YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 321 drug applications between 5 September 2024 and 11 September 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 122, covering 80 drug names.
2024/09/05 – 2024/09/11
- New acceptances this week
- 321
- Drugs with new generic filings (by drug name, de-duplicated)
- 80
- Accepted this week, now under review
- 5
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
321filings, 122 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 127 |
| Generic | 122 |
| New drug | 52 |
| Import | 9 |
| Import re-registration | 8 |
| Unspecified | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 230 |
| TCM | 53 |
| Therapeutic biologic | 35 |
| Prophylactic biologic | 2 |
| 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
80 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Nicardipine Hydrochloride Injection | 5 | 3 | 13 |
| 2 | Levocetirizine dihydrochloride Oral Solution | 5 | 2 | 5 |
| 3 | Sodium Hyaluronate Eye Drops | 3 | 2 | 30 |
| 4 | Trazodone Hydrochloride Tablets | 3 | 2 | 5 |
| 5 | Sodium Bicarbonate Injection | 3 | 2 | 10 |
| 6 | Brexpiprazole Orally Disintegrating Tablets | 3 | 1 | 10 |
| 7 | Erythromycin Lactobionate for Injection | 3 | 1 | 13 |
| 8 | 注射用头孢唑肟钠 · No verified English name | 3 | 1 | 4 |
| 9 | Acetylcysteine Solution For Inhalation | 2 | 2 | 4 |
| 10 | Bilastine Tablets | 2 | 2 | 7 |
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
215 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Gan Li Pharma Shandong Co., Ltd. romanized | 8 | 1 | 0 |
| 2 | Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized | 6 | 4 | 6 |
| 3 | Anhui Pioneer Pharmaceutical Co., Ltd | 5 | 3 | 4 |
| 4 | Hua Run Shuang He Pharma Co., Ltd. romanized | 5 | 1 | 0 |
| 5 | Ren He Yi Kang Group Co., Ltd. romanized | 4 | 2 | 2 |
| 6 | Hainan Guang Sheng Yu Pharmaceutical Co., Ltd. romanized | 4 | 2 | 3 |
| 7 | ASPEN PHARMA TRADING LIMITED | 4 | 1 | 0 |
| 8 | Eli Lilly Nederland B.V. | 4 | 1 | 0 |
| 9 | Ha Yao Group Pharmaceutical Factory romanized | 4 | 1 | 0 |
| 10 | San Pu 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
110 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/09/11Import · Class 2.2 | 艾加莫德α注射液(皮下注射) · No verified English nameJXSL2400164 | argenx BV; Zai Lab (Shanghai) Co. Ltd. |
| 2024/09/11Generic · Class 3 | MOVICOL Ready To Take Sachet, Powder For Oral SolutionCYHS2403033 | Heilongjiang Zhong Gui Pharmaceutical Co., Ltd. romanized |
| 2024/09/11Generic · Class 3 | Metaraminol Tartrate InjectionCYHS2403029 | Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Chengdu Shi Hai Tong Pharma Co., Ltd. romanized |
| 2024/09/11Generic · Class 3 | Bupivacaine Hydrochloride InjectionCYHS2403026 | Shijiazhuang Kai Da Bio Gong Cheng Co., Ltd. romanized |
| 2024/09/11Generic · Class 3 | Levocetirizine dihydrochloride Oral SolutionCYHS2403025 | Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2024/09/11Generic · Class 3 | Levocetirizine dihydrochloride Oral SolutionCYHS2403024 | Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2024/09/11Generic · Class 3 | Levocetirizine dihydrochloride Oral SolutionCYHS2403023 | Anhui Si Huan Ke Bao Pharmaceutical Co., Ltd. romanized |
| 2024/09/11Generic · Class 3 | Levocetirizine dihydrochloride Oral SolutionCYHS2403020 | Beijing SL Pharmaceutical Co., Ltd. |
