YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 278 drug applications between 29 June 2022 and 5 July 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 44, covering 33 drug names.
2022/06/29 – 2022/07/05
- New acceptances this week
- 278
- Drugs with new generic filings (by drug name, de-duplicated)
- 33
- Accepted this week, now under review
- 2
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
278filings, 44 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 129 |
| New drug | 52 |
| Generic | 44 |
| Import | 25 |
| Import re-registration | 25 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 216 |
| Therapeutic biologic | 37 |
| TCM | 20 |
| Prophylactic biologic | 5 |
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
33 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Urapidil Hydrochloride Injection | 4 | 2 | 6 |
| 2 | Dapoxetine Hydrochloride Tablets | 3 | 2 | 20 |
| 3 | Sodium Hyaluronate Eye Drops | 2 | 2 | 30 |
| 4 | Indobufen Tablets | 2 | 1 | 6 |
| 5 | Levetiracetam extended-release tablets | 2 | 1 | 0 |
| 6 | Levofloxacin Injection | 2 | 1 | 1 |
| 7 | Paliperidone Extend-release Tablets | 2 | 1 | 2 |
| 8 | 苯磺酸左氨氯地平片 · No verified English name | 2 | 1 | 45 |
| 9 | Sodium Valproate Oral Solution | 1 | 1 | 1 |
| 10 | 低钙腹膜透析液(乳酸盐-G2.5%) · No verified English name | 1 | 1 | 4 |
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
158 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hebei Wu Luo Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 2 | Hubei Kang Wei Yuan Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 3 | Ren He Yi Kang Group Co., Ltd. romanized | 6 | 4 | 0 |
| 4 | AstraZeneca UK Limited | 6 | 2 | 0 |
| 5 | MUNDIPHARMA GmbH | 6 | 1 | 0 |
| 6 | Janssen Research & Development LLC | 5 | 4 | 0 |
| 7 | Shanghai Hai Yan Pharmaceuticals Technology Co., Ltd. romanized | 4 | 2 | 0 |
| 8 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 4 | 2 | 0 |
| 9 | Jiang You Pharmaceutical (Chang De) Co., Ltd. romanized | 4 | 2 | 0 |
| 10 | Hunan Er Kang Pharmaceutical Co., Ltd. romanized | 4 | 2 | 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
77 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/07/05Import · Class 1 | RO6868847薄膜包衣片 · No verified English nameJXHL2200174 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2022/07/05Import · Class 1 | RO6868847薄膜包衣片 · No verified English nameJXHL2200173 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2022/07/05Import · Class 2.2 | TAR-200 · No verified English nameJXHL2200170 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/07/05Generic · Class 3 | Indobufen TabletsCYHS2201013 | Fu Ou Pharmaceuticals Technology (Hu Zhou) Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2022/07/05Generic · Class 3 | Indobufen TabletsCYHS2201012 | Fu Ou Pharmaceuticals Technology (Hu Zhou) Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2022/07/05Generic · Class 3 | Procaterol Hydrochloride Oral SolutionCYHS2201004 | Guangxi Jia Jin Pharma Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2022/07/05New drug · Class 1 | 重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白注射液 · No verified English nameCXSL2200309 | Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized |
| 2022/07/05New drug · Class 1 | 重组人源化PDL1/CTLA-4双特异性单域抗体Fc融合蛋白注射液 · No verified English nameCXSL2200308 | Jiangsu Kang Ning Jie Rui Biopharmaceutical Co., Ltd. romanized |
| 2022/07/05New drug · Class 1 | YZJ-4729酒石酸盐注射液 · No verified English nameCXHL2200482 | Shanghai Hai Yan Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/07/05New drug · Class 1 | IN10018片 · No verified English nameCXHL2200481 | Ying Shi Bio Technology (Shanghai) Co., Ltd. romanized |
| 2022/07/05New drug · Class 1 | IN10018片 · No verified English nameCXHL2200480 | Ying Shi Bio Technology (Shanghai) Co., Ltd. romanized |
| 2022/07/05New drug · Class 1 | YZJ-5053片 · No verified English nameCXHL2200479 | Shanghai Hai Yan Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/07/05New drug · Class 1 | YZJ-5053片 · No verified English nameCXHL2200478 | Shanghai Hai Yan Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/07/05New drug · Class 1 | YZJ-5053片 · No verified English nameCXHL2200477 | Shanghai Hai Yan Pharmaceuticals Technology Co., Ltd. romanized |
| 2022/07/05New drug · Class 1 | ENC0364 胶囊 · No verified English nameCXHL2200476 | Yi Nuo (Zhejiang) Pharma Co., Ltd. romanized |
| 2022/07/05New drug · Class 1 | ENC0364 胶囊 · No verified English nameCXHL2200475 | Yi Nuo (Zhejiang) Pharma Co., Ltd. romanized |
| 2022/07/05New drug · Class 2.4 | 硫酸阿托品滴眼液 · No verified English nameCXHL2200474 | Ai Er Health Yan Yao (Liaoning) Co., Ltd. romanized |
| 2022/07/05New drug · Class 2.4 | 硫酸阿托品滴眼液 · No verified English nameCXHL2200473 | Ai Er Health Yan Yao (Liaoning) Co., Ltd. romanized |
| 2022/07/05New drug · Class 2.4 | 硫酸阿托品滴眼液 · No verified English nameCXHL2200472 | Ai Er Health Yan Yao (Liaoning) Co., Ltd. romanized |
| 2022/07/05New drug · Class 1 | WJB001胶囊 · No verified English nameCXHL2200465 | Wei Jing Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2022/07/05New drug · Class 1 | WJB001胶囊 · No verified English nameCXHL2200464 | Wei Jing Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2022/07/05New drug · Class 1 | ENC0364 胶囊 · No verified English nameCXHL2200416 | Yi Nuo (Zhejiang) Pharma Co., Ltd. romanized |
| 2022/07/04Import · Class 1 | Cetrelimab · No verified English nameJXSL2200102 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2022/07/04Import · Class 1 | BN301 · No verified English nameJXSL2200101 | Sutro Biopharma Inc.; BioNova Pharmaceuticals (Shanghai) Limited |
| 2022/07/04Import · Class 1 | BN301 · No verified English nameJXSL2200100 | Sutro Biopharma Inc.; BioNova Pharmaceuticals (Shanghai) Limited |
| 2022/07/04Import · Class 2.4 | Upadacitinib片 · No verified English nameJXHL2200169 | AbbVie Inc. |
| 2022/07/04Generic · Class 3 | Levetiracetam extended-release tabletsCYHS2200993 | Hua Run Sai Ke Pharma Co., Ltd. romanized |
| 2022/07/04Generic · Class 3 | Levetiracetam extended-release tabletsCYHS2200992 | Hua Run Sai Ke Pharma Co., Ltd. romanized |
| 2022/07/04New drug · Class 1 | AC-003胶囊 · No verified English nameCXHL2200471 | Ai Ke Nuo Biopharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2022/07/04New drug · Class 1 | AC-003胶囊 · No verified English nameCXHL2200470 | Ai Ke Nuo Biopharmaceuticals (Suzhou) Co., Ltd. romanized |
47 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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