YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 434 drug applications between 9 May 2024 and 15 May 2024 (data as of 13 November 2026 06:00). Of these, generic applications numbered 112, covering 80 drug names.
2024/05/09 – 2024/05/15
- New acceptances this week
- 434
- Drugs with new generic filings (by drug name, de-duplicated)
- 80
- Accepted this week, now under review
- 3
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
434filings, 112 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 176 |
| Generic | 112 |
| New drug | 100 |
| Import | 25 |
| Import re-registration | 12 |
| Unspecified | 6 |
| Drug-device combination product | 3 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 301 |
| Therapeutic biologic | 71 |
| TCM | 53 |
| Prophylactic biologic | 6 |
| Drug-device combination | 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
80 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Vonoprazan Fumarate Tablets | 5 | 3 | 60 |
| 2 | Sacubitril Valsartan Sodium Tablets | 3 | 2 | 70 |
| 3 | Benidipine Hydrochloride Tablets | 3 | 2 | 4 |
| 4 | Fluvoxamine Maleate Tablets | 3 | 2 | 0 |
| 5 | Sildenafil Citrate Tablets | 3 | 1 | 12 |
| 6 | Deutetrabenazine Tablets | 3 | 1 | 0 |
| 7 | Nicorandil for Injection | 3 | 1 | 1 |
| 8 | Famotidine Injection | 2 | 2 | 8 |
| 9 | Phenylephrine Hydrochloride Injection | 2 | 2 | 5 |
| 10 | 聚乙二醇钠钾散 · No verified English name | 2 | 2 | 3 |
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
238 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jilin Heng Xing Technology Pharmaceutical Co., Ltd. romanized | 19 | 17 | 0 |
| 2 | Anhui Feng Yuan Pharma Co., Ltd. Huai Hai Pharmaceutical Factory romanized | 10 | 2 | 0 |
| 3 | Janssen Research & Development LLC | 7 | 3 | 0 |
| 4 | Yi Chang Ren Fu Pharma Co., Ltd. romanized | 7 | 2 | 0 |
| 5 | Guangzhou Yi Pin Hong Pharmaceutical Co., Ltd. romanized | 7 | 2 | 1 |
| 6 | Hubei Di Liu Pharmaceutical Co., Ltd. romanized | 6 | 4 | 0 |
| 7 | Bai Ao Tai Biopharmaceutical Co., Ltd. romanized | 6 | 3 | 0 |
| 8 | Shandong Sheng Di Pharmaceuticals Co., Ltd. romanized | 6 | 2 | 0 |
| 9 | Jiangsu Heng Rui Pharmaceuticals Co., Ltd. romanized | 6 | 2 | 0 |
| 10 | Xian Da Heng Pharmaceutical Co., Ltd. romanized | 5 | 5 | 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
158 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2024/05/15Import · Class 2.2 | 艾加莫德α注射液(皮下注射) · No verified English nameJXSS2400042 | argenx BV; Patheon Italia S. p. A.; Zai Lab (Shanghai) Co. Ltd. |
| 2024/05/15Import · Class 1 | PF-06823859注射液 · No verified English nameJXSL2400092 | Pfizer Inc.; Pfizer Investment Co. Ltd. |
| 2024/05/15New drug · Class 1 | 注射用BA1302 · No verified English nameCXSL2400321 | Shandong Bo An Bio Technology Co., Ltd. romanized |
| 2024/05/15New drug · Class 1 | RC148注射液 · No verified English nameCXSL2400320 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
| 2024/05/15New drug · Class 1 | FS-8002注射液 · No verified English nameCXSL2400319 | Hua Pu Bio Technology (Hebei) Co., Ltd. romanized; Hua Pu Shijiazhuang Pharmaceuticals Co., Ltd. romanized; Fu Sheng Kang (Shanghai) Bio Technology Co., Ltd. romanized |
| 2024/05/15New drug · Class 1 | 注射用RC88 · No verified English nameCXSL2400318 | Rong Chang Biopharmaceutical (Yan Tai) Co., Ltd. romanized |
| 2024/05/15New drug · Class 1 | 注射用SHR-A1921 · No verified English nameCXSL2400317 | Suzhou Sheng Di Ya Biopharmaceuticals Co., Ltd. romanized |
