2018 is a year full of challenges and chances for every industry. Some discovered new chances while some failed to fulfill expectations. Some struggled while some thrived. For pharma industry, 2018 is a year featured CHANGE
2018 is a year full of challenges and chances for every industry. Some discovered new chances while some failed to fulfill expectations. Some struggled while some thrived. For the pharma industry, 2018 is a year featured CHANGE - the change of leaders, the change of tech and the change of environment. Among all news and events, EqualOcean chooses four discussed-the-most events to conclude the year for the pharma industry.
Dying to Survive and Cancer Drug 0-Tariff
In 2018, a film named Dying to Survive has unexpectedly aroused public keen attention to leukemia and cancer drugs. In China, like many other countries in the world, most cancer treatment drugs, especially those patented drugs, are not covered in state-funded healthcare security. On May 1st, China removed import tariffs on all 28 imported cancer drugs. On Oct. 10th, the National Healthcare Security Administration announced that 17 cancer drugs are under the coverage of state-funded healthcare security.
According to Qianzhan’s report of cancer drug market, the increase of cancer drug’s market maintains at 20% annually, and in 2017, the market size had reached CNY 141 billion. Nearly half of the cancer drug market is dominated by imported drugs. With the tariff, pharma agents and monopolized market, the drug price becomes unaffordable for many. On December 24th, the Ministry of Finance of PRC announced that started on January 1st, 2019, China would adjust the tariff of some commodities that include cancer drug’s ingredients and 0-tariff would be applied.
The Waterloo of Changsheng Bio-Technology, the Used-to-be King of Vaccine
In July, shortly after 8 months, another vaccine scandal shocked the country again. Changsheng Bio Tech (CBT) was found it forging rabies vaccine records. In last year, CBT was caught for selling ineffective DPT vaccine, which had been used for children nationwide. The successive vaccine scandal tremendously destructed the public’s trust towards vaccines.
On July 5th, CFDA and Changchun province initiated the investigation of CBT and CBT was accused of forging production records, changing process parameters and facilities on the quiet. An article name King of Vaccine stirred up the public and pushed the event to a climax. Along with the fermenting process of the scandal, CFDA and Changchun province government executed administration penalties onto CBT with a fine total at CNY 9.1 billion and revoked its drug manufacturing license. CBT has been facing a delisting crisis.
The scandal significantly impacted the stock market and vaccine-related legislation. Shanghai and Shenzhen Stock Exchange issued New Rules for Compulsory Delisting for Serious Violations. CBT’s problem exposed the hole in vaccine regulation system. On November 11th, the State Administration of Market Regulation published the announcement of the Public Consultation of the PRC Vaccine Regulation Act.
Unprofitable Pharma Enterprises Could Launch IPO on HKSE
After a 5-year long run, the new rule, which is praised as the Greatest Reform of HKSE IPO for the Past 25 Years, was installed in April. The rule changed the IPO requirements in biopharma tech companies’ profitability. Unprofitable pharma enterprises are allowed to be listed in HKSE considering the characteristics of the industry. In May 2018, Ping An Good Doctor went public in HKSE and broke the HKSE IPO issue price record. Besides Ping An Good Doctor, other four not-yet-making-profit biopharma companies went public in HKSE.
Biopharma companies are lining up to be listed in HKSE. As commonly known, pharma companies heavily invest in the drug R&D process, which is long and unpredictable to be commercialized. Going public can release biopharma enterprises’ financial stress and speed up the new drug R&D process and commercialization with public financing.
Two Homegrown PD-1 Drugs Approved by CFDA
Early on June 15, 2018, China National Drug Administration (CNDA) approved nivolumab, the country’s first immuno-oncology and the first PD-1 therapy. Along with the approval of PD-1 medicine, domestic pharmaceuticals companies are active in PD-1 and other oncology treatments' R&D. On Aug. 6, CDA approved palbociclib, the first CDK4/6 therapy for advanced breast cancer.
On December 17th, CNDA approved KEYTRUDA. This is the first approval of homegrown invented PD-1 antibody therapy. In 10 days, Innovent’s Anti-PD-1 antibody Tyvyt® (Sintilimab injection) for Hodgkin's lymphoma was approved. CNDA is accelerating the availability of Anti-PD-1 option to advanced melanoma patients.