?) the two key clinical-first-line treatment of nasopharyngeal carcinoma (NPC), second-line and above nasopharyngeal carcinoma (NPC) has submitted a listing application to the FDA Biologics License Application(BLA), and the Coherus will continue to promote the FDA approval of the drug in the year.

event 2

on September 25, 2023, junshi biology announced that the main study endpoint progression-free survival (PFS, based on independent image evaluation) of the randomized, controlled, multicenter phase iii clinical study (MELATORCH study, NCT03430297) of the company's product treprizumab (PD-1) compared with dacarbazine for first-line treatment of unresectable or metastatic melanoma reached the preset superiority boundary of the scheme. The company plans to submit a listing application for the new indication to the regulatory authorities in the near future.

comments

FDA's on-site review is over, and the overseas listing process is substantially advanced

as an important link for the company's innovative drugs to go to sea, FDA's on-site review of Junshi Biology in domestic clinical and production centers is currently the company's top priority. The overall process was smooth, with only one center receiving an FDA 483 form and one result flagged, and the partners Coherus confident that the issue could be resolved and optimistic about the results of the review. It is expected that the combination of gemcitabine/cisplatin as a first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal cancer, as well as a single drug for recurrent or metastatic nasopharyngeal cancer after platinum-containing treatment of second-line and above treatment, is expected to be approved by the FDA within the year, will be the first to open the overseas market.

Tuoyi continues to pursue clinical benefits and expand its exclusive indication advantage As the only indication approved for melanoma PD-1 drug in China, Treplimab continues to pursue its greater clinical benefits for cancer patients and continues to expand its advantages in exclusive indications. As the first pivotal clinical registration study of PD-(L)1 inhibitors to achieve positive results in the first-line treatment of advanced melanoma in China, MELATORCH study (NCT03430297) aims to compare the efficacy and safety of treprolizumab versus dacarbazine in patients with unresectable or metastatic melanoma who have not received previous systemic antineoplastic therapy. The results of the study show that first-line treatment of unresectable or metastatic melanoma with terreprilumab significantly prolongs PFS compared with dacarbazine. Safety data for treprozumab were similar to previous studies and no new safety signals were identified. Detailed data from this study will be presented at subsequent international academic conferences.

lay a solid foundation for globalization, and the multi-party extension will soon go to sea

since 2023, junshi biology has firmly laid out overseas commercialization. through the establishment of a joint venture company with kanglianshengji, a subsidiary of kangzhe pharmaceutical, it mainly covers 9 southeast Asian countries and other regions, and cooperates with Dr.

Reddy's to lay out the Indian market and cooperate with European and European and European partners Coherus, Hikma, junshi Bio has gradually developed a commercial layout in more than 50 countries such as Europe, America, Southeast Asia, and the Belt and Road, and explored the overseas payment market. With the substantial progress of Tuoyi's listing in the United States, its multi-party sea process is also gradually advancing.

the local market sales improved significantly, the operation speed effect is significant

in the first half of 2023, Junshi biological commercial drug revenue reached 0.625 billion yuan. As the only anti-PD-1 monoclonal antibody drug used in the national medical insurance catalog for the treatment of melanoma, Junshi Bio's core product Tuoyi (Treplimab) revenue is about 0.447 billion yuan, accounting for more than 70% of total product sales revenue, a year-on-year increase About 50%. On January 28, 2023, Mindewei (VV116), an innovative class 1 drug with oral nucleoside anti-SARS-CoV-2, was approved for listing by NMPA with conditions, achieving sales revenue of 0.11 billion yuan, and Junmaikang (Adalimumab) revenue of 68 million yuan. Junshi Bio adheres to the product strength-oriented sales strategy, in the PD-1 application in the field of urothelial cancer to achieve a leading advantage, in the face of medical policy changes since the second half of this year, the company will continue to comply with the practice, the quality and price of the United States PD-1 to benefit more cancer patients.

investment proposal

we expect the company's revenue from 2023 to 2025 to be 1.524 billion yuan, 2.685 billion yuan and 4.228 billion yuan respectively, up 4.8, 76.2 and 57.5 respectively year on year. It is estimated that the net profit attributable to the parent will be -1.391 billion yuan, -0.834 billion yuan and -0.203 billion yuan respectively, up 41.7, 40.0 and 75.7 respectively year on year. We are optimistic that the early medical insurance price reduction pressure to the end, the renewal of the new rules is expected to increase the amount of price, new indications at home and abroad to occupy the exclusive advantage of the segment, maintain the "buy" rating.

risk tips

new drug research and development failure, approval and access is not as expected, industry policy changes, sales fluctuations and other risks.