YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 411 drug applications between 3 August 2024 and 9 August 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 124, covering 87 drug names.
2024/08/03 – 2024/08/09
- New acceptances this week
- 411
- Drugs with new generic filings (by drug name, de-duplicated)
- 87
- 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
411filings, 124 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 186 |
| Generic | 124 |
| New drug | 48 |
| Import | 24 |
| Unspecified | 17 |
| Import re-registration | 12 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 289 |
| TCM | 60 |
| Therapeutic biologic | 45 |
| Biologic | 9 |
| Prophylactic biologic | 8 |
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
87 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | 生理氯化钠溶液 · No verified English name | 5 | 1 | 17 |
| 2 | Cefoperazone Sodium and Sulbactam Sodium for Injection | 4 | 2 | 14 |
| 3 | Bisoprolol Fumarate and Amlodipine Besylate Tablets | 3 | 3 | 9 |
| 4 | Sacubitril Valsartan Sodium Tablets | 3 | 1 | 70 |
| 5 | Metformin Hydrochloride Extended-release Tablets | 3 | 1 | 10 |
| 6 | Pioglitazone and Metformin Hydrochloride Tablets | 2 | 2 | 10 |
| 7 | 氯化钙注射液 · No verified English name | 2 | 2 | 6 |
| 8 | Hydrotalcite Chewable Tablets | 2 | 2 | 6 |
| 9 | Irbesartan Tablets | 2 | 1 | 4 |
| 10 | Diclofenac Diethylamine Emulgel | 2 | 1 | 20 |
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
242 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Boehringer Ingelheim International GmbH | 15 | 2 | 0 |
| 2 | Hua Bei Pharmaceutical Jin Tan Bio Technology Co., Ltd. romanized | 8 | 1 | 0 |
| 3 | Shenyang Hong Yao Group Co., Ltd. romanized | 7 | 7 | 0 |
| 4 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized | 7 | 3 | 0 |
| 5 | Hunan San Xue Pharma Co., Ltd. romanized | 6 | 5 | 0 |
| 6 | Novo Nordisk A/S | 6 | 2 | 0 |
| 7 | Qilu Pharmaceutical Co., Ltd. | 5 | 4 | 3 |
| 8 | Hebei Dao En Pharma Co., Ltd. romanized | 5 | 1 | 5 |
| 9 | Shanghai Wan Shi Cheng Pharma Co., Ltd. romanized | 4 | 4 | 0 |
| 10 | Shandong Qidu Pharmaceutical Co., Ltd. | 4 | 4 | 4 |
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
129 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/08/09Import · Class 2.4 | 艾伏尼布片 · No verified English nameJXHL2400198 | Institut de Recherches Internationales Servier; Servier (Beijing) Pharmaceutical Research & Development Co. LTD |
| 2024/08/09Generic · Class 3 | Phenylephrine Hydrochloride InjectionCYHS2402578 | Shanghai Xuan Xin Pharmaceuticals Technology Co., Ltd. romanized; Shandong Fang Ming Pharma Group Co., Ltd. romanized |
| 2024/08/09Generic · Class 3 | 枸橼酸西地那非口溶膜 · No verified English nameCYHS2402577 | Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2024/08/09Generic · Class 3 | 枸橼酸西地那非口溶膜 · No verified English nameCYHS2402576 | Sichuan Kelun Pharmaceutical Co., Ltd. |
| 2024/08/09Generic · Class 3 | Norepinephrine Bitartrate InjectionCYHS2402575 | Yunnan Yao Ke Yuan Biopharmaceuticals Co., Ltd. romanized; Chu Xiong He Chuang Pharma Co., Ltd. romanized |
| 2024/08/09Generic · Class 3 | 生理氯化钠溶液 · No verified English nameCYHS2402574 | Hebei Dao En Pharma Co., Ltd. romanized; Hebei Tian Cheng Pharma Co., Ltd. romanized |
| 2024/08/09Generic · Class 3 | 生理氯化钠溶液 · No verified English nameCYHS2402573 | Hebei Dao En Pharma Co., Ltd. romanized; Hebei Tian Cheng Pharma Co., Ltd. romanized |
| 2024/08/09Generic · Class 3 | 生理氯化钠溶液 · No verified English nameCYHS2402572 | Hebei Dao En Pharma Co., Ltd. romanized; Hebei Tian Cheng Pharma Co., Ltd. romanized |
