YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 355 drug applications between 12 May 2023 and 18 May 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 69, covering 48 drug names.
2023/05/12 – 2023/05/18
- New acceptances this week
- 355
- Drugs with new generic filings (by drug name, de-duplicated)
- 48
- 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
355filings, 69 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 202 |
| Generic | 69 |
| New drug | 52 |
| Import | 18 |
| Import re-registration | 9 |
| Unspecified | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 204 |
| TCM | 107 |
| Therapeutic biologic | 41 |
| Biologic | 2 |
| Prophylactic biologic | 1 |
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
48 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 | 硝普钠氯化钠注射液 · No verified English name | 4 | 1 | 3 |
| 3 | 吸入用七氟烷 · No verified English name | 3 | 1 | 0 |
| 4 | Paroxetine Hydrochloride Enteric-Coated Sustained-Release Tablets | 3 | 1 | 0 |
| 5 | Indobufen Tablets | 2 | 2 | 6 |
| 6 | 腺苷钴胺胶囊 · No verified English name | 2 | 2 | 8 |
| 7 | Ipratropium Bromide Inhalation Solution | 2 | 1 | 2 |
| 8 | Quetiapine Fumarate Extended-release Tablets | 2 | 1 | 0 |
| 9 | Isoprenaline Hydrochloride Injection | 2 | 1 | 7 |
| 10 | Tirofiban Hydrochloride And Sodium Chloride Injection | 2 | 1 | 2 |
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
177 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Chongqing Di Kang Zhong Yao Pharmaceutical Co., Ltd. romanized | 51 | 50 | 0 |
| 2 | An Yang Guang Sheng Heng Pharmaceutical Co., Ltd. romanized | 31 | 24 | 0 |
| 3 | Ping Guang Pharmaceutical Co., Ltd. romanized | 14 | 14 | 0 |
| 4 | AbbVie Inc. | 6 | 2 | 0 |
| 5 | Zhong Jia Bio Technology (Hubei Sheng) Co., Ltd. romanized | 5 | 3 | 0 |
| 6 | Hubei Lang De Pharma Co., Ltd. romanized | 4 | 2 | 0 |
| 7 | Shanghai Hui Lun Jiangsu Pharma Co., Ltd. romanized | 4 | 1 | 4 |
| 8 | Shanghai Yin Nuo Biopharmaceuticals Gong Cheng Co., Ltd. romanized | 4 | 1 | 0 |
| 9 | Hainan Pu Li Pharmaceutical Co., Ltd. romanized | 4 | 1 | 4 |
| 10 | Bright Future Pharmaceuticals Factory | 3 | 3 | 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
97 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/05/18Import · Class 1 | BI 764532 输注用浓缩粉末 · No verified English nameJXSL2300096 | Boehringer Ingelheim International GmbH; Boehringer Ingelheim (China) Investment Co. Ltd. |
| 2023/05/18Generic · Class 3 | Indobufen TabletsCYHS2301349 | Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized |
| 2023/05/18Generic · Class 3 | Indobufen TabletsCYHS2301348 | Jewim Pharmaceutical (Shandong) Co., Ltd. |
| 2023/05/18Generic · Class 3 | Isoprenaline Hydrochloride InjectionCYHS2301346 | Chengdu Giantech Hi-technology Development Co., Ltd.; E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanized |
| 2023/05/18Generic · Class 3 | Isoprenaline Hydrochloride InjectionCYHS2301345 | Chengdu Giantech Hi-technology Development Co., Ltd.; E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanized |
| 2023/05/18Generic · Class 3 | Carbocisteine Oral SolutionCYHS2301344 | Ningbo Zhuo Lun Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/05/18Generic · Class 3 | Carbocisteine Oral SolutionCYHS2301343 | Ningbo Zhuo Lun Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2023/05/18Generic · Class 3 | Amisulpride Oral SolutionCYHS2301342 | Guangzhou Da Guang Pharmaceutical Co., Ltd. romanized; Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2023/05/18New drug · Class 3.2 | 尼妥珠单抗注射液 · No verified English nameCXSS2300035 | Bai Tai Bio Pharma Co., Ltd. romanized |
