on September 1, 2023, junshi biology (688180) announced that the company would hold a performance briefing on August 31, 2023, guosheng Securities, Derui Hengfeng, Industrial Securities, Nomura, West China Securities, UBS, CITIC Jiantou Securities, citi, Debang Securities, Guotai Junan Securities, Donghai Asset Management, aj securities, Kaisheng Investment, Anyuan Investment, Carlyle Investment, Huafu Fund, Jinglin Investment, Shangshi Investment, Panjing Investment, Nut Fund, Minsheng Securities, Huaxin Securities, changjiang securities, Fenganyan Investment, Shanghai investment, Dongcai, Yi Zhenglang Investment, Shenzhen Hongpomegranate Investment Management Co., Ltd., Fuguo Fund, Hongcheng Investment, Dongkai Investment, Bank of China Securities, Singapore Government Investment Co., Ltd., Northeast Securities, Shanghai Life Insurance, Danshui Spring, Tibet Yuancheng Investment Management Co., Ltd., Huatai Securities, Chengjin Assets, Sunshine Asset Management, Shenwan Hongyuan Securities, Hongshang Capital, Xi 'an Jiao Hui Venture Capital Management Co., Ltd., Ltd., Wolong Private Placement, CITIC Securities, Ltd. Zeng Investment Management Co., Ltd., Beijing Fengrui Private Equity Fund Management Co., Ltd., Jiangsu Ruihua Investment Holding Group Co., Ltd., Shenzhen Shangcheng Asset Management Co., Ltd., Xinhua Asset Management (Hong Kong) Co., Ltd., Dawei Investment, Chaos Investment, Juming Investment, First Beijing, Oriental Marathon Investment, Guangfa Securities, Hillern Investment, WT asset management, Hang Seng Qianhai Fund, Ocean Capital, Hongding Investment, Minghe Investment, CICC securities, Western Securities, Agricultural Bank of China Life Insurance, Xide Boyuan Capital, Zheshang Securities, Jingling Investment, Caitong Securities, Beijing Xiaoying Investment Management Co., Ltd., Harvest Fund, Rongshu Investment, Yanyi Assets, China Merchants Xinnuo, Green Fund, Jiahe Fund, Ping An Wealth Management, Guojin Securities, Donghai Self-operated, Park Yi Assets, Tairen Capital, PICC Assets, Houweiran (Shanghai) Private Fund Management Co, shanghai Dabaoxiang Investment Management, Yujin Investment, Galaxy Fund, China Post Fund, Cinda Securities, Guoxin Securities, hsbc, Everbright Securities, Shiyu Capital, Rosefinch Fund, Dongxing Securities, Shenzhen Jingtai Lifeng Investment, Yu Yi Asset, Shenzhen Yihu Investment Management Co., Ltd., Da Dao Asset, Biyun Yinxia, Model Capital, Gao Yi Asset, Dongwu Fund, Levy Capital, Hong Kong Hongli, Liqing Investment, Happiness Life Insurance, jingxi Assets, Rongtong Fund, CITIC Financial Management, Red Chip Investment, Guorong Securities, Jianxin Fund, Sequoia Capital, China Overseas Fund, Shenzhen Fruit Capital, Taiping Capital Management, Longhang Assets, Beijing Zhihe Private Equity Fund Management Co., Ltd., Huitian Fu Fund, Owen participated.

The details are as follows:

Q: Anti-BTLA monoclonal antibody registration clinical development plan? Follow-up indication layout plan?

A: Tifcemalimab (code name TB004/JS004) is the world's first self-developed anti-tumor recombinant humanized anti-BTL monoclonal antibody specific to B and T lymphocyte attenuator (BTL) that enters the clinical development stage (first-in-human), the early data for relapsed/refractory lymphoma and extensive small cell lung cancer, which have been published at SCO, SH and other academic conferences, are bright, and the company believes that the combination of tifcemalimab and treplimab is a promising anti-cancer treatment strategy that is expected to increase patients' response to immunotherapy and expand the range of people who may benefit.

in June 2023 and August 2023, FD and NMP respectively agreed to the company to carry out a randomized, double-blind, placebo-controlled, international multicenter phase III clinical study of tifcemalimab combined with triplimumab as consolidation therapy for patients with limited-stage small cell lung cancer who have not progressed after radiotherapy and chemotherapy. This study is the first confirmatory study of anti-BTL monoclonal antibody drugs. Academician Yu Jinming, Dean of the Cancer Hospital of Shandong First Medical University, will be the main investigator. It is planned to enroll 756 patients in China, the United States, Europe and other places. The company has fully communicated with regulators on program design, clinical endpoint selection and patient ratio, and will start the group as soon as possible in the fourth quarter of this year.

At the same time, a number of phase Ib/II clinical studies of tifcemalimab combined with treprozumab are being carried out simultaneously in China and the United States, covering multiple tumor species such as lung cancer. After obtaining more data accumulation, the company will carry out the layout of subsequent registered clinical studies based on clinical data and communication with regulatory agencies to promote the application and commercialization of tifcemalimab combined with Treplimab in more tumor species.

Q: Is the progress of treprozumab going to sea?

a: in may 2023, FD has successfully completed the pre-license examination (Pre-License Inspection,PLI) of the company's production base for treprozumab combined with gemcitabine/cisplatin as first-line treatment for patients with advanced recurrent or metastatic nasopharyngeal carcinoma and single-agent for second-line and above treatment after platinum-containing treatment for recurrent or metastatic nasopharyngeal carcinoma (BL), the application for listing of Treplimab in the United States is progressing smoothly. At present, GCP(Good Clinical Practice) related verification is in progress and is expected to be completed in early September.

in addition, the first-line treatment of treprozumab combined with cisplatin and gemcitabine for patients with locally recurrent or metastatic nasopharyngeal carcinoma, and the first-line treatment of treprozumab combined with paclitaxel and cisplatin for patients with unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma have been accepted by the European Medicines Agency (EM) and the UK Medicines and Health Products Administration (MHR).

