Domestic oncology NGS enterprises go overseas to find technological and commercial leaps

At the beginning of the new year, a number of companies announced the progress of their products going overseas. On January 3, Burnstone Medical announced that its pan-cancer early screening products were recognized by the FDA as breakthrough therapies. Subsequently, Shihe Genomics announced that the MRD monitoring products of pan-cancer species obtained the EU CE certification.

Although the threshold for CE certification is not high, it is only a small test; The FDA's breakthrough medical device designation has a threshold, which is only an encouragement in the early stage of research and development, and there is still a certain distance from the actual approval and even commercialization of the product.

But, regardless, these are still good news for the entire oncology NGS industry.

After all, this means that domestic oncology NGS companies are no longer trapped in involution, but hope to break through in more mature overseas markets and complete the leap of technology and business.

It belongs to the era of tumor NGS navigation, although it has not yet arrived, but it will eventually come.

01

Rolled up the tumor NGS industry

Back a few years ago, the oncology NGS industry was still a pig on the wind, and "unicorns" were running everywhere. At the moment, many people may not think so.

This can be seen through the stock price of Burnstone Medical. In 2021, Burnstone Medical's share price fell by 58%. On the basis of the slash, its share price fell by another 78% in 2022, truly interpreting "there is no minimum, only lower".

This is not surprising. In all segments of the oncology NGS industry, the domestic market is still in its infancy. The implication is that the market may still need to be cultivated to grow, and the capacity is limited at this stage, and the future prospects are worrying.

What's more, there are too many players in the limited market, and there are signs of involution in the industry early on. Whether it is companion diagnosis, MRD, or single cancer species, pan-cancer early screening products, the entrants are like carp across the river.

As early as 2020, Yongyuan announced that its pan-cancer early screening product PanSeer will be commercialized in 2023 at the earliest.

In the same year, Burnstone Medical also launched the first prospective, multi-center pan-cancer early screening clinical research project "PREDICT" in China.

According to incomplete statistics, there are currently more than 10 domestic enterprises that have entered the early screening of pan-cancer species, including Börcheng, Laimeng Juntai, Siqin Medical, Jiyinga, Tongshu Gene and other players, all of which have pan-cancer early screening research or clinical products.

Whether it is for the development of the enterprise itself or for the development of the entire oncology NGS industry in China, this kind of involution is not a good phenomenon.

Oncology NGS companies may be in the time to move from involution to outvolution.

02 

Foreign moons are more "round"

What is a roll? It's nothing more than going out.

The reason is simple, foreign moons are more "round". Especially in the European and American markets, the commercialization logic of tumor NGS has been verified. The companion diagnostic market has been fully verified, even pan-tumor early screening products, which are also in the early stage and whose products have not yet been fully validated, have entered the "big sale" stage.

In June 2021, GRAIL launched Galleri, the world's first pan-cancer early screening product. In the third quarter of 2022, Lumina, the parent company of GRAIL, expects Galleri to have sales of about $50 million to $60 million last year.

In the absence of health insurance support, Galleri's commercial performance is enough to prove that the moon overseas is indeed rounder again.

You know, although the price of Galleri is not low, nearly a thousand dollars ($950), there is still no shortage of buyers.

Currently, Galleri's commercialization channels include the physician channel, the large enterprise channel, and the commercial insurance/health system channel.

For Galleri, the highest acceptance is naturally the group of people who are not bad money, and this group of people usually has perennial doctor consultants. Moreover, this part of the population is not small, GRAIL previously predicted in the prospectus that there are about 1 million in the United States.

Based on this, the group of doctors with health testing needs has become an important partner in GRAIL's development, which is one of the predictors of Galleri's rapid expansion.

Similarly, the insurance/health system and large corporations don't get too bothered by Galleri's price factor.

For the commercial insurance/health system, the cost of treatment can vary from early detection of cancer to late detection of cancer in the insured, and the cost of treatment can be tens of thousands or even hundreds of thousands of dollars.

For large enterprises, Galleri has become one of the employee benefits, the price is not too high, and it can also reflect humanistic care. As a result, commercial insurance and large enterprises have also become the main channels for Galleri's sales.

The domestic market development stage and payment ability have always been a major obstacle to the development of the tumor NGS industry.

In this case, going to sea has naturally become a way out that oncology NGS companies have to consider. To put it bluntly, the domestic market is still in its early stages, why not go to the mature market development and look for opportunities first?

 03 

Look for technological and commercial leaps

On January 3, Burnstone Medical announced that its pan-cancer early screening products were recognized as breakthrough medical devices by the FDA. This is also the second domestic enterprise to win this award for early screening products after Geneson.

This is enough to show that going to sea and entering the new world is not only a beautiful vision, more and more companies are trying to take steps.

Of course, more mature markets also have higher requirements for the technology of enterprises. Whether it is CE certification or breakthrough therapy, it is far from enough.

For a company to be recognized, it must show real skills (clinical data). Otherwise, there may be an endless abyss waiting for the enterprise.

In this regard, Guardant Health is a typical negative textbook.

On December 15, 2022, Guardant Health announced ECLIPSE study data from its colorectal cancer liquid biopsy product Shield.

With the announcement of the results, Guardant Health's stock price fell by 27%, which can be called the first tragedy in the field of early tumor screening in 2022; Shares of rival Exact Sciences jumped 16 percent.

The reason is not difficult to understand. The results showed that Shield had a sensitivity of 83% and a specificity of 90% for colorectal cancer;

The competitor Exact Sciences' Cologuard has a sensitivity of 92.3% for early colorectal cancer and 42% for adenocarcinoma, respectively.

In the US colorectal cancer early screening market, detection performance is the most core. Previously, there have been stories of rollovers in the field, with the protagonist being Epi ProColon.

Epi ProColon is the first approved colorectal cancer screening product in the United States, although it has a compliance advantage, but the product performance is not outstanding, the overall sensitivity is only 68%, and the detection rate of adenocarcinoma is as low as 11%, which is far from the gold standard colonoscopy, and it is not as good as Cologuard.

This has also led to the fact that Epi ProColon is rarely mentioned in the market because it is not endorsed by doctors and is still excluded from clinical practice guidance.

These rollover cases are enough to show that although the commercialization environment in the overseas market is more mature, the market also has a higher pursuit of product performance. In fact, whether it is innovative drugs or innovative devices, it is usually the players with the most outstanding performance that win most of the market.

Challenges and opportunities coexist. For those oncology NGS companies that want to go overseas and complete the technical and commercial leap, they must have excellent product performance.

Of course, no matter what the outcome is, the ability to bravely go out and try to seek recognition from foreign regulatory systems for oncology NGS companies is worthy of recognition.