Performance fell by 79.8%. Is Geli's entry into the oncology field "a slow step" or a discovery of the blue ocean?

As the first biopharmaceutical company listed on the Hong Kong Stock Exchange in an "unprofitable" manner, when the latecomers Cinda and Junshi have achieved profitability, Gerry Pharmaceuticals is still in the "quagmire" of unprofitable.

A few days ago, Geli Pharmaceutical released its 2020 performance report.

On the other hand, Ge Li, who has "focused on the development and commercialization of innovative drugs for hepatitis C, HIV and hepatitis B" as its main business line, stated in the annual report that the company will focus on NASH, tumor lipid metabolism and oral administration from 2021.

Is Ge Li looking for transformation?

01.

Guli Pharmaceutical released its 2020 performance report on March 30.

Obviously, the domestic hepatitis C drug market has been significantly compressed by the "soul bargaining" of the medical insurance negotiations in 2019.

In addition, the R&D expenditure of Gerry Pharmaceuticals decreased from 126 million yuan in 2019 to 109.

The hepatitis C drugs did not perform well, and Gale urgently needed other products to prove itself.

In November 2020, Gallite announced a change in the use of proceeds from the global sale to expand the clinical cure for hepatitis B and the research and development portfolio of non-alcoholic steatohepatitis.

The non-steatohepatitis market is currently one of the key areas of Gerry Pharmaceuticals.

About 25% of people in the world suffer from non-alcoholic steatohepatitis.

Relying on the research team established in the research and development of innovative hepatitis C drugs to empower research and development in the fields of chronic hepatitis B and non-steatohepatitis, Gally established the world's first-tier non-steatohepatitis product pipeline in two and a half years.

On February 25 this year, Clarence announced that the company's wholly-owned subsidiary Gan Lai Pharmaceutical's ASC41 oral tablet has been approved by the FDA to carry out clinical trials for non-alcoholic steatohepatitis indications and launched a global development plan.

The approval of the U.

The analysis believes that if ASC41 is clinically successful in the United States, it will reverse the current decline that Geria is facing.

02.
Arrived late, cut into the blue ocean of tumor layout?

"Starting from 2021, we will focus on the four major treatment areas of non-alcoholic steatohepatitis, tumor lipid metabolism and oral checkpoint inhibitors, hepatitis B clinical treatment and HIV/AIDS.
" In the 2020 annual report, Gerry clarified the company’s future development Four directions.

Unlike most biotech start-ups, Wu Jinzi, the founder of Geli, had a professional background in researching antiviral drugs abroad.
At the beginning of the establishment of Geli, he chose to use antiviral drugs as a breakthrough in research and development.
Eight years after its establishment, why did Gale choose to break into the already crowded tumor track?

Gery, which began to focus on tumor treatment, chose the treatment of glioblastoma as the breakthrough point for the first FASN inhibitor ASC40 in its innovative drug research and development pipeline, and successively invested in equity and signed an exclusive license agreement in 2019 and 2020.
In cooperation with Sagimet Biosciences (formerly 3-V Biosciences), we have obtained the exclusive development, manufacturing and commercialization rights of FASN inhibitor ASC40 and subsequent compounds for non-steat hepatitis and tumor indications in Greater China and some overseas.

Although the current homogeneity problem in the field of tumor treatment is serious, analysis believes that the FASN inhibitor track that Gerry chose to enter is still in the blue ocean.

Lipid metabolism plays a key role in many tumors.
Fatty acid synthase (FASN) is one of the most important proteins that regulate lipid metabolism.
Many solid tumors and hematological tumors overexpress fatty acid synthase, including glioblastoma, non-small cell lung cancer, breast cancer, ovarian cancer, prostate cancer, colon cancer, pancreatic cancer, and non-Hodgkin's lymphoma.

Relevant research data and academic papers show that in addition to the combination of fatty acid synthase inhibitors and anti-angiogenic drugs, fatty acid synthase inhibitors combined with signal transduction inhibitors and immunotherapy have the potential to treat a variety of tumors.
The song Li plan is to use ASC40 and chemotherapy to treat high-grade astrocytoma immediately after surgery and radiotherapy; and to treat a variety of solid tumors in combination with ASC40 and other therapies.

At the same time as the annual report was announced, Gale announced that the company will accelerate its investment in the oncology field and will carry out clinical trials of ASC40 (TVB-2640) combined with bevacizumab in China.

According to previously disclosed information, a phase II clinical trial of ASC40 (TVB-2640) combined with bevacizumab in the treatment of patients with first recurrence of high-grade astrocytoma initiated by the investigator and completed in the United States has achieved positive results , Gale plans to launch a randomized, double-blind, placebo-controlled pivotal phase II clinical trial of ASC40 (TVB-2640) combined with bevacizumab in China.
The trial population is the same as the US trial patient population (high-level star Patients with cell tumor recurrence for the first time).
Judging from the data published in the 2020 European Society of Medical Oncology Annual Meeting, ASC40 (TVB-2640) combined with bevacizumab is safe and well tolerated in this patient population.

On the track of the development of innovative drugs for tumor therapy, compared with the increasingly fierce competition for homogeneity of PD-1/PD-L1, CD19, HER2, VEGF/VEGFR and other targets, currently only ASC40 in the research and development of FASN inhibitors The clinical phase of research has already begun.
FASN inhibitors are also expected to be used in non-small cell lung cancer, rectal cancer, breast cancer, prostate cancer, and other solid tumors that highly express FASN during tumor progression.
The application market has great room for expansion.

Obviously, Song Li is in the first echelon of innovative research and development of tumor lipid metabolism pathway.

In the past few years, Gally has continued to develop in tumor lipid metabolism and oral PD-L1 small molecule inhibitors through a combination of external license introduction and internal independent research and development.
Judging from the annual report, the current tumor pipeline of Golly includes two mechanisms of tumor lipid metabolism and oral checkpoint inhibitors, with a total of four drugs.
In addition to ASC40, which is about to launch a key phase II clinical study in China, it also includes a new generation of FASN inhibitor ASC60, and two self-developed oral PD-L1 small molecule inhibitors.

Regarding the upcoming key phase II clinical study of ASC40, Wu Jinzi said: “The latest breakthrough in the phase II clinical trial in patients with first recurrence of high-grade astrocytoma shows that oral fatty acid synthase inhibitors can be used in a variety of solid tumors.
Play an important role in the treatment.
In the future, Gale will continue to cooperate with other pharmaceutical companies to develop a variety of drug solutions combined with fatty acid synthase inhibitors.
"

Original title: Performance fell by 79.
8%.
After the accidental hepatitis C drug crash, Geli entered the oncology field.
Is it "a slow step" or a discovery of the blue ocean?