YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 299 drug applications between 19 August 2022 and 25 August 2022 (data as of 13 November 2026 06:00). Of these, generic applications numbered 59, covering 39 drug names.
2022/08/19 – 2022/08/25
- New acceptances this week
- 299
- Drugs with new generic filings (by drug name, de-duplicated)
- 39
- 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
299filings, 59 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 157 |
| Generic | 59 |
| New drug | 54 |
| Import | 17 |
| Unspecified | 8 |
| Import re-registration | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 224 |
| Therapeutic biologic | 45 |
| TCM | 26 |
| Biologic | 3 |
| 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
39 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Sodium Bicarbonate Ringer’s Injection | 4 | 3 | 1 |
| 2 | Magnesium Sulfate Injection | 3 | 1 | 7 |
| 3 | Oseltamivir Phosphate Capsules | 3 | 1 | 39 |
| 4 | Peramivir Injection | 2 | 2 | 7 |
| 5 | Esmolol Hydrochloride Injection | 2 | 2 | 3 |
| 6 | Tacrolimus Ointment | 2 | 1 | 6 |
| 7 | Tadalafil Tablets | 2 | 1 | 23 |
| 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
167 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 | Li Zhu Group Li Zhu Pharmaceutical Factory romanized | 6 | 1 | 0 |
| 8 | Yi Chang Dong Yang Guang Chang Jiang Pharma Co., Ltd. romanized | 4 | 2 | 0 |
| 9 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 4 | 2 | 0 |
| 10 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 4 | 2 | 4 |
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
94 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2022/08/24Import · Class 1 | JDQ443片 · No verified English nameJXHL2200253 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd |
| 2022/08/24Import · Class 1 | NORA520片 · No verified English nameJXHL2200245 | Gerbera Therapeutics Inc.; Nanjing Noratech Pharmaceuticals. Ltd |
| 2022/08/24Import · Class 1 | NORA520片 · No verified English nameJXHL2200244 | Gerbera Therapeutics Inc.; Nanjing Noratech Pharmaceuticals. Ltd |
| 2022/08/24New drug · Class 1 | 肿瘤浸润T淋巴细胞 · No verified English nameCXSL2200399 | Beijing Xun Sheng Bio Yi Xue Research Co., Ltd. romanized |
| 2022/08/24New drug · Class 1 | 注射用BGB-B167 · No verified English nameCXSL2200398 | Guangzhou Bai Ji Shen Zhou Biopharmaceutical Co., Ltd. romanized |
| 2022/08/24New drug · Class 1 | BR790片 · No verified English nameCXHL2200619 | Shanghai Ge Fei Mu Biopharmaceuticals Technology Co., Ltd. romanized |
| 2022/08/24New drug · Class 1 | BR790片 · No verified English nameCXHL2200618 | Shanghai Ge Fei Mu Biopharmaceuticals Technology Co., Ltd. romanized |
| 2022/08/24New drug · Class 1 | HLX208片 · No verified English nameCXHL2200616 | Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized |
| 2022/08/24New drug · Class 1 | HRS-1358片 · No verified English nameCXHL2200615 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2022/08/24New drug · Class 1 | HRS-1358片 · No verified English nameCXHL2200614 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2022/08/24New drug · Class 2.2 | 华法林钠颗粒 · No verified English nameCXHL2200613 | Xinjiang Te Feng Pharma Co., Ltd. romanized |
| 2022/08/23Import · Class 1 | Peresolimab注射液 · No verified English nameJXSL2200141 | Eli Lilly and Company; Lilly Suzhou Pharmaceutical Co. Ltd. |
| 2022/08/23Import · Class 1.1 | MVA-BN-RSV疫苗 · No verified English nameJXSL2200138 | Bavarian Nordic A/S; Nuance Pharma (Shanghai) Co. Ltd. |
| 2022/08/23Import · Class 2.2 | 帕博利珠单抗注射液 · No verified English nameJXSL2200134 | Merck Sharp &. Dohme Corp.; MSD R&D (China) Co. Ltd. |
| 2022/08/23Import · Class 2.4 | ABL001胶囊装微片 · No verified English nameJXHL2200252 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2022/08/23Import · Class 2.4 | ABL001胶囊装微片 · No verified English nameJXHL2200251 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
64 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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