YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 82 drug applications between 2 December 2022 and 8 December 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 10, covering 8 drug names.
2022/12/02 – 2022/12/08
- New acceptances this week
- 82
- Drugs with new generic filings (by drug name, de-duplicated)
- 8
- 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
82filings, 10 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 48 |
| New drug | 12 |
| Generic | 10 |
| Import re-registration | 6 |
| Import | 4 |
| Unspecified | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 61 |
| Therapeutic biologic | 14 |
| TCM | 7 |
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
8 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Tedizolid Phosphate Tablets | 2 | 2 | 1 |
| 2 | Elagolix Sodium Tablets | 2 | 1 | 2 |
| 3 | Salbutamol Sulfate Inhalation Solution | 1 | 1 | 2 |
| 4 | Desloratadine Tablets | 1 | 1 | 0 |
| 5 | 帕拉米韦氯化钠注射液 · No verified English name | 1 | 1 | 17 |
| 6 | Atomoxetine Hydrochloride Oral Solution | 1 | 1 | 0 |
| 7 | Moxifloxacin Hydrochloride Tablets | 1 | 1 | 11 |
| 8 | Minoxidil Topical 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
42 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shandong Wei Gao Shu Xue Technology Zhuang Bei Co., Ltd. romanized | 11 | 2 | 0 |
| 2 | Sichuan Hong Ming Bo Si Pharma Co., Ltd. romanized | 8 | 4 | 0 |
| 3 | Shanghai Joint Sai Er Bio Gong Cheng Co., Ltd. romanized | 4 | 1 | 0 |
| 4 | Atlantic Laboratories Corporation Ltd. | 3 | 1 | 0 |
| 5 | Janssen Research & Development LLC | 3 | 1 | 0 |
| 6 | Santen Pharmaceutical Co. Ltd. | 3 | 1 | 0 |
| 7 | Wuxi He Yu Biopharmaceuticals Technology Co., Ltd. romanized | 3 | 1 | 0 |
| 8 | Hebei Wu Luo Pharma Co., Ltd. romanized | 3 | 1 | 0 |
| 9 | Aristo Pharma GmbH | 2 | 1 | 0 |
| 10 | F.Hoffmann-La Roche Ltd | 2 | 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
18 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/12/08Generic · Class 3 | Minoxidil Topical SolutionCYHS2202039 | Jiangsu Chen Pai Bang De Pharma Co., Ltd. romanized |
| 2022/12/08Generic · Class 3 | Elagolix Sodium TabletsCYHL2200108 | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. |
| 2022/12/08Generic · Class 3 | Elagolix Sodium TabletsCYHL2200107 | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. |
| 2022/12/08New drug · Class 1 | 重组人IL12/15-PDL1B单纯疱疹Ⅰ型溶瘤病毒注射液(Vero细胞) · No verified English nameCXSL2200593 | Zhong Sheng Fu Nuo Jian Bio Technology (Shanghai) Co., Ltd. romanized |
| 2022/12/08New drug · Class 1 | KD-025细胞注射液 · No verified English nameCXSL2200592 | Nanjing Kai Di Medical Technology Co., Ltd. romanized |
| 2022/12/08New drug · Class 1 | 齐瑞索韦肠溶胶囊 · No verified English nameCXHS2200063 | Shanghai Ai Ke Bai Fa Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai He Quan Pharmaceuticals Co., Ltd. romanized |
| 2022/12/08New drug · Class 1 | 齐瑞索韦肠溶胶囊 · No verified English nameCXHS2200062 | Shanghai Ai Ke Bai Fa Biopharmaceuticals Technology Co., Ltd. romanized; Shanghai He Quan Pharmaceuticals Co., Ltd. romanized |
| 2022/12/08New drug · Class 1 | NB004片 · No verified English nameCXHL2200927 | Ningbo Xin Wan Technology Development Co., Ltd. romanized |
| 2022/12/08New drug · Class 1 | ABSK121-NX片 · No verified English nameCXHL2200926 | Wuxi He Yu Biopharmaceuticals Technology Co., Ltd. romanized |
| 2022/12/08New drug · Class 1 | ABSK121-NX片 · No verified English nameCXHL2200925 | Wuxi He Yu Biopharmaceuticals Technology Co., Ltd. romanized |
| 2022/12/08New drug · Class 1 | ABSK121-NX片 · No verified English nameCXHL2200924 | Wuxi He Yu Biopharmaceuticals Technology Co., Ltd. romanized |
| 2022/12/07Import · Class 1 | GDC-0077 · No verified English nameJXHL2200344 | F.Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2022/12/07Import · Class 1 | GDC-0077 · No verified English nameJXHL2200343 | F.Hoffmann-La Roche Ltd |
| 2022/12/07Generic · Class 3 | 帕拉米韦氯化钠注射液 · No verified English nameCYHS2202034 | Jiangsu Wu Zhong Pharmaceuticals Group Co., Ltd. Suzhou Pharmaceutical Factory romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2022/12/07New drug · Class 1 | NBL-020注射液 · No verified English nameCXSL2200591 | Shanghai Xin Shi Biopharmaceuticals Co., Ltd. romanized |
| 2022/12/07New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSL2200590 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2022/12/07New drug · Class 2.2 | 特瑞普利单抗注射液 · No verified English nameCXSL2200589 | Shanghai Jun Shi Biopharmaceuticals Technology Co., Ltd. romanized |
| 2022/12/07New drug · Class 1 | 注射用TSN222 · No verified English nameCXHL2200923 | Tai Li Bio Technology (Shanghai) Co., Ltd. romanized |
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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