YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 233 drug applications between 15 March 2024 and 21 March 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 53, covering 41 drug names.
2024/03/15 – 2024/03/21
- New acceptances this week
- 233
- Drugs with new generic filings (by drug name, de-duplicated)
- 41
- Accepted this week, now under review
- 1
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
233filings, 53 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 123 |
| Generic | 53 |
| New drug | 34 |
| Unspecified | 10 |
| Import | 8 |
| Import re-registration | 5 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 139 |
| TCM | 55 |
| Therapeutic biologic | 32 |
| Biologic | 5 |
| Prophylactic biologic | 2 |
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
41 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Tadalafil Tablets | 6 | 2 | 23 |
| 2 | Ethyl Iosapentate Capsules | 2 | 1 | 27 |
| 3 | Carbidopa and Levodopa Sustained-release Tablets | 2 | 1 | 2 |
| 4 | Perampanel Tablets | 2 | 1 | 2 |
| 5 | Bromhexine Hydrochloride Solution For Inhalation | 2 | 1 | 1 |
| 6 | Montelukast Sodium Chewable Tablets | 2 | 1 | 4 |
| 7 | Esmolol Hydrochloride and Sodium Chloride Injection | 2 | 1 | 0 |
| 8 | Amlodipine Besylate Tablets | 2 | 1 | 8 |
| 9 | Lactulose Oral Solution | 1 | 1 | 34 |
| 10 | Morinidazole and Sodium Chloride Injection | 1 | 1 | 9 |
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
131 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Guo Da (Jilin) Pharmaceutical Group Co., Ltd. romanized | 31 | 31 | 0 |
| 2 | Henan Shuang He Hua Li Pharma Co., Ltd. romanized | 14 | 3 | 0 |
| 3 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized | 4 | 4 | 0 |
| 4 | Xiamen Te Bao Bio Gong Cheng Co., Ltd. romanized | 4 | 1 | 0 |
| 5 | Kunming Nan Jiang Pharmaceutical Co., Ltd. romanized | 4 | 1 | 0 |
| 6 | Hainan Ling Kang Pharmaceutical Co., Ltd. romanized | 4 | 1 | 0 |
| 7 | Shenyang Hong Qi Pharmaceutical Co., Ltd. romanized | 3 | 2 | 1 |
| 8 | Hui Rui Pharmaceutical Technology Co., Ltd. romanized | 3 | 2 | 0 |
| 9 | IPSEN PHARMA | 3 | 1 | 0 |
| 10 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD | 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
57 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/03/21Generic · Class 3 | Potassium Phosphates InjectionCYHS2400885 | Suzhou Lang Ke Bio Technology Co., Ltd. romanized; Yang Zhou Zhong Bao Pharma Co., Ltd. romanized |
| 2024/03/21Generic · Class 3 | Amlodipine Besylate and Benazepril Hydrochloride CapsulesCYHS2400884 | Beijing Foyou Pharma CO.,LTD |
| 2024/03/21Generic · Class 3 | Raltitrexed for InjectionCYHS2400880 | Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized; HARBIN MEDISAN PHARMACEUTICAL CO.,LTD. |
| 2024/03/21Generic · Class 3 | Isoprenaline Hydrochloride InjectionCYHS2400879 | Yuan Da Pharmaceuticals (Zhongguo) Co., Ltd. romanized |
| 2024/03/21New drug · Class 1 | GCB-001 · No verified English nameCXSL2400199 | Shanghai Jin Ke Bo Bio Technology Co., Ltd. romanized |
| 2024/03/21New drug · Class 1 | BAT7104注射液 · No verified English nameCXSL2400198 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2024/03/21New drug · Class 1 | 注射用BAT8008 · No verified English nameCXSL2400197 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized |
| 2024/03/20Import · Class 1 | LY3819469注射液 · No verified English nameJXHL2400066 | Eli Lilly and Company |
