As the regulatory factor for cell growth first discovered, the nerve growth factor (NGF) features dual biological functions of nourishing neurons and promoting neurite growth, and plays an important role in regulating the development, differentiation, growth, regeneration and functional property expression of central and surrounding neurons.

Italian scientist Montalcini and U.S. scientist Cohen won the 86^th Nobel Prize in Physiology or Medicine in 1986 due to the discovery of NGF and outstanding contributions to NGF research; the experiments of the two scientists showed that NGF could promote the cranial nerve regeneration, which caused a great sensation in the medical community.

NGF can be extracted from mice, snake venom and human placentas, etc. The NGF extracted from mouse submandibular gland is called mouse nerve growth factor (mNGF) and that from human placentas is called human nerve growth factor (hNGF). hNGF is currently not available in the market, and mNGF is the main NGF in the market owing to the richness, high homology with humans (reaching 90%) and simple extraction process.

China is at the forefront of the world in researching NGF. CFDA formally approved the trial production of the Nobex (mouse nerve growth factor for injection) of Xiamen Bioway (now, Sinobioway Biomedicine) on January 6, 2003, with the approval No.: GYS ZI S20020116, which is the first NGF product marketed in the world.

There have been 4 manufacturers producing "mouse nerve growth factor for injection" in China so far, separately being Nobex of Sinobioway Biomedicine, Sutaisheng of Staidson, Jinlujie of Wuhan Hiteck, and Likangle of Livzon. mNGF is mainly indicated for promoting recovery of nerve injury, and treating optic nerve injury and n-hexane induced peripheral neuropathy. mNGF is widely applied clinically as a kind of neurotrophic drug, and is frequently used by many medical departments like ophthalmology, neurology, neurosurgery and orthopedics.

Manufacturers and marketing time of mouse nerve growth factor for injection

According to the data disclosed in the company annual reports, the 2016 sales of the 3 mNGFs: Sutaisheng, Nobex, and Likangle totaled RMB 2.53 billion, with the market size expanded by nearly 8 times in 5 years compared to the RMB 340 million at the end of 2011, and with the compound average growth rate of up to 49.4%, which can be called a myth in China.

Sales of Chinese mouse nerve growth factor for injection (RMB 100 million)

 "Sutaisheng" of Staidson has the largest market share among Chinese mNGFs, with the 2016 sales reaching RMB 1.24 billion, growing by 12.05%, and accounting for 88.3% of the company’s operating income, which can be described as a core product of Staidson. Staidson, in order to further consolidate the market, also actively expands the new indication of Sutaisheng, with the clinical trial application for the new indication of treating "diabetic foot" and "peripheral nerve injury" having been approved and being conducted. Furthermore, the hNGF of Staidson is currently under the preclinical safety evaluation stage.

Not to be outdone, the Nobex of Sinobioway Biomedicine reached sales of RMB 800 million in 2016, growing by 18.57%. The project of Nobex’s treatment of optic nerve injury is under Phase III clinical study. Nobex’s new indication for "diabetic foot" has been approved the clinical trial. The company is also deeply digging into its new indication of treating optic nerve injury, and developing new dosage forms including eye drops and injection.

As a unique variety in China, mNGF has a very high gross margin: the gross margin of Nobex and Sutaisheng separately reached 94.04% and 91.12% in 2016. However, the medical insurance reimbursable range of mNGF is restricted to traumatic optic nerve injury or n-hexane poisoning in the 2017 new edition of national medical insurance catalog of China just issued.

Source: Data of Pharmcube