Yaojie Ankang (Nanjing) Technology Co., Ltd. (hereinafter referred to as “Yaojie Ankang”) once again submitted an IPO application to the Hong Kong Stock Exchange.

As early as August 2021, Yaojie Ankang submitted an IPO application to the Hong Kong Stock Exchange. Since then, it has submitted A-share IPO consultation and filing materials to the Securities Regulatory Authority, but no progress has been made.

The core drug of Yaojiekang is tinengotinib (TT-00420), an MTK inhibitor that simultaneously targets FGFR/VEGFR, JAK, and Aurora. It is mainly used to treat cholangiocarcinoma, and has now entered phase 2 clinical trials in China.

Since core drugs have not yet been commercialized, the current revenue of Pharmaceutical Jieankang is almost zero. Net losses in 2022 and 2023 are 0.252 billion yuan and 0.343 billion yuan, respectively.

All of this has put a certain amount of financial pressure on Yaojiekang. As of the end of 2023, the amount of cash and cash equivalents was $0.497 billion, plus the low risk wealth management products it holds, and the total amount still exceeds 0.8 billion yuan.

According to the 2023 net loss estimate, this funding may help Yaojie Ankang last at least 2 years.

This is the third time that Yaojie Ankang is sprinting to an IPO.

In August 2021, Yaojie Ankang submitted an IPO application to the Hong Kong Stock Exchange, but has not entered the hearing process since then.

After the initial sell-off in Hong Kong was unsuccessful, Yaojie Ankang switched to A-shares.

In October 2022, Yaojie Ankang submitted listing guidance materials to the Securities Regulatory Bureau under the sponsorship of CITIC Securities. As of April this year, after experiencing 6 rounds of IPO counseling, there have been no new developments.

Until now, Yaojie Ankang has once again returned to the embrace of the Hong Kong market.

In the past three years of wandering, since the core drugs of Pharmaceutical Jieankang have never been commercialized, the revenue is basically zero, and the fundamentals have not changed much.

However, research and development of Tinengotinib, the core drug of Pharmaceutical Jieankang, has been further advanced.

Tinengotinib is mainly used to treat cholangiocarcinoma. Currently, phase 3 international multicenter clinical trials are being conducted in the US, South Korea, the United Kingdom, the European Union, etc., while China is undergoing phase 2 key clinical trials.

“We expect priority approval of Tinengotinib with conditions in China, followed by approval in other regions.” Yao Jieankang pointed out.

Currently, cholangiocarcinoma is still treated as an incurable disease, and the survival rate is low. The 5-year survival rate for cholangiocarcinoma in the US is about 10%, which is lower than the 5-year survival rate for all cancer types of 69%. For example, Nintendo's president, Satoshi Iwata, died of cholangiocarcinoma.

TinengoTinib is characterized by simultaneously targeting the three pathways FGFR/VEGFR, JAK, and Aurora.

Among them, FGFR is the key pathway.

FGFR includes 4 subtypes from 1-4, whose dysfunction or causes cancer. The study found that FGFR variants occurred in urothelial cancer, cholangiocarcinoma, endometrial cancer, and breast cancer.

“The unique binding model with FGFR enables tinengotinib to overcome polyclonal mutations and target cancers caused by FGFR (such as FGFR mutated cholangiocarcinoma and pan-FGFR solid tumors), and the unique combination of key pathways makes it effective against various cancer types (including prostate cancer, breast cancer, and biliary tract cancer).” Yao Jieankang pointed out.

This means that in the future, Jieankang will have the opportunity to explore more possibilities of Tinengotinib in other indications.

However, tinengotinib is not the only drug that targets FGFR and can be used to treat cholangiocarcinoma.

The FDA has approved a total of 3 FGFR inhibitors for the treatment of cholangiocarcinoma: fubatinib from the Japanese pharmaceutical company Taiho Oncology, Novartis infigratinib, and pemitinib from the US pharmaceutical company InCyte.

Pemitinib is the first FGFR inhibitor approved to treat cholangiocarcinoma, and has been introduced to China by Cinda Biotech (1801.HK).

Currently, Tinengotinib's advantage over competitors is that it is the first and only drug in the world that has entered the registered clinical stage and is being studied for patients with recurrent or refractory cholangiocarcinoma with FGFR inhibitors.

Generally understood, tinengotinib is still effective in solving drug resistance problems caused by the use of FGFR inhibitors to treat cholangiocarcinoma, and can fill the current treatment gap, that is, back-line treatment.

