YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 138 drug applications between 2 May 2022 and 8 May 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 20, covering 14 drug names.
2022/05/02 – 2022/05/08
- New acceptances this week
- 138
- Drugs with new generic filings (by drug name, de-duplicated)
- 14
- 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
138filings, 20 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 60 |
| New drug | 37 |
| Generic | 20 |
| Import | 17 |
| Unspecified | 2 |
| Import re-registration | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 88 |
| Therapeutic biologic | 28 |
| TCM | 18 |
| Prophylactic biologic | 4 |
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
14 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 奥氮平盐酸氟西汀胶囊 · No verified English name | 5 | 1 | 0 |
| 2 | Amisulpride Injection | 2 | 1 | 1 |
| 3 | Moxifloxacin Hydrochloride Eye Drops | 2 | 1 | 4 |
| 4 | 复方聚乙二醇电解质散(Ⅲ) · No verified English name | 1 | 1 | 1 |
| 5 | Tinidazole Tablets | 1 | 1 | 0 |
| 6 | 氧(液态) · No verified English name | 1 | 1 | 13 |
| 7 | Voriconazole for Injection | 1 | 1 | 5 |
| 8 | Dexrazoxane for Injection | 1 | 1 | 1 |
| 9 | Roxatidine Acetate Hydrochloride For Injection | 1 | 1 | 5 |
| 10 | Atomoxetine Hydrochloride Oral Solution | 1 | 1 | 0 |
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
78 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | UNION therapeutics A/S | 6 | 2 | 0 |
| 2 | Chengdu Hong Ji Bio Technology Co., Ltd. romanized | 6 | 1 | 0 |
| 3 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 5 | 3 | 0 |
| 4 | Jiangsu Zhang Tai Pharma Co., Ltd. romanized | 5 | 1 | 5 |
| 5 | Jilin Zhen Yuan Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 6 | Beijing Ke Xing Bio Zhi Pin Co., Ltd. romanized | 4 | 2 | 0 |
| 7 | N.V. Organon | 4 | 1 | 0 |
| 8 | Changchun Jin Sai Pharma Co., Ltd. romanized | 4 | 1 | 0 |
| 9 | Shandong Han Fang Pharmaceutical Co., Ltd. romanized | 3 | 3 | 0 |
| 10 | Pfizer Inc. | 3 | 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
62 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/05/07Import · Class 2.2 | 纳武利尤单抗注射液 · No verified English nameJXSL2200055 | Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd. |
| 2022/05/07Generic · Class 3 | 奥氮平盐酸氟西汀胶囊 · No verified English nameCYHS2200710 | Jiangsu Zhang Tai Pharma Co., Ltd. romanized |
| 2022/05/07Generic · Class 3 | 奥氮平盐酸氟西汀胶囊 · No verified English nameCYHS2200709 | Jiangsu Zhang Tai Pharma Co., Ltd. romanized |
| 2022/05/07Generic · Class 3 | 奥氮平盐酸氟西汀胶囊 · No verified English nameCYHS2200708 | Jiangsu Zhang Tai Pharma Co., Ltd. romanized |
| 2022/05/07Generic · Class 3 | 奥氮平盐酸氟西汀胶囊 · No verified English nameCYHS2200707 | Jiangsu Zhang Tai Pharma Co., Ltd. romanized |
| 2022/05/07Generic · Class 3 | 奥氮平盐酸氟西汀胶囊 · No verified English nameCYHS2200706 | Jiangsu Zhang Tai Pharma Co., Ltd. romanized |
| 2022/05/07New drug · Class 1 | 注射用SKB264 · No verified English nameCXSL2200208 | Sichuan Ke Lun Bo Tai Biopharmaceuticals Co., Ltd. romanized |
| 2022/05/07New drug · Class 1 | 注射用重组人源化抗CD47单克隆抗体 · No verified English nameCXSL2200207 | Le Pu Bio Technology Co., Ltd. romanized |
| 2022/05/07New drug · Class 1 | KH631眼用注射液 · No verified English nameCXSL2200206 | Chengdu Hong Ji Bio Technology Co., Ltd. romanized |
| 2022/05/07New drug · Class 1 | KH631眼用注射液 · No verified English nameCXSL2200205 | Chengdu Hong Ji Bio Technology Co., Ltd. romanized |
| 2022/05/07New drug · Class 1 | KH631眼用注射液 · No verified English nameCXSL2200204 | Chengdu Hong Ji Bio Technology Co., Ltd. romanized |
| 2022/05/07New drug · Class 1 | KH631眼用注射液 · No verified English nameCXSL2200203 | Chengdu Hong Ji Bio Technology Co., Ltd. romanized |
| 2022/05/07New drug · Class 1 | KH631眼用注射液 · No verified English nameCXSL2200202 | Chengdu Hong Ji Bio Technology Co., Ltd. romanized |
| 2022/05/07New drug · Class 1 | KH631眼用注射液 · No verified English nameCXSL2200201 | Chengdu Hong Ji Bio Technology Co., Ltd. romanized |
| 2022/05/07New drug · Class 1 | 注射用SHR-1802 · No verified English nameCXSL2200200 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2022/05/07New drug · Class 1 | 阿得贝利单抗注射液 · No verified English nameCXSL2200199 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2022/05/07New drug · Class 1 | 阿得贝利单抗注射液 · No verified English nameCXSL2200198 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2022/05/07New drug · Class 1 | 注射用SHR-A1811 · No verified English nameCXSL2200197 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2022/05/07New drug · Class 1 | PM8001注射液 · No verified English nameCXSL2200195 | Pu Mi Si Bio Technology (Zhuhai) Co., Ltd. romanized |
| 2022/05/07New drug · Class 1 | EG017软膏 · No verified English nameCXHL2200286 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2022/05/07New drug · Class 1 | EG017软膏 · No verified English nameCXHL2200285 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2022/05/07New drug · Class 1 | EG017软膏 · No verified English nameCXHL2200284 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2022/05/07New drug · Class 1 | EG017软膏 · No verified English nameCXHL2200283 | Changchun Jin Sai Pharma Co., Ltd. romanized |
| 2022/05/07New drug · Class 1 | HRS-7085片 · No verified English nameCXHL2200282 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2022/05/07New drug · Class 1 | HRS-7085片 · No verified English nameCXHL2200281 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2022/05/07New drug · Class 1 | SPN0103-009注射液 · No verified English nameCXHL2200280 | Hangzhou Ao Sai Nuo Bio Technology Co., Ltd. romanized |
| 2022/05/07New drug · Class 2.4 | Pyrotinib Maleate TabletsCXHL2200279 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2022/05/07New drug · Class 2.4 | Pyrotinib Maleate TabletsCXHL2200278 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2022/05/07New drug · Class 1 | HRS-1167片 · No verified English nameCXHL2200277 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2022/05/07New drug · Class 1 | HRS-1167片 · No verified English nameCXHL2200276 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
32 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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