CBL-514 Injection
CBL-514 Market value
US$130B2030 Global local fat reduction
market
2030 Global Dercum’s disease market
2030 Global cellulite treatment market
- First-in-class lipolysis injection that can induce fat cell apoptosis without causing necrosis or damage to other tissues or cells.
- The efficacy is significant and can be observed within 2 weeks.
- On average of 25% (around 120 mL) of the treated area fat can be reduced. 50% of fat can be reduced at most. The curative effect is better than other non-surgical products.
- The drug is safe and well tolerated, with mild side effects, no sequelae or systemic side effects.
- The world's only local fat reduction injection that can be used in a large treatment area such as abdomen and thighs.
Indications
- Non-Surgical Fat Reduction
- Dercum’s Disease
- Cellulite
- Lipoma
Stage
Non-Surgical Fat Reduction
Market Overview
According to the 2021 Deloitte China Body Sculpting Market Industry Development White Paper, China’s local fat reduction and body sculpting medical aesthetic market, including invasive and non-invasive medical treatments, will exceed US$1.5 billion in 2020 and have a CAGR of 25%. It is estimated that by 2030 China market will reach US$15.4 billion, and the global market will reach US$42 billion in 2026, and US$102.5 billion in 2030.
Introduction to Body Fat Reduction Treatments
According to the latest survey data from 2020 American Society for Dermatologic Surgery (ASDS), the number of consumers receiving body sculpting treatment in 2019 increased by 60%, compared with the previous year, and among them, the number of those who sought non‐invasive treatment increased by about 47%. Moreover, American Society for Aesthetic Plastic Surgery (ASAPS) indicates that the number of invasive and non-invasive lipolysis treatments performed in the US increased respectively by -0.4% and 8.2%, compared with 2019. This shows the trend that consumers are gradually turning to non-invasive local fat reduction treatments.
The current local fat reduction treatments include invasive procedure (liposuction surgery and abdominal shaping surgery) and non-invasive procedure (with local lipolysis devices or injections). Invasive surgery is more effective, but the risk is high, with obvious side effects and sequelae, and the recovery period is 3 to 6 months. The side effects of non-invasive local lipolysis or injections are comparatively milder, but the efficacy of most current products is not visible, and the treatment areas are limited, not to mention the long wait, at least 12 weeks, for the outcome. In addition, the current non-invasive local lipolysis still has a certain degree of side effects and sequelae, and the treatment cost is quite expensive. Consequently, less than 40% of people still tolerate the current local fat reduction treatments, and more than 60% of people, dissatisfied with the current methods, are held back by the fear of side effects and sequelae, according to the annual report of the American Society for Aesthetic Plastic Surgery (ASAPS). Thus, the market is grossly underestimated.
R&D Progress
CBL-514 injection is a first-in-class innovative small molecule drug in medical aesthetic, which can induce fat cell apoptosis to reduce local fat at the injection site accurately without causing necrosis or damage to other tissue cells. The curative effect, close to liposuction surgery, is significantly better than current non-surgical liposuction products. It is safe and has great tolerability. Via subcutaneous fat injection, CBL-514 can reduce local fat without surgery, to fulfill the purpose of body curve sculpture.
The Phase IIa of CBL-514 injection for the indication of medical aesthetic non-surgical lipolysis was completed in November 2020. The results show that CBL-514 can relevantly reduce the subcutaneous fat at the treatment site, and the primary and secondary efficacy indicators have reached significant statistical difference (p<0.00001), and dose-dependent, drug safety and tolerability are good. It was approved by the US FDA and the Australian 2 stage Phase II IND in December 2020, and the subjects were enrolled in Q1 of 2021, and the Phase II-stage 1 was completed in December 2021.
The results of phase I and phase IIa of CBL-514 show that CBL-514 injection can effectively reduce the subcutaneous fat at the injection site for non-invasive lipolysis indications without causing tissue necrosis or obvious side effects at the injection site. The post-recovery period is short, the efficacy can be seen within two weeks, and the product is safe and has good tolerance. It is currently the only lipolysis injection that can be used in a wide range of treatment sites such as abdomen or thigh. CBL-514 can greatly reduce the surgical risk, postoperative side effects and sequelae caused by current invasive surgery, and significantly shorten the postoperative recovery period. The curative effect of CBL-514 in local lipolysis is 3~6 times that of existing non-invasive lipolysis products. The lipolysis mechanism of the product is novel and safe. It conforms to the three major trends of medical aesthetic market: natural, safe and effective. It is expected to be the leading product of non-invasive fat reduction after launching.
