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The 20 billion market is "full of smoke", and the osteoporosis research and development competition is about to start! Who can dominate?

 Last Update: 2022-11-05
 Source: Internet
 Author: User

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There was a great opportunity for treatment in front of me, but I didn't cherish
it.

I didn't regret it until I missed it
.

If God could give me another chance to start over, I would say, "I'll hurry up and take my medicine!" ”

Although this passage is a joke, it is likely to be a reality
for osteoporosis patients.

It is understood that osteoporosis (OP) usually has no obvious clinical manifestations in the early stage, and patients often find themselves sick after pain, spinal deformation and fractures, so they are considered "silent killers"
.

"Killers" are everywhere! How is the progress of cracking the killer osteoporosis drugs? The 20 billion market is "full of smoke", who can dominate?

The 20 billion market is "full of smoke"

According to the results of the epidemiological survey of osteoporosis released by China's National Health Commission in 2018, the number of osteopenia and OP patients in China has reached more than 300 million, and the prevalence of OP in people over 50 years old is 19.
2%.

The prevalence of OP in people over 65 years of age reached 32.
0%, of which 51.
6%
were women.

More than 300 million

With the increasing aging of the world, OP has become one of
the most important health science issues in the world.
The global osteoporosis drug market was worth $11.
5 billion in 2018.

And China is the country with the largest number of osteoporosis patients in the world
.
In 2017, the market size of osteoporosis drugs in China has exceeded 20 billion yuan
.

Currently, drugs are one of
the best treatments for osteoporosis.

According to the mechanism of action, the current clinical OP treatment drugs can be roughly divided into:

Basic medications for bone health, bone resorption inhibitors, bone formation promoters, calcium absorption promoters, and other mechanism drugs
.

Basic medication for bone health

Mainly calcium and vitamin D, mainly used in children and adolescents
.
Calcium absorption promoters include calcitriol, alfacaltriol
.

Inhibitors of bone resorption

These include calcitonins (eel calcitonin and salmon calcitonin), bisphosphonates, denosumab, and selective estrogen receptor modulators (e.
g.
, raloxifene).

Drugs that promote bone formation

Including teriparatide and abavirotide , the main treatment population is severe OP patients who are not sensitive to other therapeutic agents and increasingly young postmenopausal female OP patients
.

Table 1 Some anti-osteoporosis drugs and their classification

Source: Publicly available sources

Calcium absorption promoter

It is a commonly used drug intervention method to improve OP patients, among which idecalcidol is a new type of active vitamin D3 analogue, with an innovative breakthrough dual mechanism of action, which can not only effectively inhibit cortical bone resorption, increase cortical circumference, volumetric bone density and femoral neck cortical bone mass, thereby improving the biomechanical properties of femoral neck, but also effectively promote bone shaping, and ultimately improve the continuity of bone trabeculae, enhance the formation of bone trabeculae, and more effectively reduce the risk
of fracture.

In December 2020, the Idecalcifer softgels developed by Roche's Japanese Sino-foreign Pharmaceutical Co.
, Ltd.
were approved in China for the treatment of postmenopausal female OP, and the trade name is edirol
.

The original calciferol softgel market is doing well, with global sales of $889 million
in 2020.

However, Idecalciferol is about to be localized, and on October 9 this year, Taifeng Biologics has obtained the first imitation production approval for
Idecalciferol soft capsules.

Bisphosphonates

Currently the most widely used anti-OP drugs in clinical practice, they are stable analogues of pyrophonates, which are characterized by containing P-C-P groups
.

Due to its high affinity with bone hydroxyapatite, bisphosphonates specifically bind to the bone surface where bone turnover is active, inhibiting the maturation and activity of osteoclasts, thereby inhibiting bone resorption
.
Not only can prevent bone loss, bisphosphonates can also increase bone mass, improve bone density in the lumbar spine and hip, and reduce the risk of
fractures in vertebral bodies and hips.

At present, bisphosphonates have developed from the first generation to the third generation, and there are more than 10 mature varieties in domestic clinical application, such as the first generation of etidronate sodium and clodronate sodium; The second generation of clodronate, pamidronate, the third generation of alendronate, risedronate, zoledronic acid, ibandronate and IMRADRONATE
.

In recent years, the domestic bisphosphonate market as a whole has maintained a growth trend, but the growth rate has slowed down, and it is reported that the sales in 2020 will be 3.
004 billion yuan
.

From the perspective of specific varieties, the third-generation zoledronic acid and ibandronate sodium market account for a relatively large
proportion.

Denosumab is also a rising star in anti-OP drugs, a fully humanized monoclonal IgG2 antibody targeting RANKL approved for postmenopausal female OP at high risk of fracture, and for the treatment of OP patients at high risk of fracture to increase bone mass, under the trade name Prolia
.

Studies have shown that treatment with denosumab for 3 years can significantly reduce the risk of new vertebral fractures by 68%, reduce the risk of refractures by 46%, and reduce the risk of refractures by 59%
after 10 years of treatment.

