YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 220 drug applications between 2 January 2021 and 8 January 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 25, covering 21 drug names.
2021/01/02 – 2021/01/08
- New acceptances this week
- 220
- Drugs with new generic filings (by drug name, de-duplicated)
- 21
- 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
220filings, 25 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 128 |
| New drug | 33 |
| Generic | 25 |
| Import | 23 |
| Unspecified | 7 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 142 |
| Therapeutic biologic | 55 |
| TCM | 18 |
| 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
21 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Pramipexole Dihydrochloride Prolonged-release Tablets | 3 | 1 | 0 |
| 2 | Ornidazole Injection | 2 | 1 | 0 |
| 3 | Empagliflozin Tablets | 2 | 1 | 18 |
| 4 | Rivaroxaban Tablets | 1 | 1 | 3 |
| 5 | Risperidone Oral Solution | 1 | 1 | 6 |
| 6 | Ambroxol Hydrochloride Solution For Inhalation | 1 | 1 | 10 |
| 7 | Diquafosol Sodium Eye Drops | 1 | 1 | 5 |
| 8 | Ibuprofen Suspension | 1 | 1 | 14 |
| 9 | Dutasteride Soft Capsules | 1 | 1 | 0 |
| 10 | 泊沙康唑注射液 · No verified English name | 1 | 1 | 1 |
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
138 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | BIOTON S.A. | 7 | 3 | 0 |
| 2 | Hua Lan Bio Gong Cheng Co., Ltd. romanized | 6 | 1 | 0 |
| 3 | Boehringer Ingelheim International GmbH | 5 | 1 | 0 |
| 4 | AstraZeneca AB | 4 | 2 | 0 |
| 5 | BAXTER S.A.S | 4 | 2 | 0 |
| 6 | Les Laboratoires Servier | 4 | 2 | 0 |
| 7 | CSPC OUYI PHARMACEUTICAL CO., LTD. | 4 | 2 | 4 |
| 8 | Fresenius Kabi Austria GmbH | 4 | 1 | 0 |
| 9 | Qilu Pharmaceutical Co., Ltd. | 3 | 3 | 2 |
| 10 | Merz Pharmaceuticals GmbH | 3 | 2 | 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
52 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/01/08Import · Class 3.1 | 注射用A型肉毒毒素(150KD,不含复合蛋白) · No verified English nameJXSS2100002 | Merz Pharmaceuticals GmbH; Merz Pharma GmbH & Co. KGaA |
| 2021/01/08Import · Class 3.1 | 注射用A型肉毒毒素(150KD,不含复合蛋白) · No verified English nameJXSS2100001 | Merz Pharmaceuticals GmbH; Merz Pharma GmbH & Co. KGaA |
| 2021/01/08Import · Class 1 | 注射用TAK-755 · No verified English nameJXSL2100004 | Baxalta Innovations GmbH |
| 2021/01/08Import · Class 1 | 注射用TAK-755 · No verified English nameJXSL2100003 | Baxalta Innovations GmbH |
| 2021/01/08Import · Class 2.4 | ATG-010片 · No verified English nameJXHL2100001 | Karyopharm Therapeutics Inc. |
| 2021/01/08Generic · Class 3 | Adenosine InjectionCYHS2100016 | Beijing Xian Tong International Pharmaceuticals Technology Co., Ltd. romanized; Shandong Qidu Pharmaceutical Co., Ltd. |
| 2021/01/08Generic · Class 3 | Ornidazole InjectionCYHS2100004 | Hebei Kai Wei Heng Cheng Pharmaceutical Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized |
| 2021/01/08Generic · Class 3 | Ornidazole InjectionCYHS2100003 | Hebei Kai Wei Heng Cheng Pharmaceutical Co., Ltd. romanized; Hebei Kai Wei Pharmaceutical Co., Ltd. romanized |
