YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 390 drug applications between 1 February 2023 and 7 February 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 123, covering 86 drug names.
2023/02/01 – 2023/02/07
- New acceptances this week
- 390
- Drugs with new generic filings (by drug name, de-duplicated)
- 86
- 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
390filings, 123 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 164 |
| Generic | 123 |
| New drug | 64 |
| Import | 16 |
| Import re-registration | 14 |
| Unspecified | 9 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 301 |
| Therapeutic biologic | 47 |
| TCM | 40 |
| Prophylactic biologic | 2 |
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
86 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral Solution | 5 | 2 | 23 |
| 2 | Lactulose Oral Solution | 4 | 2 | 34 |
| 3 | Phenylephrine Hydrochloride Injection | 4 | 2 | 5 |
| 4 | Minoxidil Topical Solution | 4 | 2 | 0 |
| 5 | Calcium Levofolinate Injection | 4 | 1 | 0 |
| 6 | Phloroglucinol Injection | 3 | 3 | 2 |
| 7 | Peramivir Injection | 3 | 2 | 7 |
| 8 | Amoxicillin Sodium for Injection | 3 | 1 | 0 |
| 9 | Indobufen Tablets | 2 | 2 | 6 |
| 10 | Mecobalamin Tablets | 2 | 2 | 16 |
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
237 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Ping Guang Pharmaceutical Co., Ltd. romanized | 13 | 12 | 0 |
| 2 | Anhui Pioneer Pharmaceutical Co., Ltd | 9 | 3 | 0 |
| 3 | Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized | 7 | 2 | 0 |
| 4 | Tianjin Bai Te Medical Yong Pin Co., Ltd. romanized | 6 | 6 | 6 |
| 5 | Hunan Ke Lun Pharmaceutical Co., Ltd. romanized | 6 | 4 | 4 |
| 6 | Qilu Pharmaceutical Co., Ltd. | 6 | 3 | 1 |
| 7 | Bracco Imaging Italia s.r.l. | 6 | 1 | 0 |
| 8 | Sichuan Kelun Pharmaceutical Co., Ltd. | 5 | 4 | 1 |
| 9 | Henan Sheng Bai Quan Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Sichuan Hui Yu Pharmaceutical Co., Ltd. romanized | 4 | 3 | 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
130 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/02/07Import · Class 2.2 | 索安非托片 · No verified English nameJXHL2300020 | Axsome Malta Ltd.; Ignis Therapeutics (Suzhou) Limited |
| 2023/02/07Generic · Class 3 | Trimebutine Maleate TabletsCYHS2300384 | Shanxi Zhen Dong An Xin Biopharmaceutical Co., Ltd. romanized |
| 2023/02/07Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2300383 | Zhejiang Kang Run Pharmaceutical Co., Ltd. romanized |
| 2023/02/07Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2300382 | Zhejiang Kang Run Pharmaceutical Co., Ltd. romanized |
| 2023/02/07Generic · Class 3 | Potassium Aspartate InjectionCYHS2300373 | Jilin Si Zhang Pharmaceutical Co., Ltd. romanized |
| 2023/02/07Generic · Class 3 | Methocarbamol InjectionCYHS2300368 | Nanjing Sai Rui Pu Dun Pharmaceutical Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized |
| 2023/02/07Generic · Class 3 | Penicillin G Sodium For InjectionCYHS2300364 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; NORTH CHINA PHARMACEUTICAL COMPANY.LTD |
| 2023/02/07New drug · Class 3.3 | 托珠单抗注射液 · No verified English nameCXSS2300005 | Hangzhou Bo Zhi Rui Biopharmaceutical Co., Ltd. romanized |
