YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 228 drug applications between 1 November 2021 and 7 November 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 32, covering 27 drug names.
2021/11/01 – 2021/11/07
- New acceptances this week
- 228
- Drugs with new generic filings (by drug name, de-duplicated)
- 27
- 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
228filings, 32 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 136 |
| Generic | 32 |
| New drug | 25 |
| Import | 18 |
| Import re-registration | 13 |
| Unspecified | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 168 |
| Therapeutic biologic | 35 |
| TCM | 20 |
| Prophylactic biologic | 5 |
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
27 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Ozagrel Sodium Injection | 2 | 1 | 3 |
| 2 | Amlodipine Besylate and Atorvastatin Calcium Tablets | 2 | 1 | 2 |
| 3 | Remifentanil Hydrochloride for Injection | 2 | 1 | 2 |
| 4 | Sodium Hyaluronate Eye Drops | 2 | 1 | 30 |
| 5 | 阿普米司特片 · No verified English name | 2 | 1 | 3 |
| 6 | ω-3 鱼油中长链脂肪乳/氨基酸(16)/葡萄糖(30%)注射液 · No verified English name | 1 | 1 | 0 |
| 7 | 丙酸氟替卡松吸入粉雾剂 · No verified English name | 1 | 1 | 1 |
| 8 | Rivaroxaban Tablets | 1 | 1 | 3 |
| 9 | Linaclotide Capsules | 1 | 1 | 13 |
| 10 | Desogestrel and Ethinylestradiol Tablets | 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
127 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Fei Sen You Si Ka Bi Hua Rui Pharmaceutical Co., Ltd. romanized | 8 | 1 | 0 |
| 2 | Guangdong Ke Lun Pharma Co., Ltd. romanized | 7 | 2 | 0 |
| 3 | Hua Bei Pharmaceutical Jin Tan Bio Technology Co., Ltd. romanized | 7 | 1 | 0 |
| 4 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized | 7 | 1 | 0 |
| 5 | Hainan Tong Yong San Yang Pharma Co., Ltd. romanized | 6 | 2 | 0 |
| 6 | Shaanxi Nian Qing Bao Pharmaceutical Co., Ltd. romanized | 5 | 5 | 0 |
| 7 | Novartis Pharma Schweiz AG | 5 | 2 | 0 |
| 8 | UCB Pharma SA | 5 | 2 | 0 |
| 9 | Liu He Zhang Long Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Chongqing Duo Dai Pharmaceuticals Technology Co., Ltd. romanized | 4 | 4 | 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
50 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/11/05Import · Class 2.2 | 度伐利尤单抗注射液 · No verified English nameJXSL2101125 | MedImmune LLC; AstraZeneca Investment (China) Co. Limited |
| 2021/11/05Import · Class 2.2 | 阿普唑仑吸入粉剂 · No verified English nameJXHL2101234 | UCB Pharma SA; UCB Trading (Shanghai) Co. Ltd. |
| 2021/11/05Import · Class 1 | BBP-398 胶囊 · No verified English nameJXHL2101233 | Navire Pharma Inc.; Shanghai LianBio Development Co. Ltd. |
| 2021/11/05Import · Class 1 | BBP-398胶囊 · No verified English nameJXHL2101232 | Navire Pharma Inc.; Shanghai LianBio Development Co. Ltd. |
| 2021/11/05Generic · Class 3 | Neostigmine Methylsulfate InjectionCYHS2101978 | Guangzhou Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized |
| 2021/11/05Generic · Class 3 | 丙酸氟替卡松吸入粉雾剂 · No verified English nameCYHL2101034 | Run Sheng Pharma Co., Ltd. romanized |
| 2021/11/04Generic · Class 3 | ω-3 鱼油中长链脂肪乳/氨基酸(16)/葡萄糖(30%)注射液 · No verified English nameCYHL2101035 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2021/11/04New drug · Class 3.3 | 冻干人用狂犬病疫苗(人二倍体细胞) · No verified English nameCXSS2101046 | Beijing Min Hai Bio Technology Co., Ltd. romanized |