A 10-year follow-up study found that denosumab consistently increased bone mineral density in postmenopausal osteoporosis patients and reduced the risk of fractures of
the vertebral body and hip.

In addition, denosumab is also approved for the prevention of bone-related events (SREs) in patients with multiple myeloma and bone metastases from solid tumors, for the treatment of adult and skeletally mature adolescents with giant cell tumor of bone (GCTB), and for hypercalcemia (HCM) of bisphosphonate-refractory malignancies, under the trade name Xgeva
.

Denosumab was developed by Amgen, and sales have been climbing since the launch of Proli Global sales reached $3.
248 billion
in 2021.
However, denosumab was only approved by the NMPA in June 2020 for the treatment of OP in postmenopausal women at high risk of fracture, under the trade name Proli.

At present, more than ten domestic companies have begun to lay out the denosumab biosimilars market, among which Qilu Pharmaceutical, Boan Biologics and Mabwell Biologics have successively submitted their biosimilar marketing applications
.

Table 2 Prolia sales in recent years (US$ billion)

Teriparatide and abalotide in drugs that promote bone formation are parathyroid hormone (PTH) analogues, but only teriparatide has been approved
in China.

Originally developed by Lilly, teriparatide is approved for the treatment of postmenopausal women and men with OP at high risk of fracture under the trade name Porteo
.

Porteo sales peaked in 2017 ($1.
749 billion), but sales have begun to decline in recent years, falling to $802 million
in 2021.

Who can laugh at the "osteoporosis" rivers and lakes?

In addition to Lilly's teriparatide, the teriparatide-related products developed by Xaar and Salubris have also been approved
in China.

Abalotide

Originally developed by Ispen, France, it was later licensed to Radius Health, approved by the FDA in April 2017 for postmenopausal women with OP at high risk of fracture, is branded as Tymlos
.

It is reported that Tymlos' sales have climbed from $12 million in 2017 to $
208.
40 million in 2020.

Moreover, in recent years, global regulators have also approved a new anti-OP drug, Amgen/Uniratio Evenity (Romosozumab).

The drug is a humanized IgG2 monoclonal antibody targeting osteosclerostinin (Wnt signaling pathway inhibitor), which, by binding to osteosclerostin, antagonizes its activity, blocks the sclerostin-LRP-5/6 pathway, thereby promoting new bone formation and reducing bone resorption
.

Studies have found that the drug can increase bone density in the spine, total hip joint, and femoral neck with superior efficacy to teriparatide and dradronate
.
Moreover, the drug is able to increase markers of bone formation and reduce markers of
bone resorption.

Romosozumab

In January 2019, Romosozumab was first approved in Japan to reduce the risk of fracture and increase bone density in men at high risk of fracture and postmenopausal women with OP, and in April 2019 in the United States for the treatment of OP in postmenopausal women with a history of OP fractures, multiple risk factors for fractures,
or failure (or drug intolerance) of other treatment options.

The drug is administered by subcutaneous injection, once a
month.

It is reported that in the US market, Romosozumab is priced at $1825 per dose, and the total 12-month course of treatment
is $21900.
According to Amgen's earnings report, Evenity Sales in 2020 and 2021 were USD 350 million and USD 530 million
, respectively.

In addition, there are currently several OP drugs
under development worldwide.

Such as Transcenta Group's TST002 (Blosozumab) (Phase II clinical trial), Hengrui Pharmaceutical's SHR-1222 (Phase I clinical trial), Salubris SAL056 (Phase III clinical trial) and Uni-Hong Group's Uni-PTH
.

TST002(Blosozumab)

It is a humanized anti-scleroitin monoclonal antibody for severe OP, which has the dual effects of enhancing bone anabolism and anti-bone resorption, which can promote bone formation and inhibit bone loss, thereby rapidly increasing bone density and increasing bone strength
.
The drug was first researched and developed by Eli Lilly, and in 2019, Transcenta Group obtained its development and commercialization authorization
in Greater China.

SHR-1222

It is also a monoclonal antibody drug
that targets hard bone.
In the OVX model, SHR-1222 binds to and inhibits sclerostonin with competitive in vivo efficacy
.
SHR-1222 dose-dependently increases systemic and lumbar bone density
.

SAL056

It is a lyophilized preparation developed by Salubris for weekly injection of teriparatide, and the clinical trial for OP in postmenopausal women at high risk of fracture has entered phase
3.

Uni-PTH

It is an anabolic (bone growth) agent used to treat osteoporosis and bone pain
.
The mechanism of treatment is very different
from the existing products on the market.
Compared to products that inhibit bone resorption, Uni-PTH is effective in stimulating the formation of new bone on the resting bone
surface.

By stimulating new bone production, Uni-PTH can rapidly improve bone quality and restore bone density over a six-month treatment period, thus reducing the risk of fracture and bone pain, and is particularly effective
in patients with moderate to severe osteoporosis and bone pain.

Moreover, the second-generation Uni-PTH has been modified on the basis of the first-generation Uni-PTH to make it more convenient for patients to use
.

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