| 2023/02/07New drug · Class 1 | CAStem细胞注射液 · No verified English nameCXSL2300091 | Beijing Ze Hui Chen Xing Bio Technology Co., Ltd. romanized |
| 2023/02/07New drug · Class 1 | Y332 · No verified English nameCXSL2300090 | Wuhan You Zhi You Biopharmaceutical Co., Ltd. romanized |
| 2023/02/07New drug · Class 1 | Y400 · No verified English nameCXSL2300089 | Shenzhen Shi Kang Zhe Wei Sheng Pharmaceuticals Development Co., Ltd. romanized |
| 2023/02/07New drug · Class 2.2 | 纳曲酮植入剂 · No verified English nameCXHS2300025 | Shenzhen Shan Kang Pharmaceuticals Technology Co., Ltd. romanized |
| 2023/02/07New drug · Class 2.2 | 盐酸曲美他嗪多释片 · No verified English nameCXHL2300176 | Yue Yang Pharmaceuticals Kai Fa (Guangzhou) Co., Ltd. romanized |
| 2023/02/07New drug · Class 2.4 | 注射用紫杉醇聚合物胶束 · No verified English nameCXHL2300175 | Shanghai Yi Zhong Pharma Co., Ltd. romanized |
| 2023/02/07New drug · Class 1 | SY-5933片 · No verified English nameCXHL2300174 | Shou Yao Holding (Beijing) Co., Ltd. romanized |
| 2023/02/07New drug · Class 1 | 注射用JJH201601脂质体 · No verified English nameCXHL2300173 | Jiangsu Ji Bei Er Pharma Co., Ltd. romanized |
| 2023/02/06Generic · Class 3 | Indobufen TabletsCYHS2300362 | Chengdu Shuo De Pharma Co., Ltd. romanized |
| 2023/02/06Generic · Class 3 | Furosemide InjectionCYHS2300361 | Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2023/02/06Generic · Class 3 | Furosemide InjectionCYHS2300360 | Ren He Yi Kang Group Co., Ltd. romanized; Hebei Ren He Yi Kang Pharma Co., Ltd. romanized |
| 2023/02/04Import · Class 3.1 | 尘螨变应原舌下片 · No verified English nameJXSS2300015 | ALK-Abelló A/S; Catalent UK Swindon Zydis Limited |
| 2023/02/04Import · Class 3.1 | 注射用tisotumab vedotin · No verified English nameJXSL2300032 | Seagen Inc.; Zai Lab (Shanghai) CO. Ltd. |
| 2023/02/04Import · Class 1 | Milvexian片 · No verified English nameJXHL2300019 | Janssen Research & Development LLC; Johnson & Johnson (China) Investment Ltd. |
| 2023/02/04Generic · Class 3 | Mesalamine extended release capsulesCYHS2300356 | Jiangsu An Bi Sheng Pharmaceutical Co., Ltd. romanized |
| 2023/02/04Generic · Class 3 | 奥美拉唑碳酸氢钠干混悬剂(Ⅰ) · No verified English nameCYHS2300355 | Shandong Yi Kang Pharma Co., Ltd. romanized |
| 2023/02/04Generic · Class 3 | Oxaliplatin InjectionCYHS2300352 | Shanghai Chuang Nuo Pharmaceutical Co., Ltd. romanized |
| 2023/02/04Generic · Class 3 | Betahistine Dihydrochloride TabletsCYHS2300349 | Sen Miao (Shandong) Pharma Co., Ltd. romanized; Jinan Yong Ning Pharmaceutical Co., Ltd. romanized |
| 2023/02/04Generic · Class 3 | Famotidine InjectionCYHS2300342 | Guangzhou Lv Shi Zi Pharmaceutical Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2023/02/04Generic · Class 3 | Isoprenaline Hydrochloride InjectionCYHS2300340 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2023/02/04Generic · Class 3 | Metformin Hydrochloride Extended-release TabletsCYHS2300337 | Zhejiang Zhong Yan Pharmaceuticals Technology Co., Ltd. romanized; Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized |
| 2023/02/04Generic · Class 3 | Calcium Levofolinate InjectionCYHS2300334 | Zhejiang Pu Li Pharma Co., Ltd. romanized |
100 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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