On December 16, 2024, Fujian Guangshengtang Pharmaceutical Co., Ltd. (stock abbreviation: Guangshengtang; Stock Code:300436. SZ) announced that the company's innovative hepatitis B treatment drug GST-HG141 (English generic name: Neracorvir; Chinese generic name: nerecovir) was added to the Breakthrough Therapy List, which is expected to accelerate the development of the drug.

Year-to-date, Guangzhou Xiangxue Pharmaceutical (Rights Protection) Co., Ltd. (stock abbreviation: Xiangxue Pharmaceutical; Stock Code:300147. SZ), Mabwell (Shanghai) Biotechnology Co., Ltd. (stock abbreviation: Mabwell; Stock Code:688062. SH), Jiangsu Hengrui Pharmaceutical Co., Ltd. (stock abbreviation: Hengrui Pharmaceutical; Stock Code:600276. SH) and other listed companies have also been included in the Breakthrough Therapy Variety List.

Source: photo.com

Guangshengtang's innovative drug for the treatment of hepatitis B was included in the Breakthrough Therapy List

On December 16, Guangshengtang announced that the innovative drug for the treatment of hepatitis B, Nericovir, an innovative drug for the treatment of hepatitis B of Fujian Guangsheng Zhonglin Biotechnology Co., Ltd., a subsidiary of the company's innovative drug holding, was included in the list of breakthrough therapy varieties by the Center for Drug Evaluation of the National Medical Products Administration (hereinafter referred to as the Drug Evaluation Center).

According to the announcement, the proposed indication of nerecovir is chronic hepatitis B, which is a new mechanism of treatment drug, and the existing data suggest that it has obvious clinical advantages, which meets the relevant requirements of the "Measures for the Administration of Drug Registration" and the "Announcement of the State Food and Drug Administration on the Release of the Working Procedures for the Review of Breakthrough Therapy Drugs (Trial)".

Guangshengtang said that nerecovir is a new type of hepatitis B core protein or nucleocapsid modulator, which belongs to a new class of anti-hepatitis B virus drugs under development with a new mechanism, and the company has its global independent intellectual property rights. To date, no similar product has been launched worldwide.

Nerecovir has obtained a study summary report for the Phase II clinical trial in September 2024. The results of the study showed that nerecovir had a good safety profile and significant efficacy in patients with chronic hepatitis B hypoviremia, and had a further significant inhibitory effect on hepatitis B virus DNA on the basis of nucleoside drug therapy.

At the same time, the nerecovir administration group (including the high-dose and low-dose groups) also had a significant inhibitory effect on the pgRNA of hepatitis B virus. Nucleos(t)ide drugs do not have any inhibitory effect on hepatitis B virus pgRNA. These results show a novel antiviral mechanism of action that distinguishes nerecovir from and is superior to nucleos(t)ide drugs.

Guangshengtang said that nerecovir is a potential first-in-class innovative drug in the world, which is expected to promote new progress in the treatment of hepatitis B. The inclusion of nerecovir in the Breakthrough Therapy Variety List is a recognition of its obvious clinical advantage data, and the company will accelerate the Phase III pivotal registration clinical trial under the guidance of the Drug Evaluation Center to provide patients with new treatment options as soon as possible.

Guangshengtang is committed to creating innovative drugs belonging to Chinese, and contributing to the core strength of promoting the R&D, innovation and development of independent and controllable drugs in China. Through independent research and development, cooperative development and industrial mergers and acquisitions, Guangshengtang has formed a layout of liver health product lines with nucleos(t)-based anti-hepatitis B virus drugs and liver-protecting drugs as the core, covering hepatitis B, hepatitis C, fatty liver, liver fibrosis, liver cancer and other liver health product lines, and actively expanding products in the fields of cardiovascular and men's health.

In terms of innovative drugs, Guangshengtang has successively established six innovative drugs in the fields of anti-novel coronavirus, liver cancer, non-alcoholic steatohepatitis, liver fibrosis, and clinical cure of hepatitis B.

Among them, in the field of hepatitis B, in 2015, Guangshengtang proposed the "Peak Plan" of the clinical cure roadmap for hepatitis B, and clinically cured hepatitis B through the multi-target combination of GST-HG131/GST-HG121, GST-HG141 and existing nucleos(t)-based anti-hepatitis B virus drugs.

In addition to nerecovir, which was included in the Breakthrough Therapy Designation, GST-HG131 is a hepatitis B surface antigen inhibitor with an innovative therapeutic mechanism that inhibits hepatitis B surface antigen secretion, and was granted clinical trial notice in March 2020, making it the first hepatitis B surface antigen (HBsAg) inhibitor approved for clinical trial in China. In September 2024, GST-HG131 completed the Phase II.a clinical trial of chronic hepatitis B, and achieved a positive effect significantly better than that of placebo control.