| 2024/09/11Generic · Class 3 | Levocetirizine dihydrochloride Oral SolutionCYHS2403019 | Beijing SL Pharmaceutical Co., Ltd. |
| 2024/09/11Generic · Class 3 | Metoclopramide Hydrochloride InjectionCYHS2403018 | Hua Xia Sheng Sheng Pharma (Beijing) Co., Ltd. romanized |
| 2024/09/11Generic · Class 3 | Vitamin K1 InjectionCYHS2403017 | Qilu Pharmaceutical (Hainan) Co., Ltd |
| 2024/09/11Generic · Class 3 | Sitagliptin and Metformin Hydrochloride Extended-release TabletsCYHS2403016 | Zhejiang He Ze Pharmaceuticals Technology Co., Ltd. romanized; Ningbo Shuang Cheng Pharma Co., Ltd. romanized |
| 2024/09/11Generic · Class 3 | Potassium Chloride GranulesCYHS2403013 | Shenyang Tian Bang Pharma Co., Ltd. romanized |
| 2024/09/11Generic · Class 3 | Trazodone Hydrochloride TabletsCYHS2403009 | Beijing Foyou Pharma CO.,LTD |
| 2024/09/11Generic · Class 3 | Sodium Bicarbonate InjectionCYHS2403007 | Chengdu Giantech Hi-technology Development Co., Ltd.; Chengdu Tian Tai Shan Pharmaceutical Co., Ltd. romanized |
| 2024/09/11Generic · Class 3 | Bumetanide InjectionCYHS2403001 | Wuhan Hai Te Biopharmaceutical Co., Ltd. romanized |
| 2024/09/11Generic · Class 3 | Propafenone Hydrochloride InjectionCYHS2403000 | Nan Yang Pu Kang Pharma Co., Ltd. romanized |
| 2024/09/11Generic · Class 3 | Trazodone Hydrochloride TabletsCYHS2402998 | Zhong Run Pharma Co., Ltd. romanized; Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2024/09/11Generic · Class 3 | Trazodone Hydrochloride TabletsCYHS2402997 | Zhong Run Pharma Co., Ltd. romanized; Shenzhen Xin Li Tai Pharma Co., Ltd. romanized |
| 2024/09/11Generic · Class 3 | Multiple Electrolyte Additive For InjectionCYHS2402996 | Chengdu Rui Er Pharmaceuticals Technology Co., Ltd. romanized; Hunan Ke Lun Pharmaceutical Co., Ltd. romanized |
| 2024/09/11Generic · Class 3 | Sodium Bicarbonate InjectionCYHS2402995 | Shaanxi Li Cai Pharma Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized |
| 2024/09/11Generic · Class 3 | Sodium Bicarbonate InjectionCYHS2402994 | Shaanxi Li Cai Pharma Co., Ltd. romanized; Jiangsu Da Hong Ying Heng Shun Pharma Co., Ltd. romanized |
| 2024/09/11Generic · Class 3 | Brivaracetam TabletsCYHL2400184 | Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized |
| 2024/09/11Generic · Class 3 | Brivaracetam TabletsCYHL2400183 | Shandong Bai Nuo Pharmaceuticals Co., Ltd. romanized |
| 2024/09/11New drug · Class 1.1 | 金蚕颗粒 · No verified English nameCXZL2400051 | Sichuan Sheng Zhong Pharmaceuticals Ke College romanized |
| 2024/09/11New drug · Class 1 | 注射用DB-1419 · No verified English nameCXSL2400605 | Ying En Bio Technology (Shanghai) Co., Ltd. romanized |
| 2024/09/11New drug · Class 1 | 靶向CD19和CD22 的嵌合抗原受体自体T细胞注射液 · No verified English nameCXSL2400604 | Shanghai Pharmaceuticals Group Bio Zhi Liao Technology Co., Ltd. romanized |
| 2024/09/11New drug · Class 1 | 注射用MCLA-129 · No verified English nameCXSL2400603 | Bei Da Pharma Co., Ltd. romanized |
| 2024/09/11New drug · Class 2.2 | 布瑞哌唑口溶膜 · No verified English nameCXHS2400091 | Bo Zhi Yan Xin Tai Zhou Drug Technology Co., Ltd. romanized |
| 2024/09/11New drug · Class 2.2 | 布瑞哌唑口溶膜 · No verified English nameCXHS2400090 | Bo Zhi Yan Xin Tai Zhou Drug Technology Co., Ltd. romanized |
80 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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