YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 177 drug applications between 26 September 2023 and 2 October 2023 (data as of 13 November 2026 06:00). Of these, generic applications numbered 40, covering 30 drug names.
2023/09/26 – 2023/10/02
- New acceptances this week
- 177
- Drugs with new generic filings (by drug name, de-duplicated)
- 30
- 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
177filings, 40 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 97 |
| Generic | 40 |
| New drug | 33 |
| Import | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 117 |
| TCM | 32 |
| Therapeutic biologic | 27 |
| In vitro diagnostic reagent | 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
30 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Minoxidil Liniment | 6 | 1 | 52 |
| 2 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
| 3 | Bisoprolol Fumarate Tablets | 2 | 1 | 6 |
| 4 | Pregabalin Capsules | 2 | 1 | 12 |
| 5 | Sodium Hyaluronate Eye Drops | 2 | 1 | 30 |
| 6 | Calcitriol Injection | 2 | 1 | 0 |
| 7 | Acetylcysteine Effervescent Tablets | 1 | 1 | 3 |
| 8 | 二甲双胍恩格列净片(Ⅰ) · No verified English name | 1 | 1 | 7 |
| 9 | 二甲双胍恩格列净片(Ⅵ) · No verified English name | 1 | 1 | 4 |
| 10 | Diprophylline Injection | 1 | 1 | 7 |
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
105 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Zhong Jia Bio Technology (Hubei Sheng) Co., Ltd. romanized | 10 | 4 | 0 |
| 2 | Shanghai Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized | 8 | 1 | 0 |
| 3 | Shen Wei Pharma Group Co., Ltd. romanized | 7 | 4 | 0 |
| 4 | Shandong Tai He Pharmaceuticals Technology Co., Ltd. romanized | 6 | 1 | 6 |
| 5 | Amgen Inc. | 4 | 2 | 0 |
| 6 | Chengdu Kang Hong Pharma Group Co., Ltd. romanized | 4 | 2 | 1 |
| 7 | Sichuan Pharmaceutical Formulations Co., Ltd. romanized | 4 | 1 | 0 |
| 8 | Jilin Sheng Shang Cheng Pharma Co., Ltd. romanized | 3 | 3 | 0 |
| 9 | Sichuan Zhi Qiang Pharmaceuticals Technology Kai Fa Co., Ltd. romanized | 3 | 3 | 0 |
| 10 | Shanghai Pharmaceuticals Group Qingdao Guo Feng Pharma Co., Ltd. romanized | 3 | 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
52 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2023/09/29Import · Class 2.4 | 马立巴韦片 · No verified English nameJXHL2300245 | Takeda Pharmaceuticals U.S.A. Inc.; Takeda(China) International |
| 2023/09/29New drug · Class 1 | NB002注射液 · No verified English nameCXSL2300663 | Suzhou Luo Cheng Biopharmaceuticals Co., Ltd. romanized |
| 2023/09/29New drug · Class 2.2 | 巯嘌呤微片 · No verified English nameCXHS2300091 | Hua Run Shuang He Pharma Co., Ltd. romanized |
| 2023/09/28Import · Class 1 | XXB750注射液 · No verified English nameJXSL2300170 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2023/09/28Generic · Class 3 | Roxatidine Acetate Hydrochloride For InjectionCYHS2302623 | Guangdong Zhong Sheng Pharma Co., Ltd. romanized |
| 2023/09/28Generic · Class 3 | 腺苷钴胺胶囊 · No verified English nameCYHS2302622 | Chengdu Hui De Pharmaceuticals Technology Co., Ltd. romanized; Sichuan Bei Ling He Yi Pharmaceutical Co., Ltd. romanized |
| 2023/09/28Generic · Class 3 | Sodium Bicarbonate Ringer’s InjectionCYHS2302620 | Hebei Tian Cheng Pharma Co., Ltd. romanized |
| 2023/09/28Generic · Class 3 | Magnesium Sulfate InjectionCYHS2302618 | Hainan Quan Ying Pharma Co., Ltd. romanized; Shanghai Jin Di Jiu Zhou Pharma (An Yang) Co., Ltd. romanized |
| 2023/09/28New drug · Class 2.3 | 尪痹胶囊 · No verified English nameCXZL2300065 | Liaoning Hua Run Ben Xi San Yao Co., Ltd. romanized |
