YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 382 drug applications between 6 February 2024 and 12 February 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 111, covering 86 drug names.
2024/02/06 – 2024/02/12
- New acceptances this week
- 382
- 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
382filings, 111 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 152 |
| Generic | 111 |
| New drug | 78 |
| Import | 21 |
| Unspecified | 11 |
| Import re-registration | 9 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 286 |
| Therapeutic biologic | 52 |
| TCM | 35 |
| Prophylactic biologic | 5 |
| Biologic | 4 |
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 | Sacubitril Valsartan Sodium Tablets | 5 | 2 | 70 |
| 2 | Oseltamivir Phosphate Capsules | 3 | 1 | 39 |
| 3 | Fusidic Acid Cream | 2 | 2 | 15 |
| 4 | 洛索洛芬钠凝胶贴膏 · No verified English name | 2 | 2 | 9 |
| 5 | Mecobalamin Tablets | 2 | 2 | 16 |
| 6 | Magnesium Sulfate Injection | 2 | 2 | 7 |
| 7 | Tacrolimus Capsules | 2 | 1 | 2 |
| 8 | Tacrolimus Ointment | 2 | 1 | 6 |
| 9 | Tadalafil Tablets | 2 | 1 | 23 |
| 10 | Diclofenac Sodium Sustained Release Tablets | 2 | 1 | 10 |
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
230 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Hui Yin Bi Group Jiangxi Dong Ya Pharmaceutical Co., Ltd. romanized | 11 | 9 | 0 |
| 2 | Bai Ji Shen Zhou (Suzhou) Bio Technology Co., Ltd. romanized | 9 | 2 | 0 |
| 3 | Hebei Bian Que Pharmaceutical Co., Ltd. romanized | 7 | 7 | 0 |
| 4 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 6 | 5 | 5 |
| 5 | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 6 | 4 | 6 |
| 6 | Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized | 6 | 1 | 0 |
| 7 | Hangzhou Gao Guang Pharmaceutical Co., Ltd. romanized | 6 | 1 | 0 |
| 8 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 5 | 3 | 0 |
| 9 | AbbVie Inc. | 5 | 1 | 0 |
| 10 | Suzhou Te Rui Pharma Co., Ltd. romanized | 5 | 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
137 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/02/10Generic · Class 3 | Metoclopramide Hydrochloride InjectionCYHS2400606 | Wuhan Tian An Pharmaceuticals Technology Co., Ltd. romanized; Hubei Jin Yao Pharma Co., Ltd. romanized |
| 2024/02/09Import · Class 1 | SGN-B6A · No verified English nameJXSL2400043 | Seagen Inc.; IQVIA RDS (Shanghai) Co. Ltd |
| 2024/02/09Generic · Class 3 | Ebastine Oral SolutionCYHS2400603 | Beijing Wo Bang Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Ou Ge Pharmaceutical Co., Ltd. romanized |
| 2024/02/09New drug · Class 1 | TQB3107片 · No verified English nameCXHL2400193 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2024/02/09New drug · Class 1 | TQB3107片 · No verified English nameCXHL2400192 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2024/02/09New drug · Class 1 | TQG3926片 · No verified English nameCXHL2400191 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2024/02/09New drug · Class 1 | TQG3926片 · No verified English nameCXHL2400190 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2024/02/08Import · Class 3.1 | 注射用德曲妥珠单抗 · No verified English nameJXSS2400013 | Daiichi Sankyo Europe GmbH; Baxter Oncology GmbH; DAIICHI SANKYO(CHINA)HOLDINGS CO. LTD. |
| 2024/02/08Import · Class 3.1 | 塔奎妥单抗注射液 · No verified English nameJXSS2400012 | Janssen-Cilag International NV; Patheon Manufacturing Services LLC; Johnson & Johnson Pharmaceutical Ltd. |
