YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 167 drug applications between 12 June 2021 and 18 June 2021 (data as of 13 November 2026 06:00). Of these, generic applications numbered 25, covering 21 drug names.
2021/06/12 – 2021/06/18
- New acceptances this week
- 167
- 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
167filings, 25 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 94 |
| New drug | 30 |
| Generic | 25 |
| Import | 9 |
| Unspecified | 8 |
| Import re-registration | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 122 |
| Therapeutic biologic | 32 |
| TCM | 12 |
| Prophylactic biologic | 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
21 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Levetiracetam Oral Solution | 2 | 2 | 3 |
| 2 | 头孢克肟胶囊 · No verified English name | 2 | 1 | 2 |
| 3 | 注射用头孢曲松钠/氯化钠注射液 · No verified English name | 2 | 1 | 3 |
| 4 | Magnesium Sulfate Injection | 2 | 1 | 7 |
| 5 | Propofol Medium And Long Chain Fat Emulsion Injection | 1 | 1 | 3 |
| 6 | 吸入用七氟烷 · No verified English name | 1 | 1 | 0 |
| 7 | Ipratropium Bromide Inhalation Solution | 1 | 1 | 2 |
| 8 | Ambroxol Hydrochloride Solution For Inhalation | 1 | 1 | 10 |
| 9 | Tenofovir Disoproxil Fumarate Tablets | 1 | 1 | 0 |
| 10 | Lamotrigine Dispersible Tablets | 1 | 1 | 2 |
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
103 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Wuhan Fu Xing Bio Pharma Co., Ltd. romanized | 6 | 1 | 0 |
| 2 | Dong Bei Pharmaceutical Group Shenyang Di Yi Pharmaceutical Co., Ltd. romanized | 5 | 4 | 0 |
| 3 | CSPC OUYI PHARMACEUTICAL CO., LTD. | 5 | 2 | 0 |
| 4 | Bayer AG | 5 | 1 | 0 |
| 5 | Lian Cardiovascular Limited | 5 | 1 | 0 |
| 6 | Haerbin Han Bang Medical Technology Co., Ltd. romanized | 5 | 1 | 0 |
| 7 | Hangzhou Sen Ze Pharmaceuticals Technology Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Nang Kuang Pharmaceutical Co. Ltd | 4 | 1 | 0 |
| 9 | Aspen OOS B.V | 3 | 3 | 0 |
| 10 | ZHE JIANG HUA HAI PHARMACEUTICALCO.,LTD. | 3 | 3 | 3 |
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
47 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2021/06/18Generic · Class 3 | Nifedipine Extended-Release TabletsCYHS2101305 | Nanjing Yi Heng Pharmaceutical Co., Ltd. romanized |
| 2021/06/18New drug · Class 1 | EX101注射液 · No verified English nameCXSL2101140 | Guangzhou Ai Si Mai Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/06/18New drug · Class 1 | 重组人源化抗表皮生长因子受体单克隆抗体注射液 · No verified English nameCXSL2101139 | Shanghai Jin Man Te Bio Technology Co., Ltd. romanized |
| 2021/06/18New drug · Class 1 | 重组抗PD-1全人源单克隆抗体注射液 · No verified English nameCXSL2101138 | Shi Yao Group Zhong Qi Pharmaceutical Technology (Shijiazhuang) Co., Ltd. romanized |
| 2021/06/18New drug · Class 1 | 注射用IMM01 · No verified English nameCXSL2101109 | Yi Ming Ang Ke Biopharmaceuticals Technology (Shanghai) Co., Ltd. romanized |
| 2021/06/18New drug · Class 1 | SYHX1901片 · No verified English nameCXHL2101206 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2021/06/18New drug · Class 1 | SYHX1901片 · No verified English nameCXHL2101205 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2021/06/18New drug · Class 2.4 | 注射用苏拉明钠 · No verified English nameCXHL2101187 | Guangdong Kang Da Pharmaceutical Co., Ltd. romanized |
