YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 322 drug applications between 13 August 2024 and 19 August 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 92, covering 67 drug names.
2024/08/13 – 2024/08/19
- New acceptances this week
- 322
- Drugs with new generic filings (by drug name, de-duplicated)
- 67
- Accepted this week, now under review
- 6
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
322filings, 92 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 144 |
| Generic | 92 |
| New drug | 58 |
| Import | 17 |
| Unspecified | 6 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 219 |
| TCM | 52 |
| Therapeutic biologic | 42 |
| Prophylactic biologic | 8 |
| 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
67 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Ketorolac Tromethamine Injection | 4 | 2 | 4 |
| 2 | 甲磺酸多沙唑嗪片 · No verified English name | 3 | 1 | 0 |
| 3 | Epalrestat Tablets | 2 | 2 | 1 |
| 4 | Pranoprofen Eye Drops | 2 | 2 | 7 |
| 5 | Bisoprolol Fumarate and Amlodipine Besylate Tablets | 2 | 2 | 9 |
| 6 | Eperisone Hydrochloride Tablets | 2 | 2 | 8 |
| 7 | 依伏卡塞片 · No verified English name | 2 | 1 | 9 |
| 8 | Sodium Tetradecyl Sulphate Injection | 2 | 1 | 0 |
| 9 | Tropicamide Phenylephrine Eye Drops | 2 | 1 | 8 |
| 10 | Vonoprazan Fumarate Tablets | 2 | 1 | 60 |
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
196 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | NAPP PHARMACEUTICALS LIMITED | 9 | 1 | 0 |
| 2 | Shanxi Hua Kang Pharma Co., Ltd. romanized | 6 | 4 | 0 |
| 3 | Novartis Pharma AG | 6 | 2 | 0 |
| 4 | Shanghai Pharmaceuticals Group Qingdao Guo Feng Pharma Co., Ltd. romanized | 5 | 5 | 0 |
| 5 | Shandong Bu Zhang Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 6 | Shanghai Shang Yao Di Yi Sheng Hua Pharma Co., Ltd. romanized | 4 | 3 | 2 |
| 7 | Janssen Research & Development LLC | 4 | 2 | 0 |
| 8 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 4 | 2 | 0 |
| 9 | Takeda Manufacturing Austria AG | 4 | 1 | 0 |
| 10 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 4 | 1 | 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
110 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/08/19New drug · Class 1 | RJMty19注射液 · No verified English nameCXSL2400553 | Zhejiang Rui Jia Mei Bio Technology Co., Ltd. romanized |
| 2024/08/17Import · Class 1 | AZD5492 · No verified English nameJXSL2400149 | AstraZeneca AB; AstraZeneca Global ll&U (China) Co. Ltd. |
| 2024/08/17Generic · Class 3 | Bumetanide InjectionCYHS2402684 | Sichuan Wo Xiang Biopharmaceuticals Co., Ltd. romanized; Chengdu Di Yi Pharmaceutical Co., Ltd. romanized |
| 2024/08/17Generic · Class 3 | Sodium Tetradecyl Sulphate InjectionCYHL2400167 | Shanghai Shang Yao Di Yi Sheng Hua Pharma Co., Ltd. romanized |
| 2024/08/17Generic · Class 3 | Sodium Tetradecyl Sulphate InjectionCYHL2400166 | Shanghai Shang Yao Di Yi Sheng Hua Pharma Co., Ltd. romanized |
| 2024/08/17Generic · Class 3 | 利多卡因丙胺卡因气雾剂 · No verified English nameCYHL2400165 | Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized |
| 2024/08/17New drug · Class 1 | SYS6026注射液 · No verified English nameCXSL2400552 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2024/08/17New drug · Class 1 | LAT010注射液 · No verified English nameCXSL2400551 | Lai Te Kang (Suzhou) Biopharmaceutical Co., Ltd. romanized |
| 2024/08/17New drug · Class 1 | G01滴眼液 · No verified English nameCXSL2400550 | Qingdao Wan Ming Sai Bo Biopharmaceuticals Co., Ltd. romanized |
| 2024/08/17New drug · Class 1 | G01滴眼液 · No verified English nameCXSL2400549 | Qingdao Wan Ming Sai Bo Biopharmaceuticals Co., Ltd. romanized |
| 2024/08/17New drug · Class 1 | G01滴眼液 · No verified English nameCXSL2400548 | Qingdao Wan Ming Sai Bo Biopharmaceuticals Co., Ltd. romanized |
| 2024/08/17New drug · Class 1 | 重组全人源抗PCSK9单克隆抗体注射液 · No verified English nameCXSL2400547 | Xin Li Tai (Chengdu) Bio Technology Co., Ltd. romanized; Xin Li Tai (Suzhou) Pharma Co., Ltd. romanized; Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2024/08/17New drug · Class 1 | HRS-6208胶囊 · No verified English nameCXHL2400849 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/08/17New drug · Class 1 | HRS-6208胶囊 · No verified English nameCXHL2400848 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/08/16Import · Class 2.2 | 度伐利尤单抗注射液 · No verified English nameJXSS2400067 | AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca Investment (China) Co. Ltd. |
| 2024/08/16Import · Class 2.2 | 度伐利尤单抗注射液 · No verified English nameJXSS2400066 | AstraZeneca UK Limited; Catalent Indiana LLC; AstraZeneca Investment (China) Co. Ltd. |
| 2024/08/16Import · Class 2.4 | Axitinib TabletsJXHS2400055 | Pfizer Europe MA EEIG; Pfizer Manufacturing Deutschland GmbH; Pfizer Investment Co. Ltd. |
| 2024/08/16Import · Class 2.4 | Axitinib TabletsJXHS2400054 | Pfizer Europe MA EEIG; Pfizer Manufacturing Deutschland GmbH; Pfizer Investment Co. Ltd. |
| 2024/08/16Import · Class 1 | KFA115 · No verified English nameJXHL2400206 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2024/08/16Import · Class 1 | KFA115 · No verified English nameJXHL2400205 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2024/08/16Import · Class 1 | KFA115 · No verified English nameJXHL2400204 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2024/08/16Import · Class 1 | KFA115 · No verified English nameJXHL2400203 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2024/08/16Import · Class 1 | HRO761 · No verified English nameJXHL2400202 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2024/08/16Import · Class 1 | HRO761 · No verified English nameJXHL2400201 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2024/08/16Generic · Class 3 | 复方聚乙二醇(3350)电解质散 · No verified English nameCYHS2402675 | Beng Bu Feng Yuan Tu Shan Pharmaceutical Co., Ltd. romanized |
| 2024/08/16Generic · Class 3 | 盐酸纳美芬注射液 · No verified English nameCYHS2402674 | Jiangsu Yu Xing Pharmaceuticals Technology Co., Ltd. romanized; Ya Bang Pharmaceuticals Co., Ltd. romanized |
| 2024/08/16Generic · Class 3 | Etoposide InjectionCYHS2402672 | Hainan Brilliant Pharmaceutical Co., Ltd. |
| 2024/08/16Generic · Class 3 | Asenapine Maleate Sublingual TabletsCYHS2402669 | HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. |
| 2024/08/16Generic · Class 3 | Asenapine Maleate Sublingual TabletsCYHS2402668 | HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. |
| 2024/08/16Generic · Class 3 | Nitroglycerin InjectionCYHS2402667 | Shaanxi Dun Si Pharmaceutical Co., Ltd. romanized |
80 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.