YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 29 drug applications between 2 October 2021 and 8 October 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 2, covering 1 drug name.
2021/10/02 – 2021/10/08
- New acceptances this week
- 29
- Drugs with new generic filings (by drug name, de-duplicated)
- 1
- 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
29filings, 2 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 16 |
| Unspecified | 5 |
| New drug | 4 |
| Generic | 2 |
| Import | 2 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 20 |
| Therapeutic biologic | 5 |
| TCM | 2 |
| 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
1 drug with new generic filings
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Cyclophosphamide Capsules | 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
20 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shandong Xuan Zhu Pharmaceuticals Technology Co., Ltd. romanized | 3 | 1 | 0 |
| 2 | Shenzhen Li Jian Pharma Co., Ltd. romanized | 3 | 1 | 0 |
| 3 | Merck & Co. Inc | 2 | 2 | 0 |
| 4 | LG Chem Ltd. | 2 | 1 | 0 |
| 5 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 2 | 1 | 2 |
| 6 | Jiangsu En Hua Pharma Co., Ltd. romanized | 2 | 1 | 0 |
| 7 | Fa Bo Jin (Zhongguo) Pharmaceuticals Technology Kai Fa Co., Ltd. romanized | 2 | 1 | 0 |
| 8 | Anidro do Brasil Extracoes S.A. | 1 | 1 | 0 |
| 9 | BioInvent International AB | 1 | 1 | 0 |
| 10 | F. Hoffmann-La Roche Ltd | 1 | 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
8 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/10/08Import · Class 2.2 | 阿替利珠单抗注射液 · No verified English nameJXSL2101116 | F. Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2021/10/08Import · Class 1 | BI-1206 · No verified English nameJXSL2101115 | BioInvent International AB; CASI Pharmaceuticals (China) Co. Ltd. |
| 2021/10/08Generic · Class 3 | Cyclophosphamide CapsulesCYHS2101811 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/10/08Generic · Class 3 | Cyclophosphamide CapsulesCYHS2101810 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/10/08New drug · Class 1 | LY01019注射液 · No verified English nameCXSL2101351 | Shandong Bo An Bio Technology Co., Ltd. romanized |
| 2021/10/08New drug · Class 1 | SIM1811-03注射液 · No verified English nameCXSL2101350 | Jiangsu Xian Sheng Biopharmaceutical Co., Ltd. romanized |
| 2021/10/08New drug · Class 1 | 重组人源化单克隆抗体MIL62注射液 · No verified English nameCXSL2101347 | Beijing Tian Guang Shi Bio Technology Co., Ltd. romanized |
| 2021/10/08New drug · Class 2.2 | 醋酸阿比特龙软胶囊 · No verified English nameCXHL2101528 | Zhejiang He Ze Pharmaceuticals Technology 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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