YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 296 drug applications between 20 August 2022 and 26 August 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 54, covering 34 drug names.
2022/08/20 – 2022/08/26
- New acceptances this week
- 296
- Drugs with new generic filings (by drug name, de-duplicated)
- 34
- Accepted this week, now under review
- 2
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
296filings, 54 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 163 |
| Generic | 54 |
| New drug | 49 |
| Import | 22 |
| Unspecified | 4 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 205 |
| Therapeutic biologic | 51 |
| TCM | 33 |
| Prophylactic biologic | 4 |
| 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
34 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Acetylcysteine Solution For Inhalation | 3 | 3 | 4 |
| 2 | Potassium Chloride Injection | 3 | 2 | 10 |
| 3 | Magnesium Sulfate Injection | 3 | 1 | 7 |
| 4 | Peramivir Injection | 2 | 2 | 7 |
| 5 | Esmolol Hydrochloride Injection | 2 | 2 | 3 |
| 6 | Sodium Bicarbonate Ringer’s Injection | 2 | 2 | 1 |
| 7 | Tacrolimus Ointment | 2 | 1 | 6 |
| 8 | Piracetam Injection | 2 | 1 | 9 |
| 9 | Bromhexine Hydrochloride Solution For Inhalation | 2 | 1 | 1 |
| 10 | Tobramycin Eye Drops | 2 | 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
155 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Henan Run Hong Ben Cao Pharmaceutical Co., Ltd. romanized | 16 | 15 | 0 |
| 2 | Guo Yao Group Gong Ye Co., Ltd. romanized | 12 | 12 | 0 |
| 3 | Hubei Mei Lin Pharma Co., Ltd. romanized | 10 | 6 | 0 |
| 4 | Lanzhou Fu Ci (Rui Nuo Xin) Pharma Co., Ltd. romanized | 9 | 9 | 0 |
| 5 | Henan Fu Ren Tang Pharmaceutical Co., Ltd. romanized | 8 | 8 | 0 |
| 6 | Novartis Pharma AG | 7 | 3 | 0 |
| 7 | Shenyang San Sheng Pharmaceutical Co., Ltd. romanized | 7 | 2 | 2 |
| 8 | Li Zhu Group Li Zhu Pharmaceutical Factory romanized | 6 | 1 | 0 |
| 9 | Hubei Kang Wei Yuan Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Yi Chang Dong Yang Guang Chang Jiang Pharma 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
96 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2022/08/26Import · Class 1 | Ponsegromab 注射液 · No verified English nameJXSL2200147 | Pfizer Inc.; Pfizer Investment CO. Ltd |
| 2022/08/26Import · Class 1 | Ponsegromab 注射液 · No verified English nameJXSL2200146 | Pfizer Inc.; Pfizer Investment CO. Ltd |
| 2022/08/26Import · Class 3.1 | 注射用A型肉毒毒素 · No verified English nameJXSL2200145 | AbbVie Limited; Allergan Information Consulting (Shanghai) Co. Ltd. |
| 2022/08/26Import · Class 3.1 | 注射用A型肉毒毒素 · No verified English nameJXSL2200144 | AbbVie Limited; Allergan Information Consulting (Shanghai) Co. Ltd. |
| 2022/08/26Import · Class 3.1 | 注射用A型肉毒毒素 · No verified English nameJXSL2200143 | AbbVie Limited; Allergan Information Consulting (Shanghai) Co. Ltd. |
| 2022/08/26Generic · Class 3 | Potassium Chloride InjectionCYHS2201394 | Guangzhou Ai Qi Xi Pharmaceuticals Technology Co., Ltd. romanized; Hebei Tian Cheng Pharma Co., Ltd. romanized |
| 2022/08/26Generic · Class 3 | Potassium Chloride InjectionCYHS2201393 | Guangzhou Ai Qi Xi Pharmaceuticals Technology Co., Ltd. romanized; Hebei Tian Cheng Pharma Co., Ltd. romanized |