| 2023/05/18New drug · Class 1 | 注射用DR10624 · No verified English nameCXSL2300353 | Zhejiang Dao Er Bio Technology Co., Ltd. romanized |
| 2023/05/18New drug · Class 1 | 注射用DR10624 · No verified English nameCXSL2300352 | Zhejiang Dao Er Bio Technology Co., Ltd. romanized |
| 2023/05/18New drug · Class 3.3 | 重组人促卵泡激素注射液 · No verified English nameCXSL2300351 | Chengdu Jing Ze Biopharmaceutical Co., Ltd. romanized |
| 2023/05/18New drug · Class 3.3 | 重组人促卵泡激素注射液 · No verified English nameCXSL2300350 | Chengdu Jing Ze Biopharmaceutical Co., Ltd. romanized |
| 2023/05/18New drug · Class 2.4 | Azacitidine For InjectionCXHL2300536 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2023/05/18New drug · Class 2.2 | LPC-003口溶膜 · No verified English nameCXHL2300535 | Hainan Zhong Wang Medical Technology Kai Fa Co., Ltd. romanized |
| 2023/05/18New drug · Class 1 | HJ891胶囊 · No verified English nameCXHL2300534 | Chengdu Hua Jian Wei Lai Technology Co., Ltd. romanized |
| 2023/05/17Import · Class 1 | JNJ-81201887 (AAVCAGsCD59) · No verified English nameJXSL2300095 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2023/05/17Import · Class 1 | JNJ-81201887 (AAVCAGsCD59) · No verified English nameJXSL2300094 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2023/05/17Generic · Class 3 | Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2301339 | Shanghai Hui Lun Jiangsu Pharma Co., Ltd. romanized |
| 2023/05/17Generic · Class 3 | Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2301338 | Shanghai Hui Lun Jiangsu Pharma Co., Ltd. romanized |
| 2023/05/17Generic · Class 3 | Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2301337 | Shanghai Hui Lun Jiangsu Pharma Co., Ltd. romanized |
| 2023/05/17Generic · Class 3 | Metformin Hydrochloride And Empagliflozin Extended Release TabletsCYHS2301336 | Shanghai Hui Lun Jiangsu Pharma Co., Ltd. romanized |
| 2023/05/17Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2301335 | Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2023/05/17Generic · Class 3 | Pregabalin Oral SolutionCYHS2301334 | Changzhou Si Yao Pharmaceutical Co., Ltd. romanized |
| 2023/05/17Generic · Class 3 | 腺苷钴胺胶囊 · No verified English nameCYHS2301332 | Shandong Lu Kang Pharmaceuticals Group Sai Te Co., Ltd. romanized |
| 2023/05/17Generic · Class 3 | Cycloserine CapsulesCYHS2301331 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2023/05/17Generic · Class 3 | 腺苷钴胺胶囊 · No verified English nameCYHS2301329 | Beijing Yuan Fang Tong Da Pharmaceuticals Technology Co., Ltd. romanized; Beijing Jing Feng Pharmaceutical Group Co., Ltd. romanized |
| 2023/05/17Generic · Class 3 | Nicorandil for InjectionCYHS2301328 | Chongqing De Cheng Yong Dao Pharmaceuticals Co., Ltd. romanized; Chongqing Huapont Pharmaceutical Co., Ltd. |
| 2023/05/17Generic · Class 3 | 硫酸特布他林口服溶液 · No verified English nameCYHS2301327 | Chengdu Li Er Pharma Co., Ltd. romanized |
| 2023/05/17Generic · Class 3 | 硫酸特布他林口服溶液 · No verified English nameCYHS2301326 | Chengdu Li Er Pharma Co., Ltd. romanized |
67 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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