| 2024/02/08Import · Class 3.1 | 塔奎妥单抗注射液 · No verified English nameJXSS2400011 | Janssen-Cilag International NV; Patheon Manufacturing Services LLC; Johnson & Johnson Pharmaceutical Ltd. |
| 2024/02/08Import · Class 1 | 镥[177Lu]Lu-NeoB注射液 · No verified English nameJXHL2400032 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2024/02/08Import · Class 1 | 用于制备放射性药物[68Ga]Ga-NeoB注射液的药盒 · No verified English nameJXHL2400031 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2024/02/08Generic · Class 3 | 氯化钙注射液 · No verified English nameCYHS2400602 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2024/02/08Generic · Class 3 | Diphenhydramine Hydrochloride InjectionCYHS2400599 | Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Ya Bang Pharmaceuticals Co., Ltd. romanized |
| 2024/02/08Generic · Class 3 | Diphenhydramine Hydrochloride InjectionCYHS2400598 | Nanjing Ze Heng Pharmaceuticals Technology Kai Fa Co., Ltd. romanized; Ya Bang Pharmaceuticals Co., Ltd. romanized |
| 2024/02/08Generic · Class 3 | Fexofenadine Hydrochloride Oral SuspensionCYHS2400592 | Haerbin Kui Hua Pharma Co., Ltd. romanized; Kui Hua Pharma Group Chongqing Xiao Kui Hua Er Tong Pharmaceutical Co., Ltd. romanized |
| 2024/02/08Generic · Class 3 | Piracetam InjectionCYHS2400580 | Sichuan Xin Si Dun Pharmaceutical Co., Ltd. romanized |
| 2024/02/08Generic · Class 3 | Memantine Hydrochloride OD TabletsCYHS2400578 | Beijing Xing Hao Pharmaceuticals Co., Ltd. romanized; Beijing Xing Hao Ying Sheng Pharma Co., Ltd. romanized |
| 2024/02/08Generic · Class 3 | Memantine Hydrochloride OD TabletsCYHS2400577 | Beijing Xing Hao Pharmaceuticals Co., Ltd. romanized; Beijing Xing Hao Ying Sheng Pharma Co., Ltd. romanized |
| 2024/02/08Generic · Class 3 | Procaterol Hydrochloride Solution for InhalationCYHS2400570 | Beijing Bai Ya Joint Drug Research Institute Co., Ltd. romanized; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized |
| 2024/02/08Generic · Class 3 | Sodium Bicarbonate InjectionCYHS2400568 | Guangzhou He He Pharmaceuticals Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2024/02/08Generic · Class 3 | Acetylcysteine InjectionCYHS2400567 | Zhong Run Pharma Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2024/02/08Generic · Class 3 | Pimavanserin Tartrate CapsulesCYHL2400037 | Hua Zhong Pharma Co., Ltd. romanized |
| 2024/02/08New drug · Class 1 | 夫那奇珠单抗注射液 · No verified English nameCXSS2400019 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2024/02/08New drug · Class 1 | 夫那奇珠单抗注射液 · No verified English nameCXSS2400018 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2024/02/08New drug · Class 1 | 夫那奇珠单抗注射液 · No verified English nameCXSS2400017 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2024/02/08New drug · Class 1 | M108单抗注射液 · No verified English nameCXSL2400118 | Ming Ji Biopharmaceutical (Beijing) Co., Ltd. romanized |
| 2024/02/08New drug · Class 1 | RJK002注射液 · No verified English nameCXSL2400117 | Shanghai Rui Ji Kang Biopharmaceuticals Co., Ltd. romanized |
| 2024/02/08New drug · Class 1 | MSCohi-O镜片 · No verified English nameCXSL2400116 | Guangdong Pu Luo Kai Rong Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/02/08New drug · Class 1 | MSCohi-O镜片 · No verified English nameCXSL2400115 | Guangdong Pu Luo Kai Rong Biopharmaceuticals Technology Co., Ltd. romanized |
107 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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