YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 229 drug applications between 28 January 2021 and 3 February 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 40, covering 30 drug names.
2021/01/28 – 2021/02/03
- New acceptances this week
- 229
- Drugs with new generic filings (by drug name, de-duplicated)
- 30
- Accepted this week, now under review
- 5
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
229filings, 40 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 89 |
| Import | 43 |
| New drug | 41 |
| Generic | 40 |
| Unspecified | 11 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 188 |
| Therapeutic biologic | 23 |
| TCM | 10 |
| Prophylactic biologic | 5 |
| Biologic | 3 |
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
30 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Duloxetine Hydrochloride Enteric Capsules | 3 | 1 | 4 |
| 2 | Tenofovir alafenamide Fumarate Tablets | 2 | 2 | 0 |
| 3 | Peramivir Injection | 2 | 2 | 7 |
| 4 | Sodium Valproate Concentrated Solution for Injection | 2 | 1 | 0 |
| 5 | Irbesartan Tablets | 2 | 1 | 4 |
| 6 | Ipratropium Bromide Inhalation Solution | 2 | 1 | 2 |
| 7 | Pramipexole Dihydrochloride Prolonged-release Tablets | 2 | 1 | 0 |
| 8 | Tirofiban Hydrochloride And Sodium Chloride Injection | 2 | 1 | 2 |
| 9 | 莫米松福莫特罗吸入气雾剂 · No verified English name | 2 | 1 | 0 |
| 10 | Edaravone 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
142 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Suzhou Kai Tuo Pharma Co., Ltd. romanized | 9 | 2 | 0 |
| 2 | Hubei Yi Ban Tian Pharmaceutical Co., Ltd. romanized | 5 | 2 | 0 |
| 3 | AbbVie Inc. | 4 | 2 | 0 |
| 4 | Amgen Inc. | 4 | 2 | 0 |
| 5 | AstraZeneca AB | 4 | 2 | 0 |
| 6 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 4 | 2 | 4 |
| 7 | Dr. Reddy's Laboratories Limited | 4 | 1 | 0 |
| 8 | Zhejiang Hai Kang Bio Zhi Pin Co., Ltd. romanized | 4 | 1 | 0 |
| 9 | Guo Yao Group Wei Qi Da Pharma Co., Ltd. romanized | 3 | 3 | 0 |
| 10 | CSPC OUYI PHARMACEUTICAL CO., LTD. | 3 | 3 | 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
82 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/02/03Import · Class 1 | PF-06480605注射液 · No verified English nameJXSL2100017 | Pfizer Inc. |
| 2021/02/03Import · Class 1 | RO7030816 · No verified English nameJXSL2100016 | F. Hoffmann-La Roche Ltd |
| 2021/02/03Import · Class 1 | RO7030816 · No verified English nameJXSL2100015 | F. Hoffmann-La Roche Ltd |
| 2021/02/03Import · Class 1 | Finerenone薄膜衣片 · No verified English nameJXHS2100018 | Bayer AG |
| 2021/02/03Import · Class 1 | Finerenone薄膜衣片 · No verified English nameJXHS2100017 | Bayer AG |
| 2021/02/03Import · Class 2.4 | 阿贝西利片 · No verified English nameJXHL2100044 | Eli Lilly and Company |
| 2021/02/03Import · Class 2.4 | 环硅酸锆钠散 · No verified English nameJXHL2100042 | AstraZeneca AB |
| 2021/02/03Import · Class 2.4 | 环硅酸锆钠散 · No verified English nameJXHL2100041 | AstraZeneca AB |
| 2021/02/03Import · Class 1 | 注射用Trilaciclib · No verified English nameJXHL2100040 | G1 THERAPEUTICS INC. |
| 2021/02/03Import · Class 2.4 | Olaparib TabletsJXHL2100039 | AstraZeneca AB |
| 2021/02/03Import · Class 2.4 | Olaparib TabletsJXHL2100038 | AstraZeneca AB |
| 2021/02/03Import · Class 1 | Navitoclax片 · No verified English nameJXHL2100037 | AbbVie Inc. |
| 2021/02/03Import · Class 1 | Navitoclax片 · No verified English nameJXHL2100036 | AbbVie Inc. |
| 2021/02/03Import · Class 1 | ABBV-744片 · No verified English nameJXHL2100035 | AbbVie Inc. |
| 2021/02/03Import · Class 1 | ABBV-744片 · No verified English nameJXHL2100034 | AbbVie Inc. |
| 2021/02/03Generic · Class 3 | Metaraminol Tartrate InjectionCYHS2100153 | Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Ya Bang Pharmaceuticals Co., Ltd. romanized |
| 2021/02/03Generic · Class 3 | Tofacitinib Citrate Extended Release tabletsCYHS2100152 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2021/02/03Generic · Class 3 | Tirofiban Hydrochloride And Sodium Chloride InjectionCYHS2100151 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2021/02/03Generic · Class 3 | Tirofiban Hydrochloride And Sodium Chloride InjectionCYHS2100150 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2021/02/03Generic · Class 3 | 盐酸肾上腺素注射液 · No verified English nameCYHS2100148 | Wuhan Wu Yao Pharmaceutical Co., Ltd. romanized; Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanized |
| 2021/02/03Generic · Class 3 | 莫米松福莫特罗吸入气雾剂 · No verified English nameCYHL2100012 | Health Yuan Pharma Group Co., Ltd. romanized |
| 2021/02/03Generic · Class 3 | 莫米松福莫特罗吸入气雾剂 · No verified English nameCYHL2100011 | Health Yuan Pharma Group Co., Ltd. romanized |
| 2021/02/03New drug · Class 1.1 | T89(Compound Danshen Dripping Pill) · No verified English nameCXZL2100002 | Tian Shi Li Pharmaceuticals Group Co., Ltd. romanized |
| 2021/02/03New drug · Class 2.2 | 注射用重组人尿激酶原 · No verified English nameCXSS2100013 | Tian Shi Li Biopharmaceuticals Co., Ltd. romanized |
| 2021/02/03New drug · Class 1 | MG-K10人源化单抗注射液 · No verified English nameCXSL2100043 | Shanghai Mai Ji Bio Technology Co., Ltd. romanized |
| 2021/02/03New drug · Class 1 | SHR-1314注射液 · No verified English nameCXSL2100042 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2021/02/03New drug · Class 1 | HLX26单抗注射液 · No verified English nameCXSL2100041 | Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized |
| 2021/02/03New drug · Class 1 | 注射用NVS451融合蛋白 · No verified English nameCXSL2100040 | Guo Yao Zhong Sheng Bio Technology Research Institute Co., Ltd. romanized |
| 2021/02/03New drug · Class 1 | NBL-012注射液 · No verified English nameCXSL2100039 | Shanghai Xin Shi Biopharmaceuticals Co., Ltd. romanized |
| 2021/02/03New drug · Class 1 | EX101注射液 · No verified English nameCXSL2100036 | Guangzhou Ai Si Mai Biopharmaceuticals Technology Co., Ltd. romanized |
52 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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