is only one step ahead of commercialization, and and platinum pharmaceutical "sell" two drugs one by one.
Recently, Hebo Pharmaceutical has issued two announcements in succession, announcing the authorization of batolizumab to Shiyao Group and terminated the clinical phase III trial of its core product Tenacept.
is "sold"
According to the announcement, Hebo Pharmaceutical and Shi Pharmaceutical Group's subsidiary Enbipu Pharmaceutical entered into an exclusive authorization agreement for batolizumab. Enbipu Pharmaceutical obtained the exclusive authorization for the development, production and commercialization of batolizumab in Greater China. As the consideration of obtaining the exclusive authorization of the product in the region, Enbipu Pharmaceutical agreed to pay the following payments to Shanghai Hebo Pharmaceuticals, including a down payment of RMB 150 million, a potential technical milestone payment of up to RMB 50 million, a potential development and regulatory milestone payment of up to RMB 400 million, and a potential sales milestone payment of up to US$ 57.5 million (approximately RMB 411 million). Based on this calculation, the total transaction amount has exceeded 1 billion yuan.
It is understood that batolizumab (HBM9161) is a whole human monoclonal antibody that selectively binds and inhibits neonatal FcRn. It can block the binding of FcRn-IgGs to each other and accelerate the clearance of IgG in vivo, and is expected to cover 60-70 pathogenic IgG-mediated autoimmune diseases. The drug was originally developed by Hanall Pharmaceuticals. In September 2017, HeBo Pharmaceuticals reached a partnership with the company to acquire the Greater China interests of two new biologics for up to $81 million in advance, development, registration and sales milestones, as well as a royalty based on net sales, one of which is batolizumab.
Currently, Hebo Pharmaceutical is developing bartolizumab in Greater China for multiple indications such as myasthenia gravis (MG), immune thrombocytopenia (ITP), optic neural crest myelitis lineage disease (NMOSD), thyroid-related eye disease (TED), chronic inflammatory demyelinating multiple radar neuropathy (CIDP) and pemphigus (PV).
It is worth mentioning that batolizumab is the first FcRn inhibitor developed in Greater China. It was certified as the first "breakthrough treatment" for the indication of myasthenia gravis in 2021. This indication was expected to be approved for marketing in 2023.
Myasthenia gravis indications have been included in the "First Rare Disease Catalog". Relevant statistics show that the current incidence of myasthenia gravis indications in China is 0.68/100,000 people, with about 200,000 patients. Mainstream therapies include the use of cholinesterase inhibitors, glucocorticoid , immunosuppressant , intravenous injection of immunoglobulin , plasma replacement, anti-CD20 monoclonal antibody and thymus resection, but these therapies have certain limitations, such as side effects. Therefore, there are a large number of unmet clinical needs in the field of myasthenia gravis treatment. According to Frost and Sullivan, with the increase in the diagnosis and treatment rate of myasthenia gravis in China and the introduction of innovative therapies, the market size is expected to grow rapidly, reaching US$1.078 billion in 2030.
In terms of FcRn inhibitor approval, there is currently only one product in the world that has been approved, namely Vyvgart developed by argenx SE. It was approved by the US FDA in December last year to treat systemic myasthenia gravis (gMG), and achieved a net sales of US$21.2 million in the first quarter of this year.
Therefore, bartolizumab was once highly expected. Once it is approved for marketing, it may bring good economic benefits to Hebo Pharmaceutical. But now, Hebo Pharmaceutical has "monetized" it in advance. Hebo Pharmaceutical said that authorizing bartolizumab can obtain corresponding income on the one hand, and on the other hand, it can also redistribute its resources to the development of other projects such as HBM4003, HBM7008 and HBM9378, as well as other assets in the preclinical stage to expand its product portfolio.
is stopped
If product authorization can bring rich cash flow to support other project development, then stopping the clinical development of related products is a helpless choice for another aspect of platinum pharmaceuticals.