GST-HG121 is a hepatitis B surface antigen inhibitor that acts by degrading RNA and can effectively inhibit HBsAg expression. In July 2022, the first subject in the phase I clinical trial was successfully enrolled.   

During the year, a number of listed companies also included drugs in the Breakthrough Therapy List

Year-to-date, Xiangxue Pharmaceutical, Mabwell, Chongqing Zhixiang Jintai Biopharmaceutical Co., Ltd. (stock abbreviation: Zhixiang Jintai; Stock Code:688443. SH), Sichuan Baili Tianheng Pharmaceutical Co., Ltd. (stock abbreviation: Baili Tianheng; Stock Code:688506. SH), Hengrui Pharmaceutical and many other listed companies have also included drugs in the list of breakthrough therapy varieties.

On July 30, Xiangxue Pharmaceutical announced that the TAEST16001 injection declared by the company's subsidiary, Guangdong Xiangxue Precision Medical Technology Co., Ltd. (hereinafter referred to as Xiangxue Life Science), was included in the list of breakthrough therapy varieties by the Drug Review Center. According to the announcement, TAEST16001 injection is intended to be used for the treatment of soft tissue sarcoma with tissue genotype HLA-A*02:01 and positive expression of tumor antigen NY-ESO-1.

Xiangxue Pharmaceutical said that Xiangxue Life Science is the leading enterprise in TCR-T cell immunotherapy. TAEST16001 Injection is the first TCR-T cell therapy product developed based on Xiangxue Life Sciences' TCR-T cell product technology development platform and production preparation system, and it is also the first TCR-T cell product in China to obtain IND approval and carry out clinical research.

On August 12, Mabwell announced that 9MW2821, an innovative drug developed by the company with independent intellectual property rights, was included in the list of breakthrough therapy varieties by the Drug Evaluation Center for the treatment of locally advanced or metastatic urothelial carcinoma that has failed previous platinum-based chemotherapy and PD-(L)1 inhibitor therapy.

Mabwell said that 9MW2821 is the company's new site-directed conjugated ADC drug targeting Nectin-4, which is an innovative product developed by the company using the ADC drug development platform, and realizes the site-specific modification of antibodies through conjugation technology linkers with independent intellectual property rights and optimized ADC conjugation process.

9MW2821 is the first drug with the same target in China to carry out clinical trials, and it is also the first drug with the same target in the world to disclose clinical efficacy data in the indications of cervical cancer, esophageal cancer and breast cancer. In addition to being included in the Breakthrough Therapy Variety List by the Drug Review Center, 9MW2821 also received multiple review designations from the U.S. Food and Drug Administration (FDA) in 2024.

On August 13, Zhixiang Jintai announced that the company's product GR1803 injection indication "relapsed and refractory multiple myeloma that has received at least 3 lines of prior therapy" was included in the breakthrough therapy drug program by the Drug Review Center. 

On October 8, Baili Tianheng announced that the company's self-developed innovative biological drug BL-B01D1 for injection is used for patients with locally advanced or metastatic non-squamous non-small cell lung cancer with EGFR-sensitive mutations who have failed EGFR-TKI treatment, as well as for the treatment of previously anti-PD-1/ Two indications for patients with locally advanced or metastatic EGFR wild-type non-small cell lung cancer who have failed platinum-based chemotherapy have been granted Breakthrough Therapy Designation by the Center for Drug Review. As of the date of the announcement, three indications of BL-B01D1 have been included in the Breakthrough Therapy Variety List by the Center for Drug Review.

On October 14, Hengrui Pharmaceutical announced that the company's HR19042 capsules for the treatment of active autoimmune hepatitis were included in the list of breakthrough therapy varieties by the Drug Evaluation Center. According to the announcement, HR19042 capsule is an oral enteric-coated sustained-release capsule, which can selectively exert anti-inflammatory effects on the liver. Hengrui Pharmaceutical said that for autoimmune hepatitis, there is no similar product approved for this indication in China.

In addition, on December 16, Hengrui Pharmaceutical announced that its subsidiary Shanghai Hengrui Pharmaceutical Co., Ltd.'s SHR-A2102 for injection for the indication of monotherapy for the treatment of locally advanced or metastatic urothelial carcinoma that has failed previous platinum-containing chemotherapy and PD-(L)1 inhibitor therapy was included in the list of proposed breakthrough therapy varieties by the Drug Review Center, and the publicity period is 7 days.