| 2021/11/04New drug · Class 2.2 | 信迪利单抗注射液 · No verified English nameCXSS2101045 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2021/11/04New drug · Class 1 | TWP-103注射液 · No verified English nameCXSL2101402 | Tai Ze Hui Kang Biopharmaceuticals Co., Ltd. romanized |
| 2021/11/04New drug · Class 1 | KN056注射液 · No verified English nameCXSL2101386 | Suzhou Kang Ning Jie Rui Bio Technology Co., Ltd. romanized |
| 2021/11/04New drug · Class 1 | WTS-007胶囊 · No verified English nameCXHL2101624 | Hangzhou Wu Tong Shu Pharma Co., Ltd. romanized |
| 2021/11/04New drug · Class 1 | WTS-007胶囊 · No verified English nameCXHL2101623 | Hangzhou Wu Tong Shu Pharma Co., Ltd. romanized |
| 2021/11/04New drug · Class 1 | WTS-007胶囊 · No verified English nameCXHL2101622 | Hangzhou Wu Tong Shu Pharma Co., Ltd. romanized |
| 2021/11/03Import · Class 3.1 | 西妥昔单抗注射液 · No verified English nameJXSS2101029 | Merck Europe B.V.; Merck Healthcare KGaA; Merck Serono Co. Ltd. |
| 2021/11/03Import · Class 1 | 3D-197注射液 · No verified English nameJXSL2101123 | 3D Medicines Inc.; 3D Medicines (Shanghai) Co. Ltd. |
| 2021/11/03Import · Class 2.1 | 注射用托伐普坦磷酸钠 · No verified English nameJXHL2101231 | Otsuka Pharmaceutical Co. Ltd.; Otsuka Beijing Research Insititute |
| 2021/11/03Import · Class 2.1 | 注射用托伐普坦磷酸钠 · No verified English nameJXHL2101230 | Otsuka Pharmaceutical Co. Ltd.; Otsuka Beijing Research Insititute |
| 2021/11/03Generic · Class 3 | 地氯雷他定口服溶液 · No verified English nameCYHS2101958 | Heng Chang (Guangzhou) Xin Yao Research Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized |
| 2021/11/03Generic · Class 3 | Remifentanil Hydrochloride for InjectionCYHL2101032 | Jiangsu En Hua Pharma Co., Ltd. romanized |
| 2021/11/03Generic · Class 3 | Remifentanil Hydrochloride for InjectionCYHL2101031 | Jiangsu En Hua Pharma Co., Ltd. romanized |
| 2021/11/03New drug · Class 1.3 | 重组带状疱疹疫苗(CHO细胞) · No verified English nameCXSL2101408 | Shanghai Mai Ke Kang Bio Technology Co., Ltd. romanized; Chengdu Mai Ke Kang Bio Technology Co., Ltd. romanized |
| 2021/11/02Import · Class 1 | Afuresertib片 · No verified English nameJXHL2101229 | Laekna Limited; Laekna Therapeutics Shanghai Co. Ltd. |
| 2021/11/02Import · Class 1 | Afuresertib片 · No verified English nameJXHL2101228 | Laekna Limited; Laekna Therapeutics Shanghai Co. Ltd. |
| 2021/11/02Generic · Class 3 | Trihexyphenidyl Hydrochloride TabletsCYHS2101959 | Beijing Si Li An Pharma Co., Ltd. romanized |
| 2021/11/02Generic · Class 3 | Dexrazoxane for InjectionCYHS2101956 | Guangdong Zhong Run Drug Research and Development Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2021/11/02Generic · Class 3 | Ozagrel Sodium InjectionCYHS2101939 | Guangxi Ming Lei Wei Sheng Pharmaceutical Co., Ltd. romanized |
| 2021/11/02Generic · Class 3 | Ozagrel Sodium InjectionCYHS2101938 | Guangxi Ming Lei Wei Sheng Pharmaceutical Co., Ltd. romanized |
| 2021/11/02Generic · Class 3 | Bismuth subcitrate potassium, Metronidazole and Tetracycline Hydrochloride CapsulesCYHS2101929 | Hubei Jing Jiang Yuan Pharmaceutical Co., Ltd. romanized |
| 2021/11/02New drug · Class 1 | IBI110 · No verified English nameCXSL2101406 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
20 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.
Subscribe to the weekly
No account needed.
The email carries the same content as this page, in the language you subscribe in: section counts, top-10 lists and definitions, with a link to the full report. Your address is used only to send the report.