YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 350 drug applications between 15 February 2023 and 21 February 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 91, covering 63 drug names.
2023/02/15 – 2023/02/21
- New acceptances this week
- 350
- Drugs with new generic filings (by drug name, de-duplicated)
- 63
- Accepted this week, now under review
- 1
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
350filings, 91 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 185 |
| Generic | 91 |
| New drug | 35 |
| Import | 19 |
| Import re-registration | 16 |
| Unspecified | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 280 |
| TCM | 40 |
| Therapeutic biologic | 29 |
| 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
63 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 | 4 | 3 | 23 |
| 2 | Roxatidine Acetate Hydrochloride For Injection | 3 | 3 | 5 |
| 3 | Levofloxacin Tablets | 3 | 2 | 7 |
| 4 | Empagliflozin Tablets | 3 | 2 | 18 |
| 5 | Tranexamic Acid Injection | 3 | 1 | 11 |
| 6 | Duloxetine Hydrochloride Enteric Capsules | 3 | 1 | 4 |
| 7 | Lidocaine and Prilocaine Cream | 2 | 2 | 24 |
| 8 | Sodium Hyaluronate Eye Drops | 2 | 2 | 30 |
| 9 | Mannitol-S Injection | 2 | 2 | 1 |
| 10 | Elagolix Tablets | 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
214 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shenyang Jun Yuan Pharma Co., Ltd. romanized | 16 | 10 | 0 |
| 2 | Guangxi Yu Yuan Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 3 | An Qing Hui Yin Bi Pharmaceutical Co., Ltd. romanized | 6 | 5 | 0 |
| 4 | NAPP PHARMACEUTICALS LIMITED | 6 | 1 | 0 |
| 5 | Sichuan Kelun Pharmaceutical Co., Ltd. | 5 | 3 | 2 |
| 6 | Rui Yang Pharmaceutical Co., Ltd. romanized | 5 | 2 | 2 |
| 7 | Haerbin Zhen Bao Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 8 | Bai Yin Zhen Ya Wei Sheng Cai Liao Co., Ltd. romanized | 4 | 3 | 0 |
| 9 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 4 | 3 | 1 |
| 10 | Heilongjiang Song Ci Pharmaceutical Co., Ltd. romanized | 4 | 3 | 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
85 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/02/21Import · Class 1 | PRV-3279 · No verified English nameJXSL2300037 | Provention Bio Inc; HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO. LTD. |
| 2023/02/21Import · Class 1 | GDC-0077 · No verified English nameJXHL2300031 | F.Hoffmann-La Roche Ltd; Roche (China) Holding Ltd. |
| 2023/02/21Import · Class 1 | GDC-0077 · No verified English nameJXHL2300029 | F. Hoffmann-La Roche Ltd |
| 2023/02/21Generic · Class 3 | Roxatidine Acetate Hydrochloride For InjectionCYHS2300603 | Fujian Sheng Min Dong Li Jie Xun Pharma Co., Ltd. romanized |
| 2023/02/21Generic · Class 3 | Potassium Chloride GranulesCYHS2300600 | Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized |
| 2023/02/21Generic · Class 3 | Potassium Chloride GranulesCYHS2300599 | Xi Zhou Pharmaceuticals Technology (Zhejiang) Co., Ltd. romanized; Zhejiang Bei Sheng Pharma Han Sheng Pharmaceutical Co., Ltd. romanized |
| 2023/02/21Generic · Class 3 | Minoxidil LinimentCYHS2300598 | Sichuan Kelun Pharmaceutical Co., Ltd.; Guangdong Ke Hong Pharma Co., Ltd. romanized |
| 2023/02/21Generic · Class 3 | Minoxidil LinimentCYHS2300597 | Sichuan Kelun Pharmaceutical Co., Ltd.; Guangdong Ke Hong Pharma Co., Ltd. romanized |
