YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 311 drug applications between 15 November 2024 and 21 November 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 99, covering 78 drug names.
2024/11/15 – 2024/11/21
- New acceptances this week
- 311
- Drugs with new generic filings (by drug name, de-duplicated)
- 78
- Accepted this week, now under review
- 4
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
311filings, 99 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 130 |
| Generic | 99 |
| New drug | 58 |
| Unspecified | 12 |
| Import | 7 |
| Import re-registration | 4 |
| Drug-device combination | 1 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 246 |
| TCM | 31 |
| Therapeutic biologic | 26 |
| Prophylactic biologic | 5 |
| Biologic | 3 |
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
78 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Vonoprazan Fumarate Tablets | 4 | 2 | 60 |
| 2 | 西甲硅油乳剂 · No verified English name | 3 | 3 | 3 |
| 3 | Ambroxol Hydrochloride Oral Solution | 3 | 2 | 46 |
| 4 | Pregabalin Oral Solution | 3 | 1 | 5 |
| 5 | Tobramycin Eye Drops | 2 | 2 | 2 |
| 6 | Oxybuprocaine Hydrochloride Eye Drops | 2 | 2 | 10 |
| 7 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 8 | Acetylcysteine Granules | 2 | 1 | 4 |
| 9 | Lamotrigine Tablets | 2 | 1 | 0 |
| 10 | Piperacillin Sodium for Injection | 2 | 1 | 16 |
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
208 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Shandong Wei Zhi Bai Ke Pharma Co., Ltd. romanized | 13 | 6 | 0 |
| 2 | Heilongjiang Sheng Fu Le Kang Pharma Co., Ltd. romanized | 6 | 5 | 0 |
| 3 | Shanghai Run Shi Pharmaceuticals Technology Co., Ltd. romanized | 6 | 1 | 0 |
| 4 | Qiong Lai Tian Yin Pharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 5 | Bristol-Myers Squibb Australia Pty Ltd | 4 | 1 | 0 |
| 6 | Wan Bang De Pharmaceutical Group Co., Ltd. romanized | 3 | 3 | 0 |
| 7 | Guangzhou Nuo Jin Pharmaceutical Co., Ltd. romanized | 3 | 3 | 0 |
| 8 | Shijiazhuang Shi Hua Xin Pharma Co., Ltd. romanized | 3 | 3 | 3 |
| 9 | Janssen Research & Development LLC | 3 | 2 | 0 |
| 10 | Shanghai Pharmaceuticals Group Co., Ltd. romanized | 3 | 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
100 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/11/21Import · Class 2.4 | Adagrasib 片 · No verified English nameJXHL2400270 | Mirati Therapeutics Inc. a Bristol-Myers Squibb Company; Bristol-Myers Squibb (China) Investment Co. Ltd |
| 2024/11/21Generic · Class 3 | Dopamine Hydrochloride InjectionCYHS2404003 | Kai Feng Kang Nuo Pharma Co., Ltd. romanized |
| 2024/11/21Generic · Class 3 | Sulindac TabletsCYHS2404001 | Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized |
| 2024/11/21Generic · Class 3 | Sulindac TabletsCYHS2404000 | Fu An Pharma Group Qing Yu Tang Pharmaceutical Co., Ltd. romanized |
| 2024/11/21Generic · Class 3 | Multiple Electrolytes and Sodium Acetate InjectionCYHS2403996 | NANJING ZENKOM PHARMACEUTICAL CO.,LTD.; Shandong Hua Lu Pharmaceutical Co., Ltd. romanized |
| 2024/11/21Generic · Class 3 | 头孢克肟颗粒 · No verified English nameCYHS2403992 | Hainan Huluwa Pharmaceutical Group Co., Ltd. |
| 2024/11/21Generic · Class 3 | 腺苷钴胺胶囊 · No verified English nameCYHS2403991 | Anhui Pioneer Pharmaceutical Co., Ltd |
| 2024/11/21Generic · Class 3 | Fexofenadine Hydrochloride Oral SuspensionCYHS2403986 | Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized |
