YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 248 drug applications between 2 February 2025 and 8 February 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 88, covering 65 drug names.
2025/02/02 – 2025/02/08
- New acceptances this week
- 248
- Drugs with new generic filings (by drug name, de-duplicated)
- 65
- Accepted this week, now under review
- 10
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
248filings, 88 of them generic
By application type
| Application type | Filings |
|---|---|
| Generic | 88 |
| Supplement | 79 |
| New drug | 57 |
| Import re-registration | 11 |
| Import | 9 |
| Unspecified | 4 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 183 |
| Therapeutic biologic | 43 |
| TCM | 19 |
| Biologic | 2 |
| 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
65 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Vonoprazan Fumarate Tablets | 9 | 6 | 60 |
| 2 | Brexpiprazole Tablets | 3 | 1 | 31 |
| 3 | Polidocanol Injection | 3 | 1 | 23 |
| 4 | Cetrorelix Acetate for Injection | 2 | 2 | 4 |
| 5 | Tadalafil Tablets | 2 | 1 | 23 |
| 6 | Voglibose Tablets | 2 | 1 | 0 |
| 7 | Perampanel Tablets | 2 | 1 | 2 |
| 8 | Procaterol Hydrochloride Solution for Inhalation | 2 | 1 | 2 |
| 9 | Sodium Hyaluronate Eye Drops | 2 | 1 | 30 |
| 10 | Imatinib Mesylate Tablets | 2 | 1 | 5 |
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
163 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized | 9 | 3 | 0 |
| 2 | Jiangsu Hao Sen Pharma Group Co., Ltd. romanized | 9 | 2 | 0 |
| 3 | Nanjing Wei Li Zhi Bo Bio Technology Co., Ltd. romanized | 4 | 2 | 0 |
| 4 | Jinan Gao Hua Pharmaceutical Co., Ltd. romanized | 4 | 2 | 4 |
| 5 | Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized | 4 | 2 | 0 |
| 6 | Fujian Sheng Di Pharmaceuticals Co., Ltd. romanized | 4 | 2 | 0 |
| 7 | Bristol-Myers Squibb Pharma EEIG | 4 | 1 | 0 |
| 8 | Pfizer Europe MA EEIG | 4 | 1 | 0 |
| 9 | Beijing Hua Shen Pharmaceutical Co., Ltd. romanized | 3 | 3 | 0 |
| 10 | Wuhan Jiu An Pharma Co., Ltd. romanized | 3 | 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
92 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/02/08Import · Class 2.2 | Tezepelumab注射液 · No verified English nameJXSL2500021 | AstraZeneca AB; AstraZeneca Investment (China) Co. Ltd. |
| 2025/02/08Import · Class 1 | TAK-279胶囊 · No verified English nameJXHL2500018 | Takeda Development Center Americas Inc.; Takeda (China) International Trading Co. Ltd |
| 2025/02/08Generic · Class 3 | Indocyaninegreen for InjectionCYHS2500640 | Hainan Brilliant Pharmaceutical Co., Ltd. |
| 2025/02/08Generic · Class 3 | 微量元素注射液4-I · No verified English nameCYHS2500635 | Hefei Shi Wei Lai Drug Kai Fa Co., Ltd. romanized; Guangdong Sunho Pharmaceutical Co., Ltd. |
| 2025/02/08Generic · Class 3 | Polymyxin B sulfate for InjectionCYHS2500632 | Fujian Sheng Fu Kang Pharma Co., Ltd. romanized; Hainan Quan Xing Pharmaceutical Co., Ltd. romanized |
| 2025/02/08Generic · Class 3 | MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2500631 | Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized; Hua Yi Tai Kang Pharma Co., Ltd. romanized |
| 2025/02/08Generic · Class 3 | 尿素[13C]呼气试验药盒 · No verified English nameCYHS2500629 | Shenzhen Shi Zhong He Hai De Wei Bio Technology Co., Ltd. romanized |
| 2025/02/08New drug · Class 3.3 | 司库奇尤单抗注射液 · No verified English nameCXSS2500024 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2025/02/08New drug · Class 3.3 | 司库奇尤单抗注射液 · No verified English nameCXSS2500023 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2025/02/08New drug · Class 1 | 注射用ZG006 · No verified English nameCXSL2500122 | Name not romanized |
| 2025/02/08New drug · Class 1 | XS228细胞注射液 · No verified English nameCXSL2500121 | Shi Ze Biopharmaceuticals (Suzhou) Co., Ltd. romanized; Shi Ze Biopharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2025/02/08New drug · Class 1 | 注射用BL-B01D1 · No verified English nameCXSL2500120 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2025/02/08New drug · Class 1 | 注射用BL-B01D1 · No verified English nameCXSL2500119 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2025/02/08New drug · Class 1 | 注射用BL-B01D1 · No verified English nameCXSL2500118 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2025/02/08New drug · Class 1 | 注射用BL-B01D1 · No verified English nameCXSL2500117 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2025/02/08New drug · Class 1 | 注射用BL-B01D1 · No verified English nameCXSL2500116 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2025/02/08New drug · Class 1 | 注射用BL-B01D1 · No verified English nameCXSL2500115 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2025/02/08New drug · Class 1 | 注射用BL-B01D1 · No verified English nameCXSL2500114 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2025/02/08New drug · Class 1 | LBL-007注射液 · No verified English nameCXSL2500113 | Nanjing Wei Li Zhi Bo Bio Technology Co., Ltd. romanized |
| 2025/02/08New drug · Class 1 | 注射用LBL-024 · No verified English nameCXSL2500112 | Nanjing Wei Li Zhi Bo Bio Technology Co., Ltd. romanized |
| 2025/02/08New drug · Class 1 | SHR-4849注射液 · No verified English nameCXSL2500111 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized; Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/02/08New drug · Class 2.2 | SHR-8068注射液 · No verified English nameCXSL2500110 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2025/02/08New drug · Class 2.2 | 阿得贝利单抗注射液 · No verified English nameCXSL2500109 | Shanghai Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2025/02/08New drug · Class 1 | 注射用RC108 · No verified English nameCXSL2500108 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
| 2025/02/08New drug · Class 1 | 注射用LBL-024 · No verified English nameCXSL2500107 | Nanjing Wei Li Zhi Bo Bio Technology Co., Ltd. romanized |
| 2025/02/08New drug · Class 1 | 注射用LBL-024 · No verified English nameCXSL2500106 | Nanjing Wei Li Zhi Bo Bio Technology Co., Ltd. romanized |
| 2025/02/08New drug · Class 1 | 注射用BL-M11D1 · No verified English nameCXSL2500105 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2025/02/08New drug · Class 2.2; 2.4 | 洛索洛芬钠滴眼液 · No verified English nameCXHS2500016 | Run Er Yan Ke Drug (Guangzhou) Co., Ltd. romanized |
| 2025/02/08New drug · Class 1 | UA026片 · No verified English nameCXHL2500176 | Name not romanized |
| 2025/02/08New drug · Class 1 | UA026片 · No verified English nameCXHL2500175 | Name not romanized |
62 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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