| 2024/05/15New drug · Class 2.2 | BCM347口溶膜 · No verified English nameCXHS2400043 | Bo Zhi Yan Xin Tai Zhou Drug Technology Co., Ltd. romanized |
| 2024/05/15New drug · Class 2.2 | BCM347口溶膜 · No verified English nameCXHS2400042 | Bo Zhi Yan Xin Tai Zhou Drug Technology Co., Ltd. romanized |
| 2024/05/14Import · Class 3.1 | 本瑞利珠单抗注射液 · No verified English nameJXSS2400041 | AstraZeneca AB; Name not romanized |
| 2024/05/14Generic · Class 3 | Phenylephrine Hydrochloride InjectionCYHS2401460 | Zhejiang Bo Xiao Biopharmaceutical Co., Ltd. romanized |
| 2024/05/14Generic · Class 3 | Metoclopramide Hydrochloride InjectionCYHS2401459 | Jiangsu Bao Dong Pharmaceuticals Technology Co., Ltd. romanized; Jiangsu Yue Xing Pharma Co., Ltd. romanized |
| 2024/05/14Generic · Class 3 | Famotidine InjectionCYHS2401455 | Hainan Wei Jian Pharma Co., Ltd. romanized; Shandong Fang Ming Pharma Group Co., Ltd. romanized |
| 2024/05/14Generic · Class 3 | Phenylephrine Hydrochloride InjectionCYHS2401452 | Yunnan Long Hai Tian Ran Zhi Wu Pharma Co., Ltd. romanized |
| 2024/05/14Generic · Class 3 | Desonide CreamCYHS2401451 | Hainan Quan Ying Pharma Co., Ltd. romanized; Su Zhou Yi Fan Pharma Co., Ltd. romanized |
| 2024/05/14Generic · Class 3 | Cycloserine CapsulesCYHS2401450 | Hebei Long Hai Pharma Co., Ltd. romanized |
| 2024/05/14Generic · Class 3 | 山梨醇甘露醇冲洗剂 · No verified English nameCYHS2401447 | Hainan Ai Ke Pharmaceutical Co., Ltd. romanized |
| 2024/05/14Generic · Class 3 | 复方聚乙二醇(3350)电解质散 · No verified English nameCYHS2401444 | Chongqing Xi Er An Pharma Co., Ltd. romanized |
| 2024/05/14Generic · Class 3 | Arformoterol Tartrate Inhalation SolutionCYHL2400094 | Hainan Huluwa Pharmaceutical Group Co., Ltd. |
| 2024/05/14Generic · Class 3 | 右美沙芬安非他酮缓释片 · No verified English nameCYHL2400093 | CSPC OUYI PHARMACEUTICAL CO., LTD. |
| 2024/05/14New drug · Class 1 | SCT650C 注射液 · No verified English nameCXSL2400316 | Shen Zhou Xi Bao Gong Cheng Co., Ltd. romanized |
| 2024/05/14New drug · Class 1 | WGc-043 注射液 · No verified English nameCXSL2400315 | Chengdu Wei Si Jin Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/05/14New drug · Class 1 | WGc-043 注射液 · No verified English nameCXSL2400314 | Chengdu Wei Si Jin Biopharmaceuticals Technology Co., Ltd. romanized |
| 2024/05/14New drug · Class 1 | IBI3003 · No verified English nameCXSL2400313 | Xin Da Biopharmaceutical (Suzhou) Co., Ltd. romanized |
| 2024/05/14New drug · Class 1 | 注射用YK012 · No verified English nameCXSL2400312 | Yi Ke Si Te (Beijing) Pharmaceuticals Technology Development Co., Ltd. romanized |
| 2024/05/14New drug · Class 1.3 | 重组带状疱疹疫苗(CHO细胞) · No verified English nameCXSL2400311 | Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Nanjing) Co., Ltd. romanized; Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Hangzhou) Co., Ltd. romanized |
| 2024/05/14New drug · Class 1.3 | 重组带状疱疹疫苗(CHO细胞) · No verified English nameCXSL2400310 | Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Nanjing) Co., Ltd. romanized; Yuan Da Sai Wei Xin Sheng Ming Ke Xue (Hangzhou) Co., Ltd. romanized |
| 2024/05/14New drug · Class 1 | 注射用RFUS-250 · No verified English nameCXHL2400491 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2024/05/14New drug · Class 1 | 注射用RFUS-250 · No verified English nameCXHL2400490 | Yi Chang Ren Fu Pharma Co., Ltd. romanized |
| 2024/05/14New drug · Class 1 | HSK39004吸入混悬液 · No verified English nameCXHL2400489 | Xizang Hai Si Ke Pharmaceutical Co., Ltd. romanized |
128 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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