| 2022/08/26Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2201392 | Shandong He Qi Pharmaceutical Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2022/08/26Generic · Class 3 | 盐酸左沙丁胺醇雾化吸入溶液 · No verified English nameCYHS2201391 | Shandong He Qi Pharmaceutical Co., Ltd. romanized; Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized |
| 2022/08/26Generic · Class 3 | Peramivir InjectionCYHS2201390 | Qinghai Chen Fei Pharmaceutical Co., Ltd. romanized |
| 2022/08/26Generic · Class 3 | 复方维生素C聚乙二醇(3350)钠钾散 · No verified English nameCYHS2201371 | Shu Tai Shen (Beijing) Biopharmaceutical Co., Ltd. romanized |
| 2022/08/26Generic · Class 3 | Pregabalin Extended release TabletsCYHL2200073 | Jiangsu En Hua Pharma Co., Ltd. romanized; Suzhou En Hua Biopharmaceuticals Technology Co., Ltd. romanized |
| 2022/08/26New drug · Class 2.2 | 斯鲁利单抗注射液 · No verified English nameCXSS2200076 | Shanghai Fu Hong Han Lin Biopharmaceutical Co., Ltd. romanized |
| 2022/08/26New drug · Class 1 | RGT-264磷酸盐片 · No verified English nameCXHL2200631 | Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized |
| 2022/08/26New drug · Class 1 | RGT-264磷酸盐片 · No verified English nameCXHL2200630 | Shanghai Qi Lu Rui Ge Pharmaceuticals Research and Development Co., Ltd. romanized |
| 2022/08/26New drug · Class 1 | 注射用KMHH-03 · No verified English nameCXHL2200629 | Beijing Kang Ming Hai Hui Bio Technology Co., Ltd. romanized |
| 2022/08/25Generic · Class 3 | Piracetam InjectionCYHS2201383 | Jiangxi Yi You Pharma Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized |
| 2022/08/25Generic · Class 3 | Piracetam InjectionCYHS2201382 | Jiangxi Yi You Pharma Co., Ltd. romanized; Ma An Shan Feng Yuan Pharmaceutical Co., Ltd. romanized |
| 2022/08/25Generic · Class 3 | Sodium Bicarbonate Ringer’s InjectionCYHS2201376 | CISEN PHARMACEUTICAL CO., LTD. |
| 2022/08/25New drug · Class 1 | 注射用IBB0979 · No verified English nameCXSL2200402 | Sheng He (Zhongguo) Biopharmaceutical Co., Ltd. romanized |
| 2022/08/25New drug · Class 1 | GC101腺相关病毒注射液 · No verified English nameCXSL2200400 | Beijing Jin Lan Ji Yin Technology Co., Ltd. romanized |
| 2022/08/25New drug · Class 1 | CX1440胶囊 · No verified English nameCXHL2200628 | Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized |
| 2022/08/25New drug · Class 1 | CX1440胶囊 · No verified English nameCXHL2200627 | Hangzhou Bang Shun Pharmaceutical Co., Ltd. romanized |
| 2022/08/25New drug · Class 1 | 注射用XCCS605B · No verified English nameCXHL2200626 | Shanghai Hua Yu Bio Technology Co., Ltd. romanized |
| 2022/08/25New drug · Class 1 | NRT6003注射液 · No verified English nameCXHL2200621 | Chengdu Niu Rui Te Medical Technology Co., Ltd. romanized |
| 2022/08/25New drug · Class 2.2 | HF158K1 · No verified English nameCXHL2200617 | Hangzhou Gao Tian Biopharmaceuticals Co., Ltd. romanized |
| 2022/08/24Import · Class 1 | Tiragolumab注射液 · No verified English nameJXSL2200140 | F. Hoffmann -La Roche Ltd; Roche (China) Holding Ltd |
| 2022/08/24Import · Class 2.4 | INC280 · No verified English nameJXHL2200256 | Janssen Research & Development LLC; China Novartis Institutes for BioMedical Research Co. Ltd |
| 2022/08/24Import · Class 2.4 | INC280 · No verified English nameJXHL2200255 | Janssen Research & Development LLC; China Novartis Institutes for BioMedical Research Co. Ltd |
| 2022/08/24Import · Class 1 | JDQ443片 · No verified English nameJXHL2200254 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd |
66 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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