YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 353 drug applications between 25 March 2026 and 31 March 2026 (data as of 14 November 2026 06:00). Of these, generic applications numbered 46, covering 35 drug names.
2026/03/25 – 2026/03/31
- New acceptances this week
- 353
- Drugs with new generic filings (by drug name, de-duplicated)
- 35
- Accepted this week, now under review
- 78
DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.
Names with a public page are linked.
New acceptances this week
By application type and drug type
353filings, 46 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 218 |
| New drug | 56 |
| Generic | 46 |
| Import re-registration | 13 |
| Unspecified | 11 |
| Import | 9 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 182 |
| TCM | 142 |
| Therapeutic biologic | 25 |
| Biologic | 2 |
| Prophylactic biologic | 2 |
DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.
Most new generic filings, by drug
35 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Oxycodone Hydrochloride and Naloxone Hydrochloride Prolonged-release Tablets | 3 | 1 | 3 |
| 2 | Tacrolimus Sustained-release Capsules | 2 | 1 | 6 |
| 3 | Linagliptin and Metformin Hydrochloride Extended Release Tablets | 2 | 1 | 4 |
| 4 | Diclofenac Diethylamine Emulgel | 2 | 1 | 20 |
| 5 | Cefditoren Pivoxil Granules | 2 | 1 | 18 |
| 6 | Montelukast Sodium Chewable Tablets | 2 | 1 | 4 |
| 7 | Baricitinib Tablets | 2 | 1 | 32 |
| 8 | Epinastine Hydrochloride Tablets | 2 | 1 | 2 |
| 9 | Labetalol Hydrochloride Tablets | 2 | 1 | 3 |
| 10 | Mirogabalin Besilate Tablets | 2 | 1 | 61 |
DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.
Most new acceptances, by company
215 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Dong E E Jiao Co., Ltd. romanized | 15 | 13 | 0 |
| 2 | Yi Chun Kang Er Xin Pharma Co., Ltd. romanized | 11 | 10 | 0 |
| 3 | Ha Yao Group Bio Gong Cheng Co., Ltd. romanized | 9 | 3 | 0 |
| 4 | Henan Nuo Mei Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 5 | Takeda Development Center Americas Inc. | 5 | 1 | 0 |
| 6 | Jiangsu Fei Sen You Si Pharmaceuticals Yong Pin Co., Ltd. romanized | 4 | 4 | 0 |
| 7 | Shaanxi Pan Long Pharma Group Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Novartis Pharma Schweiz AG | 4 | 2 | 0 |
| 9 | Eli Lilly and Company | 4 | 1 | 0 |
| 10 | Sanofi Winthrop Industrie | 4 | 1 | 0 |
DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.
Under-review list changes
Compared across this platform's snapshots of the under-review list
Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.
DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.
