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"kechuangban daily" september 30 (reporter zheng bingxun)recently, visen pharmaceuticals (hereinafter referred to as "visen pharmaceuticals"), which focuses on providing treatment solutions for endocrine diseases in china, submitted ipo documents to the hong kong stock exchange for the fourth time.

the product pipeline map of weisheng pharmaceutical shows that the company currently has 3 products under development, including 1 core product and 2 main drug candidates. in,the core product, lonapegsomatropin, is a once-weekly long-acting growth hormone replacement therapy used to treat growth hormone deficiency in children.(pghd, a short stature common in patients under 18 years of age due to insufficient growth hormone).

the two main drug candidates are navepegritide and palopegteriparatide, which are used to treat achondroplasia and chronic hypoparathyroidism respectively. navirpetide is also a long-acting treatment administered once weekly, and paropectin and teriparatide are administered once daily.

if weisheng pharmaceutical successfully lands on the hong kong stock exchange this time, it is expected to win the title of "the first growing stock in hong kong stocks". but at the same time,as no product has yet been commercialized, weisheng pharmaceutical is facing continued losses., and the cash on its books is being consumed rapidly year by year. if it cannot raise funds through ipo or other methods, it may be difficult to support the product until the launch date.

▌core products face multiple potential competitors

ipo documents show that ascendis pharma was jointly established in 2018 by three founding shareholders, ascendis pharma a/s, vivo capital, and sofinnova. in november of the year of its establishment, weisheng pharmaceutical signed three exclusive cooperation agreements with ascendis pharma, thereby introducing the above-mentioned 3 products including lonbeta somatostatin, navirpetide and paropate teriparatide, forming its own core product pipeline.

before ascendis pharma introduced the three products, ascendis pharma had already conducted relevant research on them, among which longbei growth promoter had the fastest progress.

specifically, ascendis pharma has conducted research on many children with growth hormone deficiency in three phase iii projects of lonbei somatropin. at present, the drug has also completed phase iii pivotal trials in china. compared to daily injections of short-acting human growth hormone, lonbeta is a once-weekly long-acting growth hormone (lagh) that has been proven to have a higher 52-week annualized growth rate (ahv). for short-acting human growth hormone.

data show that in 2023, there will be 8.1 million cases of dwarfism under the age of 18 in china, and 3.4 million cases of pghd during the same period. according to frost & sullivan, china's human growth hormone market has grown from 4 billion yuan in 2018 to 11.6 billion yuan in 2023, and is expected to grow to 28.6 billion yuan by 2030.by then, the lagh market size is expected to reach 21.1 billion yuan, accounting for approximately 73.8% of china's human growth hormone market size.

at present, one lagh therapy product has been approved for marketing in china. it is polyethylene glycol recombinant human growth hormone injection (jinsai zengxiao water injection) from changchun high-tech subsidiary jinsai pharmaceutical. the specific indication is to treat internal diseases. slow growth in children caused by source of growth hormone deficiency. abroad, in addition to ascendis pharma's skytrofa, lagh therapies from novo nordisk, pfizer, kinsey pharmaceuticals and other companies have also been approved for the treatment of pghd.

according to ascendis pharma's annual report, since the launch of lonbei somatropin in the fourth quarter of 2021, product sales revenue of 900,000 euros, 35.7 million euros, and 179 million euros have been obtained in 2021-2023 respectively. sales in 2024 are expected to be further reaching 220-240 million euros.

weisheng pharmaceutical revealed that the domestic bla for the company's longpei growth promoter was submitted in january 2024 and was accepted by the state food and drug administration in march of the same year. the bla is expected to be approved in mid-2025.weisheng pharmaceutical also stated that since there is currently only one lagh product in china and only a few products under development, it is expected that the competitive landscape of lagh will not be too fierce in the future.

however, a reporter from "kechuangban daily" found thatalthough the number of lagh products currently under research in china is not large, the research and development progress of some companies is comparable to that of weisheng pharmaceutical.

