YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 223 drug applications between 14 January 2021 and 20 January 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 27, covering 20 drug names.
2021/01/14 – 2021/01/20
- New acceptances this week
- 223
- Drugs with new generic filings (by drug name, de-duplicated)
- 20
- 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
223filings, 27 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 128 |
| New drug | 30 |
| Generic | 27 |
| Import | 19 |
| Unspecified | 13 |
| Import re-registration | 6 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 178 |
| Therapeutic biologic | 38 |
| TCM | 4 |
| Prophylactic biologic | 2 |
| In vitro diagnostic reagent | 1 |
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
20 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Lacosamide Oral Solution | 2 | 2 | 0 |
| 2 | Oseltamivir Phosphate Capsules | 2 | 2 | 39 |
| 3 | Levocarnitine Injection | 2 | 1 | 4 |
| 4 | Thiotepa for Injection | 2 | 1 | 0 |
| 5 | Duloxetine Hydrochloride Enteric Capsules | 2 | 1 | 4 |
| 6 | Citicoline Sodium Injection | 2 | 1 | 3 |
| 7 | Dabigatran Etexilate Capsules | 2 | 1 | 2 |
| 8 | Ornidazole Injection | 1 | 1 | 0 |
| 9 | Nimodipine Oral Solution | 1 | 1 | 4 |
| 10 | Plerixafor Injection | 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
130 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 6 | 1 | 0 |
| 2 | Boehringer Ingelheim International GmbH | 5 | 3 | 0 |
| 3 | Sichuan Kelun Pharmaceutical Co., Ltd. | 5 | 3 | 2 |
| 4 | GUERBET | 5 | 1 | 0 |
| 5 | Guilin Pharmaceutical Co. Ltd China | 5 | 1 | 0 |
| 6 | Qilu Pharmaceutical Co., Ltd. | 4 | 4 | 2 |
| 7 | Dong Guan Shi Dong Yang Guang Bio Yao Research and Development Co., Ltd. romanized | 4 | 2 | 0 |
| 8 | Shandong Yu Man Kun Bio Technology Co., Ltd. romanized | 4 | 2 | 4 |
| 9 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 4 | 2 | 2 |
| 10 | Haikou Shi Pharmaceutical Factory Co., Ltd. romanized | 4 | 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
50 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/01/20Import · Class 3.1 | 注射用司妥昔单抗 · No verified English nameJXSS2100005 | EUSA Pharma (Netherlands) B.V.; Cilag AG |
| 2021/01/20Import · Class 3.1 | 注射用司妥昔单抗 · No verified English nameJXSS2100004 | EUSA Pharma (Netherlands) B.V.; Cilag AG |
| 2021/01/20Import · Class 1 | IMGN853 · No verified English nameJXSL2100009 | ImmunoGen Inc. |
| 2021/01/20Import · Class 1 | RO7445482注射液 · No verified English nameJXHL2100021 | F. Hoffmann-La Roche Ltd. |
| 2021/01/20New drug · Class 3.3 | 德谷胰岛素注射液 · No verified English nameCXSL2100024 | Dong Guan Shi Dong Yang Guang Bio Yao Research and Development Co., Ltd. romanized |
| 2021/01/20New drug · Class 1 | 异体内皮祖细胞(EPCs)注射液 · No verified English nameCXSL2100023 | Cheng Nuo Zai Sheng Yi Xue Technology (Zhuhai Heng Qin Xin Qu) Co., Ltd. romanized |
| 2021/01/20New drug · Class 1 | JMT601注射液 · No verified English nameCXSL2100022 | Shanghai Jin Man Te Bio Technology Co., Ltd. romanized |
| 2021/01/20New drug · Class 1 | HEC88473注射液 · No verified English nameCXSL2100021 | Dong Guan Shi Dong Yang Guang Bio Yao Research and Development Co., Ltd. romanized |
| 2021/01/20New drug · Class 1 | HEC88473注射液 · No verified English nameCXSL2100020 | Dong Guan Shi Dong Yang Guang Bio Yao Research and Development Co., Ltd. romanized |
| 2021/01/20New drug · Class 1 | RO7049389片 · No verified English nameCXHL2100038 | Luo Shi Research and Development (Zhongguo) Co., Ltd. romanized |
| 2021/01/20New drug · Class 1 | RO7049389片 · No verified English nameCXHL2100037 | Luo Shi Research and Development (Zhongguo) Co., Ltd. romanized |
| 2021/01/19Import · Class 2.2 | 阿替利珠单抗注射液 · No verified English nameJXSL2100008 | F.Hoffmann-La Roche Ltd |
| 2021/01/19Import · Class 1 | BI685509片 · No verified English nameJXHL2100020 | Boehringer Ingelheim International GmbH |
| 2021/01/19Import · Class 1 | BI685509片 · No verified English nameJXHL2100019 | Boehringer Ingelheim International GmbH |
| 2021/01/19Import · Class 1 | BI685509片 · No verified English nameJXHL2100018 | Boehringer Ingelheim International GmbH |
| 2021/01/19Generic · Class 3 | Ornidazole InjectionCYHS2100074 | Xian Wan Long Pharmaceutical Co., Ltd. romanized |
| 2021/01/19Generic · Class 3 | Nimodipine Oral SolutionCYHS2100073 | Guangdong Jin Cheng Jin Su Pharmaceutical Co., Ltd. romanized; Zhejiang Kang En Bei Pharmaceutical Co., Ltd. romanized |
| 2021/01/19Generic · Class 3 | Olprinone Hydrochloride InjectionCYHS2100070 | Ji Chuan Pharma Group Co., Ltd. romanized |
| 2021/01/19New drug · Class 3.3 | 特立帕肽注射液 · No verified English nameCXSS2100011 | Xin Li Tai (Suzhou) Pharma Co., Ltd. romanized |
| 2021/01/19New drug · Class 1 | HEC88473注射液 · No verified English nameCXSL2100019 | Dong Guan Shi Dong Yang Guang Bio Yao Research and Development Co., Ltd. romanized |
| 2021/01/19New drug · Class 2.2 | 贝伐珠单抗注射液 · No verified English nameCXSL2100018 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2021/01/19New drug · Class 1 | SHR-1701注射液 · No verified English nameCXSL2100017 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2021/01/19New drug · Class 1 | NR082眼用注射液 · No verified English nameCXSL2100016 | Wuhan Niu Fu Si Bio Technology Co., Ltd. romanized |
| 2021/01/19New drug · Class 1 | HRS2543片 · No verified English nameCXHL2100036 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/01/19New drug · Class 1 | HRS2543片 · No verified English nameCXHL2100035 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/01/19New drug · Class 1 | HRS2543片 · No verified English nameCXHL2100034 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2021/01/19New drug · Class 2.4 | 甲磺酸阿美替尼片 · No verified English nameCXHL2100033 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized |
| 2021/01/19New drug · Class 1 | 双环铂注射液 · No verified English nameCXHL2100032 | Beijing Suo Pu Xing Da Pharmaceuticals Research Co., Ltd. romanized |
| 2021/01/18New drug · Class 1 | 西奥罗尼胶囊 · No verified English nameCXHL2100009 | Shenzhen Wei Xin Bio Technology Co., Ltd. romanized |
| 2021/01/16Import · Class 1 | JDQ443片 · No verified English nameJXHL2100017 | Novartis Pharma AG |
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.
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