Dercum’s Disease
Market Overview
The U.S. market for Dercum's disease in 2019 was approximately US$3.74 billion (approximately one-third of the world), and the global market is estimated to be approximately US$10.9 billion. It is estimated that the global market will reach US$17.7 billion in 2026 with a CAGR value of 7.1%.
Note: The US market value is estimated by the USA prevalence(124,500) * lipoma treatment avg cost (US$2,000) * 15 lipomas in a patient.
Introduction to Dercum’s Disease
Dercum’s disease is a rare disease characterized by painful lipomas with abnormal accumulation of subcutaneous fat in some parts of the patient's trunk, accompanied by severe spontaneous pain in this part. The nature of the pain is acupuncture-like or knife-cutting sharp pain, which is paroxysmal or persistent. It is estimated that approximately 200,000 people in the United States suffer from Dercum’s disease. The cause of this sinus root's disease has not yet been determined. Studies have pointed out that it may be related to nervous system dysfunction, mechanical pressure on nerve tissue, and adipose tissue metabolism disorder.
Currently, there is no approved drug for Dercum’s disease, the; therefore, surgery and analgesics are the major means to relieve symptoms. However, the efficacies are rather poor and temporary. On the other hand, surgical resection or liposuction comes multiple side effects and sequelae, and it often causes lipoma recurrence or even worsening afterward.
| Existing Therapies | Surgical Excision | Analgesics | Immunomodulators | |
| Target | Lipoma removal | Pain relief | Inhib the effect of certain substances | Pain relief |
| Disadvantage | High postoperative recurrence, multiple wounds, etc. | Temporary pain relief, poor efficacy, severe side effects, etc. | Poor efficacy, unable to cure the disease, severe side effects, etc. | Temporary pain relief, unable to cure the diseaseetc. |
| Side Effect | Bruising, pain, infection, redness, dimpling at the surgical site, etc. | Apprehension, dizziness, drowsiness, etc. | Headache, tiredness, diarrhea, upset, stomach, infection, hyperhypersensitivity. | Burning and redness at the treatment site |
R&D Progress
CBL-514's indication for treating Dercum's disease is under investigation. The IND of the Phase 2 study has been approved by the U.S. FDA and the study was completed in April, 2023.
Cellulite
Market Overview
According to the Future Market Insights report, the global cellulite treatment market size was approximately US$2.49 billion in 2018, and it is estimated to reach US$4.5 billion in 2026. According to foreign studies, about 85% of women after puberty have cellulite problems, and with the increase of age and obesity, the probability of obtaining cellulite becomes higher and higher.
Introduction to Cellulite
Cellulite is characterized by the nonpathological appearance of the dimpled skin surface (likened to orange peel, cottage cheese, or mattress appearance), which occurs on the thighs and buttocks. As many as 80 to 90% of women experience cellulite dimpling at some point in their life. The relief alterations of cellulite include depressions and raised areas. The depressions are caused by retraction of the skin by subcutaneous fibrous septa, while raised areas are projections of fat and subcutaneous structures to the skin surface.
The current treatment for cellulite includes non-invasive (medical devices and collagenase-related products) and invasive options. However, their efficacy remains limited as the current treatment options can only treat cellulite temporarily. Additionally, most products would cause significant side effects after administration, including severe bruising, pain, and pigmentation, making most patients reluctant to receive them. The clinical need for cellulite treatment remains unmet.
| Existing Therapies | Non-Invasive Drugs | Non-Invasive Devices | Minimally Invasive Treatments | |
| FDA Approved Indications | Treatment of moderate to severe cellulite | Short-term improvement in the appearance of cellulite | Short-term improvement in the appearance of cellulite | Long-term improvement in the appearance of cellulite |
| Efficacy | 10 weeks after 3 treatments, 6~8% was a two-grade improvement | 10 weeks after treatment, improve the appearance of cellulite | 1 year after treatment, increases 25% in Skin thickness and 29% in skin elasticity | After treatment, results lasting up to 2 years |
| Side Effect | Hypersensitivity, Bruising, Pain, Pruritus, Immunogenicity | Pain, No adverse events were identified as serious or severe | Pain, Redness, Swelling, Bruising, Itching, Blistering, Necrosis | Swelling, Pain, Bruising |
R&D Progress
CBL-514's indication for cellulite treatment is currently under investigation. The Phase II study IND has received U.S. FDA approval in August 2022.