specifically, companies that are researching, developing and launching related products in china include but are not limited to i-mab biotech, tebao biotech, anhui anke, etc. among them, tebao biotech's 2024 semi-annual report shows that its y-type polyethylene glycol recombinant human growth hormone (ypeg-gh) has completed phase iii clinical research and received acceptance of drug registration application in january 2024. it is expected to be launched in 2025 the key progress of completing the launch of new drugs in october.

compared with longbei growth promoter, the other two products under development are expected to contribute commercial income to weisheng pharmaceutical later.

among them, paropelteriparatide is undergoing a phase iii pivotal trial in china and is expected to submit an nda to the state food and drug administration in the first half of 2025. paropate, teriparatide is currently the only parathyroid hormone replacement therapy that has begun clinical development in china. in 2023, the number of patients with hypoparathyroidism in china will be 410,100, and it is expected to reach 495,600 in 2030.

navirpetide has currently completed the double-blind phase of the phase ii clinical trial for the treatment of achondroplasia in china, and will complete the last visit of the last patient in the open-label phase of the trial in april 2024. however, weisheng pharmaceutical has not yet disclosed its nda schedule. in 2023, the number of patients with achondroplasia in china will be 51,200, and it is expected to reach 51,900 in 2030.

▌the cash on the account is in a hurry

as mentioned above, since no product has been approved for marketing, weisheng pharmaceutical has not received any sales revenue since its establishment, and only has a small amount of other revenue from government subsidies and other aspects. however, due to higher r&d expenses and management expenses,weisheng pharmaceutical has been in a state of loss, and it is expected that the net loss will increase significantly in 2024 with the transfer of technology and the development of localized production.

according to ipo documents, in 2022, 2023 and the first four months of 2024, weisheng pharmaceutical's research and development costs are 180 million yuan, 57.69 million yuan, and 25.77 million yuan respectively, and management expenses are 177 million yuan, 79.94 million yuan, and 25.77 million yuan, respectively. 35.15 million yuan.during the same period, weisheng pharmaceutical's net losses were 289 million yuan, 249 million yuan, and 60.32 million yuan respectively, with a total net loss of nearly 600 million yuan.

at the same time, the cash and cash equivalents on weisheng pharmaceutical's books decreased from 626 million yuan at the end of 2022 to 348 million yuan at the end of 2023, and further decreased to 330 million yuan by the end of april 2024.if the consumption rate for the whole year of 2023 is followed, and considering that more work will be carried out in 2024, the cash flow on weisheng pharmaceutical's books may not be able to support it until longbai growth promoter is approved for marketing.

since its establishment, weisheng pharmaceutical has received two rounds of financing. among them, series a financing was completed in 2018, when the company was established, by issuing a total of 40 million preferred shares to the founding shareholders with a cash consideration of us$40 million. series b financing was completed in early 2021, with a total financing of us$150 million. investors include red shirt china, orbo capital, sherpa investment, etc.

in order to alleviate financial constraints, weisheng pharmaceutical plans to prioritize the funds raised from this ipo for the bla work and commercial launch of its core product longbei somatotropin, and also for paromidate, teriparatide and navirbeta. clinical research on peptides, and others will be used for working capital, etc.

in fact, weisheng pharmaceutical is currently preparing for commercialization of the product for its expected launch, and has begun to build a commercialization team with expertise in endocrinology. among them, for longbei somatropin, which is in advanced progress, weisheng pharmaceutical plans to deploy a team of pediatric endocrinology medical representatives to cover public hospitals and private clinics.

in terms of specific cooperation, weisheng pharmaceutical has signed a cooperation agreement with shanghai pharmaceuticals holdings at the end of october 2023 to establish the necessary management framework that complies with the good manufacturing practice (gsp). in december of the same year, visun pharmaceuticals and wuxi biologics reached a cooperation agreement, and will begin commercializing the core products produced by wuxi biologics once the products receive marketing authorization applications.

in addition, in august this year, weisheng pharmaceutical also reached a cooperation with united family healthcare, which currently has more than 10 hospitals and more than 20 clinics in china. weisheng pharmaceutical stated that this cooperation will focus on jointly developing diagnosis, treatment and service capabilities for children with medical needs for growth and development.