YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 62 drug applications between 3 October 2021 and 9 October 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 10, covering 7 drug names.
2021/10/03 – 2021/10/09
- New acceptances this week
- 62
- Drugs with new generic filings (by drug name, de-duplicated)
- 7
- 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
62filings, 10 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 33 |
| Generic | 10 |
| New drug | 8 |
| Unspecified | 5 |
| Import | 5 |
| Import re-registration | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 41 |
| Therapeutic biologic | 14 |
| TCM | 5 |
| 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
7 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Parecoxib Sodium for Injection | 3 | 2 | 2 |
| 2 | Cyclophosphamide Capsules | 2 | 1 | 2 |
| 3 | Salbutamol Sulfate Inhalation Solution | 1 | 1 | 2 |
| 4 | Diquafosol Sodium Eye Drops | 1 | 1 | 5 |
| 5 | Sildenafil Citrate Tablets | 1 | 1 | 12 |
| 6 | Olprinone Hydrochloride Injection | 1 | 1 | 1 |
| 7 | Esmolol Hydrochloride and Sodium Chloride Injection | 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
47 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 | Zhejiang Guo Jing Pharma Co., Ltd. romanized | 3 | 1 | 0 |
| 3 | Shenzhen Li Jian Pharma Co., Ltd. romanized | 3 | 1 | 0 |
| 4 | Merck & Co. Inc | 2 | 2 | 0 |
| 5 | Bioshin Limited | 2 | 1 | 0 |
| 6 | LG Chem Ltd. | 2 | 1 | 0 |
| 7 | Shanghai Hua Yuan Pharma (Ningxia) Sha Sai Pharmaceutical Co., Ltd. romanized | 2 | 1 | 2 |
| 8 | Shanghai Fu Hong Han Lin Biopharmaceutical Co., Ltd. romanized | 2 | 1 | 0 |
| 9 | Guo Yao Yi Xin Pharmaceutical Co., Ltd. romanized | 2 | 1 | 0 |
| 10 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 2 | 1 | 2 |
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
16 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/10/09Import · Class 1 | Troriluzole 胶囊 · No verified English nameJXHL2101196 | Bioshin Limited; BioShin (Shanghai) Co. Ltd. |
| 2021/10/09Import · Class 1 | Troriluzole 胶囊 · No verified English nameJXHL2101195 | Bioshin Limited; BioShin (Shanghai) Co. Ltd. |
| 2021/10/09Import · Class 1 | 注射用 WCK5222 · No verified English nameJXHL2101191 | Wockhardt Bio AG; Labcorp Pharmaceutical Research and Development (Beijing) Co. Ltd. |
| 2021/10/09Generic · Class 3 | Olprinone Hydrochloride InjectionCYHS2101826 | Wu Hu Yang Yan Pharmaceutical Co., Ltd. romanized |
| 2021/10/09New drug · Class 1.1 | 九味疏风平喘颗粒 · No verified English nameCXZL2101028 | Jiangsu Kang Yuan Pharma Co., Ltd. romanized |
| 2021/10/09New drug · Class 1 | LBL-019注射液 · No verified English nameCXSL2101348 | Nanjing Wei Li Zhi Bo Bio Technology Co., Ltd. romanized |
| 2021/10/09New drug · Class 1 | TST005注射液 · No verified English nameCXSL2101346 | Mai Bo Si Biopharmaceuticals (Suzhou) Co., Ltd. romanized |
| 2021/10/09New drug · Class 1 | SHR-1314注射液 · No verified English nameCXSL2101345 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 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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