“Measures to Accelerate High-quality Development of Innovative Drugs in Pingshan, Shenzhen (Trial)” will take effect on June 10, 2025 and remain valid for three years. More details about the policy can be found at https://www.szpsq.gov.cn/zwgk/gfxwj/bmgfxwj/content/post_12203973.html 

I. Application requirements

1. Applicants must be independent legal entities engaged in biopharmaceutical business in Pingshan during the year preceding the application year.

2. Applicants must have at least one Class 1 innovative drug development pipeline that has entered or completed Phase III clinical trials, or at least two Class 2 or Class 3 drug development pipelines that have entered or completed Phase III clinical trials. Drugs exempted from Phase III clinical trials prior to application due to breakthrough therapy designation, emergency use authorization, or cell and gene therapy will be treated as equivalent to having completed Phase III.

3. The applicant or its actual controller must hold a leading position in the industry.

II. Funding policies

1. Support for innovation team building: Applicant entities establishing a team of over 30 talents working in Pingshan, with at least 10 holding doctoral degrees, are eligible for an annual merit-based reward of 1 million yuan.

2. R&D incentives: Applicant entities may receive a 5% merit-based reward on audited local R&D expenditures from the previous year, subject to a maximum of 5 million yuan annually per applicant. Entities receiving rewards under Clause 4 on clinical trial support are not eligible for this reward.

3. Investment incentives: Applicant entities may receive a merit-based 10% reward on investments made locally in the previous year, capped at 10 million yuan annually per applicant. The maximum reward for a single project is 30 million yuan, with a funding period of up to 3 years.

4. Support for clinical trials: Applicants conducting approved clinical trials of Class1-3 chemical drugs, biological products, or traditional Chinese medicines may receive merit-based rewards equal to 20% of audited R&D expenditures. Maximum rewards are: 1 million yuan for Phase I clinical trials, 3 million yuan for Phase II, and 7 million yuan for Phase III. A single enterprise’s eligible expenditures may be retroactively applied for up to 36 months.

5. Support for obtaining MAH certificates: Applicants obtaining new drug Marketing Authorization Holder (MAH) certificates may receive merit-based rewards as follows: 5 million yuan for Category B; for Category A, 10 million yuan for Class 1, 6 million yuan for Class 2, and 2 million yuan for Class 3 drug registrations. The maximum total support per applicant entity under this clause is 20 million yuan.

6. Cultivation of high-quality pharmaceutical products: Applicant entities’ drugs that reach local sales revenue milestones for the first time will be eligible for rewards. When multiple milestones are reached simultaneously, only the highest reward applies, up to 50 million yuan in total. 

For sales up to 1 billion yuan for the first time, every 200 million yuan increment constitutes a milestone, with an additional 2 million yuan reward per milestone; for sales above 1 billion yuan, every 500 million yuan increment constitutes a milestone, with an additional 5 million yuan reward per milestone.

7. Cultivation of international pharmaceutical products: For innovative drugs registered and sold in countries/regions including the U.S. (FDA), Europe (EMA/CE), Japan (PMDA), WHO member states, BRICS countries, and Belt and Road Initiative countries, applicants will receive 3 million yuan per country, capped at 10 million yuan per applicant entity.

8. Encouragement of licensing transactions: Innovative drug companies engaging in licensing transactions locally, without investment ties between the parties, may receive a merit-based reward equivalent to a specified proportion of the transaction amount, capped at 50 million yuan for the licensor.

Supplementary provisions

1. Subject to fiscal budget, generally no more than five enterprises will be rewarded under each clause annually, based on merit. Rewards follow principles of “optimal, maximum, and non-overlapping” and will be coordinated with other incentive policies available in Pingshan.

2. The Science, Technology and Innovation Bureau of Pingshan is responsible for interpreting these measures. Adjustments will be made in response to changes in national, provincial, or municipal policies.

3. This policy specifically supports innovative drugs. Other biopharmaceutical companies not engaged in clinical trials will be supported under “Measures for High-Quality Development of Biopharmaceuticals in Pingshan District.”