“Nearly all patients will progress after receiving FGFR inhibitors. “NCCN or CSCO guidelines lack treatment recommendations for FGFR inhibitors after resistance, so there is an unmet clinical need.” Yao Jieankang pointed out, “Currently, there are no recommended options for third-line treatment of cholangiocarcinoma; patients can only choose chemotherapy whose clinical benefits are unclear.”

According to the results of a US clinical study provided by the drug Jieankang, as of March 28, 2024, 43 patients with advanced cholangiocarcinoma who had previously used FGFR inhibitors were treated with tinengoTinib, ORR (objective remission rate) was 30%, DCR (disease control rate) was 93%, and the median PFS (survival without progression) was 6 months.

However, with the average sales growth rate of pemitinib for frontline treatment of cholangiocarcinoma, the sales prospects for tinengotinib as later-line treatment are still unknown.

According to Incyte's annual financial reports, the product revenue of pemitinib, which was launched in 2020, was 0.069 billion US dollars in the year after launch, an increase of 165% over the previous year.

However, growth has stalled since then, and sales revenue for both 2022 and 2023 remained around $0.084 billion.

This may all bring more uncertainty to Pharmaceutical Jieankang's subsequent commercialization of Tinengotinib.

Looking at it this way, if Pharmaceutical Jieankang wants to expand the sales scale of Tinengotinib in the future, it may still need to explore more indications.

Currently, the drug Jieankang is still promoting clinical trials of Tinengotinib to treat prostate cancer, breast cancer, and biliary tract cancer. Whether this can bring more possibilities to this drug remains to be seen.

Pharmaceutical Jieankang is also promoting clinical development of a total of 5 pipelines: TT-00973 for advanced solid tumors, TT-01488 for B-cell lymphoma, TT-01688 for nonspecific ulcerative colitis or atopic dermatitis, TT-00920 for heart failure, and TT-01025 for non-alcoholic fatty liver disease.

The layout of some indications is indeed a promising direction for the market.

In addition to Tinengotinib, the drug TT-01688 is currently progressing rapidly in the research pipeline, and its use in the treatment of atopic dermatitis has entered phase 2 clinical trials in China.

There is indeed a broad market for atopic dermatitis. Market Us predicts that by 2032, the global atopic dermatitis treatment market will reach $24.5 billion.

This has attracted many companies to join the battle of drugs to treat autoimmune diseases.

However, TT-01688 was not self-developed by Yaojiekang. Instead, it was introduced from the Korean pharmaceutical company LG Chem. It only received the rights of the Greater China region, which means that it may also be difficult for TT-01688 to carry the banner of Yaojie Ankang's revenue.

TT-01025, which is still in phase 1 clinical trials, is mainly used to treat non-alcoholic fatty liver disease, and this indication is also seen as having prospects of over 10 billion US dollars.

However, TT-01025 was “returned”, bringing more uncertainty to the future of this drug.

In 2020, Yaojie Ankang authorized the commercial rights of TT-01025 to LG Chem. However, the two sides terminated the agreement in 2023, and the future commercialization rights of TT-01025 have also returned to Pharmaceutical Jieankang.

Overall, the total number of clinical pipelines laid out by Yaojie Ankang has reached 6, all of which have put some pressure on its finances.

In 2023, the R&D cost of Yaojie Ankang reached 0.344 billion yuan, but the amount of cash and cash equivalents during the same period was only 0.497 billion yuan.

However, Yaojie Ankang's current assets can still be “first aided.” As of the end of 2023, the amount of financial assets held by Yaojie Ankang was 0.342 billion yuan measured at fair value and changes included in current profit and loss.

According to Yaojie Ankang's prospectus, the financial assets measured at fair value and whose changes are included in current profit and loss mainly include 5 capital protected structured deposits issued by China CITIC Bank, Bank of Nanjing, and China Merchants Bank, and 1 wealth management product of CITIC Securities. The risk is relatively manageable.

Based on this calculation, Yaojie Ankang's quick-acting capital still reached 0.839 billion yuan.

Based on a net loss of 0.343 billion yuan in 2023, the capital in Yaojie Ankang's hands can last at least 29 months.

“We will continue to closely monitor operating cash flow and anticipate the next round of financing if necessary, with a buffer period of at least 12 months.” Yao Jieankang pointed out.