YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 469 drug applications between 7 June 2026 and 13 June 2026 (data as of 13 November 2026 06:00). Of these, generic applications numbered 89, covering 59 drug names.
2026/06/07 – 2026/06/13
- New acceptances this week
- 469
- Drugs with new generic filings (by drug name, de-duplicated)
- 59
- Accepted this week, now under review
- 143
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
469filings, 89 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 282 |
| Generic | 89 |
| New drug | 71 |
| Import | 17 |
| Unspecified | 5 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 243 |
| TCM | 154 |
| Therapeutic biologic | 69 |
| Prophylactic biologic | 3 |
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
59 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Mirogabalin Besilate Tablets | 6 | 3 | 61 |
| 2 | Nafamostat Mesilate for Injection | 5 | 3 | 38 |
| 3 | Dotinurad Tablets | 4 | 2 | 55 |
| 4 | Pregabalin Orally Disintegrating Tablets | 3 | 1 | 3 |
| 5 | Rotigotine Patches | 3 | 1 | 7 |
| 6 | 西诺氨酯片 · No verified English name | 3 | 1 | 24 |
| 7 | Brexpiprazole Tablets | 2 | 1 | 31 |
| 8 | Bumetanide Injection | 2 | 1 | 13 |
| 9 | 帕拉米韦氯化钠注射液 · No verified English name | 2 | 1 | 17 |
| 10 | Pregabalin Extended release Tablets | 2 | 1 | 13 |
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
286 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Eli Lilly and Company | 7 | 2 | 0 |
| 2 | AstraZeneca AB | 6 | 4 | 0 |
| 3 | Liaoning Xin Shan Yuan Pharma Co., Ltd. romanized | 6 | 2 | 3 |
| 4 | Amgen Inc. | 6 | 1 | 0 |
| 5 | Hua Run Shuang He Xiang Zhong Pharma (Hunan) Co., Ltd. romanized | 5 | 5 | 0 |
| 6 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized | 5 | 2 | 0 |
| 7 | Beijing Tong Ren Tang Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Guo Yao Group Xinjiang Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 9 | Shandong Yi Dao Kang Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized | 4 | 4 | 1 |
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
124 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2026/06/12Import · Class 1 | AZD2936 · No verified English nameJXSL2600141 | AstraZeneca AB; AstraZeneca Global R&D (China) Co. Ltd. |
| 2026/06/12Import · Class 2.4 | BMS-986510胶囊 · No verified English nameJXHL2600218 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2026/06/12Import · Class 2.4 | BMS-986510胶囊 · No verified English nameJXHL2600217 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2026/06/12Import · Class 2.4 | BMS-986510胶囊 · No verified English nameJXHL2600216 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2026/06/12Generic · Class 3 | Nafamostat Mesilate for InjectionCYHS2601406 | Chongqing Huapont Pharmaceutical Co., Ltd. |
| 2026/06/12Generic · Class 3 | Nafamostat Mesilate for InjectionCYHS2601405 | Chongqing Huapont Pharmaceutical Co., Ltd. |
| 2026/06/12Generic · Class 3 | Cyclophosphamide InjectionCYHS2601403 | Shanghai Chuang Nuo Pharmaceutical Co., Ltd. romanized |
| 2026/06/12Generic · Class 3 | Minoxidil LinimentCYHS2601401 | Hubei Kang Zheng Pharma Co., Ltd. romanized |
| 2026/06/12Generic · Class 3 | Minoxidil LinimentCYHS2601400 | Hubei Kang Zheng Pharma Co., Ltd. romanized |
| 2026/06/12Generic · Class 3 | Cetirizine Hydrochloride InjectionCYHS2601399 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized |
| 2026/06/12New drug · Class 2.2 | 皮内注射用重组卡介苗 · No verified English nameCXSL2600636 | Chengdu An Yong Ding Ye Bio Technology Co., Ltd. romanized |
| 2026/06/12New drug · Class 1 | 重组抗IL-4Rα人源化单克隆抗体注射液 · No verified English nameCXSL2600635 | San Sheng Guo Jian Pharma (Shanghai) Co., Ltd. romanized |
| 2026/06/12New drug · Class 1 | AZD5863 · No verified English nameCXSL2600634 | A Si Li Kang Quan Qiu Research and Development (Zhongguo) Co., Ltd. romanized |
| 2026/06/12New drug · Class 1 | GC012F注射液 · No verified English nameCXSL2600633 | Gen Xi Bio Technology (Shanghai) Co., Ltd. romanized; A Si Li Kang Investment (Zhongguo) Co., Ltd. romanized; Suzhou Gen Xi Bio Technology Co., Ltd. romanized |
| 2026/06/12New drug · Class 1 | 注射用Efimosfermin alfa · No verified English nameCXSL2600632 | Ge Lan Su Shi Ke (Zhongguo) Investment Co., Ltd. romanized |
| 2026/06/12New drug · Class 1 | IBI3040 · No verified English nameCXHL2600710 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2026/06/12New drug · Class 1 | IBI3032 · No verified English nameCXHL2600709 | Xin Da Bio Technology Co., Ltd. romanized |
| 2026/06/12New drug · Class 1 | IBI3032 · No verified English nameCXHL2600708 | Xin Da Bio Technology Co., Ltd. romanized |
| 2026/06/12New drug · Class 1 | IBI3032 · No verified English nameCXHL2600707 | Xin Da Bio Technology Co., Ltd. romanized |
| 2026/06/12New drug · Class 1 | IBI3032 · No verified English nameCXHL2600706 | Xin Da Bio Technology Co., Ltd. romanized |
| 2026/06/12New drug · Class 1 | RN5681注射液 · No verified English nameCXHL2600705 | Shenzhen Shi Da Rui Bio Technology Research Co., Ltd. romanized |
| 2026/06/11Import · Class 2.4 | Elafibranor片 · No verified English nameJXHL2600215 | Ipsen Bioscience Inc.; Ipsen (Shanghai) Innovation Pharmaceutical Co. Ltd |
| 2026/06/11Generic · Class 3 | Chloroprocaine Hydrochloride InjectionCYHS2601393 | Jiangsu Vanguard Pharmaceutical Co., Ltd. |
| 2026/06/11Generic · Class 3 | Chloroprocaine Hydrochloride InjectionCYHS2601392 | Jiangsu Vanguard Pharmaceutical Co., Ltd. |
| 2026/06/11Generic · Class 3 | Ambroxol Hydrochloride DropsCYHS2601389 | Anhui Kang Rong Pharma Co., Ltd. romanized |
| 2026/06/11Generic · Class 3 | Bumetanide InjectionCYHS2601384 | Dan Dong Yi Chuang Pharma Co., Ltd. romanized |
| 2026/06/11Generic · Class 3 | Bumetanide InjectionCYHS2601382 | Dan Dong Yi Chuang Pharma Co., Ltd. romanized |
| 2026/06/11Generic · Class 3 | 磷酸奥司他韦颗粒 · No verified English nameCYHS2601380 | Chongqing Wan Lin Biopharmaceuticals Technology Co., Ltd. romanized; Hunan Jiudian Pharmaceutical Co., Ltd |
| 2026/06/11Generic · Class 3 | Bromhexine Hydrochloride Oral SolutionCYHS2601379 | Jiangsu Shen Hua Pharma Co., Ltd. romanized |
| 2026/06/11New drug · Class 3.1 | 苓桂术甘汤颗粒 · No verified English nameCXZS2600031 | Changsha Xin Lin Pharmaceutical Co., Ltd. romanized |
94 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.
Subscribe to the weekly
No account needed.
The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.