| 2024/08/09Generic · Class 3 | 生理氯化钠溶液 · No verified English nameCYHS2402571 | Hebei Dao En Pharma Co., Ltd. romanized; Hebei Tian Cheng Pharma Co., Ltd. romanized |
| 2024/08/09Generic · Class 3 | 生理氯化钠溶液 · No verified English nameCYHS2402570 | Hebei Dao En Pharma Co., Ltd. romanized; Hebei Tian Cheng Pharma Co., Ltd. romanized |
| 2024/08/09Generic · Class 3 | 维生素K滴剂 · No verified English nameCYHS2402569 | Hangzhou Mu Yuan Biopharmaceuticals Technology Co., Ltd. romanized; Zhejiang Wei Kang Pharma Co., Ltd. romanized |
| 2024/08/09Generic · Class 3 | 维生素B6注射液 · No verified English nameCYHS2402559 | Jiangsu Yu Xing Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized |
| 2024/08/09Generic · Class 3 | Sodium Bicarbonate Ringer’s InjectionCYHS2402545 | Hainan Ai Ke Pharmaceutical Co., Ltd. romanized |
| 2024/08/09Generic · Class 3 | Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2402544 | Hainan Huluwa Pharmaceutical Group Co., Ltd. |
| 2024/08/09Generic · Class 3 | Esomeprazole Magnesium Enteric-Coated CapsulesCYHS2402543 | Hainan Huluwa Pharmaceutical Group Co., Ltd. |
| 2024/08/09Generic · Class 3 | Metoclopramide Hydrochloride InjectionCYHS2402540 | Chengdu Giantech Hi-technology Development Co., Ltd.; E Mei Shan Tong Hui Pharmaceutical Co., Ltd. romanized |
| 2024/08/09Generic · Class 3 | Enzalutamide TabletsCYHS2402539 | Ao Rui Te Pharma Co., Ltd. romanized; Jiangsu Xuan Tai Pharma Co., Ltd. romanized |
| 2024/08/09Generic · Class 3 | Enzalutamide TabletsCYHS2402538 | Ao Rui Te Pharma Co., Ltd. romanized; Jiangsu Xuan Tai Pharma Co., Ltd. romanized |
| 2024/08/09Generic · Class 3 | Potassium Phosphates InjectionCYHS2402537 | Shandong Ru Zhi Biopharmaceuticals Technology Co., Ltd. romanized; Zhi He (Shandong) Da Pharmaceutical Factory Co., Ltd. romanized |
| 2024/08/09Generic · Class 3 | Bupivacaine Hydrochloride InjectionCYHS2402536 | Hui Yu Yuan He (Hainan) Pharma Co., Ltd. romanized; Hainan Tong Yong Kang Li Pharmaceutical Co., Ltd. romanized |
| 2024/08/09Generic · Class 3 | Bupivacaine Hydrochloride InjectionCYHS2402535 | Hui Yu Yuan He (Hainan) Pharma Co., Ltd. romanized; Hainan Tong Yong Kang Li Pharmaceutical Co., Ltd. romanized |
| 2024/08/09Generic · Class 3 | 盐酸毛果芸香碱滴眼液 · No verified English nameCYHL2400163 | Beijing Foyou Pharma CO.,LTD |
| 2024/08/09Generic · Class 3 | 酮洛芬凝胶贴膏 · No verified English nameCYHL2400162 | Shenzhen Fa Ma Yi Medicines Technology Co., Ltd. romanized |
| 2024/08/09New drug · Class 1.3 | 四价流感重组蛋白疫苗 · No verified English nameCXSL2400528 | Guangdong Hua Nan Yi Miao Co., Ltd. romanized |
| 2024/08/09New drug · Class 1 | IBI3001 · No verified English nameCXSL2400527 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2024/08/09New drug · Class 1 | 注射用DNV3 · No verified English nameCXSL2400526 | Zhejiang Shi Mai Pharma Co., Ltd. romanized |
| 2024/08/09New drug · Class 1 | HRS-5041片 · No verified English nameCXHL2400808 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2024/08/09New drug · Class 1 | HRS-5041片 · No verified English nameCXHL2400807 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized; Chengdu Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2024/08/09New drug · Class 1 | HRS-1358片 · No verified English nameCXHL2400806 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
| 2024/08/09New drug · Class 1 | HRS-1358片 · No verified English nameCXHL2400805 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized |
99 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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