Class 3 and new-drug acceptances
75 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/03/31Generic · Class 3 | Labetalol Hydrochloride TabletsCYHS2600756 | Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized |
| 2026/03/31Generic · Class 3 | Labetalol Hydrochloride TabletsCYHS2600755 | Chongqing Sheng Hua Xi Pharma Co., Ltd. romanized |
| 2026/03/31Generic · Class 3 | 比拉斯汀口崩片 · No verified English nameCYHS2600754 | Jiangxi Shimei Pharmaceutical Co., Ltd |
| 2026/03/31Generic · Class 3 | Ebastine Oral SolutionCYHS2600749 | Jiangsu Chen Pai Bang De Pharma Co., Ltd. romanized |
| 2026/03/31New drug · Class 2.2 | 司普奇拜单抗注射液 · No verified English nameCXSS2600062 | Chengdu Kang Nuo Xing Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/03/31New drug · Class 2.2 | 司普奇拜单抗注射液 · No verified English nameCXSS2600061 | Chengdu Kang Nuo Xing Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/03/31New drug · Class 1 | BBT001注射液 · No verified English nameCXSL2600364 | Shan Zhu Yao (Beijing) Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/03/31New drug · Class 1 | ARD-489AD片 · No verified English nameCXHL2600402 | Ke Hui Zhi Yao (Shenzhen) Xin Yao Research Center Co., Ltd. romanized |
| 2026/03/31New drug · Class 1 | ARD-489AD片 · No verified English nameCXHL2600401 | Ke Hui Zhi Yao (Shenzhen) Xin Yao Research Center Co., Ltd. romanized |
| 2026/03/31New drug · Class 1 | HRS9531注射液 · No verified English nameCXHL2600400 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/03/31New drug · Class 1 | HRS9531注射液 · No verified English nameCXHL2600399 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/03/31New drug · Class 1 | HRS9531注射液 · No verified English nameCXHL2600398 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2026/03/30Generic · Class 3 | Linagliptin and Metformin Hydrochloride Extended Release TabletsCYHS2600746 | Nan Tong Lian Ya Pharma Co., Ltd. romanized |
| 2026/03/30Generic · Class 3 | Linagliptin and Metformin Hydrochloride Extended Release TabletsCYHS2600745 | Nan Tong Lian Ya Pharma Co., Ltd. romanized |
| 2026/03/30New drug · Class 2.1 | 热毒宁颗粒 · No verified English nameCXZS2600018 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized |
| 2026/03/30New drug · Class 1 | 注射用QLF4113 · No verified English nameCXSL2600363 | Qilu Pharmaceutical Co., Ltd. |
| 2026/03/30New drug · Class 1.2 | 猴痘mRNA疫苗 · No verified English nameCXSL2600362 | Jiangsu Zhong Hui Yuan Tong Bio Technology Co., Ltd. romanized; Yi Hui Bio Technology (Shanghai) Co., Ltd. romanized |
| 2026/03/30New drug · Class 1 | 注射用BL-M14D1 · No verified English nameCXSL2600361 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2026/03/30New drug · Class 1 | IBI354 · No verified English nameCXSL2600360 | Xin Da Biopharmaceuticals Technology (Hangzhou) Co., Ltd. romanized |
| 2026/03/30New drug · Class 1 | ICP-B208 · No verified English nameCXSL2600359 | Beijing Nuo Cheng Jian Hua Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/03/30New drug · Class 1 | ADRX-0405 · No verified English nameCXSL2600358 | Shanghai De Feng Pharma Co., Ltd. romanized |
| 2026/03/30New drug · Class 2.2; 2.4 | DMET25001缓释片 · No verified English nameCXHL2600397 | Wuhan Long Sheng Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/03/30New drug · Class 2.2; 2.4 | DMET25001缓释片 · No verified English nameCXHL2600396 | Wuhan Long Sheng Pharmaceuticals Technology Co., Ltd. romanized |
| 2026/03/30New drug · Class 1 | 注射用WP1302 · No verified English nameCXHL2600395 | Bai Ming Xin Kang Bio Technology (Zhejiang) Co., Ltd. romanized |
| 2026/03/28Import · Class 1 | AZD2936 · No verified English nameJXSL2600087 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/03/28Generic · Class 3 | 磷酸奥司他韦颗粒 · No verified English nameCYHS2600737 | Hunan Pu Dao Pharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd |
| 2026/03/28New drug · Class 3.1 | 麦门冬汤颗粒 · No verified English nameCXZS2600017 | Guangdong Yi Fang Pharmaceutical Co., Ltd. romanized |
| 2026/03/28New drug · Class 1.1 | 香术调脾和中颗粒 · No verified English nameCXZL2600032 | Shanxi Sheng Zhong Pharmaceuticals Research Institute (Shanxi Sheng Zhong Hospital) romanized |
| 2026/03/28New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSL2600357 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2026/03/28New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSL2600356 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
45 more not listed (at most 30 rows).
DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.
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