This time, the clinical development of another blockbuster drug is used to treat moderate to severe dry eye diseases. Based on the observed trend of insufficient efficacy, the Independent Data Monitoring Committee (IDMC) recommended that Platinum Medicine end the Phase III clinical trial. Therefore, no new subjects will be enrolled in this trial.
Tenarcept was also originally developed by Hanall Pharmaceuticals and was introduced with batolizumab. Because of the huge unmet clinical demand in the field of dry eye disease,Tenarcept is also regarded as the "dear" of Hebo Pharmaceutical. Hebo Pharmaceutical once said that it will submit an application for marketing next year based on its relevant clinical data.
Dry eye disease is a chronic ocular surface disease caused by multiple factors. According to Frost & Sullivan statistics, about 86 million people in China suffered from moderate to severe dry eye disease in 2019. With the aging of the population and the use of electronic products, the number of patients will grow rapidly, and will increase to about 106 million by 2030. According to the calculation data, according to the current 86 million dry eye patients, the market size of this field exceeds 2.5 billion yuan.
At this stage, domestic treatment of dry eye disease mainly relies on artificial tears to relieve symptoms. For moderate to severe dry eye diseases, only cyclosporine eye drops, an anti-inflammatory drug has been approved. The application for the new drug of Cyclosporine A Eye Gel of Makoto Ophthalmology was accepted by in June this year, and has not been approved so far.
At the same time, many domestic companies are also planning to develop dry eye diseases, including Hengrui Medicine , Li's Pharmaceutical Factory, Weimou Bio, Yisheng Bio, etc. The simultaneous competition among many companies, coupled with the unsatisfactory clinical trial data, finally allowed Hebo Pharmaceutical to "stop the loss in time". However, Hebo Pharmaceutical stated that it will continue to follow up for existing subjects in accordance with the clinical trial plan, and will further evaluate and decide on the future plan for the development of Tenacept based on the remaining trials collected all data, which does not guarantee that it will be able to successfully market Tenacept.
The Way to Survive
Regarding this time, he and Platinum Pharmaceutical "sell" two drugs one after another. The industry said that this is actually the "way to Survive" in the current capital winter.
According to the semi-annual report data released by Hebo Pharmaceutical in August, in the first half of this year, Yinghebo Pharmaceutical achieved revenue of US$27.63 million, a year-on-year increase of 1149.10%, and the book cash balance was US$200 million, but the R&D expenses in the same period were as high as US$84 million, administrative expenses were US$15 million, and the losses also expanded by 18.67% year-on-year to US$73 million. If the funds are consumed according to this amount, there will be no funds to make up for the middle, and Hebo Pharmaceutical's cash flow will not last for two years.
Some industry insiders said that the current investment in innovative drugs is affected by the economic environment, and the inflow of funds will decrease in the next few years, which will directly affect the investment in innovative drugs research and development. With funding constraints, Biotech shrinks its front line, selects to focus on developing some more favorable projects, or cooperates with some other large companies to accelerate commercialization and achieve "self-generating" is a way to break through.
Previously, Hebo Pharmaceutical authorized a preclinical CLDN18.2xCD3 bispecific antibody (HBM7022) to AstraZeneca to obtain cash reflux. Hebo Pharmaceuticals received a $25 million advance payment, as well as a total milestone payment up to $325 million and royalties.
It is also worth noting that except for tenaciper and batolizumab, HeBM Pharmaceutical's existing R&D pipeline products are extremely limited, among which the fastest-progress HBM4003 is a fully human anti-CTLA-4 antibody. Its semi-annual report shows that HBM4003 single drug and the indications for combined treatment with PD-1 are in the Ib/II trial stage, and there is another bispecific antibody HBM7008, which targets the tumor-related antigen B7H4/4-1BB, was approved for clinical trials in June this year.
Affected by the above news, Hebo Pharmaceutical's stock continued to fall today, closing at HK$1.35 per share, with a total market value of HK$1.037 billion.
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