Up to now, the company has extensively deployed a global commercialization network including emerging markets, and has reached commercialization cooperation in more than 50 countries with many overseas partners such as Coherus, Hikma, Dr. Reddy's, and Companda biotechnology, covering the Americas, the Middle East, North Africa, Southeast Asia and other regions. The company will maintain close communication with regional partners to accelerate the global commercial revenue of Treplimab.

Q: domestic sales strategy, sales situation and sales expectation of Treplimab under the current policy environment?

A: In the current policy environment, innovative pharmaceutical companies need to value cash flow more and make reasonable plans for personnel and costs. Since 2022, the company has continued to optimize the organizational structure of the commercialization team, greatly improving the execution and sales efficiency of the commercialization team, and making positive progress in commercialization. The company's basic strategy for commercialization has always been to adhere to the concept of academic promotion, combined with the clinical efficacy and characteristics of Treprimab, the latest research results, safety information, etc., to deliver immunotherapy and company product information to doctors, so that doctors Fully understand the product power of Treprimab to better meet the clinical needs of doctors and patients.

At present, based on the leading safety and efficacy, the brand power of Treplimumab has achieved remarkable results. In the first half of 2023, Treplimab achieved sales revenue of about 0.447 billion yuan, an increase of about 50% year-on-year. The growth rate of sales revenue far exceeded the growth rate of sales expenses, and the per capita yield of sales staff also increased significantly. In the future, in an environment where the industry tends to be compliant, Treplimab is expected to more fully reflect the therapeutic value advantage and achieve sustainable revenue growth.

In addition, in the first half of this year, the data read-out of four large phase III clinical studies with teripilumab was completed, including perioperative period of non-small cell lung cancer (Neotorch study, NCT04158440), advanced triple negative breast cancer (TORCHLIGHT study, NCT04085276), first-line treatment of renal cell carcinoma (RENOTORCH study, NCT04394975) and first-line treatment of extensive stage small cell lung cancer (EXTENTORCH study, NCT04012606), and the corresponding new indications for listing applications have been accepted by NMP, so far, ten indications of Treplimab have been approved or accepted by NMP. First-line kidney cancer, advanced triple-negative breast cancer, and non-small cell lung cancer perioperative treatment are all indications that the company is leading in progress and has a long medication cycle. If approved smoothly, the company will gain a first-mover advantage in the marketing of the corresponding indications. In addition, a number of Phase III registered clinical trials of Treplimab are also in progress, covering front-line and perioperative indications with long treatment cycles and large number of patients, such as first-line liver cancer, perioperative period of esophageal squamous cell carcinoma, postoperative assistance for gastric cancer, and postoperative assistance for liver cancer. The approval of the above indications and the smooth progress of the registration clinic, which is underway and will soon usher in data readout, will also continue to improve the commercialization of Treplimab in China this year and in the future.

Q: Early project planning, key promotion of variety and personnel structure adjustment?

A: In the first half of 2023, the company's research and development expenses decreased by 11% year-on-year, mainly due to controlling the research and development investment of the pipeline in the initial stage, optimizing the allocation of resources, and focusing on the research and development pipeline with more innovation potential, differentiation and leading progress.

at present, the company has early projects covering various drug types in the fields of tumor, self-immunity, metabolism and nervous system, including anti-Claudin18.2 DC (code JS107), PI3K-α oral small molecule inhibitor (code JS105), siRN drug targeting NGPTL3 (code JS401), anti-CGRP monoclonal antibody (code JS010), CD20 x CD3 bispecific antibody (code JS203), etc. The company's clinical team will regularly comb the data and competitive landscape of early-stage projects to push more advantageous products into the registered clinical trial phase as soon as possible.

In addition, the company has also adjusted the structure and personnel of the clinical team, introduced industry talents, and reduced redundancy to improve research and development efficiency and reduce costs. The company's clinical structure includes teams in medicine, operations, regulatory registration, clinical pharmacology, quality management, etc. Each team works together to maintain efficient internal communication. As of the end of the reporting period, the number of research and development personnel decreased compared with the same period of the previous year, but the team's execution efficiency was significantly improved. In the first half of the year, there were bright performances in the readout of registered clinical data, application for listing, and advancement of research pipelines.

Junshi Bio (688180) is mainly engaged in the discovery and development of innovative drugs, as well as clinical research and development and commercialization on a global scale.

junshi biological 2023 report showed that the company's main revenue was 0.67 billion yuan, down 29.21 percent from the same period last year. Net profit attributable to parent -0.997 billion yuan, down 9.32 percent from the same period last year; Deduct non-net profit -0.971 billion yuan, down 2.64 percent from the same period last year; In the second quarter of 2023, the company's single-quarter main revenue was 0.415 billion yuan, up 30.97 percent from the same period last year. Net profit -0.454 billion yuan, up 12.02 year-on-year; Single-quarter non-net profit -0.412 billion yuan, up 20.28 year-on-year; Debt ratio 25.42, investment income -28.0706 million yuan, financial expenses -42.1465 million yuan, gross profit margin 62.35.

The stock has been rated by three agencies and bought by three in the last 90 days.

The following is detailed earnings forecast information:

FinancingThe securities lending data showed that the stock's net financing outflow in the past three months was 63.7295 million, and the financing balance decreased; the net outflow of securities lending was 0.156 billion, and the securities lending balance decreased.

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