| 2024/11/21Generic · Class 3 | Levocetirizine dihydrochloride Oral SolutionCYHS2403983 | Hefei Guo Gao Pharma Co., Ltd. romanized; Yang Zhou Shi San Yao Pharmaceutical Co., Ltd. romanized |
| 2024/11/21Generic · Class 3 | Polymyxin B sulfate for InjectionCYHS2403981 | Hainan Shuang Cheng Pharma Co., Ltd. romanized |
| 2024/11/21Generic · Class 3 | Ambroxol Hydrochloride and Clenbuterol Hydrochloride Oral SolutionCYHS2403980 | Beijing Kang Er Fu Pharma Co., Ltd. romanized; Beijing Cheng Ji Pharmaceutical Co., Ltd. romanized |
| 2024/11/21Generic · Class 3 | Lidocaine Hydrochloride Topical SolutionCYHL2400231 | Fu Ou Pharmaceuticals Technology (Hu Zhou) Co., Ltd. romanized |
| 2024/11/21Generic · Class 3 | Lidocaine Hydrochloride Topical SolutionCYHL2400230 | Fu Ou Pharmaceuticals Technology (Hu Zhou) Co., Ltd. romanized |
| 2024/11/21New drug · Class 2.2 | 派安普利单抗注射液 · No verified English nameCXSS2400125 | Zheng Da Tian Qing Kang Fang (Shanghai) Biopharmaceuticals Technology Co., Ltd. romanized; Zheng Da Tian Qing Pharma Group Nanjing Shun Xin Pharmaceutical Co., Ltd. romanized; Zhong Shan Kang Fang Biopharmaceuticals Co., Ltd. romanized |
| 2024/11/21New drug · Class 2.4 | Anlotinib Hydrochloride CapsulesCXHS2400120 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2024/11/21New drug · Class 2.4 | Anlotinib Hydrochloride CapsulesCXHS2400119 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2024/11/21New drug · Class 2.4 | Anlotinib Hydrochloride CapsulesCXHS2400118 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2024/11/21New drug · Class 2.2 | 氢溴酸伏硫西汀口崩片 · No verified English nameCXHS2400117 | Shenzhen Shi Fan Gu Pharma Co., Ltd. romanized; Hua Yi Tai Kang Pharma Co., Ltd. romanized |
| 2024/11/21New drug · Class 2.2 | 氢溴酸伏硫西汀口崩片 · No verified English nameCXHS2400116 | Shenzhen Shi Fan Gu Pharma Co., Ltd. romanized; Hua Yi Tai Kang Pharma Co., Ltd. romanized |
| 2024/11/21New drug · Class 1 | SPH9788片 · No verified English nameCXHL2401269 | Shanghai Pharmaceuticals Group Co., Ltd. romanized |
| 2024/11/21New drug · Class 1 | SPH9788片 · No verified English nameCXHL2401268 | Shanghai Pharmaceuticals Group Co., Ltd. romanized |
| 2024/11/21New drug · Class 1 | SPH9788片 · No verified English nameCXHL2401267 | Shanghai Pharmaceuticals Group Co., Ltd. romanized |
| 2024/11/21New drug · Class 2.2 | 注射用硼[10B]法仑 · No verified English nameCXHL2401266 | Hainan Pu Li Pharmaceutical Co., Ltd. romanized |
| 2024/11/21New drug · Class 1 | BPI-452080片 · No verified English nameCXHL2401265 | Bei Da Pharma Co., Ltd. romanized |
| 2024/11/21New drug · Class 1 | BPI-452080片 · No verified English nameCXHL2401264 | Bei Da Pharma Co., Ltd. romanized |
| 2024/11/21New drug · Class 1 | BPI-452080片 · No verified English nameCXHL2401263 | Bei Da Pharma Co., Ltd. romanized |
| 2024/11/21New drug · Class 2.2 | 盐酸普萘洛尔滴剂 · No verified English nameCXHL2401262 | Hainan Nuo En Bio Technology Co., Ltd. romanized |
| 2024/11/21New drug · Class 2.2 | 盐酸普萘洛尔滴剂 · No verified English nameCXHL2401261 | Hainan Nuo En Bio Technology Co., Ltd. romanized |
| 2024/11/21New drug · Class 2.2 | ZL2301 · No verified English nameCXHL2401260 | Guangdong Zhong Li Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/11/21New drug · Class 2.2 | ZL2301 · No verified English nameCXHL2401259 | Guangdong Zhong Li Pharmaceuticals Technology Co., Ltd. romanized |
70 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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