| 2021/01/08New drug · Class 1 | CBP-201注射液 · No verified English nameCXSL2100006 | Suzhou Kang Nai De Biopharmaceuticals Co., Ltd. romanized |
| 2021/01/08New drug · Class 1 | 杰洛利单抗注射液 · No verified English nameCXSL2100005 | Jia He Bio Pharma Co., Ltd. romanized |
| 2021/01/08New drug · Class 1 | 西奥罗尼胶囊 · No verified English nameCXHL2100010 | Shenzhen Wei Xin Bio Technology Co., Ltd. romanized |
| 2021/01/08New drug · Class 1 | VVN001滴眼液 · No verified English nameCXHL2100008 | Wei Mou Bio Technology (Shanghai) Co., Ltd. romanized |
| 2021/01/08New drug · Class 1 | VVN001滴眼液 · No verified English nameCXHL2100007 | Wei Mou Bio Technology (Shanghai) Co., Ltd. romanized |
| 2021/01/08New drug · Class 1 | 吸入用TQC3721混悬液 · No verified English nameCXHL2100006 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2021/01/07Import · Class 2.2 | DS-8201a · No verified English nameJXSL2100002 | Daiichi Sankyo Inc. |
| 2021/01/06Import · Class 2.2 | 阿替利珠单抗注射液 · No verified English nameJXSL2100001 | F.Hoffmann-La Roche Ltd |
| 2021/01/06Generic · Class 3 | Ambroxol Hydrochloride Solution For InhalationCYHS2100007 | Suzhou Hong Sen Pharma Co., Ltd. romanized |
| 2021/01/06Generic · Class 3 | Aripiprazole Oral SolutionCYHS2100005 | Changzhou Si Yao Pharmaceutical Co., Ltd. romanized |
| 2021/01/06New drug · Class 1.3 | 广防风胶囊 · No verified English nameCXZL2000031 | Shanghai Yao Gang Bio Technology Co., Ltd. romanized |
| 2021/01/06New drug · Class 1.3 | 广防风根 · No verified English nameCXZL2000030 | Shanghai Yao Gang Bio Technology Co., Ltd. romanized |
| 2021/01/06New drug · Class 2.2 | 替雷利珠单抗注射液 · No verified English nameCXSL2100004 | Bai Ji Shen Zhou (Shanghai) Bio Technology Co., Ltd. romanized |
| 2021/01/06New drug · Class 3.3 | 重组抗RANKL全人源单克隆抗体注射液 · No verified English nameCXSL2100003 | Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/01/06New drug · Class 3.4 | 注射用A型肉毒毒素 · No verified English nameCXSL2100002 | Lanzhou Bio Technology Kai Fa Co., Ltd. romanized |
| 2021/01/06New drug · Class 3.4 | 注射用A型肉毒毒素 · No verified English nameCXSL2100001 | Lanzhou Bio Technology Kai Fa Co., Ltd. romanized |
| 2021/01/06New drug · Class 2.2 | 组分无细胞百白破联合疫苗 · No verified English nameCXSL2000386 | Zhongguo Yi Xue Ke College Yi Xue Bio Xue Research Institute romanized |
| 2021/01/06New drug · Class 1 | 注射用GQ1001冻干粉针剂 · No verified English nameCXSL2000385 | Qi De Pharmaceuticals Technology (Suzhou) Co., Ltd. romanized |
| 2021/01/06New drug · Class 1 | NH102盐酸盐片 · No verified English nameCXHL2100005 | Jiangsu En Hua Pharma Co., Ltd. romanized |
| 2021/01/06New drug · Class 1 | NH102盐酸盐片 · No verified English nameCXHL2100004 | Jiangsu En Hua Pharma Co., Ltd. romanized |
| 2021/01/06New drug · Class 1 | NH102盐酸盐片 · No verified English nameCXHL2100003 | Jiangsu En Hua Pharma Co., Ltd. romanized |
| 2021/01/06New drug · Class 1 | YZJ-3058片 · No verified English nameCXHL2100002 | Shanghai Hai Yan Pharmaceuticals Technology Co., Ltd. romanized |
22 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.