| 2021/06/17Import · Class 1 | 注射用STP705 · No verified English nameJXHL2101092 | Sirnaomics Inc.; Sirnaomics Biopharmaceuticals (Suzhou) Co. Ltd. |
| 2021/06/17Generic · Class 3 | 头孢克肟胶囊 · No verified English nameCYHS2101301 | Shandong Yu Xin Pharma Co., Ltd. romanized; Shandong Luo Xin Pharma Group Co., Ltd. romanized |
| 2021/06/17Generic · Class 3 | 头孢克肟胶囊 · No verified English nameCYHS2101300 | Shandong Yu Xin Pharma Co., Ltd. romanized; Shandong Luo Xin Pharma Group Co., Ltd. romanized |
| 2021/06/17Generic · Class 3 | Magnesium Sulfate InjectionCYHS2101298 | Shijiazhuang Xing Ze Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized |
| 2021/06/17Generic · Class 3 | Magnesium Sulfate InjectionCYHS2101297 | Shijiazhuang Xing Ze Pharmaceuticals Technology Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized |
| 2021/06/17Generic · Class 3 | Treprostinil InjectionCYHS2101273 | Jiangsu Zhong Qiang Pharma Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2021/06/17New drug · Class 2.2 | 康复新肠溶胶囊 · No verified English nameCXZL2101012 | ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. |
| 2021/06/17New drug · Class 1 | 重组仙台病毒/Ⅱ型单纯疱疹病毒注射液 · No verified English nameCXSL2101136 | Guo Yao Zhong Sheng Bio Technology Research Institute Co., Ltd. romanized |
| 2021/06/17New drug · Class 1 | SHR-1316注射液 · No verified English nameCXSL2101129 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2021/06/17New drug · Class 1 | IBI110 · No verified English nameCXSL2101126 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2021/06/17New drug · Class 2.2 | 贝伐珠单抗注射液 · No verified English nameCXSL2101125 | Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized |
| 2021/06/17New drug · Class 1 | 斯鲁利单抗注射液 · No verified English nameCXSL2101124 | Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized |
| 2021/06/17New drug · Class 1 | 注射用SMET12 · No verified English nameCXSL2101118 | Zhejiang Shi Mai Pharma Co., Ltd. romanized |
| 2021/06/17New drug · Class 1 | APG-2575片 · No verified English nameCXHL2101210 | Suzhou Ya Sheng Pharma Co., Ltd. romanized |
| 2021/06/17New drug · Class 1 | APG-2575片 · No verified English nameCXHL2101209 | Suzhou Ya Sheng Pharma Co., Ltd. romanized |
| 2021/06/17New drug · Class 1 | SYHX1901片 · No verified English nameCXHL2101208 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2021/06/17New drug · Class 1 | SYHX1901片 · No verified English nameCXHL2101207 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2021/06/17New drug · Class 2.2; 2.3 | 普拉克索雷沙吉兰缓释胶囊 · No verified English nameCXHL2101204 | ZHEJIANG JINGXIN PHARMACEUTICAL CO.,LTD. |
| 2021/06/16Generic · Class 3 | Ambroxol Hydrochloride Solution For InhalationCYHL2101016 | Tai Yang Sheng (Bo Zhou) Biopharmaceuticals Technology Co., Ltd. romanized |
| 2021/06/16New drug · Class 1 | AK104注射液 · No verified English nameCXSL2101137 | Kang Fang Pharma Co., Ltd. romanized |
| 2021/06/15Import · Class 2.2 | 帕博利珠单抗注射液 · No verified English nameJXSL2101041 | Merck Sharp & Dohme Corp.; MSD R&D(China)Co. Ltd. |
| 2021/06/15Import · Class 1 | Mavacamten胶囊 · No verified English nameJXHL2101091 | Lian Cardiovascular Limited; Shanghai LianBio Development Co. Ltd. |
17 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.