| 2023/09/28New drug · Class 1 | CAB-AXL-ADC注射剂 · No verified English nameCXSL2300662 | Kai Bo Si (Shanghai) Biopharmaceuticals Co., Ltd. romanized |
| 2023/09/28New drug · Class 1 | 注射用THDBH120 · No verified English nameCXHL2301040 | Dong Bao Zi Xing (Hangzhou) Biopharmaceuticals Co., Ltd. romanized |
| 2023/09/28New drug · Class 1 | 注射用THDBH120 · No verified English nameCXHL2301039 | Dong Bao Zi Xing (Hangzhou) Biopharmaceuticals Co., Ltd. romanized |
| 2023/09/28New drug · Class 1 | 注射用THDBH120 · No verified English nameCXHL2301038 | Dong Bao Zi Xing (Hangzhou) Biopharmaceuticals Co., Ltd. romanized |
| 2023/09/27Generic · Class 3 | Oseltamivir Phosphate For Oral SuspensionCYHS2302613 | Jiangsu Jia You Pharma Group Co., Ltd. romanized; Wuhan Hai Te Biopharmaceutical Co., Ltd. romanized |
| 2023/09/27New drug · Class 1 | 苏帕鲁肽注射液 · No verified English nameCXSS2300085 | Shanghai Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized; Zhi Xiang Bio (Suzhou) Co., Ltd. romanized |
| 2023/09/27New drug · Class 1 | 苏帕鲁肽注射液 · No verified English nameCXSS2300084 | Shanghai Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized; Zhi Xiang Bio (Suzhou) Co., Ltd. romanized |
| 2023/09/27New drug · Class 1 | 苏帕鲁肽注射液 · No verified English nameCXSS2300083 | Shanghai Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized; Zhi Xiang Bio (Suzhou) Co., Ltd. romanized |
| 2023/09/27New drug · Class 1 | 苏帕鲁肽注射液 · No verified English nameCXSS2300082 | Shanghai Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized; Zhi Xiang Bio (Suzhou) Co., Ltd. romanized |
| 2023/09/27New drug · Class 1 | 苏帕鲁肽注射液 · No verified English nameCXSS2300081 | Shanghai Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized; Zhi Xiang Bio (Suzhou) Co., Ltd. romanized |
| 2023/09/27New drug · Class 1 | 苏帕鲁肽注射液 · No verified English nameCXSS2300080 | Shanghai Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized; Zhi Xiang Bio (Suzhou) Co., Ltd. romanized |
| 2023/09/27New drug · Class 1 | 苏帕鲁肽注射液 · No verified English nameCXSS2300079 | Shanghai Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized; Zhi Xiang Bio (Suzhou) Co., Ltd. romanized |
| 2023/09/27New drug · Class 1 | 苏帕鲁肽注射液 · No verified English nameCXSS2300078 | Shanghai Yin Nuo Pharmaceuticals Technology Co., Ltd. romanized; Zhi Xiang Bio (Suzhou) Co., Ltd. romanized |
| 2023/09/27New drug · Class 1 | RJMty19注射液 · No verified English nameCXSL2300661 | Zhejiang Rui Jia Mei Bio Technology Co., Ltd. romanized |
| 2023/09/27New drug · Class 1 | GC012F注射液 · No verified English nameCXSL2300660 | Suzhou Gen Xi Bio Technology Co., Ltd. romanized; Gen Xi Bio Technology (Shanghai) Co., Ltd. romanized |
| 2023/09/27New drug · Class 1 | HGI-001注射液 · No verified English nameCXSL2300659 | Shenzhen Shi He Mu Ji Yin Bio Technology Co., Ltd. romanized |
| 2023/09/27New drug · Class 2.4 | 注射用重组A型肉毒毒素 · No verified English nameCXSL2300658 | Jun He Meng Biopharmaceutical (Tong Hua) Co., Ltd. romanized |
| 2023/09/27New drug · Class 2.4 | 脯氨酸恒格列净片 · No verified English nameCXHS2300090 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2023/09/27New drug · Class 2.4 | 脯氨酸恒格列净片 · No verified English nameCXHS2300089 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2023/09/27New drug · Class 1 | 注射用JMKX003801 · No verified English nameCXHL2301037 | Zhejiang Hang Yu Pharmaceutical Co., Ltd. romanized |
| 2023/09/26Generic · Class 3 | Minoxidil LinimentCYHS2302604 | Shandong Tai He Pharmaceuticals Technology Co., Ltd. romanized; Jewim Pharmaceutical (Shandong) Co., Ltd. |
22 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.