| 2024/03/20New drug · Class 1.1 | 柴桂解感颗粒 · No verified English nameCXZL2400016 | Shandong Zhong Pharmaceuticals University romanized; Shandong Gu Jin Zhong Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/03/20New drug · Class 1 | 注射用DB-1305 · No verified English nameCXSL2400196 | Ying En Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2024/03/20New drug · Class 1 | DP303c注射液 · No verified English nameCXSL2400195 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2024/03/20New drug · Class 1 | DP303c注射液 · No verified English nameCXSL2400194 | Shi Yao Group Ju Shi Biopharmaceutical Co., Ltd. romanized |
| 2024/03/20New drug · Class 2.4 | Anlotinib Hydrochloride CapsulesCXHL2400295 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2024/03/20New drug · Class 2.4 | Anlotinib Hydrochloride CapsulesCXHL2400294 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2024/03/20New drug · Class 2.4 | Anlotinib Hydrochloride CapsulesCXHL2400293 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD |
| 2024/03/20New drug · Class 1 | HLX99片 · No verified English nameCXHL2400292 | Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceutical Co., Ltd. romanized |
| 2024/03/20New drug · Class 1 | HLX99片 · No verified English nameCXHL2400291 | Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized; Shanghai Fu Hong Han Lin Biopharmaceutical Co., Ltd. romanized |
| 2024/03/20New drug · Class 1 | HLX99片 · No verified English nameCXHL2400290 | Shanghai Fu Hong Han Lin Biopharmaceutical Co., Ltd. romanized; Shanghai Fu Hong Han Lin Bio Technology Co., Ltd. romanized |
| 2024/03/20New drug · Class 1 | 盐酸希美替尼片 · No verified English nameCXHL2400289 | Zhongguo Ke College Shanghai Drug Research Institute romanized; Shanghai Run Shi Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/03/20New drug · Class 1 | 盐酸希美替尼片 · No verified English nameCXHL2400288 | Zhongguo Ke College Shanghai Drug Research Institute romanized; Shanghai Run Shi Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/03/20New drug · Class 1 | D-1553片 · No verified English nameCXHL2400287 | Yi Fang Bio Technology (Shanghai) Co., Ltd. romanized |
| 2024/03/19Generic · Class 3 | Isoniazid InjectionCYHS2400870 | Shenyang Hong Qi Pharmaceutical Co., Ltd. romanized; Hainan He Rui Pharmaceutical Co., Ltd. romanized |
| 2024/03/19Generic · Class 3 | Calcium Gluconate InjectionCYHS2400869 | Shijiazhuang No.4 Pharmaceutical Co., Ltd. |
| 2024/03/19Generic · Class 3 | Famotidine InjectionCYHS2400866 | Jiangsu Lianhuan Pharmaceutical Co.,Ltd. |
| 2024/03/19Generic · Class 3 | Bromhexine Hydrochloride Solution For InhalationCYHL2400062 | Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized |
| 2024/03/19Generic · Class 3 | Bromhexine Hydrochloride Solution For InhalationCYHL2400061 | Jiangsu Zheng Da Qing Jiang Pharmaceutical Co., Ltd. romanized |
| 2024/03/19Generic · Class 3 | Pimavanserin Tartrate CapsulesCYHL2400060 | Jiangsu Ai Li Kang Pharmaceuticals Technology Co., Ltd. romanized |
| 2024/03/19New drug · Class 1 | QL1706注射液 · No verified English nameCXSL2400193 | Qilu Pharmaceutical Co., Ltd. |
| 2024/03/19New drug · Class 1 | 注射用QLS31905 · No verified English nameCXSL2400192 | Qilu Pharmaceutical Co., Ltd. |
| 2024/03/19New drug · Class 1 | 注射用YL211 · No verified English nameCXSL2400191 | Suzhou Yi Lian Biopharmaceuticals Co., Ltd. romanized |
27 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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