| 2023/02/21Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2300596 | Shandong Da Guan Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2023/02/21Generic · Class 3 | Aripiprazole Oral SolutionCYHS2300595 | Guangdong Nan Guo Pharma Co., Ltd. romanized |
| 2023/02/21Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2300594 | Shandong Da Guan Pharmaceuticals Technology Co., Ltd. romanized; Shanxi Pu De Pharma Co., Ltd. romanized |
| 2023/02/21Generic · Class 3 | Formoterol Fumarate Inhalation SolutionCYHS2300585 | Hainan Si Da Pharmaceutical Co., Ltd. romanized |
| 2023/02/21Generic · Class 3 | Nicorandil for InjectionCYHS2300584 | Rui Yang Pharmaceutical Co., Ltd. romanized |
| 2023/02/21Generic · Class 3 | Nicorandil for InjectionCYHS2300583 | Rui Yang Pharmaceutical Co., Ltd. romanized |
| 2023/02/21Generic · Class 3 | Flurbiprofen Axetil InjectionCYHL2300026 | YaoPharma Co., Ltd. |
| 2023/02/21Generic · Class 3 | Ketoprofen PatchesCYHL2300025 | Hunan Jiudian Pharmaceutical Co., Ltd |
| 2023/02/21Generic · Class 3 | 二甲磺酸赖右苯丙胺胶囊 · No verified English nameCYHL2300024 | Sichuan Ke Rui De Pharmaceutical Co., Ltd. romanized |
| 2023/02/21New drug · Class 1 | HRYZ-T101注射液 · No verified English nameCXSL2300144 | Heng Rui Yuan Zheng (Shanghai) Bio Technology Co., Ltd. romanized; Heng Rui Yuan Zheng (Guangzhou) Bio Technology Co., Ltd. romanized |
| 2023/02/21New drug · Class 1 | 普那利单抗注射液 · No verified English nameCXSL2300143 | Tian Jing Bio Technology (Hangzhou) Co., Ltd. romanized |
| 2023/02/21New drug · Class 2.2 | BCM475口溶膜 · No verified English nameCXHL2300237 | Shanghai Yun Cheng Yan Xin Bio Technology Co., Ltd. romanized |
| 2023/02/21New drug · Class 1 | AP-L1748片 · No verified English nameCXHL2300236 | Suzhou Jun Jing Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/02/21New drug · Class 1 | AP-L1748片 · No verified English nameCXHL2300235 | Suzhou Jun Jing Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/02/21New drug · Class 1 | HS-10506片 · No verified English nameCXHL2300234 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/02/21New drug · Class 1 | HS-10506片 · No verified English nameCXHL2300233 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized; Shanghai Han Sen Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/02/20New drug · Class 1 | ZT002注射液 · No verified English nameCXSL2300142 | Beijing Zhi Tai Biopharmaceuticals Technology Co., Ltd. romanized |
| 2023/02/20New drug · Class 2.4 | 替戈拉生片 · No verified English nameCXHS2300034 | Shandong Luo Xin Pharma Group Co., Ltd. romanized |
| 2023/02/18Import · Class 2.3 | IBD98-M缓释胶囊 · No verified English nameJXHL2300028 | Holy Stone Healthcare Co. Ltd.; Clinical Service Center Co. Ltd |
| 2023/02/18Generic · Class 3 | Methotrexate TabletsCYHS2300574 | Jiangsu Bai Ao Xin Kang Pharmaceuticals Technology Co., Ltd. romanized; Zhejiang Zhe Bei Pharma Co., Ltd. romanized |
| 2023/02/18Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2300572 | Ya Bao Pharma Sichuan Pharmaceutical Co., Ltd. romanized |
| 2023/02/18Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2300568 | Nanjing Ka Wen Di Xu Bio Gong Cheng Technology Co., Ltd. romanized; Jiangsu Yun Yang Group Pharma Co., Ltd. romanized |
55 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.