YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 405 drug applications between 16 May 2023 and 22 May 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 59, covering 44 drug names.
2023/05/16 – 2023/05/22
- New acceptances this week
- 405
- Drugs with new generic filings (by drug name, de-duplicated)
- 44
- Accepted this week, now under review
- 0
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
405filings, 59 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 237 |
| New drug | 68 |
| Generic | 59 |
| Import | 18 |
| Import re-registration | 14 |
| Unspecified | 9 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 254 |
| TCM | 101 |
| Therapeutic biologic | 45 |
| Biologic | 3 |
| 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
44 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Metformin Hydrochloride And Empagliflozin Extended Release Tablets | 4 | 1 | 12 |
| 2 | Paroxetine Hydrochloride Enteric-Coated Sustained-Release Tablets | 3 | 1 | 0 |
| 3 | Indobufen Tablets | 2 | 2 | 6 |
| 4 | Sodium Hyaluronate Eye Drops | 2 | 2 | 30 |
| 5 | 腺苷钴胺胶囊 · No verified English name | 2 | 2 | 8 |
| 6 | Isoprenaline Hydrochloride Injection | 2 | 1 | 7 |
| 7 | Naloxone Hydrochloride Injection | 2 | 1 | 1 |
| 8 | Dapoxetine Hydrochloride Tablets | 2 | 1 | 20 |
| 9 | 硫酸特布他林口服溶液 · No verified English name | 2 | 1 | 4 |
| 10 | Roxadustat Capsules | 2 | 1 | 17 |
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
184 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Chongqing Di Kang Zhong Yao Pharmaceutical Co., Ltd. romanized | 76 | 74 | 0 |
| 2 | Zhong Jia Bio Technology (Hubei Sheng) Co., Ltd. romanized | 24 | 12 | 0 |
| 3 | Hubei Lang De Pharma Co., Ltd. romanized | 20 | 10 | 0 |
| 4 | Ping Guang Pharmaceutical Co., Ltd. romanized | 14 | 14 | 0 |
| 5 | AbbVie Inc. | 6 | 2 | 0 |
| 6 | UCB Pharma SA | 6 | 1 | 0 |
| 7 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 5 | 2 | 0 |
| 8 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 4 | 3 | 3 |
| 9 | Shanghai Hui Lun Jiangsu Pharma Co., Ltd. romanized | 4 | 1 | 4 |
| 10 | Shanghai Yin Nuo Biopharmaceuticals Gong Cheng Co., Ltd. romanized | 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
112 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/05/22Import · Class 1 | SAR442501 · No verified English nameJXSL2300097 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2023/05/22Generic · Class 3 | Lincomycin InjectionCYHS2301368 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2023/05/22Generic · Class 3 | Biapenem For InjectionCYHS2301365 | Anhui Pioneer Pharmaceutical Co., Ltd |
| 2023/05/22Generic · Class 3 | Methotrexate TabletsCYHS2301363 | Guo Yao Yi Xin Pharmaceutical Co., Ltd. romanized |
| 2023/05/22Generic · Class 3 | Pentazocine InjectionCYHS2301361 | SHANDONG XINHUA PHARMACEUTICAL COMPANY LIMITED |
| 2023/05/22New drug · Class 1 | 注射用XNW28012 · No verified English nameCXSL2300365 | Shanghai Xin Nuo Wei Biopharmaceuticals Co., Ltd. romanized |
| 2023/05/22New drug · Class 1 | SM17单克隆抗体注射液 · No verified English nameCXSL2300364 | Xing Lian Pharma (Suzhou) Co., Ltd. romanized |
| 2023/05/22New drug · Class 1 | ONC-392注射液 · No verified English nameCXSL2300363 | Guangzhou Ang Ke Mian Yi Bio Technology Co., Ltd. romanized |
| 2023/05/22New drug · Class 1 | 靶向CD19的嵌合抗原受体基因修饰的NK细胞注射液 · No verified English nameCXSL2300362 | Shanghai Xian Bo Bio Technology Co., Ltd. romanized |
| 2023/05/22New drug · Class 1 | 靶向CD19的嵌合抗原受体基因修饰的NK细胞注射液 · No verified English nameCXSL2300361 | Shanghai Xian Bo Bio Technology Co., Ltd. romanized |
| 2023/05/22New drug · Class 1 | 靶向CD19的嵌合抗原受体基因修饰的NK细胞注射液 · No verified English nameCXSL2300360 | Shanghai Xian Bo Bio Technology Co., Ltd. romanized |
| 2023/05/22New drug · Class 1 | TQ-B3525片 · No verified English nameCXHS2300050 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2023/05/22New drug · Class 1 | XYD-A01 · No verified English nameCXHL2300555 | Kun Shan Xin Yun Da Bio Technology Co., Ltd. romanized |
| 2023/05/22New drug · Class 1 | BGB-24714胶囊 · No verified English nameCXHL2300554 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2023/05/22New drug · Class 1 | BGB-24714胶囊 · No verified English nameCXHL2300553 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2023/05/22New drug · Class 1 | BGB-24714胶囊 · No verified English nameCXHL2300552 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized |
| 2023/05/22New drug · Class 2.1 | SF001 · No verified English nameCXHL2300551 | Pu Ji Bio Technology (Tai Zhou) Co., Ltd. romanized |
| 2023/05/22New drug · Class 2.1 | SF001 · No verified English nameCXHL2300550 | Pu Ji Bio Technology (Tai Zhou) Co., Ltd. romanized |
| 2023/05/22New drug · Class 2.1 | SF001 · No verified English nameCXHL2300549 | Pu Ji Bio Technology (Tai Zhou) Co., Ltd. romanized |
| 2023/05/22New drug · Class 1 | YL-17231片 · No verified English nameCXHL2300548 | Shanghai Ying Li Pharma Co., Ltd. romanized |
| 2023/05/22New drug · Class 1 | YL-17231片 · No verified English nameCXHL2300547 | Shanghai Ying Li Pharma Co., Ltd. romanized |
| 2023/05/22New drug · Class 1 | YL-17231片 · No verified English nameCXHL2300546 | Shanghai Ying Li Pharma Co., Ltd. romanized |
| 2023/05/22New drug · Class 1 | ASP3082注射液 · No verified English nameCXHL2300545 | An Si Tai Lai (Zhongguo) Investment Co., Ltd. romanized |
| 2023/05/22New drug · Class 1 | APG-2449胶囊 · No verified English nameCXHL2300544 | Suzhou Ya Sheng Pharma Co., Ltd. romanized |
| 2023/05/22New drug · Class 1 | DF-006 · No verified English nameCXHL2300543 | Zhejiang Yao Yuan Bio Technology Co., Ltd. romanized |
| 2023/05/19Import · Class 1 | Cenerimod片 · No verified English nameJXHL2300122 | Idorsia Pharmaceuticals Ltd; Idorsia (Beijing) Pharmaceuticals Co. Ltd |
| 2023/05/19Import · Class 1 | Aficamten片 · No verified English nameJXHL2300121 | Cytokinetics Incorporated; Ji Xing Pharmaceuticals (Shanghai) Co. Ltd |
| 2023/05/19Import · Class 1 | Aficamten片 · No verified English nameJXHL2300120 | Cytokinetics Incorporated; Ji Xing Pharmaceuticals (Shanghai) Co. Ltd |
| 2023/05/19Generic · Class 3 | Naloxone Hydrochloride InjectionCYHS2301360 | Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2023/05/19Generic · Class 3 | Naloxone Hydrochloride InjectionCYHS2301359 | Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
82 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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