On January 9, 2023 (U.S. time), at the 41st J.P. Morgan Healthcare Conference, a top conference on global pharmaceutical and healthcare investment held in San Francisco, CA. Simcere held an invitation-only promotional session for the Lecheng Route and introduced this rapid access mechanism to the China market to leading global innovative drug companies.
Hainan Lecheng Pilot Zone is the first "special medical treatment zone" in China. COSELA® (trilaciclib hydrochloride for injection), an innovative pre-chemotherapy drug that provides comprehensive myeloprotection, jointly developed by Simcere Pharmaceutical Group and G1 Therapeutics Inc., was rapidly launched in the China market enabled by the advantageous policies of Lecheng Pilot Zone. COSELA is anticipated to benefit millions of patients who are taking chemotherapy in China. On a basis of this registrational success of COSELA®, Simcere and Lecheng Administration jointly held a promotional session at J.P. Morgan Healthcare Conference in the U.S. to further improve awareness of Hainan Lecheng Pilot Zone and Simcere’s pioneering work in this access route in order to stimulate the entry of more innovative drugs into the China market.
The exclusive promotional session at J.P. Morgan Healthcare Conference, themed "Rapid Access to the China Market, attracted more than 140 global innovative drug and medical device companies.
The session was hosted by Dr. Kevin Oliver, PhD, COO & Business Development, US, Senior Vice President, M&A at Simcere Pharmaceutical Group. Feng Fei, governor of Hainan Province, delivered opening remarks via a live video feed, and stated that: "Lecheng Pilot Zone is one of the key parks in Hainan Free Trade Port and a pilot zone for China's reform and innovative development of medical treatment and pharmaceuticals. So far, the zone has introduced 282 types of international innovative drugs and medical devices and become one of the most important channels for international innovative drugs and medical devices to enter mainland China."
He also said that Hainan welcomes investors and talents in all walks of life from all around the world to invest and run their businesses in Hainan Free Trade Port.
Lv Xiaolei, executive deputy director of Lecheng Administrative, showed how real-world studies in Lecheng promote drug and medical device products registration and launch in the China market with some successful case studies.
In 2018, the State Council granted Hainan Province the only authority nationwide to approve imported medical devices and drugs (vaccines excluded) for clinical emergency use and allowed the use of innovative drugs and medical devices that have not been registered in China, but have been launched in Europe, the U.S., Japan. The policy enables Chinese patients to access potentially life-changing new treatment options or medical devices that are in urgent need and facilitates the unique "Lecheng Real World Study" for unlaunched new drugs in Hainan Province.
Today, 9 international innovative drug and medical device products have been approved for launch in China faster by leveraging Lecheng Real World Study data in their clinical evaluation. As an example, COSELA® , a first-in-class innovative pre-chemotherapy drug jointly developed by Simcere and G1 Therapeutics, that provides comprehensive myeloprotection against chemotherapy damage, was approved to launch in China in July 2022, only 1 year and 5 months after its approval in the U.S.
The pilot preferential policies in Lecheng have generated strong interest from investors and senior executives from European and US drug and medical device companies. During the Q&A panel, company executives discussed with officers from Lecheng Administration details of in-licensed drug and medical device application procedures, the scope of application of Real World Study data in pilot zone, project application procedures and other benefits of utilizing this unique zone to deliver new treatments to one of the world’s largest pharmaceutical markets.
Zhou Gaobo, Simcere's Chief Investment Officer, Dr. Tamas Oravecz, PhD, Senior Vice President and Chief Scientific Officer of Simcere of America, Dr. Bijoyesh Mookerjee, MD, Chief Medical Officer in Oncology, and Dr. Kevin Oliver, PhD, discussed how Simcere develops its business globally, how it collaborates with the company’s strategic partners through collaborative innovation, and its successful case study with COSELA at the conference.
The session is the first exclusive promotional session held by Lecheng Pilot Zone in the U.S. and is one of the measures of collaborative innovation in the strategic partnership between Lecheng Pilot Zone and Simcere. Simcere will continue to work as the “partner of choice” between international innovative pharmaceutical companies and the China market to help introduce more therapeutics and medical devices into Lecheng in Hainan Province, and accelerate the entry of these treatments and medical devices into the China market, so they can begin impacting the lives of Chinese patients nationwide.
About J.P. Morgan Healthcare Conference
J.P. Morgan Healthcare Conference began in 1983 and has become one of the premier healthcare investment gatherings on the largest scale, with most information and most attentions in the world, bringing together industry leaders around the world, emerging fast-growth companies, innovative technology creators, and members of the investment community, and thus is deemed as a barometer of development and investment in medical field.
About Hainan Lecheng Pilot Zone
Hainan Boao Lecheng International Medical Tourism Pilot Zone at Hainan Free Trade Port (Lecheng Pilot Zone) is the only "special medical treatment zone" nationwide. On February 28, 2013, the State Council approved to set up Boao Lecheng International Medical Tourism Pilot Zone and enacted 9 supportive policies exclusively for the Zone. The policies can be boiled down to "four special permissions" which are special permissions for medical treatment, research, business operation, and international exchange. Lecheng Pilot Zone has first run pilot application of clinical Real World Study data in China, which opens up a "greenway" for international innovative drugs and medical devices to enter into the China market with shorter time. So far, 9 international innovative drugs and medical devices have gotten their special approvals to launch with the support of Real World Study data in Lecheng, Hainan Province.