YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 586 drug applications between 2 February 2024 and 8 February 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 182, covering 136 drug names.
2024/02/02 – 2024/02/08
- New acceptances this week
- 586
- Drugs with new generic filings (by drug name, de-duplicated)
- 136
- Accepted this week, now under review
- 8
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
586filings, 182 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 235 |
| Generic | 182 |
| New drug | 109 |
| Import | 33 |
| Unspecified | 16 |
| Import re-registration | 11 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 432 |
| Therapeutic biologic | 84 |
| TCM | 58 |
| Biologic | 6 |
| Prophylactic biologic | 6 |
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
136 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 | Urapidil Hydrochloride Injection | 4 | 2 | 6 |
| 3 | Diprophylline Injection | 3 | 3 | 7 |
| 4 | Tadalafil Tablets | 3 | 2 | 23 |
| 5 | Vonoprazan Fumarate Tablets | 3 | 2 | 60 |
| 6 | Diphenhydramine Hydrochloride Injection | 3 | 2 | 9 |
| 7 | LevomilnacipranHydrochloride Extended-release Capsules | 3 | 1 | 6 |
| 8 | Oseltamivir Phosphate Capsules | 3 | 1 | 39 |
| 9 | Acetylcysteine Injection | 2 | 2 | 53 |
| 10 | Lidocaine and Prilocaine Cream | 2 | 2 | 24 |
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
345 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 | Shandong Xin Shi Dai Pharma Co., Ltd. romanized | 8 | 6 | 7 |
| 4 | Hebei Bian Que Pharmaceutical Co., Ltd. romanized | 7 | 7 | 0 |
| 5 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. | 7 | 7 | 5 |
| 6 | Sichuan Yi Ke Cao Pharma Co., Ltd. romanized | 6 | 6 | 0 |
| 7 | Zhejiang Sai Mo Pharmaceutical Co., Ltd. romanized | 6 | 4 | 6 |
| 8 | Jiangsu En Hua Pharma Co., Ltd. romanized | 6 | 3 | 4 |
| 9 | AbbVie Inc. | 6 | 2 | 0 |
| 10 | Guangzhou Jia Yue Pharmaceuticals Technology Co., Ltd. romanized | 6 | 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
207 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 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 |
| 2024/02/08New drug · Class 1 | MSCohi-O镜片 · No verified English nameCXSL2400114 | Guangdong Pu Luo Kai Rong Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/02/08New drug · Class 1 | SHR-2106注射液 · No verified English nameCXSL2400113 | Guangdong Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2024/02/08New drug · Class 1 | 注射用BL-B01D1 · No verified English nameCXSL2400112 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2024/02/08New drug · Class 1 | 异体人源脂肪间充质干细胞注射液 · No verified English nameCXSL2400111 | Jiangsu De Kang Bio Technology Co., Ltd. romanized |
| 2024/02/08New drug · Class 1 | 注射用TQB2102 · No verified English nameCXSL2400110 | Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized |
| 2024/02/08New drug · Class 1 | 玛赛洛沙韦片 · No verified English nameCXHS2400011 | Nanjing Zheng Xiang Pharmaceuticals Co., Ltd. romanized; Jiangsu Xuan Tai Pharma Co., Ltd. romanized |
| 2024/02/08New drug · Class 2.2 | CB275舌下膜 · No verified English nameCXHL2400189 | Hangzhou Cheng Bang Pharmaceuticals Technology Co., Ltd. romanized |
177 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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